[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Zimbabwe\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":727},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,29,0,25,[9,42,76,108,130,152,175,196,221,269,290,322,352,382,407,433,456,476,502,526,553,591,615,646,699],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100555869","phase-1-safety-and-pharmacokinetics-study-of-pgt121414ls-alone-and-in-combination-with-vrc07-523ls-in-infants-exposed-to-hiv-1-100555869",false,"NCT06517693","Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1","Open-Label, Phase I Study of the Safety and Pharmacokinetics of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1","Inclusion Criteria:\n\n* Birthing parent is of legal age or circumstance to provide independent informed consent and is willing and able to provide written informed consent for themselves and permission for their infant's participation in this study.\n* Birthing parent has confirmed HIV-1 infection based on positive test results from two samples collected from two separate blood collection tubes.\n* Infant was singleton or twin.\n* Infant's gestational age at birth was at least 36 weeks.\n* At birth, infant's weight was at least 2 kg.\n* At entry, infant is less than 72 hours of age and is anticipated to receive study product within 72 hours after birth.\n* At screening, infant has the following laboratory test results:\n\n  * Hemoglobin, normal or grade 1 (≥13 g\u002FdL or ≥8.05 mmol\u002FL)\n  * Platelets, normal or grade 1 (≥100,000 cells\u002Fmm3 or ≥100.000 x10\\^9 cells\u002FL)\n  * Absolute neutrophil count (ANC), normal or grade 1\n\n    1. ≤24 hours old (≥4,000 cells\u002Fmm3 or ≥4.000 x10\\^9 cells\u002FL)\n    2. \\>24 hours old (≥1,250 cells\u002Fmm3 or ≥1.250 x10\\^9 cells\u002FL)\n  * Alanine transaminase (ALT), normal (\\\u003C1.25 x ULN)\n* At entry, infant is generally healthy as determined by the site investigator based on review of all available medical history information and physical examination findings.\n* Cohorts 1 and 2, Strata BF only: At entry, infant is breastfeeding or the birthing parent has indicated an intention to initiate breastfeeding.\n* Cohorts 1 and 2, Strata FF, only: At entry, infant is not breastfeeding and the birthing parent has indicated no intention to breastfeed.\n* At entry, infant is at increased risk of HIV acquisition.\n\nCohorts 1 and 2, Strata FF only:\n\n* Birthing parent had acute HIV during this pregnancy; or\n* Birthing parent with detectable viral replication (plasma HIV RNA results at least 50 copies\u002FmL) during pregnancy who did not have confirmed viral suppression, defined as at least two consecutive plasma HIV RNA results less than 50 copies\u002FmL from specimens obtained at least four weeks apart with the latest result within four weeks prior to delivery; or\n* Birthing parent not receiving appropriate ART for at least two weeks, with any part of the two-week period occurring within four weeks prior to delivery, based on birthing parent's report or available medical records.\n\nCohorts 1 and 2, BF only:\n\n* Per birthing parent's report, intends to breastfeed\n\nExclusion Criteria:\n\n* Birthing parent has received any investigational product during this pregnancy.\n* Infant has received any active or passive HIV immunotherapy or any investigational product.\n* At entry, infant with a documented positive HIV Nucleic Acid Test (NAT) result.\n* Birthing parent or infant has any condition that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.",true,"ALL","72 Hours",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS soon after birth in infants exposed to HIV-1.",[28],"HIV-1","RECRUITING","2026-08-24",{"date":32,"type":33},"2026-08-25","ACTUAL",{"date":35,"type":33},"2026-01-05",{"date":37,"type":22},"2028-06-30",{"name":39,"class":40},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",17,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100638010","clinic-vs-cliniccommunity-outreach-hpv-self-collection-to-increase-cervical-screening-in-women-living-with-hiv-100638010","NCT07624123","Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women Living With HIV","Comparison of Clinic-based Versus Clinic-plus Community Outreach-based Strategy Via HPV Self-Collection to Increase Uptake of Cervical Cancer Screening Among Women Living With HIV: a Cluster Randomized Trial (CASCADE-3001-B)","C-3001B-P-CS7","Clinic Inclusion Criteria\n\n* Clinics selected for inclusion will include those clinics that provide Human Immunodeficiency Virus (HIV) care and distribute antiretroviral therapy (ART) to Women living with Human Immunodeficiency Virus (WLWH.\n* These clinics should also have the ability to collect their own data.\n* Such clinics could be supported by national programs and bilateral donor-funded initiatives\n\nInclusion Criteria for Medical Record Abstraction\n\n* Are living with Human Immunodeficiency Virus (HIV)\n* Are 25-49 years of age, or as recommended by the Zimbabwe National Screening Guidelines\n* Live in the catchment areas of or attend a study-eligible clinic\n* Are eligible for Human Papillomavirus (HPV)-based cervicovaginal testing either because:\n* They have never undergone cervical cancer screening before, or\n* They have never undergone HPV-based testing before and are now due for Visual Inspection with Acetic Acid and Cervicography (VIAC), per national guidelines, or\n* They have previously undergone HPV-based testing, and are now due for follow-up HPV-based testing per national guidelines, and \u002For\n* They underwent ablative or excisional treatment for presumed or confirmed cervical dysplasia \\>1 year ago and have not had any follow-up cervical cancer screening since treatment.\n\nExclusion Criteria for Medical Record Abstraction\n\n* Have had their cervix removed\n* Are pregnant or \\\u003C6 weeks post-delivery\n* Were positive on their most recent cervical cancer screening test and referred for further evaluation or treatment, but did not complete their referral\n* Have previously been treated for invasive cervical cancer","FEMALE","25 Years","49 Years",{"count":54,"type":22},17734,[56],"NA","This Clinical Trials Network for Human Immunodeficiency Virus (HIV)-Associated Cervical Cancer Screening and Treatment Optimization (CASCADE)-3001-B trial aims to assess how the introduction of a community-health-worker-facilitated model, in addition to the existing static clinic-only model, influences the rates of cervical cancer screening uptake among women living with HIV (WLWH). This study involves offering human papillomavirus (HPV) self-collection for cervical cancer screening to eligible WLWH.\n\nThe 'CASCADE' Network is a clinical trials network aimed at improving cervical cancer screening, management, and pre-cancer treatment for WLWH, in various healthcare settings. The network will conduct implementation trials to improve the triage of HPV-positive WLWH, as well as algorithms to optimize access to and options for effective treatment. Trials will be conducted using a mixed-methods approach aimed at assessing implementation strategies and outcomes and their potential to integrate into existing health systems.\n\nFurther understanding of HPV-based community-based strategies to reach WLWH, and the acceptability, feasibility, appropriateness, and cost of these strategies will be valuable for cervical cancer screening programs serving WLWH. Inputs from various 'CASCADE' Clinical Sites (CS) regarding feasible screening outreach options available in their settings for WLWH have guided this study that focuses on evaluating a pragmatic HPV self-collection implementation model to improve access to screening.\n\nWhile it is clear that HPV self-collection is a highly acceptable and feasible screening option, creating opportunities to conduct self-collection in alternative venues outside the clinic premises, and with the guidance of and facilitation by trusted community healthcare workers (CHWs) is an important implementation strategy that needs to be evaluated and considered for its potential benefit. Studies have not yet evaluated a community-based approach for HPV self-collection kit distribution among WLWH - who may have different characteristics, preferences, and access to screening services than women not living with HIV. Providing WLWH with the option of receiving HPV self-collection kits in their own homes or other community-based settings ('community-based HPV self-collection') is a novel implementation strategy that could improve cervical cancer screening rates among eligible women. Therefore, this novel trial aims to evaluate the feasibility and effectiveness of implementing community-based HPV self-collection among WLWH.",[59,60,61],"Cervix Cancer","HIV Infections","HPV Infection",[63,64],"self-collection","screening","NOT_YET_RECRUITING","2026-08-20",{"date":30,"type":33},{"date":69,"type":22},"2026-08",{"date":71,"type":22},"2028-03",{"name":73,"class":74},"UNC Lineberger Comprehensive Cancer Center","OTHER",1,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":5},"100641915","phase-2-a-trial-of-stratified-patient-centered-treatment-regimens-for-active-tb-spectra-tb-100641915","NCT07595042","A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)","A Phase 2C Trial of Stratified Patient-Centered Treatment Regimens for Active TB","Inclusion Criteria:\n\n* Has pulmonary tuberculosis (TB) that is likely to respond to standard TB medicines (drug-susceptible TB), based on sputum testing done within 7 days before entering the study. The test must show Mycobacterium tuberculosis is present, with no rifamycin resistance detected and no known resistance to isoniazid or fluoroquinolones.\n* Has a SPECTRA-TB risk score and risk group assigned during screening using the study-specific calculator.\n* Has a Karnofsky performance score of 50 or higher within 30 days before entering the study.\n* Has documented HIV-1 status (either with HIV or without HIV) based on acceptable testing.\n* If living with HIV, has a CD4+ cell count of at least 50 cells\u002Fmm3 within 60 days before study entry.\n* If living with HIV, is currently receiving or plans to start an efavirenz-based or dolutegravir-based antiretroviral therapy regimen by study week 8.\n* Has laboratory test results within 7 days before study entry that meet all of the following:\n\n  * alanine aminotransferase (ALT) no more than 3 times the upper limit of normal\n  * total bilirubin no more than 2.5 times the upper limit of normal\n  * creatinine no more than 2 times the upper limit of normal\n  * potassium between 3.5 and 5.5 mEq\u002FL\n  * absolute neutrophil count at least 1000\u002Fmm3\n  * hemoglobin at least 7.0 g\u002FdL\n  * platelet count at least 100,000\u002Fmm3\n* If able to become pregnant, has a negative blood or urine pregnancy test within 7 days before study entry.\n* If able to become pregnant and sexually active in a way that could lead to pregnancy, agrees not to try to become pregnant and agrees to use at least 1 reliable non-hormonal birth control method during study treatment and for 30 days after stopping study drugs. Acceptable methods include:\n\n  * condoms\n  * intrauterine device (IUD) or intrauterine system (IUS)\n  * cervical cap with spermicide\n  * diaphragm with spermicide\n* If not able to become pregnant, has a history or documentation of menopause, hysterectomy, bilateral removal of the ovaries, or bilateral tubal ligation.\n* Has a verifiable address or place of residence and is willing to tell the study team about any change of address during treatment and follow-up.\n* Is willing and able to give informed consent, or assent with permission from a parent or legal guardian if required.\n\nExclusion Criteria:\n\n* TB bacteria are known to be resistant to 1 or more of the following medicines: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.\n* Received more than 5 days of treatment for active TB within the 24 weeks before study entry.\n* Received more than 5 days of treatment within the 30 days before study entry with certain TB medicines or related antibiotics, including isoniazid, rifampin, rifapentine, ethambutol, moxifloxacin, pyrazinamide, aminoglycosides, fluoroquinolones, linezolid, bedaquiline, pretomanid, and other specified anti-TB drugs.\n* Has suspected or confirmed TB involving the brain or central nervous system, bones, joints, heart lining (pericardium), or miliary TB.\n* Has a past history of suspected or confirmed drug-resistant TB of any type.\n* Is currently pregnant or breastfeeding.\n* Cannot take medicines by mouth.\n* Has an HIV\u002FAIDS-related opportunistic infection at study entry.\n* Has acute or chronic hepatitis B, unless the hepatitis B infection has cleared.\n* Has acute or chronic hepatitis C, unless the hepatitis C infection has cleared or has been successfully treated.\n* Has alcohol-related liver disease.\n* Has liver cirrhosis.\n* Has a history of aortic aneurysm or aortic dissection.\n* Has a known history of long QT syndrome, a first-degree relative with long QT syndrome, or a screening ECG showing QTcF greater than 470 ms that does not correct with treatment of contributing factors.\n* Is taking other medicines that can prolong the QT interval and cannot safely switch to an alternative medicine.\n* Has a known history of acute intermittent porphyria.\n* Weighs less than 30 kg.\n* Is currently using, or is expected to need within 24 weeks after enrollment, 1 or more medicines that are not allowed during the study.\n* Has a known allergy, sensitivity, or hypersensitivity to any of the study drugs or their ingredients.\n* Has active drug or alcohol use, dependence, mental illness, or another serious infection that, in the opinion of the site investigator, could make it hard to follow the study requirements.\n* Is currently taking part in another interventional clinical trial.","13 Years",{"count":85,"type":22},900,[87],"PHASE2","The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome. Participants will be assigned to lower-risk or higher-risk groups using baseline characteristics and then randomized within each group to receive either standard TB treatment or an investigational rifapentine- and moxifloxacin-containing regimen. The study will evaluate whether shorter treatment durations may be used in lower-risk participants and whether the investigational regimen may improve outcomes in higher-risk participants. Safety and tolerability will also be evaluated.",[90],"Tuberculosis",[90,92,93,94,95,96,97,98,99],"Pulmonary tuberculosis","Drug-susceptible tuberculosis","Rifampin-susceptible tuberculosis","Rifapentine","Moxifloxacin","HIV coinfection","Treatment shortening","Risk-stratified treatment","2026-08-17",{"date":102,"type":33},"2026-08-19",{"date":104,"type":22},"2026-10-30",{"date":106,"type":22},"2029-10-22",{"name":39,"class":40},{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":83,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100602518","phase-1-a-study-of-daily-rifapentine-combined-with-isoniazid-1hp-for-tuberculosis-prevention-in-children-less-than-13-years-of-age-with-and-without-hiv-100602518","NCT07124559","A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV","Phase I\u002FII Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV","Inclusion Criteria:\n\n1. A parent or legal guardian must be willing and able to give written permission for the child to participate in the study. If required by local policies, the child must also be willing and able to give written assent to participate. All sites must follow local policies and procedures.\n2. Age requirements at entry:\n\n   * Cohort 1: Children under 13 years old.\n   * Cohort 2: Children aged 12 weeks to under 13 years old.\n3. For Cohort 1 participants under 28 days old: The child must have been born at or after 37 weeks of pregnancy, as determined by the site investigator using parent\u002Fguardian report or medical records.\n4. Weight requirements at entry:\n\n   * Cohort 1: 3 kg to under 45 kg.\n   * Cohort 2: 6 kg to under 45 kg.\n5. HIV status:\n\n   * Cohort 1: Must be living without HIV.\n   * Cohort 2: Must be living with HIV.\n6. At risk of TB disease, defined as meeting at least one of the following:\n\n   * Having close contact with someone with infectious pulmonary TB within the past six months.\n   * A positive tuberculin skin test (TST) or, for those over two years old, a positive interferon gamma release assay (IGRA) if TST is not available.\n   * For Cohort 2 only: Living in a high TB burden area (≥ 60 TB cases per 100,000 people per year).\n7. Normal or mild (grade 1 or 2) test results for the following at screening (within 21 days before entry):\n\n   * ALT (liver enzyme)\n   * Estimated glomerular filtration rate (kidney function)\n   * Absolute neutrophil count (white blood cells)\n   * Hemoglobin (red blood cells)\n8. For Cohort 2 participants:\n\n   * Must have been on antiretroviral therapy (ART) for at least 12 weeks before entry.\n   * Must have been on a specific ART regimen (once-daily DTG and two NRTIs) for at least 14 days before entry.\n   * Must have used the same formulation of DTG (tablet or dispersible tablet) for at least three days before entry.\n   * Must agree to continue the same formulation of DTG for the study duration.\n   * Must have an HIV-1 RNA level below 200 copies\u002FmL at screening.\n9. Must intend to stay in the same area for the study duration.\n10. Must have access to at least one meal per day during the 28-day treatment period.\n\nExclusion Criteria:\n\n1. The child has active TB, confirmed by medical records, parent\u002Fguardian report, or tests during screening, indicated by:\n\n   * Currently being treated for active TB.\n   * Symptoms like poor growth, poor weight gain, weight loss, cough for at least 11 days, or fever for at least eight days.\n   * X-ray or CT scan showing TB.\n   * Positive TB test results (e.g., culture, Xpert MTB\u002FRIF Ultra, Truenat M.tb, other nucleic acid tests, urine tests).\n2. The child has been exposed to an adult with drug-resistant TB (resistant to Rifampicin or Isoniazid) within the past six months.\n3. The child has taken the following medications:\n\n   * Daily Isoniazid in the 28 days before entry.\n   * Any prohibited medications listed in the study within three days before entry.\n4. The child has any of the following conditions:\n\n   * Acute or chronic hepatitis.\n   * Allergy to Isoniazid or rifamycins.\n   * Porphyria.\n   * Severe peripheral neuropathy.\n5. The child has severe acute malnutrition (weight-for-height\u002Flength less than -3 z-scores of WHO standards). Note: Children who are stunted (height-for-age more than two standard deviations below WHO standards) are eligible.\n6. For Cohort 2: The child has an active AIDS-defining opportunistic infection.\n7. The child has started menstruation.\n8. The child has taken NVP, EFV, lopinavir\u002Fritonavir, and\u002For raltegravir within 14 days before entry.\n9. The child has received long-term immunosuppressive therapy (more than eight days) within 30 days before entry. Note: Short courses of steroids (seven days or less) may be allowed with approval.\n10. The child is a result of a multiple birth (e.g., twins, triplets).\n11. The child has any other significant medical condition that would make participation unsafe, complicate data interpretation, or interfere with study objectives, as determined by the site investigator.",{"count":116,"type":22},144,[25,87],"This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB). The study will take place at multiple locations and children under 13 years old will be divided into two groups: one group will include children without HIV, and the other group will include children with HIV who are on antiretroviral treatment. Up to 144 children will participate, and participants in each group will be followed for 24 weeks.",[90],[121,90,122],"HIV","Latent Tuberculosis",{"date":102,"type":33},{"date":125,"type":22},"2026-10-15",{"date":127,"type":22},"2028-05-31",{"name":39,"class":40},11,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":18,"minAge":138,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":5},"100530851","phase-2-trial-of-novel-regimens-for-the-treatment-of-pulmonary-tuberculosis-100530851","NCT06192160","Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis","A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis","RAD-TB","Inclusion Criteria:\n\n1. Pulmonary TB (among individuals either without history of prior TB treatment or with history of TB treatment completed more than 2 years prior to study entry), identified within 7 days prior to study entry by at least one sputum specimen positive for Mtb by Xpert. Semiquantitative Mtb results of \"medium\" or \"high\" from Xpert MTB\u002FRIF Ultra are required.\n2. Pulmonary TB with documented INH susceptibility (by Line Probe Assay (LPA) or Xpert MTB\u002FXDR or other validated molecular test) and with documented RIF susceptibility (by LPA or Xpert MTB\u002FRIF or Xpert MTB\u002FRIF Ultra or other validated molecular test) within 7 days prior to study entry.\n3. Documentation of HIV-1 infection status, as below:\n\n   Presence or absence of HIV-1 infection, as documented by:\n   * Any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit, any time prior to study entry. AND for a positive result confirmation by one of the following:\n   * A second antibody test from different manufacturers or based on different principles and epitopes (combination antigen-antibody-based rapid tests may be used), or\n   * HIV-1 antigen, or\n   * Plasma HIV-1 RNA viral load, or\n   * A licensed Western blot\n4. For individuals with HIV: CD4+ cell count ≥100 cells\u002Fmm3 based on testing performed within 30 days prior to study entry.\n5. For individuals with HIV: Currently being treated with dolutegravir-based antiretroviral therapy (ART), or plan to initiate dolutegravir-based ART at or before study week 8.\n6. Individuals age ≥18 years.\n7. The following laboratory values obtained within 7 days prior to study entry at any network-approved non-U.S. laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs:\n\n   * Serum or plasma alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)\n   * Serum or plasma total bilirubin ≤2 times ULN\n   * Serum or plasma creatinine ≤2 times ULN\n   * Serum or plasma potassium ≥3.5 mEq\u002FL\n   * Serum or plasma magnesium ≥1.0 mEq\u002FL (≥0.500 mmol\u002FL)\n   * Absolute neutrophil count (ANC) ≥1500\u002Fmm\\^3\n   * Hemoglobin ≥9.0 g\u002FdL\n   * Platelet count ≥100,000\u002Fmm\\^3\n   * Negative for, hepatitis B surface antigen (HBsAg)\n   * Negative for hepatitis C virus (HCV) antibody (or if HCV antibody positive, must have a negative HCV PCR)\n8. For female study candidates who are of reproductive potential, negative pregnancy test (urine HCG or serum β-HCG) within 3 days (72 hours) prior to entry by any network-approved non-U.S. laboratory or clinic that operates in accordance with GCLP and participates in appropriate external quality assurance programs.\n\n   Females who are of reproductive potential and who participate in sexual activity that could lead to pregnancy must agree to use at least two of the following forms of birth control while receiving TB study medications and for 12 months after stopping study medications:\n   * Male or female condoms\n   * Diaphragm or cervical cap (with spermicide, if available)\n   * Intrauterine device (IUD) or intrauterine system (IUS)\n   * Hormone-based birth control (e.g., oral contraceptives, Depo-Provera, NuvaRing, implants)\n\n   Female study candidates who are of reproductive potential, but who abstain from sexual activity that could lead to pregnancy require no additional contraception.\n\n   Female study candidates who are not of reproductive potential are eligible without requiring the use of contraceptives. Self-reported history is acceptable documentation of menopause (i.e., at least 1 year amenorrheic), hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; these candidates are all considered not of reproductive potential.\n9. For male study candidates who engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives while the individual is on study and for 90 days after experimental treatment discontinuation.\n\n   For male study candidates who have undergone successful vasectomy with documented azoospermia or have documented azoospermia for any other reason, are eligible without requiring the use of contraceptives.\n10. For male study candidates with pregnant partners, willingness to use condoms during vaginal intercourse while on study and for 90 days after experimental treatment discontinuation.\n11. For male study candidates, willingness to refrain from sperm donation while on study and for 90 days after experimental treatment discontinuation.\n12. Documentation of Karnofsky performance score ≥60 obtained within 14 days prior to study entry.\n13. Chest x-ray obtained within 14 days prior to study entry.\n14. A verifiable address or residence readily accessible for visiting, and willingness to inform the study team of any change of address during study treatment and follow-up period.\n15. Ability and willingness of individual to provide informed consent.\n\nExclusion Criteria:\n\n1. More than cumulative 7 days of treatment directed against active TB for the current TB episode in the 60 days preceding study entry.\n2. Current extrapulmonary TB, in the opinion of the investigator.\n3. QTcF interval \\>450 ms within 7 days prior to study entry.\n4. History of or ongoing heart failure.\n5. Personal or family history of congenital QT prolongation.\n6. History of known, untreated, ongoing hypothyroidism.\n7. History of or ongoing bradyarrhythmia.\n8. History of torsades de pointes.\n9. Current Grade 2 or higher peripheral neuropathy.\n10. Other medical conditions (e.g., diabetes, liver or kidney disease, blood disorders, chronic diarrhea), in the opinion of the site investigator, in which the current clinical condition of the participant is likely to prejudice the response to, or assessment of, treatment.\n11. Pregnant or breastfeeding or planning to become pregnant within the next 12 months.\n12. Weight \\\u003C35 kg.\n13. Unable to take oral medications.\n14. Taking any of prohibited medications.\n15. Known allergy\u002Fsensitivity or any hypersensitivity to components of investigational agents or their formulation.\n16. Active drug or alcohol use or dependence; or mental illness (e.g., major depression) that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n17. Taking an investigational drug or vaccine within 30 or more days prior to study entry.","18 Years",{"count":140,"type":22},315,[87],"A5409\u002FRAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB).\n\nA5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care \\[(SOC) isoniazid\u002Frifampicin\u002Fpyrazinamide\u002Fethambutol (HRZE)\\].\n\nThe study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of study treatment (experimental or SOC, based on treatment arm assignment) followed by 18 weeks of SOC continuation phase treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.",[144],"Pulmonary Tuberculosis",{"date":146,"type":33},"2026-08-18",{"date":148,"type":33},"2025-03-11",{"date":150,"type":22},"2027-08-11",{"name":39,"class":40},{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"100219916","phase-1-very-early-intensive-treatment-of-infants-living-with-hiv-to-achieve-hiv-remission-100219916","NCT02140255","Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission","Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I\u002FII Proof of Concept Study","Maternal Inclusion Criteria\n\n1. Presumed or confirmed maternal HIV infection:\n\n   * Mothers will be eligible to enroll with EITHER:\n\n     * Presumed HIV infection defined as at least one positive rapid HIV antibody-based test result from a sample collected in the peripartum period. Presumed infection must be confirmed within 10 business days of enrollment OR\n     * Confirmed HIV infection defined as positive results from two samples collected at different timepoints\n2. Willing and able to provide written informed consent for participation of herself and her infant. The mother must be of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with IRB\u002FEC policies and procedures. Otherwise, informed consent must be obtained from a legal guardian and the mother must provide written assent.\n3. Was not previously enrolled in this study with another infant.\n4. Did not receive ARVs during the current pregnancy.\n5. Infant is eligible per inclusion criteria.\n\nInfant Inclusion Criteria for Step 1\n\n1. Less than or equal to 48 hours of age.\n2. Greater than or equal to 37 weeks gestational age at birth (assessment of gestational age will be based on the best clinical estimate determined by date of last menstrual period, antenatal ultrasound, fundal height, or Ballard Score).\n3. Greater than or equal to 2 kilograms (kg) at birth.\n4. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.\n5. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation.\n6. Mother is eligible per inclusion criteria.\n\nInfant Inclusion Criteria for Step 2\n\n1. Enrolled in Step 1.\n2. Confirmed in utero HIV infection.\n3. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.\n4. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation.\n5. Mother (or legal guardian if applicable) is willing and able to provide written informed consent for child's participation in Step 2.\n\nInfant Inclusion Criteria for Step 3\n\n1. Enrolled in Step 2.\n2. Has reached Step 2 Week 96.\n3. Has the following results based on testing:\n\n   * No confirmed plasma HIV RNA ≥200 copies\u002FmL at Step 2 Week 24 and up to but excluding Step 2 Week 48.\n   * No plasma HIV RNA detected at Step 2 Week 48 and thereafter, with two possible exceptions\n\n     * (i) First possible exception: If HIV RNA is detected at or after Step 2 Week 48 with a result \\\u003C200 copies\u002FmL, testing will be repeated within three weeks (specimen collection for the confirmatory test must occur within three weeks of specimen collection for the initial test).\n     * If no HIV RNA is detected on the confirmatory test, or if HIV RNA is detected with a result \\\u003C200 copies\u002FmL, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2, provided no HIV RNA is detected on any subsequent tests in Step 2.\n     * If HIV RNA is detected on the confirmatory test with a result ≥200 copies\u002FmL, the infant will not be eligible for Step 3.\n     * (ii) Second possible exception: If HIV RNA is detected after Step 2 Week 48 with a result \\\u003CLOD, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2 with no RNA detected. There is no limit on the number of times HIV RNA may be detected with a result \\\u003CLOD after Week 48. However, infants with detectable RNA with a result \\\u003CLOD after Week 48 will not be considered for entry into Step 3 until after an additional 48 weeks of no RNA detected.\n     * Participants may experience either or both exceptions at different timepoints during follow-up in Step 2.\n4. If breastfed, must have permanently ceased breastfeeding, with no exposure to breast milk for at least six weeks prior to specimen collection for the testing specified in the criterion (#5) below.\n5. Has met ALL of the following additional criteria while in Step 2, based on testing between Step 2 Week 84 and Step 2 Week 192 (inclusive):\n\n   * Two consecutive negative HIV antibody tests by fourth generation ELISA at least eight weeks apart.\n   * Two consecutive HIV DNA tests with no DNA detected in at least 850,000 PBMCs assayed at least eight weeks apart.\n   * CD4 cell percentage greater than or equal to 25% and CD4 cell absolute count greater than or equal to the lower limit of normal for age (≥1000 cells\u002FmL if 2 to less than 3 years of age; ≥750 cells\u002FmL if 3 to less than 5 years of age; ≥500 cells\u002FmL if 5 years of age or older).\n   * Infant assessed by the site investigator or designee as expected to adhere to the Step 3 Schedule of Evaluations.\n   * Mother (or legal guardian if applicable) willing and able to provide written informed consent for child's participation in Step 3 and Step 4.\n6. No plasma HIV RNA detected by testing after criteria have been confirmed, with specimen collection for the assay within 14 days prior to Step 3 Entry.\n\nInfant Inclusion Criteria for Step 4\n\n1. Enrolled in Step 3.\n2. Has met at least one of the following:\n\n   * Plasma HIV RNA ≥LOD based on two assays.\n   * Plasma HIV RNA ≥1000 copies\u002FmL in the presence of fever or other sign or symptom of acute retroviral syndrome.\n   * Confirmed or suspected diagnosis of acute retroviral syndrome.\n   * Confirmed or suspected diagnosis of a new WHO Clinical Stage 3 or 4 condition.\n   * Confirmed CD4 cell percentage less than 25% and CD4 cell absolute count less than the lower limit of normal for age (\\\u003C1000 cells\u002FmL if 2 to less than 3 years of age; \\\u003C750 cells\u002FmL if 3 to less than 5 years of age; \\\u003C500 cells\u002FmL if 5 years of age or older).\n   * Otherwise assessed by the site investigator or designee, in consultation with the Clinical Management Committee (CMC), as having an indication to re-initiate treatment.","48 Hours",{"count":161,"type":22},1120,[25,87],"The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.",[165],"HIV Infection",[167],"HIV Remission",{"date":102,"type":33},{"date":170,"type":33},"2015-01-23",{"date":172,"type":22},"2031-12-31",{"name":39,"class":40},46,{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":18,"minAge":138,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":23,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},"100636695","phase-1-a-trial-to-evaluate-the-safety-and-tolerability-of-dv700p-rna-and-dv701b11-rna-immunization-in-combination-with-antiretroviral-analytical-treatment-interruption-ati-in-people-living-with-hiv-for-elicitation-of-v3-glycan-antibodies-100636695","NCT07569029","A Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in Combination With Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of V3-glycan Antibodies","A Nonrandomized Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in Combination With Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of V3-glycan Antibodies","Inclusion Criteria:\n\n* Able and willing to provide informed consent.\n* Age 18 to 60 years.\n* Documented HIV infection.\n* Lowest (nadir) CD4+ count between 250 and 450 cells\u002Fmm³.\n* On stable combination antiretroviral therapy (ART) for at least 48 weeks prior to screening.\n* Plasma HIV RNA \\\u003C50 copies\u002FmL for at least 48 weeks prior to enrollment, allowing limited transient increases.\n* CD4+ count \\>450 cells\u002Fmm³ and CD4+ percentage ≥15%.\n* Willing and able to comply with study visits and procedures.\n* Agrees not to participate in another investigational study during participation unless approved.\n* In general good health, with no clinically significant findings on physical exam or laboratory testing.\n* Hemoglobin ≥11.0 g\u002FdL (women) or ≥13.0 g\u002FdL (men).\n* Absolute neutrophil count ≥750\u002Fmm³.\n* Platelet count ≥100,000\u002Fmm³.\n* ALT \\\u003C2.5 × upper limit of normal.\n* Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73 m².\n* Serum creatinine ≤1.1 × upper limit of normal.\n* Serum calcium \\>8.5 mg\u002FdL.\n* Blood pressure within acceptable limits.\n* Agrees to use condoms during the specified period when ART is interrupted until HIV RNA is undetectable.\n* No evidence of active hepatitis C infection.\n* No evidence of active hepatitis B infection.\n* For individuals of pregnancy potential: negative pregnancy test prior to enrollment and agreement to use effective contraception during the required study period.\n* Agreement not to seek pregnancy during the required study period.\n\nExclusion Criteria:\n\n* Current use of ART that includes non-nucleoside reverse transcriptase inhibitors (NNRTIs).\n* Use of long-acting ART within 3 months prior to enrollment.\n* Known resistance to any component of the current ART regimen (excluding M184V\u002FI mutation).\n* Resistance to one or more drugs in two or more ART classes (excluding M184V\u002FI mutation).\n* Initiation of ART during acute HIV infection (within 1 year of HIV acquisition, if known).\n* History of advanced HIV-related illness (CDC Category C), except recurrent pneumonia, within 10 years prior to screening, or history of CD4 count \\\u003C200 cells\u002Fmm³ within the past 10 years.\n* History of severe HIV-related conditions, including opportunistic infections, HIV-associated cancers, lymphoma, neurocognitive disease, or progressive multifocal leukoencephalopathy.\n* Active or recent non-HIV-related cancer requiring systemic treatment within 36 months or expected need for treatment within 12 months (excluding minor skin cancers).\n* Active hepatitis B or hepatitis C infection.\n* Significant liver disease, including cirrhosis or advanced fatty liver disease.\n* Untreated or incompletely treated active or latent tuberculosis.\n* Pregnancy or breastfeeding.\n* Body mass index (BMI) ≥40 kg\u002Fm², unless approved.\n* Diabetes mellitus, except well-controlled type 2 diabetes as allowed.\n* History of or current atherosclerotic cardiovascular disease, including heart attack, angina, stroke, or peripheral arterial disease.\n* Previous receipt of an investigational HIV vaccine (prior placebo recipients allowed).\n* Receipt of a non-HIV investigational vaccine within 1 year, unless approved or licensed.\n* Conditions causing impaired immune function or use of immunosuppressive medications within the specified timeframe.\n* Prior receipt of anti-HIV monoclonal antibody therapy.\n* Receipt of certain vaccines within restricted timeframes prior to enrollment (including live or mRNA vaccines within 4 weeks).\n* Receipt of other vaccines within 14 days prior to enrollment.\n* History of myocarditis or pericarditis.\n* Recent initiation of allergy immunotherapy within 1 year (unless stable or approved).\n* Recent use of investigational agents within restricted timeframes prior to enrollment.\n* History of severe allergic reaction to mRNA vaccines or polyethylene glycol-containing products.\n* History of angioedema.\n* Idiopathic urticaria within the past year.\n* Chronic urticaria or urticaria within the past year.\n* History of urticaria associated with vaccination.\n* Bleeding disorders or use of systemic anticoagulants.\n* Conditions associated with increased risk of clotting or bleeding.\n* History of seizures within the past 3 years or use of anti-seizure medications within that period.\n* Absence of spleen or impaired splenic function.\n* Active duty or reserve military personnel (U.S.).\n* Any clinically significant medical, psychiatric, or substance use condition that may affect safety or study participation.\n* Uncontrolled or severe asthma.\n* History of immune-mediated medical conditions, except limited stable or resolved conditions as allowed.\n* Allergy to local anesthetics (e.g., lidocaine).\n* Difficulty with venous access that would interfere with study procedures.","60 Years",{"count":184,"type":22},42,[25],"This phase 1 study will evaluate the safety, tolerability, and immune responses of two experimental mRNA HIV vaccines in adults living with HIV who are in overall good health. The study will enroll about 42 participants at multiple study sites. Researchers will assess whether these vaccines can start or strengthen antibody responses against HIV. The study will also evaluate how a closely monitored planned pause in antiretroviral therapy affects these immune responses.",[121],"2026-08-13",{"date":100,"type":33},{"date":191,"type":22},"2026-09-15",{"date":193,"type":22},"2027-08-31",{"name":39,"class":40},19,{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":204,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":220},"100500546","phase-2-a-study-of-propranolol-to-treat-kaposi-sarcoma-100500546","NCT05797662","A Study of Propranolol to Treat Kaposi Sarcoma","A Phase II Study of Propranolol for the Treatment of Kaposi Sarcoma in Children and Adults","Inclusion Criteria:\n\n* Pediatric (\\\u003C 18 years) and adult (≥ 18 years) participants with biopsy-proven and measurable Kaposi Sarcoma (KS) as defined in the KS Manual of Procedures (MOP).\n* No urgent clinical indication for immediate cytotoxic chemotherapy. Participants who have received cytotoxic chemotherapy \\> 4 weeks prior to screening are eligible.\n* KS stage:\n\n  * \\\u003C 18 years:\n\n    * 1A (Mild): disease limited to skin, flat oral mucosal lesions, and\u002For flesh colored subcutaneous nodules, total \\\u003C10 lesions.\n    * 1B (Moderate): having any of the following features, alone or in combination: a total of 10-19 hyperpigmented skin\u002Foral lesions, nodular oral involvement, conjunctival eye involvement, or exophytic mass.\n  * ≥ 18 years:\n\n    * T0: confined to skin and\u002For lymph nodes and\u002For minimal oral lesions.\n    * T1: limited to tumor-associated edema of cutaneous lesions without functional impairment or flat oral lesions.\n* Performance Status:\n\n  * \\\u003C 18 years:\n\n    * Lansky performance status \\> 70%\n  * ≥ 18 years:\n\n    * Easter Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Participants must have adequate organ function, as defined by the following:\n\n  * Bilirubin (direct or total) within normal range, or total bilirubin \\\u003C3.0 mg\u002Fdl for participants with Gilbert syndrome.\n  * Calculated creatinine clearance ≥ 30 mL\u002Fmin for participants ≥ 12 years (see Appendix III); creatinine \\\u003C1.5 Upper Limit Normal (ULN) for participants \\\u003C 12 years.\n  * Hemoglobin \\> 9 g\u002FdL;\n  * Platelets \\> 100 × 109\u002FL;\n  * ANC \\> 1000 cells\u002Fmm3\n* Human Immunodeficiency Virus (HIV) positive participants must be on antiretroviral therapy (ART) that conforms to local standards of care. Participants will have been on ART for at least 12 weeks. Participants will not be excluded based on CD4 count or HIV viral load.\n* HIV positive participants must not show recent improvement on ART that may confound response evaluation:\n\n  * If on ART 12 to 24 weeks, participants must show evidence of KS progression requiring further systemic treatment.\n  * If on ART for \\>24 weeks, must show no evidence of regression in the last eight weeks.\n* HIV-negative participants must not show evidence of improvement in the three months prior to enrollment.\n* No history of asthma or diabetes mellitus (as it is a risk factor for hypoglycemia).\n* No clinically significant cardiovascular disease other than hypertension, which is permitted.\n* No use of beta-adrenergic antagonists for other indications.\n* Not pregnant or planning to become pregnant. Propranolol is United Stats Food and Drug Administration (US FDA) pregnancy category C. At this time, the study team has determined that the unknown risk to a developing fetus is greater than the potential benefit of treatment.\n* Use of effective contraception for women of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months.\n* Women of child bearing potential (WOCBP) must agree to use adequate contraception (oral contraceptive pills, intrauterine device, Nexplanon, Depo-Provera, or permanent sterilization, etc., or another acceptable method as determined by the investigator) prior to study entry, for the duration of study participation.\n* Not breast feeding.\n\nExclusion Criteria:\n\n• Participants who do not fulfill the criteria as listed in Section 3.1 above, are ineligible. Additionally, the presence of any of the following conditions will exclude a participant from study enrollment:\n\n* Children and adolescents with lymph node or visceral disease, woody edema, or ≥ 20 cutaneous lesions.\n* Children and adolescents with heart rate or systolic blood pressure \\\u003C10th percentile for age.\n* Adults with visceral disease or tumor-associated edema causing functional impairment.\n* Shortness of breath, hemoptysis, or moderate\u002Fsevere cough not attributable to causes other than KS.\n* Bleeding from the mouth or rectum not attributable to causes other than KS.\n* Treatment for active and serious infection.\n* Children with severe acute malnutrition based on World Health Organization (WHO) criteria (Mid-upper arm circumference \\\u003C11.5 cm, weight-for height Z-score \\\u003C-3 or presence of symmetrical pitting edema).\n* Given the risk of hypotension and hypoglycemia, participants must take the study drug with food. If needed, the study team will pursue additional funding to support providing supplemental food for participants who experience food insecurity.\n* Patients who experienced hypersensitivity to propranolol during initiation phase of treatment or had previous known allergy to propranolol or allergy to other β-blockers.\n* Patients with a history of uncompensated heart failure; severe sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree.\n* Patients with diagnosed obstructive airway disease such as asthma, chronic obstructive pulmonary disease (COPD), or bronchiolitis.\n* History of diabetes mellitus (as it is a risk factor for hypoglycemia)\n* Patients receiving concurrent treatment with an anticancer therapy. Patients must not have received any anticancer therapies within 30 days prior to receiving the first dose of investigational treatment.\n* Patients with concern for Kaposi Sarcoma herpesvirus (KSHV) inflammatory cytokine syndrome.",{"count":7,"type":22},[87],"A clinical study of propranolol for the treatment of Kaposi Sarcoma in children and adults. This study will be an open-label single armed treatment trial that will test the effectiveness and the safety of treating Kaposi Sarcoma with propranolol.",[207],"Kaposi Sarcoma",[207,209],"Propranolol","2026-08-07",{"date":212,"type":33},"2026-08-11",{"date":214,"type":22},"2026-09",{"date":216,"type":22},"2029-04",{"name":218,"class":219},"AIDS Malignancy Consortium","NETWORK",6,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":18,"minAge":228,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":234,"conditions":235,"keywords":239,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":268},"100535583","phase-3-shortened-regimen-for-drug-susceptible-tb-in-children-100535583","NCT06253715","Shortened Regimen for Drug-susceptible TB in Children","SMILE-TB","Inclusion Criteria:\n\n* Parent or guardian is willing and able to provide written informed consent for potential participant's study participation; in addition, when applicable per Ethics Committee\u002FInstitutional Review Board (EC\u002FIRB) policies and procedures, potential participant is willing and able to provide assent for study participation.\n* At Entry, age of less than 10 years.\n* At Entry, weight 3 kilograms (kg) or greater.\n* At Entry, diagnosed with TB disease, defined as:\n\n  * Pulmonary (including pleural effusion) and\u002For lymph node (extra-thoracic and\u002For intra-thoracic) TB with or without bacteriologic confirmation;\n  * Clinician has decided to treat with standard first-line drug-susceptible TB regimen.\n* Known HIV status or HIV testing in progress based on meeting testing requirements.\n* Has normal, Grade 1 or 2 test results for all of the following done at or within 14 days of Entry (including the most recent):\n\n  * Alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal;\n  * Total bilirubin less than or equal to 2.5 times the upper limit of normal;\n  * Potassium level of 3.0 milliequivalent\u002FL or greater;\n  * Hemoglobin level of 7.0 g\u002FdL or greater;\n  * Platelet count of 100,000\u002Fmm3 or greater;\n  * Estimated glomerular filtration rate (eGFR; bedside Schwartz formula) 60 mL\u002Fmin\u002F1.73m2 or higher.\n* For children living with HIV:\n\n  * On antiretroviral therapy (ART) at Entry: Must be on, or able to be switched to a dolutegravir-based regimen at or prior to Entry;\n  * Not on ART at Entry: Planned initiation of dolutegravir before or at study Week 4.\n* For participants who have reached menarche or who are engaging in sexual activity (self-reported): negative serum or urine pregnancy test within 7 days of Entry.\n* For participants who are engaging in sexual activity that could lead to pregnancy (self-reported): agrees to practice at least one non-hormonal method of contraception or abstain from heterosexual intercourse during study drug treatment and for 30 days after stopping study medications. Non-hormonal methods include:\n\n  * Male or female condoms\n  * Diaphragm or cervical cap (with spermicide, if available)\n  * Non-hormonal intrauterine device (IUD) or intrauterine system (IUS)\n* At Entry, intends to remain in the catchment area of the study site for the duration of study follow-up or willingness to be followed up beyond the catchment area if\u002Fwhen applicable, as determined by the site investigator based on participant\u002Fparent\u002Fguardian report.\n\nExclusion Criteria:\n\n* Presumed or documented extra-pulmonary TB involving the central nervous system and\u002For bones and\u002For joints, and\u002For miliary TB, and\u002For pericardial TB and\u002For TB of the gastrointestinal (GI) tract and\u002For renal TB.\n* Premature infant (born less than 37-weeks gestation) who is less than 3 months of age at Entry.\n* Any known contraindication to taking any study drug:\n\n  * Known allergy or intolerance to any of the study drugs or drugs in the same class as the study drugs;\n  * Any prohibited medications within three days prior to Entry or planned use within the following 6 months;\n  * Unable to take oral medications;\n  * Known history of prolonged QT syndrome not caused by electrolyte derangements.\n* Received more than 10 days of treatment directed against TB disease within 6 months preceding initiation of study drugs.\n* M. tuberculosis isolate known or suspected to be resistant to isoniazid, rifampin, pyrazinamide, ethambutol, and\u002For fluoroquinolones.\n* Known exposure to an infectious adult with drug-resistant TB, including resistance to isoniazid, rifampin, pyrazinamide, ethambutol, and\u002For fluoroquinolones.\n* Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n* Previously enrolled in this study.\n\nLate Exclusions:\n\n* M. tuberculosis cultured or detected through World Health Organization (WHO) approved molecular assays (e.g., Cepheid Xpert MTB\u002FRIF, Xpert XDR, sequencing or Hain MTB-DR plus assays) from sputum, swallowed sputum, nasopharyngeal aspirates, stool, or lymph node aspirate obtained around the time of study entry is determined to be resistant to isoniazid and\u002For rifampin and\u002For pyrazinamide and\u002For ethambutol and\u002For fluoroquinolones.\n* Any child with a clinical TB diagnosis who is found to have a definitive alternative diagnosis for their presenting signs and symptoms whose TB treatment is discontinued prior to completion.","0 Days","9 Years",{"count":231,"type":22},860,[233],"PHASE3","While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.",[90,236,237,238],"Tuberculosis, Pulmonary","Tuberculosis, Lymph Node","Mycobacterium Tuberculosis",[240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258],"tuberculosis","pediatric","stratified medicine","shortened regimen","rifapentine","moxifloxacin","dolutegravir","drug-susceptible","lymph node","pulmonary","infections","TB","mycobacterium infections","respiratory tract infections","lung diseases","antitubercular agents","respiratory tract diseases","child","paediatric","2026-07-22",{"date":261,"type":33},"2026-07-24",{"date":263,"type":33},"2025-01-15",{"date":265,"type":22},"2027-09-30",{"name":267,"class":74},"Johns Hopkins University",9,{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":17,"sex":18,"minAge":138,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":23,"phases":279,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":129},"100623001","phase-1-a-study-of-safety-and-drug-levels-of-epgt121v1-ls-pgdm1400ls-and-vrc07-523ls-in-adult-participants-without-hiv-1-100623001","NCT07390955","A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1","A Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics, and in Vitro Neutralization of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS Administered in Multiple Doses and Routes to Adult Participants Without HIV-1","Inclusion Criteria:\n\n1. Age 18 to 55 years.\n2. Can visit a participating clinic and is willing to stay in the study for its full duration.\n3. Understands the study and is able and willing to give informed consent.\n4. Agrees not to join another experimental study until the final required clinic visit.\n5. In good overall health based on medical history, physical exam, and screening lab tests.\n6. Willing to receive HIV test results.\n7. Willing to discuss personal risk of getting HIV and to have HIV prevention counseling.\n8. Judged by clinic staff to have a low risk of getting HIV and agrees to avoid higher risk behaviors through the last clinic visit.\n9. Hemoglobin levels:\n\n   * Women: at least 11.0 g\u002FdL\n   * Men: at least 13.0 g\u002FdL\n10. White blood cell count between 2,500 and 12,000 cells\u002Fmm³.\n11. White blood cell differential is normal or acceptable to clinic staff.\n12. Platelet count between 125,000 and 550,000 cells\u002Fmm³.\n13. ALT (liver enzyme) less than 1.25 times the lab's upper limit of normal.\n14. Creatinine (kidney test) less than 1.1 times the lab's upper limit of normal.\n15. Negative tests for HIV 1 and HIV 2.\n16. Negative hepatitis B surface antigen.\n17. Negative hepatitis C antibody, or a negative HCV PCR if the antibody test is positive.\n18. Urine protein is negative or only trace.\n19. If a woman who could become pregnant: negative pregnancy test within 72 hours before the first study treatment. Women with a documented total hysterectomy, both ovaries removed, both fallopian tubes removed, or menopause (no periods for at least 1 year) do not need pregnancy testing.\n20. Women who could become pregnant agree to use effective birth control for sex that could lead to pregnancy starting at least 21 days before enrollment and continuing through the last study visit.\n21. Women who could become pregnant also agree not to try to become pregnant using methods like egg retrieval, artificial insemination, or in vitro fertilization starting at least 21 days before enrollment and continuing through the last clinic visit.\n\nExclusion Criteria:\n\n1. Received blood products within 120 days before the first study dose (unless the safety review team approves earlier enrollment).\n2. Took any experimental (investigational) research drug within 30 days before the first study dose.\n3. Weighs less than 35 kg or more than 115 kg.\n4. Plans to join another study using an experimental product, or any study that requires non Network HIV antibody testing, during this study.\n5. Pregnant or breastfeeding.\n6. Previously received an HIV vaccine in a vaccine trial. If a potential participant received placebo\u002Fcontrol only, eligibility will be decided case by case by the safety review team.\n7. Received any non HIV vaccine within 14 days before enrollment or plan to get one within 14 days after enrollment. Exception: ACAM2000 smallpox vaccine within 28 days before enrollment (or scab still present if earlier) or planned within 14 days after enrollment.\n8. Received humanized or human monoclonal antibodies (mAbs), whether approved or experimental.\n9. Previously received monoclonal antibodies that target HIV.\n10. Receiving allergy shots within 30 days before the first study dose or scheduled within 14 days after the first dose.\n11. Took immune suppressing medicines within 30 days before the first study dose. Not excluded: nasal steroid sprays; inhaled steroids (see asthma item); topical steroids for mild skin conditions; or one short course of oral\u002FIV prednisone (less than 20 mg\u002Fday for under 14 days) finished at least 7 days before the first infusion\u002Finjection.\n12. History of serious reactions to components of the study products, including anaphylaxis or symptoms like hives, trouble breathing, swelling (angioedema), or abdominal pain.\n13. Received immunoglobulin within 60 days before the first study dose (separate from mAbs listed above).\n14. Autoimmune disease that is not mild, stable, and uncomplicated. Mild, stable cases not needing immune suppressing drugs may be allowed if the investigator judges low risk.\n15. Immunodeficiency.\n16. Any significant medical issue, abnormal exam or lab result, or past condition that could:\n\n    * Affect the immune system or its response,\n    * Require medicines that affect the immune system,\n    * Make repeated injections, infusions, or blood draws unsafe or not feasible (for example, very difficult veins),\n    * Need active medical care to prevent serious harm during the study,\n    * Have symptoms that could be mistaken for reactions to the study product,\n    * Or is otherwise listed among these exclusions.\n17. Any medical or skin condition, social situation, or job duty that, in the investigator's judgment, would interfere with following the study, safety assessments, or giving informed consent.\n18. A psychiatric condition that prevents following the study. Specifically excluded: psychosis, current suicide risk, or a suicide attempt within the past 3 years.\n19. Currently on tuberculosis treatment.\n20. Asthma that is more than mild and well controlled.\n21. Diabetes (type 1 or type 2). Not excluded: type 2 controlled with diet only, or a past history of gestational diabetes.\n22. High blood pressure (hypertension).\n23. Diagnosed bleeding disorder.\n24. Cancer. Not excluded: surgically removed cancers with good assurance of cure or very low risk of recurrence during the study period.\n25. Seizure disorder with any seizure in the past 3 years, or use of seizure prevention or seizure treatment medicines at any time in the past 3 years.\n26. Asplenia (no functioning spleen).\n27. History of widespread hives, swelling (angioedema), or anaphylaxis. Not excluded if due to a known trigger and there have been no reactions for at least 5 years, showing successful avoidance of the trigger.","55 Years",{"count":278,"type":22},83,[25],"This study is testing a lab-made antibody called ePGT121v1-LS that targets a specific part of HIV. Researchers will give it by vein (IV) and under the skin (SC), both on its own and together with two other antibodies, VRC07-523LS and PGDM1400LS, which target different parts of the virus. They will assess safety and side effects, determine the right dose, study how the body processes the drug (pharmacokinetics or PK), and measure how well it neutralizes HIV in the blood (serum neutralizing activity). The expectation is that ePGT121v1-LS, whether given alone or with PGDM1400LS and VRC07-523LS, by IV or SC, will be safe in generally healthy adults and that the antibodies will not interfere with each other when used together.\n\nApproximately 83 volunteers in overall good health and without HIV-1 will be enrolled into two parts (A and B).\n\nPart A has six groups. In Groups 1-3, participants will get ePGT121v1-LS given by IV at one of three dose levels: 5 mg\u002Fkg, 20 mg\u002Fkg, or 40 mg\u002Fkg. In Groups 4-6, participants will receive three antibodies-first ePGT121v1-LS, then PGDM1400LS and VRC07-523LS-given by IV at two separate visits that are 24 weeks apart. The total study duration for participants in Part A is 48 weeks of scheduled clinic visits.\n\nPart B has two groups. In Group 7, people will get ePGT121v1-LS as SC shots at two visits 12 weeks apart. Each visit will give a total of 375 mg, split into three injections of 125 mg each. In Group 8, people will also have two visits 12 weeks apart and will receive three antibodies as SC shots in this order: first ePGT121v1-LS (125 mg), then PGDM1400LS (100 mg), and then VRC07-523LS (100 mg). The total study duration for participants in Part B is 24 weeks of scheduled clinic visits.",[121],"2026-07-13",{"date":284,"type":33},"2026-07-14",{"date":286,"type":33},"2026-03-19",{"date":288,"type":22},"2027-08-30",{"name":39,"class":40},{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":18,"minAge":138,"maxAge":51,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":300,"briefSummary":301,"conditions":302,"keywords":304,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":75},"100646858","email-delivered-digital-positive-affect-intervention-for-young-adults-in-zimbabwe-100646858","NCT07682779","Email-Delivered Digital Positive Affect Intervention for Young Adults in Zimbabwe","A Brief Email-Delivered Positive Affect Intervention for Young Adults in Zimbabwe: A Feasibility Randomized Controlled Trial","SPARK-Z","Inclusion Criteria\n\nParticipants must meet all of the following criteria:\n\n1. Aged 18-25 years.\n2. Able to understand and read English.\n3. Previously participated in Stage 1 of the study and provided consent to be contacted regarding future research opportunities.\n4. Have access to a device (for example smartphone, tablet, or computer) and internet connectivity for intervention delivery.\n5. Report moderate levels of depression at baseline assessment.\n\nExclusion Criteria\n\nParticipants will be excluded if they:\n\n1. Are at high risk of suicide.\n2. Are currently experiencing a psychotic episode.\n3. Are currently experiencing interpersonal violence.",{"count":299,"type":22},100,[56],"This study evaluates the feasibility, acceptability, and preliminary efficacy of a brief email-delivered positive affect intervention for young adults in Zimbabwe. The study uses a randomised controlled trial design with two parallel arms.\n\nA total of 100 participants aged 18-25 years will be randomly assigned to two arms: an experimental arm receiving an email-delivered positive affect intervention or a control arm receiving psychoeducational materials. The intervention group will receive guided activities twice weekly over three weeks, focusing on identifying, reflecting on, and engaging in positive experiences. The control group will receive general psychoeducational materials on mental health without structured activities.\n\nAssessments will be conducted at baseline and after the intervention. The primary outcome is feasibility( including recruitment, retention, and adherence) and acceptance. Secondary outcomes include changes in positive affect, symptoms of depression and anxiety,self-stigma, and suicidal ideation.",[303],"Depression Symptoms",[305,306,307,308,309,310,311,312],"Positive affect","Intervention","Digital intervention","Young adults","Mental health outcomes","Feasibility","Zimbabwe","Randomized controlled trial","2026-06-26",{"date":315,"type":33},"2026-07-06",{"date":317,"type":22},"2026-07-01",{"date":319,"type":22},"2028-08-01",{"name":321,"class":74},"Vilnius University",{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":17,"sex":50,"minAge":330,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":334,"briefSummary":335,"conditions":336,"keywords":337,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":347,"leadSponsor":349,"locationsCount":351},"100644248","the-comprehensive-adherence-resource-and-empowerment-support-cares-study-100644248","NCT07666139","The 'Comprehensive Adherence Resource and Empowerment Support' (CARES) Study","Adapting the 'Comprehensive Adherence Resource and Empowerment Support' Intervention for Multiple PrEP Methods Among Adolescent Girls and Young Women in South Africa and Zimbabwe","CARES","Aim 2:\n\nInclusion (AGYW):\n\n* age 16-24 years (in Zimbabwe, participants aged 16 to 17 years must meet the legal criteria for emancipation to be eligible)\n* has initiated PrEP during the study, or no more than 6 months before the study initiation date (for LEN PrEP), or no more than 3 months before the study initiation date (for oral, ring, or CAB PrEP), and\n* willing and able to provide written informed consent for access to medical records, or assent and parental consent if applicable\n* fluent in one of the study languages (English, isiXhosa, Shona, Ndebele)\n* target date for PrEP resupply (i.e., to ensure continued coverage) falls within the month.","16 Years","24 Years",{"count":333,"type":22},2100,[56],"The primary aim of this study is to adapt the Comprehensive Adherence Resource and Empowerment Support (CARES) intervention to support adolescent girls and young women (AGYW) aged 16-24 in Zimbabwe and South Africa in effectively using various forms of pre-exposure prophylaxis (PrEP), specifically oral, ring, and injectable PrEP. Originally developed for a clinical trial setting, CARES has shown promising results in enhancing effective PrEP use through a structured mix of counseling, SMS\u002Fphone calls, and peer support for daily oral PrEP and the PrEP ring. However, its resource-intensive design requires adaptation for routine public health settings to ensure feasibility, fidelity, acceptability, and effectiveness. This adapted intervention will be tailored with input from AGYW, PrEP providers, and local stakeholders to support sustainable PrEP use and address HIV prevention needs among AGYW. Additionally, it will incorporate injectable PrEP and be modified to suit routine public health contexts. Once the components are finalized, the adapted CARES intervention will be evaluated for effectiveness, feasibility, fidelity, and acceptability.",[121],[338,339,340,311,341,310,342,343],"PrEP","AGYW","South Africa","Effectiveness","Acceptability","Fidelity","2026-06-23",{"date":313,"type":33},{"date":317,"type":22},{"date":348,"type":22},"2028-10-31",{"name":350,"class":74},"RTI International",2,{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":361,"briefSummary":362,"conditions":363,"keywords":368,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":75},"100643388","feasibility-study-comparing-one-vs-two-probes-for-thermal-ablation-among-cervical-cancer-screen-positive-women-living-with-hiv-in-c1001p-cs7-zimbabwe-100643388","NCT07645352","Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe","Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living With HIV","Inclusion Criteria:\n\n1. 25-49 years old\n2. Living with HIV\n\nInclusion criteria specific to the feasibility study\n\n1. Intact cervix\n2. Willing to return to facility at 6 months\n3. Willing and able to provide informed consent\n4. Positive hrHPV or VIA test within 3 months of enrollment\n5. Type 1 transformation zone (TZ1)\n6. Thermal ablation eligible\n\nExclusion Criteria:\n\n1. Screened for cervical cancer outside of study in last 6 months\n2. Currently pregnant or less than 6 weeks postpartum\n3. Prior diagnosis of cervical cancer\n4. A history of treatment for cervical precancer\n5. Total hysterectomy\n6. Currently receiving treatment for any cancer\n7. Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study\n8. Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled",{"count":360,"type":22},300,[56],"Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. While thermal ablation (TA) is a WHO- recommended treatment for cervical precancerous lesions, its efficacy can be suboptimal in WLWH. We will also conduct a feasibility treatment cohort study of up to 300 Zimbabwean WLWH to provide evidence for a larger treatment effectiveness study. The proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings and to contribute towards achieving the 90-70-90 goals of the World Health Organization's (WHO) strategy for accelerated elimination of cervical cancer as a public health problem by 2030.",[364,365,366,367],"HIV (Human Immunodeficiency Virus)","HPV","Cervical Precancer","Cervical Neoplasia",[121,369,370,371,372],"Cervical cancer screening","Treatment of Cervical Precancer","Thermal ablation","Human papillomavirus","2026-06-09",{"date":375,"type":33},"2026-06-12",{"date":377,"type":22},"2026-06",{"date":379,"type":22},"2027-05-31",{"name":381,"class":74},"Fred Hutchinson Cancer Center",{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":18,"minAge":389,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":23,"phases":392,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":406},"100541989","phase-4-a-study-to-provide-continued-access-to-study-drug-to-children-and-adolescents-who-have-completed-clinical-studies-involving-gilead-hiv-treatments-100541989","NCT06337032","A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments","An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments","Key Inclusion Criteria:\n\n* Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation.\n\nKey Exclusion Criteria:\n\n* Individuals planning to switch to B\u002FF\u002FTAF on Day 1 with plasma HIV RNA ≥ 50 copies\u002FmL during the last parent study visit prior to screening\u002FDay 1 visit.\n\n  * Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies\u002FmL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies\u002FmL).\n* Individuals planning to switch to B\u002FF\u002FTAF with any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B\u002FF\u002FTAF prior to treatment switch.\n* For those on B\u002FF\u002FTAF or planning to switch to B\u002FF\u002FTAF: previous treatment discontinuation of any component of B\u002FF\u002FTAF due to toxicity or intolerance.\n* For those planning to switch to B\u002FF\u002FTAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients.\n* Ongoing treatment with or prior use of any prohibited medications.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","1 Month",{"count":391,"type":22},350,[393],"PHASE4","The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.\n\nThe primary objectives of this study are as follows:\n\n* To provide continued access to the study drug received in the parent protocol or switch to bictegravir\u002Femtricitabine\u002Ftenofovir (B\u002FF\u002FTAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.\n* To evaluate the safety of the study drug(s) in participants with HIV-1.",[396],"HIV-1-infection",{"date":398,"type":33},"2026-06-10",{"date":400,"type":33},"2024-08-27",{"date":402,"type":22},"2034-03",{"name":404,"class":405},"Gilead Sciences","INDUSTRY",15,{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":18,"minAge":414,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":421,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":432},"100468742","phase-2-trial-of-a-six-month-regimen-of-high-dose-rifampicin-high-dose-isoniazid-linezolid-and-pyrazinamide-versus-a-standard-nine-month-regimen-for-the-treatment-of-adults-and-adolescents-with-tuberculous-meningitis-100468742","NCT05383742","Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis","A Phase II, Randomized, Open-Label Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis: Improved Management With Antimicrobial AGents Isoniazid rifampiciN LinEzolid for TBM (IMAGINE-TBM)","Inclusion Criteria:\n\n* Definite, probable, or possible TBM diagnosis wherein the participant is being committed to a full course of SOC anti-TB treatment for TBM in the setting of routine care. CSF, imaging, laboratory, and other results used to determine definite, probable, or possible TBM can be from testing performed as part of routine care, as long as obtained within 21 days prior to study entry\n* Absence of HIV-1 infection, as documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit, within 30 days prior to study entry, OR\n* HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 E\u002FCIA test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and\u002For E\u002FCIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load. Two or more HIV-1 RNA viral loads of \\>1,000 copies\u002FmL are also acceptable as documentation of HIV-1 infection, or documentation of HIV diagnosis in the medical record by a healthcare provider\n* Documentation within 3 days prior to study entry of stage of disease using BMRC TBM grade.\n* The following laboratory values obtained within 3 days prior to study entry:\n\n  * Serum creatinine ≤1.8 times upper limit of normal (ULN)\n  * Hemoglobin ≥8.0 g\u002FdL for men, ≥7.5 g\u002FdL for women\n  * Absolute neutrophil count ≥600\u002Fmm3\n  * Platelet count ≥60,000\u002Fmm3\n  * Alanine aminotransferase (ALT) ≤3 x ULN\n  * Total bilirubin ≤2 x ULN\n* For participants of reproductive potential who have not been post-menopausal for at least 24 consecutive months (i.e., no menses within the preceding 24 months), or participants who have not undergone surgical sterilization, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation, documentation of a serum or urine pregnancy test result (positive or negative; see protocol for test sensitivity requirement) within 21 days prior to study entry\n* Participants with documentation of a positive pregnancy test will be consented using the consent form for pregnant participants.\n\nParticipants of reproductive potential with documentation of a negative pregnancy test must agree to use at least one acceptable form of contraception, or abstain from sexual activity that could lead to pregnancy while receiving study treatment and for 30 days after stopping study treatment.\n\nParticipants who are not of reproductive potential or whose partner(s) has documented azoospermia are not required to use contraception. Any statement of self-reported sterility or that of the partner's must be entered in the source documents\n\n* Ability and willingness of participant or parent or legally authorized representative (for adolescents or participants unable to provide consent) to provide informed consent\u002Fassent\n* Ability to comply with the protocol requirements in the opinion of the site investigator\n\nExclusion Criteria:\n\n* More than 14 cumulative days of first-line TB medications, including but not limited to INH, RIF, EMB, and PZA, received within 90 days prior to study entry\n* Known current or previous drug resistant TB infection (i.e., resistance to one or more first-line TB medications, including but not limited to INH, RIF, EMB, LZD and PZA)\n* Known allergy\u002Fsensitivity or any hypersensitivity to components of study TB drugs (INH, RIF, LZD, PZA, and EMB) or their formulation\n* For participants who are able to undergo the Brief Peripheral Neuropathy Screen (BPNS) within 21 days prior to study entry, Grade 3 subjective peripheral neuropathy score on the BPNS AND EITHER vibratory loss OR absent ankle jerks\n* Expected concomitant use or use up to 21 days prior to study entry of monoamine oxidase inhibitors or selective serotonin reuptake inhibitors, or concomitant use of any other drug with significant interaction with the study drugs (See protocol)\n* For participants with HIV who are ART-naïve or who are not regularly taking ART, planned initiation or reinitiation of ART during screening or during the first 4 weeks after initiation of TB therapy\n* For participants with HIV and on ART that includes a protease inhibitor, nevirapine, or other prohibited ART (see protocol), contraindication to switching to an acceptable alternative regimen (e.g., efavirenz, high-dose raltegravir or dolutegravir with nucleoside reverse transcriptase inhibitors, as per local SOC) prior to randomization. TB treatment, including study drugs, should be started as soon as possible\n* Contraindication to LP at discretion of treating clinician (e.g., unequal pressures between intracranial compartments due to mass lesion, non-communicating hydrocephalus)\n* Positive cryptococcal antigen, gram stain, bacterial culture, or other test result obtained from a CSF specimen collected within 21 days prior to entry as part of routine care indicating CNS infection with a pathogen other than Mtb (e.g., cryptococcal meningitis, bacterial meningitis).","15 Years",{"count":416,"type":22},330,[87],"The purpose of this study is to compare a 6-month regimen of high-dose rifampicin (RIF), high-dose isoniazid (INH), linezolid (LZD), and pyrazinamide (PZA) versus the World Health Organization (WHO) standard of care (SOC) treatment for tuberculosis meningitis (TBM).",[420],"Tuberculous Meningitis",[422,90,423],"Tuberculosis, meningeal","CNS Disease","2026-06-01",{"date":426,"type":33},"2026-06-02",{"date":428,"type":33},"2023-12-07",{"date":430,"type":22},"2029-09-15",{"name":39,"class":40},18,{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":441,"targetDuration":4,"studyType":23,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":351},"100519361","novel-one-stop-affordable-point-of-care-and-ai-supported-system-of-screening-triage-and-treatment-selection-for-cervical-cancer-in-lmics-100519361","NCT06042543","Novel, One Stop, Affordable, Point of Care and AI Supported System of Screening, Triage and Treatment Selection for Cervical Cancer in LMICs","A Novel, One Stop, Affordable, Point of Care and Artificial Intelligence Supported System of Screening, Triage and Treatment Selection for Cervical Cancer and Precancer in the Low-to-middle Income Countries","EASTER","Inclusion Criteria:\n\n* No cervical screening during the previous 3 years\n* Between the ages of 25 and 49 years\n* Understands and signs a written informed consent form\n\nExclusion Criteria:\n\n* Refusal to take part for any reason\n* Actively menstruating or pregnant\n* Treated earlier for cervical precancer or cancer",{"count":442,"type":22},3200,[56],"Artificial intelligence (AI) is fast gaining reputation as a highly promising solution for cervical cancer screening. AI-based detection of cervical neoplasias is named automated visual exam (AVE) by the National Cancer Institute, USA. The investigators propose to develop and evaluate the performance characteristics of a novel AI system to both screen and triage women as well as help in treatment decision making. AI will analyse infrared spectroscopic signals derived from urine samples of unscreened women for the presence of high-risk human papillomavirus (hr-HPV). Our preliminary study has shown that spectroscopy can detect hr-HPV in urine. For screen-positive women the AI will interpret a set of cervical images captured with a high-quality devoted camera to detect high grade cervical precancers and cancers and to determine the type of transformation zone (TZ) (helps in treatment decision). The prototype device for image capture and the AI algorithms are already developed by us. The technologies will be further improved in part 1 (initial 2 years) and validated in part 2 (subsequent 3 years). During Part 1, the investigators will analyse urine samples collected from 1100 women at multiple screening clinics in Zimbabwe for the presence of hr-HPV using spectroscopy and use the signals generated to improve the AI algorithm. In this part the investigators will also assess the concordance between hr-HPV detection in urine samples using spectroscopy and cervical human papillomavirus (HPV) detection using a validated HPV test. The cervical image recognition device and the AI algorithm will be further improved during part 1 by collecting more images from hr-HPV positive and negative women. AI will also be trained to interpret the cervical images to determine the TZ type. In part 2 total 2100 women will be screened in Zimbabwe with AI-supported spectroscopic analysis of urine to detect hr-HPV and a validated HPV test to evaluate and compare their sensitivity and specificity to detect histology-proved high grade cervical precancers and cancers. The sensitivity and specificity of AI-supported detection of cervical neoplasias on cervical images will be evaluated to triage the HPV positive women. The accuracy of AI to determine TZ type will be compared with expert opinion. During the field validation part (part 2), the investigators will also conduct a cost analysis and compare cost of our approach to current standard Zimbabwean practice. The International Agency for Research on Cancer- World Health Organization WHO (IARC-WHO) has partnered with The Neo Sense Vector Company (NSV), Delaware, USA (industry), The Engineering Department, Lancaster University, Lancaster, UK and The University of Zimbabwe, College of Health Sciences, Harare, Zimbabwe to implement this study focusing on innovation that will greatly contribute to the global elimination of cervical cancer, a WHO priority.",[446,447],"Cervical Cancer","Screening","2026-05-27",{"date":424,"type":33},{"date":451,"type":33},"2023-12-09",{"date":453,"type":22},"2027-12-31",{"name":455,"class":74},"International Agency for Research on Cancer",{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":18,"minAge":138,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":75},"100587898","improving-engagement-in-hiv-and-cancer-care-in-zimbabwe-100587898","NCT06934369","Improving Engagement in HIV and Cancer Care in Zimbabwe","Development and Evaluation of a Multi-Component Intervention to Support HIV Care Engagement Among Patients Receiving Cancer Treatment in Zimbabwe","Inclusion Criteria:\n\n* Age 18 or older\n* Registered patient at Parirenyatwa Hospital Radiotherapy Centre, receiving cancer treatment for a new diagnosis\n* HIV-positive\n\nExclusion Criteria:\n\n* Benign diagnosis or cancer recurrence",{"count":360,"type":22},[56],"In Zimbabwe, people who have cancer and HIV may have a difficult time staying engaged in their HIV care while they are being treated for cancer. This is because HIV and cancer care are usually provided at different health facilities, which can result in barriers to accessing clinical care for both HIV and cancer at the same time. It is important to remain engaged in HIV care, and continue taking medication to treat HIV throughout cancer treatment. The goal of this project is to identify barriers that make it difficult to stay engaged in HIV care and continue HIV treatment during cancer treatment and develop strategies to address them. The investigators will accomplish this by first observing a group of 150 people with cancer and HIV who are receiving cancer treatment at Parirenyatwa Hospital, in Harare, Zimbabwe. The investigators will measure barriers to accessing HIV care, and disruptions to HIV care engagement during cancer treatment. Next, the investigators will work with experts and key stakeholders to develop strategies that can be put in place at Parirenyatwa Hospital to better support engagement in HIV care during cancer treatment. The investigators will work with the cancer ward at the hospital to implement these strategies. Finally, the investigators will observe a second group of 150 people with cancer and HIV, who begin their cancer treatment at Parirenyatwa Hospital after the strategies have been put in place. The investigators will measure acceptability of these strategies to both patients and hospital staff. The investigators will also measure barriers to accessing HIV care and disruptions to HIV care engagement in the second group. The investigators will compare barriers to HIV care and HIV care engagement in the second group to the first group, to determine whether the strategies make it easier for people with cancer and HIV to remain engaged in HIV care during cancer treatment.",[467,121],"Cancer","2026-04-29",{"date":470,"type":33},"2026-05-01",{"date":472,"type":33},"2024-11-18",{"date":474,"type":22},"2028-12-01",{"name":381,"class":74},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":17,"sex":50,"minAge":414,"maxAge":331,"enrollmentInfo":484,"targetDuration":4,"studyType":23,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":501},"100634950","peer-led-service-delivery-model-for-pregnant-and-lactating-adolescent-girls-and-young-women-in-zimbabwe-100634950","NCT07546344","Peer-led Service Delivery Model for Pregnant and Lactating Adolescent Girls and Young Women in Zimbabwe","Peer-led Service Delivery Model to Increase HIV Prevention and Contraception in Pregnant and Lactating Adolescent Girls and Young Women in Zimbabwe: a Pilot Study","Ontanga","Inclusion Criteria:\n\n* either pregnant or have at least one child who is less than 18 months of age at the time of initial engagement\n* Aged 15 - 24 years old",{"count":485,"type":22},600,[56],"This is a pilot cluster-randomized control trial co-led by Dr. Valentina Cambiano, Associate Professor of Epidemiology at University College London, UK and Professor Euphemia Sibanda, Research Director at the Centre for Sexual Health and HIV Research (CeSHHAR Zimbabwe). The goal of the proposed study is to evaluate the appropriateness, feasibility, acceptability, uptake, costs and cost-effectiveness of a community-based, HIV-status neutral peer-led service delivery model in which young mentor mothers (YMM) work with pregnant and lactating adolescent girls and young women (PL-AGYW, aged 15-24), up to two-years post-birth, in Zimbabwe to promote uptake of contraception and HIV prevention.\n\nYMM living with HIV have been found to be effective in supporting their peers for prevention of mother-to-child transmission of HIV and adherence to treatment through the \"Zvandiri\" programme. The investigators propose adapting the \"Zvandiri\" YMM to include those without HIV to promote behaviour to prevent HIV and unintended pregnancies. This proposed intervention is building on the formative work that had the overall aim of co-developing with AGYW (aged 15-24) a Pre-Exposure Prophylaxis (PrEP) implementation intervention for AGYW who need it, that attracts them to PrEP, and supports pregnant and lactating adolescent girls and young women while taking it.",[489,490,491],"HIV Prevention","Contraceptive Usage","Adherence, Medication","2026-04-16",{"date":494,"type":33},"2026-04-22",{"date":496,"type":22},"2026-04",{"date":498,"type":22},"2027-06",{"name":500,"class":74},"University College, London",3,{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":18,"minAge":414,"maxAge":276,"enrollmentInfo":510,"targetDuration":4,"studyType":23,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":75},"100533464","adaptation-of-an-intervention-addressing-barriers-to-prep-use-among-pregnant-women-in-zimbabwe-100533464","NCT06226155","Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe","TENDAI4PrEP: Adaptation of a Problem-solving Intervention to Address Individual and Provider Level Barriers to PrEP Uptake and Adherence Among Pregnant Women in Zimbabwe","TENDAI4PrEP","Inclusion Criteria:\n\nAcross all aims participants must be\n\n1. Pregnant\n2. Presenting at the Chitungwiza Central Hospital ANC\n3. Aged 15+\n4. Willing to provide informed consent or assent\n5. Have HIV negative status\n6. At risk for HIV acquisition (defined as having a male partner of unknown HIV status, suspicions of partner infidelity, reporting multiple partners, or history of STI and\u002For recent condomless sexual activity)\n7. Score \\>5 on the Shona Symptom Questionnaire\n\n   For the RCT, eligible participants must also be willing to\n8. Initiate PrEP prior to randomization\n9. Bring their pregnancy partner (if they are safe doing so).\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\u002Fassent and\u002For complete procedures in Shona or English\n2. Current interfering untreated or unstable mental health condition that precludes functional involvement in the study (e.g., active psychosis, untreated bipolar disorder)",{"count":511,"type":22},132,[56],"The purpose of this study is to develop a multi-level PrEP adherence and persistence intervention as an adaptation of the TENDAI ('grateful' in Shona) program, a problem-solving approach to reduce depression and increase HIV treatment adherence among people living with HIV in Zimbabwe. The new intervention, TENDAI4PrEP, will be designed to improve PrEP uptake and persistence among pregnant persons in Zimbabwe. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness\u002Fimplementation testing. This program will has the potential to address a critical public health challenge impacting pregnant and postpartum persons in Zimbabwe: the prevention of HIV acquisition and transmission.",[60,515,516],"Pregnancy Related","Depression, Anxiety","2026-03-30",{"date":519,"type":33},"2026-03-31",{"date":521,"type":33},"2024-10-21",{"date":523,"type":22},"2027-03-31",{"name":525,"class":74},"Massachusetts General Hospital",{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":17,"sex":50,"minAge":330,"maxAge":533,"enrollmentInfo":534,"targetDuration":4,"studyType":23,"phases":535,"briefSummary":536,"conditions":537,"keywords":539,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":501},"100615098","phase-2-phase-2b-open-label-multisite-randomized-crossover-study-of-dpp-versus-2pr-100615098","NCT07288190","Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR","A Multisite, Open-label, Randomized Crossover Study Comparing Adherence to a Single Daily Dual Prevention Pill (DPP) Versus FTC\u002FTDF and Combined Oral Contraception Separate Pill Dosing (2PR), Given for Pre-exposure Prophylaxis and Pregnancy Prevention in Women","Inclusion Criteria:\n\n* Age 16 through 39 years old (inclusive) at Screening.\n* Adults must be able and willing to provide informed consent. Adolescents (16- and 17-year-olds) will be consented according to applicable local guidelines, by obtaining participant assent and where applicable parental or guardian permission.\n* Able and willing to provide adequate locator information.\n* Able and willing to comply with all study procedures.\n* Must be post-menarche and pre-menopausal and could potentially become pregnant.\n* Sexually active, defined as having had penile-vaginal sex within the 3 months before Screening (per self-report)\n* Negative pregnancy test at Screening and Enrollment.\n* Does not intend to become pregnant within the next 12 months.\n* Willing to use COCs for at least 48 weeks as their method of contraception.\n* HIV negative at Screening and Enrollment.\n* Willing to use oral PrEP for at least 48 weeks.\n* Hepatitis B (HBV) surface antigen (HbsAg) negative per blood test at Screening.\n* Hepatitis C (HCV) negative at Screening.\n* Normal estimated creatinine clearance (eCrCl) ≥ 60 ml\u002Fmin per blood test at Screening.\n\nExclusion Criteria:\n\n* Intolerance, adverse reaction, or laboratory abnormality associated with PrEP use in the past.\n* Unable to become pregnant e.g., had a tubal ligation or hysterectomy or otherwise lacks a uterus, or is currently using another form of contraception.\n* Medically ineligible for combined hormonal contraception and specifically COCs per World Health Organization (WHO) medical eligibility criteria for contraceptive use or similar local medical eligibility guidelines (e.g., Centers for Disease Control and Prevention eligibility criteria).\n* Medically ineligible for PrEP based on WHO and\u002For local guidelines.\n* Using or planning to use another pregnancy prevention product other than oral contraception (condoms are permitted) during the next 48 weeks.\n* Using or planning to use another HIV prevention product other than condoms during the next 48 weeks.\n* Any other condition the clinician feels would jeopardize the health and wellbeing of the participant","39 Years",{"count":360,"type":22},[87],"To evaluate adherence to a single dual-prevention pill (DPP) compared with a two-pill regimen (2PR) for pre-exposure prophylaxis (PrEP) and pregnancy prevention in women without HIV.",[538,60],"Pregnancy",[540,541,542,543],"Pre-exposure Prophylaxis (PrEP)","Contraception","Dual Prevention Pill (DPP)","Pregnancy Prevention","2026-02-17",{"date":546,"type":33},"2026-02-19",{"date":548,"type":22},"2026-05-15",{"date":550,"type":22},"2028-05-15",{"name":552,"class":219},"HIV Prevention Trials Network",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":17,"sex":18,"minAge":330,"maxAge":182,"enrollmentInfo":561,"targetDuration":4,"studyType":23,"phases":563,"briefSummary":564,"conditions":565,"keywords":569,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":75},"100623952","mobile-health-supported-self-care-among-tertiary-education-students-in-zimbabwe-100623952","NCT07403318","Mobile Health Supported Self-care Among Tertiary Education Students in Zimbabwe","mHealth Supported Self-care Among Tertiary Education Students in Zimbabwe","MASCOT","Work package 1: Formative research\n\n1. Focus Group Discussions\n\n   * Aged 16 years old or over;\n   * Currently enrolled at a college\u002Funiversity where the research is being done;\n   * Willing and able to provide written informed consent.\n\n   Exclusion Criteria:\n\n   \\- None stated\n2. Key informant interviews\n\n   * Staff from MoHCC responsible for implementing or supervising implementation of HIV or sexual and reproductive health services, or for policy planning on the same topics,\n   * Staff from Ministry of Higher and Tertiary Education responsible for student health, staff from Ministry of Health implementing partners working on HIV and sexual and reproductive health services in Zimbabwe,\n   * Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n\\- None stated\n\nWork package 3: Adaptation of the parent mHealth tool\n\n1\\. Hackathon\n\n1a. Students\n\nInclusion criteria:\n\n* Enrolled in the specific institutions; in these disciplines: public health, information technology and computer science; and\n* Willing to take part in the hackathon\n\nExclusion criteria:\n\nNone stated\n\n1b. Multi-disciplinary experts\n\nInclusion criteria:\n\n* Representatives in any of the following disciplines, Digital health experts, MoHCC, HIV and SRH services, other key stakeholders; and\n* Willing to take part in the hackathon.\n\nExclusion criteria:\n\nNone stated\n\n2\\. Alpha testing\n\n2a. Students\n\nInclusion criteria:\n\n• Recruited from the same colleges\u002Funiversities that participated in formative research\n\n• Willing and able to provide written informed consent.\n\nExclusion criteria:\n\nNone stated\n\n2b. Health workers\n\nInclusion criteria:\n\n* Staff from MoHCC responsible for implementing or supervising the implementation of HIV and sexual and reproductive health services,\n* Willing and able to provide written informed consent.\n\nExclusion criteria:\n\nNone stated\n\n3\\. Beta testing\n\n3a. Students\n\nInclusion criteria:\n\n* Students who have used the mHealth tool and decision aids\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n\\- None stated\n\n4\\. Pilot of mHealth supported self-care in two colleges\u002Funiversities\n\n4a. Institutions\n\nInclusion criteria:\n\n* Less than 3500 students\n* Comparable male and female ratio\n* Participated in formative research\n\nExclusion criteria:\n\nInstitutions that participated in the formative research\n\n4b. Peer distributors\n\nInclusion criteria:\n\n* Aged \\>18 years;\n* Currently enrolled at the participating colleges\u002Funiversities\n* Willing to be a peer distributor,\n* Willing to conduct study activities according to the protocol.\n\nExclusion criteria:\n\n\\- Students who were away from college for industrial attachment during intervention implementation\n\n4c. Pilot survey\n\nInclusion criteria:\n\n* Students enrolled at the colleges\u002Funiversities for at least 6 months.\n* Willing to provide written informed consent for the survey.\n\nExclusion criteria:\n\n\\- Students who were away from college for industrial attachment during intervention implementation\n\n4d. In-depth interviews with students\n\nInclusion criteria:\n\n* Students enrolled at the colleges\u002Funiversities for at least 6 months.\n* Willing to provide written informed consent for the in-depth interviews\n\nExclusion criteria:\n\nNone defined\n\n4e. In depth interviews with Peer Distributors\n\nInclusion Criteria:\n\n* Student peer distributor at a tertiary education institution where the research is being done; and\n* Willing and able to provide written consent for the interview.\n\nExclusion criteria:\n\nNone defined\n\n4f. FGDs with students\n\nInclusion criteria:\n\n* Enrolled at the colleges\u002Funiversities for at least 6 months.\n* Willing to provide informed consent for the FGD.\n\nExclusion criteria:\n\nNone defined\n\n4g. In depth interviews with health workers\n\n* Health worker at participating college\u002Funiversity supporting the MASCOT intervention.\n* Willing and able to provide written informed consent.\n\nExclusion criteria:\n\nNone defined\n\n5\\. Cluster Randomised trial\n\n5a. Institutions\n\nInclusion criteria:\n\n* Located in 10 provinces: Harare, Mashonaland Central, West and East, Masvingo, Manicaland, Midlands Bulawayo and Matabeleland North and South\n* Maximum enrolment of 3500 students\n\nExclusion criteria:\n\nNone defined\n\n5b. Surveys, in-depth interviews with students, peer distributors and health workers and FDGs with students will be the same as for work package 4 above.\n\n5c. Costing interviews with distributors\n\nInclusion criteria:\n\n* Student peer distributor at a tertiary education institution where the research is being done; and\n* Willing and able to provide written consent for the costing interview.\n\nExclusion criteria:\n\nNone defined\n\n5d. Costing - Valuing distributor time\n\nInclusion criteria:\n\n* Student peer distributor at a tertiary institution where the research is being done.\n* Willing and able to provide written consent\n\nExclusion criteria:\n\nNone defined",{"count":562,"type":22},16000,[56],"Young people of ages 15-24 years, particularly those in Sub-Saharan Africa, do not optimally take up HIV services (HIV testing, HIV prevention and HIV treatment) and contraception. The number of new HIV infections in this group is disturbingly high and they suffer a lot of illness and death related to HIV. Research has found that four out of five sexually active adolescents in Africa are not using contraception. This means that millions of young people are exposed to unintended pregnancy and the associated negative effects such as unsafe abortions, school drop-out and reduced opportunities for both mother and baby. World Health Organisation have issued new guidelines for a new strategy, self-care, where an individual takes care of their own health and manages their illness with or without the support of a health worker. Self-care has potential to increase the number of young people who use HIV and contraception services. There is not enough information on how self-care can be done in a way that supports people to use services and maintain this use over time. Self-care can be made easier by mobile phone-based digital systems called mHealth, which may work by supporting access of services, for example where products are ordered online, or creating enabling conditions for self-care, for example through facilitating correct information-giving.\n\nWith various options for HIV prevention and contraception available, young people may need support\u002Fguidance choosing options that suit them. Health workers in overburdened health systems may be too overwhelmed to clearly present all options to guide informed decisions. Decision aids (tools that support patients\u002Fusers to make informed choices that suit their values and preferences) can enhance self-care by enabling informed decisions. Decision aids for HIV prevention and contraception need to be developed for use in self-care settings. Combining decision aids with mHealth tools can enhance self-care.\n\nThis study will be co-developed with students enrolled in colleges\u002Funiversities in Zimbabwe to develop a self-care strategy that includes mHealth together with decision aids and enables students to optimally use HIV and contraception services.\n\nThe study is divided into five stages, and builds on another study where a self-care strategy supported by an mHealth tool (without decision aids) was developed. In the first stage of the current study, preferences for decision aids and attributes to include in the mHealth tool will be obtained using qualitative research and a scoping literature review. In the second stage, findings from the first stage will be used to develop blueprints for two decision aids: one for contraception and the other for HIV prevention. In the third stage, the decision aids will be integrated with the existing mHealth tool through a crowdsourcing activity including students, and experts in health and mHealth. In the fourth stage the self-care strategy supported by mHealth and decision aids will be tested in a pilot at 2 colleges\u002Funiversities. Finally, the fifth stage be a randomised control trial, across college\u002Funiversities in Zimbabwe, to see whether the self-care strategy supported by mHealth and decision aids will be effective to promote self-care, and therefore, results in an increase in the uptake of HIV and contraception services. This study will also be applied to make recommendations on how the strategy can be provided outside of college\u002Funiversity contexts.",[566,567,568],"Unmet Need for Contraception","Uptake of HIV Prevention","Healthy Participants",[570,571,572,573,574,575,576,577,578,579,580,581,582],"contraception","decision aid","young people","community-led","mHealth","adolescent girls and young women","adolescent boys and young men","HIV prevention","HIV post-exposure prophylaxis","HIV PEP","Emergency Contraception","peer-led interventions","student-led interventions","2026-02-16",{"date":546,"type":33},{"date":586,"type":22},"2026-09-01",{"date":588,"type":22},"2029-06-30",{"name":590,"class":74},"Liverpool School of Tropical Medicine",{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":17,"sex":18,"minAge":138,"maxAge":599,"enrollmentInfo":600,"targetDuration":4,"studyType":23,"phases":602,"briefSummary":603,"conditions":604,"keywords":605,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":613,"locationsCount":501},"100563509","phase-1-a-trial-of-a-gorilla-adenovirus-vectored-networked-epitopes-vaccine-administered-to-healthy-adults-living-without-and-with-hiv-100563509","NCT06617091","A Trial of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine, Administered to Healthy Adults Living Without and With HIV.","A Phase 1 Randomized Double Blinded Placebo Controlled, Dose Ranging Trial, of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine, Administered to Healthy Adults Living Without HIV and Living With HIV, in Southern Africa","IAVI C114","Inclusion Criteria:\n\n1. At least 18 years of age on the day of screening and has not reached his or her 51st birthday on the day of signing the Informed Consent Document.\n2. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.\n3. In the opinion of the Principal Investigator or designee and based on Assessment of Informed Consent Understanding results, has understood the information provided and potential impact and\u002For risks linked to administration of the investigational product; written informed consent will be obtained from the participant before any study-related procedures are performed.\n4. All sexually active female participants capable of becoming pregnant must commit to use an effective method of contraception from 21 days prior to receiving the IP until 4 months following the last IP administration, including:\n\n   1. Intrauterine device, or contraceptive implant\n   2. Hormonal contraception\n   3. Successful vasectomy in the male partner (considered successful if a woman reports that a male partner has \\[1\\] documentation of azoospermia by microscopy (\\\u003C 1 year ago), or \\[2\\] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy)\n5. Women who have undergone a hysterectomy, bilateral oophorectomy, or tubal ligation, as well as those who are postmenopausal (\\> 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone \\[FSH\\] level \\> 40 IU\u002FL) will not be required to use contraceptives.\n6. Willing to forgo donations of blood, or any other tissues during the study.\n\n   Additional Inclusion criteria for PLWH\n7. Confirmed HIV infection (HIV Ab+ or HIV RNA+) by documentation in the medical records or in-clinic HIV testing on screening visit.\n8. CD4 ≥ 500 cells\u002Fµl at screening.\n9. Currently on ART, and documentation of continuous combination ART (cART) for at least 12 months with suppression of plasma HIV-1 viral load \\\u003C 50 copies \u002F ml for greater than 6 months prior to trial entry, measured on at least 2 independent occasions that can include the screening viral load. cART is defined as a regimen including ≥ 2 compounds, e.g., 2 nucleoside reverse transcriptase inhibitors plus either non-nucleoside reverse transcriptase inhibitor or protease inhibitor or integrase inhibitor.\n10. Viral load \\\u003C 50 copies \u002F ml at time of screening (within 28 days prior to IP administration).\n11. Must commit to adhering to a suppressive ART regimen for the duration of the study\n\nExclusion Criteria:\n\n1. Any clinically significant acute or chronic medical condition, other than HIV infection (in Part B only), that is considered progressive or in the opinion of the investigator makes the participant unsuitable for participation in the study.\n2. For the PLWH (Part B), history of AIDS-defining illness or CD4 \\\u003C 200 cells\u002Fµl.\n3. If female, pregnant, lactating or planning a pregnancy during the period of screening through completion of the study.\n4. In the past 6 months a history of alcohol or substance use, judged by the Investigator to potentially interfere with participant study compliance.\n\nBleeding disorder that was diagnosed by a physician (e.g., Factor deficiency, coagulopathy or platelet disorder that requires special precautions). Note: A participant who states that he or she has easy bruising or bleeding but does not have a formal diagnosis and has intramuscular injections and blood draws without any adverse experience, is eligible.\n\n6\\. History of a splenectomy. 7. Previous receipt of an adenovirus vectored vaccine. 8. Receipt of live attenuated vaccine or other vaccine within the previous 60 days or planned receipt within 180 days after administration of IP. Receipt of blood transfusion or blood derived products within the previous 3 months.\n\n9\\. Participation in another clinical trial of an investigational product currently, within the previous 3 months or expected participation during this study.\n\n10\\. Prior receipt of an investigational HIV vaccine candidate, monoclonal antibody or polyclonal immunoglobulin (note: receipt of placebo in a previous HIV vaccine or monoclonal antibody trial will not exclude a participant from participation if documentation is available and the Medical Monitor gives approval).\n\n11\\. History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulties, angioedema).\n\n12\\. Psychiatric condition that compromises safety of the participant and precludes compliance with the protocol. Specifically excluded are persons with history of psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.\n\n13\\. If, in the opinion of the Principal Investigator or designee, it is not in the best interest of the participant to participate in the trial.\n\n14\\. Seizure disorder: a participant who has had a seizure in the last 3 years is excluded. (Not excluded: a participant with a history of seizures who has neither required medications nor had a seizure for 3 years.) 15. Infectious disease: chronic hepatitis B infection (HbsAg positive), current hepatitis C infection (HCV Ab positive and\u002F or HCV RNA) or treatment for hepatitis C infection in the past year, or active syphilis (RPR confirmed by TPHA).\n\n16\\. A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy.\n\n17\\. Active, serious infections (other than HIV infection in PLWH) requiring parenteral antibiotic, antiviral or antifungal therapy within 30 days prior to enrollment.\n\n18\\. Any abnormal laboratory parameters at screening per protocol. 19. Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease, other than HIV among the PLWH; use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the investigator within the previous 6 months.\n\nEligibility Criteria Specific to PLWoH (Part A) People living without HIV(PLWoH) at screening, must be deemed to be at low risk of HIV infection and willing to maintain low-risk behavior for the duration of the trial.","50 Years",{"count":601,"type":22},120,[25],"A Phase 1 Randomized Double Blinded Placebo Controlled, Dose Ranging Trial, of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine (GRAdHIVNE1 Vaccine), Administered to Healthy Adults Living without HIV and Living with HIV, in Southern Africa",[121],[606],"GRAdHIVNE1 Vaccine","2026-02-11",{"date":609,"type":33},"2026-02-13",{"date":611,"type":33},"2025-07-28",{"date":523,"type":22},{"name":614,"class":219},"International AIDS Vaccine Initiative",{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":18,"minAge":138,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":23,"phases":624,"briefSummary":625,"conditions":626,"keywords":629,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":75},"100545615","the-friendship-bench-plus-trial-100545615","NCT06384209","The Friendship Bench Plus Trial","Combining Antidepressants With Psychological Therapy to Improve Depression Outcome in Zimbabwe - The Friendship Bench Plus Trial","Inclusion Criteria:\n\n* Adults ≥18 years\n* Moderate to severe depression defined as PHQ-9 ≥ 11\n* Treatment naïve to the Friendship Bench intervention at the time of recruitment\n* Speaks English or Shona (local language)\n* Written informed consent\n\nExclusion Criteria:\n\n* Mild depression defined as PHQ-9 \\\u003C11\n* Psychotic symptoms (SSQ-14 probing question 5 positive and confirmation by study coordinator)\n* High risk of suicide according to P4 screener\n* Patient has received FB in the past 12 months\n* Patient is currently under treatment (counselling, antidepressants, followed up by a psychiatrist)\n* History of or presenting with end-stage AIDS\n* History of or presenting with kidney failure\n* History of or presenting with liver failure\n* History of or presenting with serious cardio-vascular disease (including previous heart attack, stroke or arrhythmias)\n* History of or presenting with cancer\n* Positive urine pregnancy test\n* Clear intention of pregnancy during the study period\n* Not willing to use effective contraception during study period\n* Unable to comprehend the nature of the study in either English or Shona (local language)",{"count":623,"type":22},296,[56],"The goal of this randomised controlled trial is to enhance the Friendship Bench intervention with antidepressants in adults with moderate to severe depression. The main questions it aims to answer are:\n\n1. Is the combination of the Friendship Bench with nurse-led antidepressants prescribing superior to the Friendship Bench alone?\n2. What are the barriers and enablers for the prescription of antidepressants by nurses in primary care?\n\nType of study: Randomized controlled superiority trial\n\nParticipants will be randomly selected and allocated into the control arm or intervention arm. Participants in the control arm will receive six sessions of the Friendship Bench Problem Solving Therapy while those in the intervention arm will receive the Friendship Bench intervention plus Fluoxetine (Sertraline for breastfeeding women).",[627,628],"Major Depressive Disorder","Severe Depressive Episode Without Psychotic Symptoms",[630,631,632,633,634,635,636],"Depression","Depressive disorder","Problem Solving Therapy","Antidepressant","Fluoxetine","Sertraline","Nurse prescribing","2025-11-17",{"date":639,"type":33},"2025-11-20",{"date":641,"type":33},"2025-06-26",{"date":643,"type":22},"2028-02-28",{"name":645,"class":74},"University of Bern",{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":651,"acronym":652,"eligibilityCriteria":653,"healthyVolunteers":17,"sex":50,"minAge":138,"maxAge":4,"enrollmentInfo":654,"targetDuration":4,"studyType":656,"phases":4,"briefSummary":657,"conditions":658,"keywords":672,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":75},"100607934","early-life-malnutrition-environmental-enteric-dysfunction-and-microbiome-trajectories-100607934","NCT07195006","Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories","Early Life Diarrhoea Episode(s), Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories From Birth Until 3 Years of Life ; The University of Zimbabwe Birth Cohort Study-2 (UZBCS-2)","UZBCS-2","Inclusion Criteria for Cases:\n\n* MUAC ≤23 cm in pregnancy\n* ≥18 years' old\n* At least 20 weeks' gestational age\n* Height ≥150 cm\n* Planning to be staying in the study area for the next 3 years\n* Willing to participate and comply with all study requirements and procedures.\n\nAny pregnant woman meeting the above eligible criteria regardless of HIV status who meet the above inclusion criteria will be invited to participate in the study\n\nInclusion criteria for Controls\n\n* Age, HIV status, gestational age at enrolment, and area residence matched normo-nourished peers with MUAC ≥25 - ≤35 cm\n* Haemoglobin level of ≥11g\u002FdL\n* ≥18 years' old\n* At least 20 weeks' gestational age\n* Height ≥150 cm\n* Planning to stay in the study area for the next 3 years\n\nExclusion Criteria\n\n* Acute or chronic conditions in mothers interfering with the study according to the judgment of the investigator (HIV infection is not an exclusion criterion)\n* Presence of severe mental health disorders interfering with study procedures according to the judgment of the investigator.",{"count":655,"type":22},368,"OBSERVATIONAL","Malnutrition in women of reproductive age remains a public health concern in Sub-Saharan Africa (SSA). Malnutrition during pregnancy affects foetal growth with a tendency of the exposed infants to also develop it. The interaction of the mother with the infant shapes the seeding and the trajectory of the infant intestinal microbiota which is crucial for development of a healthy immune system Malnutrition has been associated with intestinal inflammation, intestinal leakage and reduced calorie absorption. Early life malnutrition and environmental enteric dysfunction (EED) immunopathology remains poorly described in the context of mother-infant dyads. This is essential as malnutrition, poor water, sanitation and hygiene (WASH), including the presence of infectious diseases limit the developmental potential of the exposed infants in SSA, including Zimbabwe. In addition, maternal stress and poor mental health may also affect standard hygiene practices, including how a mother cares for her baby, potentially aggravating EED and the risk of the infant being malnourished.\n\nPrimary outcomes\n\n1. Infant malnutrition and recovery.\n2. Gut dysfunction (gut inflammation, leaky gut, malabsorption, dysbiosis)\n3. Diarrhea episodes, defined as any episode of acute diarrhoea (≥3 passages of loose stool within 24 hours as reported by the mother) occurring before the next study visit.\n\nDefinition of malnutrition outcomes to be assessed in babies born to malnourished women, is a mid- upper arm circumference (MUAC) \\\u003C23cm;\n\n* MUAC for age: Malnourished defined as those below -2 standard (SD) of the World Health Organisation (WHO) reference\n* Weight-for-age: Underweight defined as those below -2SD WHO reference\n* Weight-for-height: Wasted defined as those below -2SD WHO reference\n* Height-for-age: Stunted defined as those below -2SD WHO reference\n* Z-scores (as they are i.e. a continuous variable, taking age of infants into account)\n* A composite variable, any of malnourished, underweight, wasted or stunted.",[659,660,661,662,663,664,665,666,667,668,669,670,671],"Malnutrition Pregnancy","Malnutrition in Children","Malnutrition (Calorie)","Environmental Enteric Dysfunction","Gut Dysbiosis","Gut Permeability, Gut Inflammation","Diarrhea Infectious","Maternal Stress","Child Mental Health","Natural Killer Cell Mediated Immunity","Mycotoxin Biomonitoring","Environmental Exposures","Cell-Mediated Immune Deficiency",[673,674,675,676,677,678,679,680,681,682,683,684,685,686,687,688,689],"diarrhoeal episodes","short chain fatty acids receptor agonists","intestinal inflammation, leakage and calory extraction","toxins in drinking water and food","macro- and micronutrient composition of breast milk","human anti-Gal antibodies","mitochondria health and nutrient uptake","endothelial dysfunction and oxidative stress","hormonal mediated molecular signalling mechanisms","interaction of epigenetics & socioeconomic factors","microbiota, pathobionts and oral microbiota","metagenomics","undernutrition and intestinal infections","infant mortality, morbidity within 1st 1000 days of life","low mid upper arm circumference","sleep adequacy in maternal mental health","chronic inflammation","2025-09-18",{"date":692,"type":33},"2025-09-26",{"date":694,"type":33},"2025-01-27",{"date":696,"type":22},"2032-12-31",{"name":698,"class":74},"University of Zimbabwe",{"id":700,"slug":701,"hasResults":12,"nctId":702,"briefTitle":703,"officialTitle":704,"acronym":705,"eligibilityCriteria":706,"healthyVolunteers":12,"sex":18,"minAge":330,"maxAge":331,"enrollmentInfo":707,"targetDuration":4,"studyType":23,"phases":709,"briefSummary":710,"conditions":711,"keywords":714,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":718,"lastUpdatePostDateStruct":719,"startDateStruct":721,"completionDateStruct":723,"leadSponsor":725,"locationsCount":501},"100553731","peer-education-for-gender-inclusion-and-substance-use-in-southern-africa-100553731","NCT06489899","Peer Education for Gender Inclusion and Substance Use in Southern Africa","Peer Education for Gender Inclusion and Substance Use in Southern Africa (PEGISUS): A Pilot Trial Testing a Peer-based Intervention in Vocational Training Programs","PEGISUS","Inclusion Criteria:\n\n* Adolescents and young adults 16 - 24 years old\n* At least weekly self-reported alcohol\u002Fdrug use in a peer group in the past month or at least monthly heavy episodic drinking with peers over the past three months\n* Comfortable communicating in the predominant local language or English\n* Lives in the target community and plans to remain in the area for the next 12 months\n* Eligible to participate in the vocational training (VT) program (according to the VT program's own entry guidelines) and willing to participate in the entirety of the program\n* Interested to participate in a substance reduction and gender equity beliefs program and able to identify 2 to 5 peers to join\n* Willing to have PEGISUS workshop sessions audio\u002Fvideo-recorded (if assigned to that group)\n\nExclusion Criteria:\n\n* Untreated major mental illness that interferes with study participation, such as active suicidality, or unmanaged bipolar disorder or psychotic disorder\n* Currently receiving psychological treatment for substance use\n* Participation in another VT\u002Fskills development program or another trial that is judged by the site investigator as non-compatible with this study\n* Unable to provide informed consent or informed assent",{"count":708,"type":22},264,[56],"The goal of this trial is to test the effectiveness of a brief, behavioral peer group intervention called \"PEGISUS\" (Peer Education for Gender Inclusion and Substance Use in Southern Africa), on substance use, which will be embedded within existing vocational training programs in Zambia, Zimbabwe, and South Africa. Established peer groups who receive the PEGISUS intervention will complete nine sessions of an adapted intervention for substance use and gender equitable beliefs, embedded into vocational training programs. This will be compared to a standard of care control condition, which involves the vocational training program that is offered through the partner organization and a healthcare referral for substance use. The vocational training program partners are Sozo Foundation (South Africa), BuildIt International (Zambia), and Masvingo Polytechnic (Zimbabwe). Participants in both conditions will complete assessments at baseline, 12-weeks follow-up, and 24-weeks follow-up, consisting of self-reported questionnaires.",[712,713],"Substance Use","Gender Role",[715,716,311,717,340],"gender","substance use","Zambia","2025-09-16",{"date":720,"type":33},"2025-09-22",{"date":722,"type":33},"2024-09-19",{"date":724,"type":22},"2026-07",{"name":726,"class":74},"University Hospital, Basel, Switzerland",""]