[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Botswana\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":460},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,49,72,95,126,160,187,210,255,278,312,335,359,384,409,438],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641915","phase-2-a-trial-of-stratified-patient-centered-treatment-regimens-for-active-tb-spectra-tb-100641915",false,"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.","ALL","13 Years",{"count":19,"type":20},900,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Tuberculosis",[26,28,29,30,31,32,33,34,35],"Pulmonary tuberculosis","Drug-susceptible tuberculosis","Rifampin-susceptible tuberculosis","Rifapentine","Moxifloxacin","HIV coinfection","Treatment shortening","Risk-stratified treatment","NOT_YET_RECRUITING","2026-08-17",{"date":39,"type":40},"2026-08-19","ACTUAL",{"date":42,"type":20},"2026-10-30",{"date":44,"type":20},"2029-10-22",{"name":46,"class":47},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",29,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"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":57,"type":20},144,[59,23],"PHASE1","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.",[26],[63,26,64],"HIV","Latent Tuberculosis",{"date":39,"type":40},{"date":67,"type":20},"2026-10-15",{"date":69,"type":20},"2028-05-31",{"name":46,"class":47},11,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":48},"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":82,"type":20},315,[23],"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.",[86],"Pulmonary Tuberculosis","RECRUITING",{"date":89,"type":40},"2026-08-18",{"date":91,"type":40},"2025-03-11",{"date":93,"type":20},"2027-08-11",{"name":46,"class":47},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":102,"minAge":80,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":125},"100512414","strategies-to-close-the-gap-from-cervical-cancer-diagnosis-to-treatment-in-botswana-100512414","NCT05952141","Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana","Thibang Diphatlha: Testing Adaptive Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana","Inclusion Criteria:\n\nPatients will be eligible if they:\n\n1. are biological females\n2. are aged 18 or older\n3. have pathology-confirmed invasive cervical cancer diagnosis\n4. have pathology results evaluated at National Health Laboratory in Botswana\n5. are citizens of Botswana\n6. have no prior history of invasive cervical cancer\n\nExclusion Criteria:\n\nPatients will be excluded if they:\n\n1. are biological males or otherwise born without a cervix\n2. are below the age of 18 due to the rarity of cervical cancer in this population\n3. do not meet study inclusion criteria","FEMALE",{"count":104,"type":20},610,[106],"NA","Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.",[109],"Cervical Cancer",[111,112,113,114],"Screening","Botswana","Treatment","Patient","2026-07-21",{"date":117,"type":40},"2026-07-22",{"date":119,"type":40},"2023-09-01",{"date":121,"type":20},"2027-08-31",{"name":123,"class":124},"Abramson Cancer Center at Penn Medicine","OTHER",3,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":134,"sex":102,"minAge":80,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":138,"conditions":139,"keywords":145,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100632658","pharmacokinetic-study-of-long-acting-antiretrovirals-and-contraceptives-in-hiv-100632658","NCT07516548","Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV","Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptive Options in HIV Prevention","PHARAOH","Parent Tshireletso Study Inclusion Criteria:\n\n1. Female 18 years of age or older and willing and able to provide an informed consent\n2. \\\u003C 14 days after delivery (calendar day of birth = day 0)\n3. Negative HIV screening test (conducted at the time of enrolment)\n4. Female \\\u003C30 years old or has had \\\u003C 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy)\n5. Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole region for 24 months\n\nParent Tshireletso Study Exclusion Criteria\n\n1. Receiving carbamazepine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (\\>1 dose oral\u002FIV), or St. John's wort\n2. Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampicin)\n3. Previous hypersensitivity reaction to CAB or other INSTI\n4. Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 2 months\n5. Plan for pediatric and post-partum care outside the government system (private clinics)\n6. Inflammatory skin condition that compromises the safety of the intramuscular injection\n7. Weight \\\u003C35kg\n\nParent Doris Duke Study Inclusion Criteria Post-partum females included;\n\n1. if HIV-uninfected or unknown HIV status, willing to be tested for HIV\n2. if HIV-infected, documented to be on DTG as part of an antiretroviral treatment regimen\n3. maternal age \\>18 years,\n4. ability to speak English or Setswana\n5. intend to be available for follow up in Molepolole, Gaborone or Mochudi for 18 months post-delivery\n6. have access to a cell phone (including phone of friend or relative)\n\nParent Doris Duke Study Exclusion Criteria Post-partum females excluded if\n\n1. did not attend antenatal care or were not included in Tsepamo surveillance\n2. maternal age \\\u003C18,\n3. females who do not speak English or Setswana,\n4. unable or unwilling to give consent\n5. will not be able to attend follow up at a study site\n6. do not have access to any cell phone for follow up calls\n\nAdditional Inclusion Criteria for this PK Study\n\n1. For DMPA and ETG implant groups, intends to initiate or continue use of DMPA or ETG implant for at least another three or six months, respectively,\n2. For the CAB-LA groups, have received at least three consecutive CAB injections on time, including the one administered concurrently while starting a contraceptive method,\n3. Willing to undergo phlebotomy every 4 weeks for the duration of the sub-study period Additional Exclusion Criteria for this PK Study\n\n1\\) Use or anticipated use of nicotine-containing products (e.g., cigarettes or hookahs) known to interact with CAB-LA for the duration of the sub-study period 2) Use within the previous 90 days, current use, or planned future concomitant use of other hormonal contraceptives, including oral contraceptive methods 3) BMI≥35 4) Has any of the following laboratory abnormalities within the last year:\n\n1. Serum ALT\\>5x ULN at the time of screening,\n2. Serum creatinine \\>2.5x ULN at the time of screening. 5) Has any other condition that, in the opinion of the sub-study PI\u002Fdesignee, would preclude informed consent, make study participation unsafe, or complicate interpretation of study outcome 6) HIV infected females on the Doris Duke parent study",true,{"count":136,"type":20},105,"OBSERVATIONAL","This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time. Women who are already using CAB-LA or not using PrEP will choose to join one of several groups based on whether they use injectable contraceptive (IM DMPA), an etonogestrel implant, or no hormonal contraceptive. Participants will have study visits every 4 to 12 weeks for up to 12 or 24 weeks after starting a contraceptive method to collect blood samples and measure levels of CAB-LA and hormone concentrations. The study will compare these levels to see if taking CAB-LA changes hormone concentrations or if using hormonal contraception changes CAB-LA drug levels. Safety, side effects, satisfaction, and continuation of CAB-LA PrEP and contraceptive methods will also be evaluated.",[140,141,142,143,144],"HIV Infections","Contraception","Drug-drug Interaction","PrEP","Long-acting Injectable Cabotegravir for PrEP",[146,147,112,148,149,143,150],"Adolescent girls and young women","Injectable cabotegravir","Long-acting injectable cabotegravir","Pharmacokinetic study","HIV prevention","2026-07-19",{"date":115,"type":40},{"date":154,"type":20},"2026-08-01",{"date":156,"type":20},"2026-12-31",{"name":158,"class":124},"University of Alabama at Birmingham",1,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":102,"minAge":80,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":170,"conditions":171,"keywords":175,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"100610354","cash-transfers-to-pregnant-women-with-hiv-100610354","NCT07226492","Cash Transfers to Pregnant Women With HIV","A Pilot Trial of an Unconditional Cash Transfer for Pregnant Women With HIV in Botswana","Inclusion Criteria:\n\n* Age 18 years or greater\n* Botswana citizen\n* Seeking\u002Freceiving antenatal care at antenatal clinics managed by the District Health Management Teams in Gaborone and Mogoditsane-Thamaga District\n* Confirmed pregnancy by standard laboratory methods (generally urine testing)\n* HIV seropositive\n* Economically vulnerable (self-reported annual income below the Botswana poverty line of 14,000 BWP per year, equivalent to the international poverty line of $2.15 in 2017 purchasing power parity)\n\nExclusion Criteria:\n\n* Does not meet all of the inclusion criteria\n* Unable to provide consent\n* Cognitive impairment, per discretion of study staff\n* Cannot be in the same household as another enrolled study participant",{"count":168,"type":20},100,[106],"The goal of this study is to evaluate the effectiveness and implementation of an unconditional cash transfer intervention to improve mental bandwidth, ART adherence, and postpartum retention among pregnant women with HIV in Botswana.\n\nThe main questions it seeks to answer are:\n\n1. Do unconditional monthly cash transfers improve mental bandwidth relative to usual care among pregnant women with HIV?\n2. Do unconditional monthly cash transfers improve ART adherence (PDC) during pregnancy and the postpartum period?\n3. Is delivery of UCTs via mobile money feasible and acceptable in public ANC clinics in Botswana?\n4. What barriers and facilitators affect implementation, and how should the model be adapted for a larger trial or a policy pilot (e.g., a pregnancy support grant)?",[63,172,173,174],"Pregnancy","HIV Antiretroviral Therapy (ART) Adherence","Post-partum",[176],"Cash-transfer","2026-07-14",{"date":179,"type":40},"2026-07-15",{"date":181,"type":40},"2026-03-09",{"date":183,"type":20},"2028-01-04",{"name":185,"class":124},"University of Pennsylvania",8,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":134,"sex":16,"minAge":194,"maxAge":4,"enrollmentInfo":195,"targetDuration":196,"studyType":137,"phases":4,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":159},"100645969","lung-health-and-the-microbiome-among-adults-in-botswana-the-go-hema-cohort-100645969","NCT07699614","Lung Health and the Microbiome Among Adults in Botswana: the Go-hema Cohort","Determinants of Lung Health Among Batswana Adults With and Without HIV: the Go-Hema Study","Inclusion Criteria:\n\n* Adults 35 years of age or older\n* In case at a clinic in Botswana\n* Documented HIV status\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Respiratory infection in the prior 4 weeks\n* Active pulmonary tuberculosis\n* Inability to perform spirometry including eye, abdominal, or\n* Thoracic surgery or myocardial infarction in the prior 6 weeks\n* Pregnancy","35 Years",{"count":19,"type":20},"4 Months","Chronic respiratory diseases like chronic obstructive pulmonary disease (COPD) are responsible for millions of deaths each year, the majority of which occur in low- and middle-income countries (LMICs). LMICs also have high rates of abnormal lung function, including restrictive spirometric pattern (RSP), which can precede the development of chronic respiratory diseases and is associated with all-cause mortality. Additionally, LMICs in sub-Saharan Africa are home to the majority of the world's population of people with HIV (PWH). HIV increases the risk of COPD and COPD associated mortality, but the mechanisms underlying this risk are incompletely understood.",[199,200],"Obstructive Pulmonary Disease","Restrictive Pulmonary Disease","2026-07-08",{"date":203,"type":40},"2026-07-13",{"date":205,"type":40},"2024-12-01",{"date":207,"type":20},"2030-12-20",{"name":209,"class":124},"Duke University",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":134,"sex":102,"minAge":218,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":21,"phases":221,"briefSummary":222,"conditions":223,"keywords":232,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":159},"100628220","healthy-expectancy-through-routine-antenatal-sti-screening-100628220","NCT07458802","Healthy Expectancy Through Routine Antenatal STI Screening","Screening and Treatment for Chlamydia Trachomatis Infection to Prevent Preterm Birth","HERA","Inclusion Criteria:\n\n1. Asymptomatic for cervicovaginitis at first ANC (i.e., not syndromically treated for an STI by clinic midwives at first ANC)\n2. Age ≥ 15 years\n3. Currently pregnant\n4. ≤20 weeks gestation (based on gestational age in obstetric record or last menstrual period if gestational age missing from record)\n5. Attending first ANC visit\n6. Residence in Gaborone, Bostwana or surrounding villages through the time of delivery\n7. Mentally competent to understand study procedures or give informed consent","15 Years",{"count":220,"type":20},2000,[106],"This study will evaluate whether routine screening and treatment for two common sexually transmitted infections, chlamydia and gonorrhoea, during pregnancy can reduce preterm birth and other poor birth outcomes in Botswana, and whether this approach is affordable and cost-effective for the health system.\n\nAbout 2,000 pregnant women attending their first antenatal care visit at up to 10 government clinics in Botswana will be invited to join the study. All women will first receive the usual antenatal care services provided in Botswana, including routine health checks and HIV and syphilis testing. Women who enroll in the study will be randomly assigned to one of two groups:\n\n1. Standard of care group: Women receive routine antenatal care only.\n2. Intervention group: In addition to routine antenatal care, women are screened for chlamydia and gonorrhoea using self-collected vaginal swabs at their first antenatal care visit and again in the third trimester.\n\nThe main outcome of the study is whether screening and treating chlamydia and gonorrhoeae reduces preterm birth (before 37 weeks). Other outcomes include low birth weight, very preterm birth, and maternal health conditions.",[224,225,226,227,228,229,230,231],"Antenatal Health","Antenatal Care","STI","Chlamydia Trachomatis Infection in Pregnancy","Chlamydia","Chlamydia Trachomatis","Chlamydia Trachomatis Infection","Preterm Birth",[233,234,235,236,237,238,239,226,240,241,242,112,243,244,245],"antenatal health","antenatal screening","chlamydia","chlamydia trachomatis","chlamydia screening","chlamydia treatment","pregnancy screening","STI screening","STI in pregnancy","preterm delivery","CT infection","chlamydia in pregnancy","birth outcomes","2026-06-30",{"date":248,"type":40},"2026-07-02",{"date":250,"type":40},"2026-05-25",{"date":252,"type":20},"2030-07-01",{"name":254,"class":124},"Adriane Wynn",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":134,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":264,"conditions":265,"keywords":266,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":159},"100638066","dynamic-decision-support-for-integrating-prep-in-clinics-for-young-people-in-alabama-and-botswana-100638066","NCT07597824","DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana","DYNAMIC PrEP","Group 1\n\n* Inclusion for Alabama site:\n\n  * 18 years of age or older\n  * Currently using or eligible for PrEP\n* Inclusion for Botswana site:\n\n  * 18 years of age or older\n  * Participated in the parent Tshireletso study in Botswana\n* Exclusion for both sites:\n\n  * Under the age of 18\n  * HIV positive\n\nGroup 2\n\n* Inclusion for both sites:\n\n  * 18 years of age or older\n  * Currently working as PrEP providers or clinic administrators at outpatient clinics\n* Exclusion for both sites:\n\n  * Under the age of 18\n\nGroup 3\n\n* Inclusion for both sites:\n\n  * 18 years of age or older\n  * Currently working as policy makers or program leaders at outpatient clinics\n* Exclusion for both sites:\n\n  * Under the age of 18",{"count":263,"type":20},1000,"This study evaluates strategies to improve access to HIV prevention through the integration of pre-exposure prophylaxis (PrEP) into existing healthcare settings, rather than limiting delivery to specialty clinics. The study addresses barriers to PrEP uptake, including limited awareness, stigma, and restricted access, and recognizes that availability alone may not ensure initiation or sustained use.\n\nThe study includes two components. First, a longitudinal cohort of current PrEP users will be followed to assess changes in access, preferences, and PrEP use over time in real-world settings. Second, a dynamic decision-support toolkit will be developed and evaluated to support patients and providers in PrEP-related decision-making. The toolkit will include patient- and provider-facing components to support clinical decision-making, improve risk understanding, and facilitate integration of PrEP into routine healthcare. The toolkit will be refined and beta-tested in selected healthcare facilities in Botswana and Alabama.",[140,141,143],[267,143,268,112,269],"HIV adherence","young adults","Alabama","2026-06-23",{"date":272,"type":40},"2026-06-25",{"date":274,"type":20},"2026-06",{"date":276,"type":20},"2031-12",{"name":158,"class":124},{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":134,"sex":102,"minAge":4,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":21,"phases":288,"briefSummary":290,"conditions":291,"keywords":294,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":159},"100586764","phase-3-sti-testing-to-enhance-prep-use-in-pregnancy-100586764","NCT06919614","STI Testing to Enhance PrEP Use in Pregnancy","Improving PrEP Outcomes Among Pregnant Women in Botswana With an Integrated STI Testing and PrEP Delivery Model","STEP-UP","Inclusion Criteria:\n\n* Pregnant and seeking antenatal care\n* Self-identifying as a cis-gender woman\n* Living without HIV\n* Not currently using PrEP\n* Planning to remain in the city\u002Ftown of enrolment until 9 months post-delivery.\n* Planning to receive antenatal and postnatal care in the city\u002Ftown of enrolment.\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Male gender\n* Not pregnant\n* Living with HIV\n* Currently using PrEP\n* Not planning to remain in the city\u002Ftown of enrolment until 9 months post-delivery\n* Not planning to receive antenatal and postnatal care in the city\u002Ftown to enrolment\n* Not able or willing to provide informed consent for participation",{"count":287,"type":20},600,[289],"PHASE3","The investigators are conducting a study in Botswana to see if offering STI testing along with expanded HIV prevention options (PrEP) helps more pregnant women start and continue using PrEP during and after pregnancy. Pregnant women (n=600) seeking antenatal care in Botswana will be enrolled and randomly assigned to receive the standard of care (standard STI assessment with no STI testing) versus STI testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis during pregnancy and postpartum. The investigators' hypothesis is that providing STI testing alongside PrEP offer will encourage more women to start and continue using PrEP.",[292,293,172],"PrEP Adherence","Sexually Transmitted Infections (STIs)",[295,143,63,296,228,297,298,299,300,301,302],"Pregancy","STIs","Gonorrhoea","Gonorrhea","Trichomonas","Dapivirine","Truvada","Oral PrEP","2026-06-09",{"date":305,"type":40},"2026-06-11",{"date":307,"type":40},"2025-06-18",{"date":309,"type":20},"2029-08-31",{"name":311,"class":124},"Botswana Harvard AIDS Institute Partnership",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":16,"minAge":319,"maxAge":320,"enrollmentInfo":321,"targetDuration":4,"studyType":21,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":334},"100555181","phase-1-the-tatelo-plus-study-100555181","NCT06508749","The Tatelo Plus Study","Phase I\u002FII Trial to Evaluate the Impact of Three Broadly Neutralizing Antibodies or Analytic Treatment Interruption on Viral Reservoir, Immune Function, and Maintenance of HIV Suppression in Early Treated Children in Botswana","Inclusion Criteria, Step 1\n\n* Previously enrolled in the EIT\u002FTatelo, or Moso Cohort Study\n* Receiving prescribed ART for at least 24 weeks prior to study entry as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records\n* 24 weeks to 12 years of age at enrollment, inclusive\n* If entering Step 1a: HIV-1 RNA \\\u003C40 copies\u002FmL for at least 24 weeks prior to entry, including documented suppression to \\\u003C40 copies\u002FmL within 30 days of Step 1 entry\n* If entering Step 1b: HIV-1 RNA \\\u003C200 copies\u002FmL for at least 24 weeks prior to entry, including documented suppression to \\\u003C40 copies\u002FmL within 30 days of Step 1 entry.\n* Normal temperature (\\\u003C37.4°C axillary, or \\\u003C38°C non-axillary) and no signs or symptoms of acute illness at entry as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records\n* Normal, grade 1 or grade 2 results for all of the following laboratory tests at screening, based on testing of specimens collected within 30 days prior to entry and grading per protocol:\n\n  * Hemoglobin\n  * Absolute neutrophil count\n  * Platelet count\n  * Alanine aminotransferase\n  * Aspartate aminotransferase\n  * Creatinine\n* For female participants who are able to become pregnant (defined as having reached menarche and not having undergone surgical sterilization), not pregnant based on testing performed from a specimen collected within 5 days prior to enrollment). Note: Pregnancy is not expected in Step 1 given the age range of eligible participants.\n* Expected to be available for the duration of participation and expected to comply with the visit schedule and other requirements as determined by the site investigator based on participant\u002Fparent\u002Fguardian report at entry\n* Not currently participating in another study of an investigational agent and is not expected to participate in any such study for the duration of participation, as determined by the site investigator based on participant\u002Fparent\u002Fguardian report at entry. Prior or current participation in the EIT\u002FTatelo or Moso cohort studies is permitted.\n* Parental\u002Flegal guardian is willing and able to provide written permission for child's participation and, child is willing and able to provide written assent for participation if 7- 17 years of age\n\nInclusion Criteria, Step 2\n\n* At or beyond the Week 24 visit in Step 1\n* Susceptible to at least 2 of the 3 bNAbs under study at or prior to Step 1 entry OR Negative EIA and negative qualitative DNA result at last available evaluation in Step 1 in the absence of available susceptibility data\n* No confirmed HIV-1 RNA ≥40 copies\u002FmL throughout Step 1 and for at least 24 weeks prior to Step 1 entry\n\nInclusion Criteria, Step 3\n\n* If entering from Step 1:\n\n  1. At or beyond the Week 24 visit in Step 1, with no confirmed HIV-1 RNA ≥40 copies\u002FmL throughout Step 1\n  2. Not eligible for Step 2\n  3. No confirmed HIV-1 RNA ≥40 copies\u002FmL for at least 96 weeks prior to Step 3 entry (or since 24 weeks of age if 96-120 weeks of age)\n  4. Detection of ≥60% of intact proviruses in heterochromatin DNA regions (i.e. non-genic DNA, satellite DNA, ZNF genes) from any PBMC sample analyzed by MIP-seq, and no recorded viremia (\\>40 copies\u002FmL) after this evaluation OR Negative EIA and negative Qualitative HIV DNA result within 12 weeks prior to Step 3 entry\n  5. Approved for entry by Clinical Management Committee (CMC)\n  6. Willingness and ability to provide independent written informed consent for participation or parental\u002Flegal guardian is willing and able to provide written permission for child's participation and, child is willing and able to provide written assent for participation if 7-17 years of age\n* If entering from Step 2:\n\n  1. At or beyond the Week 24 visit of Step 2, with HIV-1 RNA \\\u003C40 copies\u002FmL throughout Steps 1 and 2\n  2. No confirmed HIV-1 RNA ≥40 copies\u002FmL for at least 96 weeks prior to Step 3 entry (or since 24 weeks of age if 96-120 weeks of age)\n  3. Negative EIA and negative qualitative DNA result within 12 weeks prior to Step 3 entry OR Detection of ≥60% of intact proviruses in heterochromatin DNA regions (i.e. non-genic DNA, satellite DNA, ZNF genes) from any PBMC sample analyzed by MIP-seq, and no recorded viremia (\\>40 copies\u002FmL) after this evaluation entry AND approved for entry by CMC\n  4. For Moso participants, not currently being breastfed\n  5. Willingness and ability to provide independent written informed consent for participation or parental\u002Flegal guardian is willing and able to provide written permission for child's participation and, child is willing and able to provide written assent for participation if 7-17 years of age\n* If entering Step 3 directly upon enrollment:\n\n  1. Previously enrolled in the EIT\u002FTatelo, Moso, or BHP Adolescent Cohort Study\n  2. 96 weeks to 25 years of age at enrollment, inclusive\n  3. \"Non-encoding\" virus: Detection of ≥60% of intact proviruses in heterochromatin DNA regions (i.e. non-genic DNA, satellite DNA, ZNF genes) from any PBMC sample analyzed by MIP-seq, and no recorded viremia (\\>40 copies\u002FmL) after this evaluation OR \"No intact virus\": adolescent (13-25 years) with no intact HIV detected in at least 20 million PBMCs sampled within the prior 4 years\n  4. For \"non-encoding\" virus: Receiving prescribed ART prior to Step 3 entry, with HIV-1 RNA \\\u003C40 copies\u002FmL for at least 96 weeks prior to entry (or since 24 weeks of age if 96-120 weeks of age), including documented suppression to \\\u003C40 copies\u002FmL within 30 days of Step 3 entry\n  5. For \"no intact virus\": Receiving prescribed ART prior to Step 3 entry, with HIV-1 RNA \\\u003C40 copies\u002FmL for at least 10 years prior to entry, including documented suppression to \\\u003C40 copies\u002FmL within 30 days of Step 3 entry\n  6. Approved for entry by CMC\n  7. For Moso participants, not currently being breastfed\n  8. For female participants who are able to become pregnant (defined as having experienced menarche and not having undergone surgical sterilization), not pregnant based on testing performed from a specimen collected within 5 days prior to enrollment)\n  9. For female participants who are able to become pregnant (defined as having reached menarche and not having undergone surgical sterilization) and report sexual activity that could lead to pregnancy, willing to use two methods of contraception while on study. One of the two methods must be highly effective; highly effective methods include the following:\n\n     * Contraceptive intrauterine device or intrauterine system\n     * Subdermal contraceptive implant\n     * Progestogen injections\n     * Combined estrogen and progestogen oral contraceptive pills\n     * Percutaneous contraceptive patch\n     * Contraceptive vaginal ring The highly effective method must be initiated prior to enrollment. The second method must be a barrier method for dual protection against pregnancy and to avoid transmission of HIV during the ATI and other sexually transmitted infections.\n  10. For female participants who are able to become pregnant, not currently breastfeeding an infant, and not intending to breastfeed an infant for the duration of the study, based on participant\u002Fparent\u002Fguardian report at entry\n  11. For participants who report sexual activity, willing to receive counseling and to use condoms to avoid transmission of HIV\n  12. Expected to be available for the duration of participation and expected to comply with the visit schedule and other requirements as determined by the site investigator based on participant\u002Fparent\u002Fguardian report at entry\n  13. Not currently participating in another study of an investigational agent and is not expected to participate in any such study for the duration of participation, as determined by the site investigator based on participant\u002Fparent\u002Fguardian report at entry. Prior or current participation in the EIT\u002FTatelo, Moso, or BHP Adolescent cohort studies is permitted.\n  14. Willingness and ability to provide independent written informed consent for participation or parental\u002Flegal guardian is willing and able to provide written permission for child's participation and, child is willing and able to provide written assent for participation if 7-17 years of age\n\nInclusion Criteria, Step 4\n\n* Previously entered the study in Step 1 or Step 3. All participants will enter Step 4 upon completing a prior study step. Participants ending Step 1a or Step 1b who, for any reason, do not proceed to Step 2 or to Step 3 will be eligible to proceed to Step 4. Participants ending Step 2 who, for any reason, do not proceed to Step 3 will be eligible to proceed to Step 4. Participants ending Step 3 for any reason will be eligible to proceed to Step 4.\n\nExclusion Criteria:\n\n* Active tuberculosis (either suspected or proven) or malignancy.\n* Hepatitis B surface antigen (HBsAg) positive\n* Received within 30 days prior to study entry, or is identified as requiring, any of the following:\n\n  * Any immunoglobulin-based treatment\n  * Chronic (more than 14 days) systemic steroid treatment\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* For participants entering Step 1 and Step 2: \\\u003C5 kg or \\>115kg.\n* For participants entering Step 3 directly: Received NNRTI-based ART (including efavirenz, nevirapine, rilpivirine) within 14 days of Step 3 entry","24 Weeks","25 Years",{"count":322,"type":20},41,[59,23],"The purpose of this study is to advance pediatric HIV treatment and cure research by evaluating the impact of a combination of three anti-HIV-1 broadly neutralizing antibodies (bNAbs) or analytic treatment interruption (ATI) on viral reservoir, immune function, and maintenance of HIV suppression in early-treated children.",[63,140],"2026-05-27",{"date":328,"type":40},"2026-05-29",{"date":330,"type":40},"2024-11-11",{"date":332,"type":20},"2028-02-18",{"name":46,"class":47},2,{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":16,"minAge":342,"maxAge":343,"enrollmentInfo":344,"targetDuration":4,"studyType":21,"phases":346,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":358},"100490042","phase-1-study-of-oral-and-long-acting-injectable-cabotegravir-and-rilpivirine-in-virologically-suppressed-children-living-with-hiv-1-two-to-less-than-12-years-of-age-100490042","NCT05660980","Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age","Phase I\u002FII Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age","Inclusion Criteria, Step 1: Entry for Cohort 1, Cohort 2a, and Cohort 2b\n\n* Parent or legal guardian is willing and able to provide written permission for child's study participation and, when applicable per institutional review board\u002Fethics committee (IRB\u002FEC) policies and procedures, child is willing and able to provide written assent for study participation.\n\nNote: All sites must follow all applicable IRB\u002FEC policies and procedures; for US sites, this includes single IRB (sIRB) policies and procedures.\n\n* Age two years old to less than 12 years old at entry\n* Body weight ≥10 kg and \\\u003C40 kg at entry\n* At entry, willing and able to comply with the study visit schedule and other study requirements, as determined by the site investigator or designee.\n* Confirmed HIV-1-infection based on documented testing of two samples collected from two separate blood collection tubes per Sample #1 and Sample #2 requirements. Test results may be obtained from medical records or from testing performed during the study screening period\n* Has been on a stable unchanged ART regimen consisting of two or more drugs from two or more antiretroviral drug classes for at least six consecutive months (defined as 180 consecutive days) prior to entry.\n* Has no prior history of switching ART regimens for reasons related to treatment failure based on parent\u002Fguardian report and\u002For available medical records.\n\nNote: Participants undergoing dose modifications for growth or who have switched to a new formulation due to toxicity, tolerability, or changes in national treatment guidelines are considered eligible per this inclusion criterion. Treatment failure should be defined by local guidelines.\n\n* From a specimen collected less than six months (defined as within 179 days) prior to entry, has at least one of the following documented plasma HIV-1 RNA results:\n\n  * \\\u003C50 copies\u002FmL, or\n  * less than the lower limit of detection of the assay\n* From a specimen collected in the 6-18 months (defined as 180 to 545 days) prior to entry, has at least one of the following documented plasma HIV-1 RNA results:\n\n  * \\\u003C50 copies\u002FmL, or\n  * less than the lower limit of detection of the assay\n* At screening, a documented plasma HIV-1 RNA \\\u003C50 copies\u002FmL.\n\nNote: HIV-1 RNA test results at screening cannot be used to satisfy previously listed inclusion criterion. If participant does not have a documented HIV-1 RNA test result at screening that satisfies previously listed criteria, they should be referred for standard of care testing and return at a later date for screening.\n\n* Has normal, Grade 1, or Grade 2 results for all the following laboratory tests at screening (i.e., within 28 days prior to entry) based on grading per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events:\n\n  * AST (\\\u003C5.0 x ULN)\n  * ALT (\\\u003C5.0 x ULN)\n  * Total bilirubin (\\\u003C2.6 x ULN)\n  * Lipase (\\\u003C3 x ULN)\n  * Estimated glomerular filtration rate (eGFR; ≥60 ml\u002Fmin\u002F1.73 m2)\n  * Platelets (≥50,000 cells\u002Fmm3 or ≥50.00 x 109 cells\u002FL)\n  * Hemoglobin (≥8.5 g\u002FdL or ≥5.25 mmol\u002FL)\n  * Neutrophils (≥600 cells\u002Fmm3)\n\nNote: Laboratory tests may be repeated during the study screening period (i.e., within 28 days prior to entry), with the latest result used for eligibility determination. ALT and total bilirubin should also be assessed\n\n* Has no evidence of chronic hepatitis B infection based on hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), and hepatitis B surface antibody (HBsAb) testing at screening; any of the following three combinations of test results are acceptable for inclusion:\n\n  * HBsAg negative, HBcAb negative, HBsAb negative\n  * HBsAg negative, HBcAb negative, HBsAb positive\n  * HBsAg negative, HBcAb positive, HBsAb positive\n* At screening, has a mean QTc interval (based upon a triplicate reading) less than or equal to 450 msec based on an electrocardiogram (ECG) automated machine readout or calculated using the Fridericia formula.\n* For female participants of childbearing potential, not pregnant based upon negative blood or urine pregnancy test at entry. Childbearing potential is defined as nine years of age or older and:\n\n  * Having reached menarche or\n  * Engaging in sexual activity (self-reported) that could lead to pregnancy\n* For female participants of childbearing potential who are engaging in sexual activity (self-reported) that could lead to pregnancy, at entry, currently using at least one allowable highly effective method of contraception and agrees to use at least one allowable highly effective method of contraception throughout study participation and for at least 30 days after last oral product use and 48 weeks after last injectable study product use.\n\nHighly effective methods of contraception include:\n\n* Surgical sterilization (i.e., hysterectomy, bilateral oophorectomy, tubal ligation, or salpingectomy)\n* Contraceptive intrauterine device or intrauterine system\n* Subdermal contraceptive implant\n* Progestogen injections\n* Combined estrogen and progestogen oral contraceptive pills\n* Percutaneous contraceptive patch\n* Contraceptive vaginal ring\n\nInclusion Criteria, Step 2: Continuation for Cohort 1 and Cohort 2a to injection phase\n\nAll participants enrolled in Cohort 1 or Cohort 2a will be assessed for eligibility to progress from the oral lead-in phase (Step 1) to the injection phase (Step 2), primarily based on the safety assessments from the Step 1 Week 4a study visit. Clinical assessments conducted prior to administering the first injection at the Week 4b visit will also be used to confirm eligibility to receive the injectable study product.\n\nAll of the following criteria must be met in order for a participant enrolled in Cohort 1 or Cohort 2a to be included in Step 2\n\n* Currently enrolled as a participant in Step 1.\n* Has normal, Grade 1, or Grade 2 results from all of the following laboratory test results based upon specimens collected at the Week 4a study visit or from confirmatory repeat testing of Week 4a study visit laboratory tests:\n\n  * AST (\\\u003C5.0 x ULN)\n  * ALT (\\\u003C5.0 x ULN)\n  * Lipase (\\\u003C 3 x ULN)\n  * Estimated glomerular filtration rate (eGFR; ≥60 ml\u002Fmin\u002F1.73 m2))\n  * Platelets (≥50,000 cells\u002Fmm3 or ≥50.00 x 109 cells\u002FL)\n  * Hemoglobin (≥8.5 g\u002FdL or ≥5.25 mmol\u002FL)\n  * CK (\\\u003C10 x ULN)\n\nNote: For a Grade 2 ALT test result from this visit, refer to protocol for required participant management.\n\n* For female participants of childbearing potential not pregnant based upon negative blood or urine pregnancy test at the Week 4b study visit.\n* Assessed by the IoR or designee as sufficiently adherent to study products in Step 1 to permit an adequate evaluation of safety and tolerability as part of the oral lead in phase prior to entry into the injection phase.\n\nInclusion Criteria for Parents\u002FCaregivers\n\nParents\u002Fcaregivers of participants will be considered for enrollment to complete quantitative behavioral surveys and\u002For qualitative in-depth interviews (IDIs), as indicated in the SoE. One parent\u002Fcaregiver per participant should be enrolled to complete all behavioral assessments, including the IDI, when applicable. Informed consent for parent\u002Fcaregiver enrollment should be obtained at the entry visit, after the child participant's eligibility has been confirmed, and may be completed at a later date, if necessary. However, parent\u002Fcaregiver consent must occur prior to any study assessments being conducted. The enrolled caregiver may be the different than the parent or legal guardian who provided written permission for the child to participate. If, at any point the enrolled parent\u002Fcaregiver for a given participant withdraws from the study or is unable to complete remaining study assessments for any reason, they may be replaced.\n\nCaregivers must meet the following criteria to be eligible to enroll in IMPAACT 2036:\n\n* 18 years of age or older\n* Able and willing to provide written informed consent consistent with site IRB\u002FEC policies and procedures\n* Caregiver, defined as a biological parent, legal guardian, or other person who provides significant emotional, psychological, and\u002For physical care to a child enrolled in IMPAACT 2036, based on self-report\n\nExclusion Criteria, Step 1: Entry for Cohort 1, Cohort 2a, and Cohort 2b\n\nPotential participants must be excluded from the study if any of the conditions specified below are identified during the screening period (i.e., within 28 days prior to study entry). The screening period begins when parental permission and informed assent (if applicable) are obtained and ends immediately prior to enrollment. For criteria involving a potential participant's medical history, it is expected that each exclusionary condition will be assessed at screening and subsequently reviewed and confirmed on the day of study entry, prior to enrollment. In these criteria, \"at entry\" is used to refer to the day of enrollment in the study\n\n* Within 6 months prior to entry, any HIV-1 RNA value \\>400 copies\u002FmL OR two consecutive \"viral blips,\" defined as an HIV-1 RNA value ≥50 copies\u002FmL but ≤400 copies\u002FmL.\n* As determined by the IoR or designee, and based on available medical records, known or suspected resistance to NNRTIs.\n\nNote: Prior receipt of NNRTIs for prophylaxis or treatment is not exclusionary\n\n* As determined by the IoR or designee, and based on available medical records, known or suspected resistance to INSTIs.\n* Ongoing congestive heart failure, symptomatic arrhythmia, or any current clinically significant cardiac disease, as determined by the IoR or designee, and based on available medical records.\n* Has any of the following, as determined by the IoR or designee based on participant\u002Fparent\u002Fguardian report and available medical records:\n\n  * Current hepatitis C infection\n  * Current clinically significant hepatic disease\n  * Current or anticipated need for chronic anti-coagulation\n  * History of known or suspected bleeding disorder, including a history of prolonged bleeding\n  * History of sensitivity to heparin or heparin-induced thrombocytopenia, as determined by the IoR or designee, based on available medical records\n  * Risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, hypomagnesemia)\n  * Known or suspected allergy to study product components.\n  * Known phobia to needles\n* More than one seizure within one year (defined as within 365 days) prior to entry, or unstable or poorly controlled seizure disorder, as determined by the IoR or designee, and based on available medical records.\n* Has the following combination of laboratory test results at screening (i.e., from specimens collected within 28 days prior to entry): ALT greater than or equal to 3 x ULN and total bilirubin greater than or equal to 1.5 x ULN and direct bilirubin greater than 35% of total bilirubin.\n* At entry, known active tuberculosis infection, as determined by the IoR or designee based on participant\u002Fparent\u002Fguardian report and available medical records.\n* At entry, any ongoing pancreatitis as determined by the IoR or designee based on participant\u002Fparent\u002Fguardian report and available medical records.\n* At entry, has symptoms suggestive of active coronavirus disease 2019 (COVID-19) or test results or contacts that require quarantine per local clinical practice, public health, and\u002For infection control guidelines as determined by the IoR or designee based on participant\u002Fparent\u002Fguardian report and available medical records.\n\nNote: Potential participants with symptoms suggestive of active COVID-19, test results, and\u002For contacts that require quarantine may resume screening (or be re-screened) after symptoms have resolved and applicable quarantine requirements have been completed.\n\n* Receipt of any prohibited medication within 7 days prior to entry, with the exception of antiviral agents that are part of the participant's ART regimen, as determined by the site investigator based on participant\u002Fparent\u002Fguardian report and available medical records\n\nNote: Medications and vaccines approved for emergency use (e.g., COVID vaccines) that do not appear in the IMPAACT 2036 Prohibited and Precautionary Medications listing are not exclusionary may be administered as per standard of care.\n\n* Any past or current exposure to CAB LA or RPV LA\n* At entry, based on physical examination, has a current inflammatory skin condition that compromises the safety of intramuscular injections, as determined by the IoR or designee.\n* At entry, based on physical examination, has a dermatological condition overlying the buttock or upper thigh region, which, in the IoR or designee's opinion, may interfere with the interpretation of injection site reactions.\n* Enrolled in another clinical trial of an investigational agent, device, or vaccine.\n* Has any documented or suspected clinically significant medical or psychiatric condition or any other condition or social circumstance that, in the opinion of the site investigator, would make participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n\nExclusion Criteria, Step 2: Continuation for Cohort 1 and Cohort 2a to injection phase\n\nParticipants in Cohort 1 or Cohort 2a who meet any of the following criteria will be excluded from Step 2:\n\n* Has permanently discontinued oral study product.\n* Occurrence of any grade 3 or higher adverse event assessed as related to study product during Step 1.\n* Any other condition or social circumstance situation that, in the opinion of the IoR or designee, would make continued study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n\nExclusion Criteria for Parents\u002FCaregivers\n\n* Any condition or social circumstance situation that, in the opinion of the IoR or designee, would make study participation unsafe for the caregiver or the child study participant, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.","2 Years","11 Years",{"count":345,"type":20},90,[59,23],"The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age",[349],"HIV-1-infection","2026-05-18",{"date":352,"type":40},"2026-05-19",{"date":354,"type":40},"2024-01-24",{"date":356,"type":20},"2029-03-31",{"name":46,"class":47},12,{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":102,"minAge":320,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":21,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":159},"100638783","testing-the-feasibility-of-different-hpv-screening-and-care-strategies-for-women-living-with-hiv-100638783","NCT07576842","Testing the Feasibility of Different HPV Screening and Care Strategies for Women Living With HIV","CASCADE: A Feasibility Study of HPV Screening and Management Strategies Utilizing Extended Molecular HPV DNA Genotyping and HPV Viral Load in Women Living With HIV","Inclusion Criteria:\n\n* HIV-1 infection, as documented by:\n\n  1. any FDA-approved, licensed HIV rapid test performed in conjunction with screening (oral immunoblot, ELISA test kit, and confirmed by Western blot or other approved test), OR\n  2. a physician's written record that documents HIV infection with supporting information on the participant's relevant medical history and\u002For current management of HIV infection, OR\n  3. documentation of a prescription of an approved antiretroviral regimen by either possession of pill bottles or packages with prescriber's name or ARVs dispensed from an HIV clinical treatment program with participant identifiers affixed to the bottles or packages.\n* Aged 25 or older.\n* Ability to understand and the willingness to sign a written informed consent document by the participant or by the legal representative(s) of the participant.\n* Have an intact cervix.\n\nExclusion Criteria:\n\n* Current symptoms or concern for cervical cancer.\n* History of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer or current symptoms of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer.\n* Have undergone cervical hHSIL treatment in the past year.\n* Have a history of hysterectomy with removal of the cervix.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including opportunistic infections of AIDS and\u002For genitourinary infections), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Any other medical condition or social situation that would put the participant, the study staff, or the study outcomes at risk, as determined by the site investigators.",{"count":367,"type":20},750,[106],"The overall goal of this study is to inform the design and establish feasibility for a future clinical trial to determine the optimal management of women living with HIV (WLWH) with high-risk human papillomavirus (hrHPV) detected on HPV-based cervical cancer screening. WLWH have a higher diversity of anogenital HPV types causing cervical high-grade squamous intraepithelial lesions (hHSIL) and invasive cancer compared to women without HIV. While there is consensus that women testing positive for HPV 16 and\u002For 18 should be immediately managed and treated, optimal management strategies for women with other hrHPV types (non-16\u002F18) are not well defined.\n\nThis prospective cohort study will enroll WLWH undergoing cervical cancer screening using primary HPV testing. Women will self-collect vaginal specimens for hrHPV testing using the Abbott Alinity m HPV assay, which provides extended HPV genotyping and a proxy for HPV viral load based on cycle threshold (CT) values. Women with hrHPV detected will return for further evaluation and treatment as indicated. A subset of women will return at Month 6 for repeat evaluation.\n\nThe study will evaluate feasibility for a future trial by examining recruitment, retention, return for evaluation, and completion of treatment. It will also explore management strategies for women with non-16\u002F18 hrHPV based on extended genotyping and HPV viral load compared to standard of care approaches using visual inspection with acetic acid (VIA).",[371,372,109,373,374],"Human Papillomavirus (HPV)","HPV Associated Cancers","Human Immunodeficiency Virus (HIV)","Cervical Intraepithelial Neoplasia (CIN)","2026-05-04",{"date":377,"type":40},"2026-05-08",{"date":379,"type":20},"2026-06-01",{"date":381,"type":20},"2027-06-01",{"name":383,"class":124},"University of California, San Diego",{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":390,"enrollmentInfo":391,"targetDuration":4,"studyType":21,"phases":393,"briefSummary":394,"conditions":395,"keywords":398,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":159},"100501331","rct-of-an-intersectional-stigma-intervention-to-sustain-viral-suppression-among-women-living-with-serious-mental-illness-and-hiv-in-botswana-100501331","NCT05807867","RCT of an Intersectional Stigma Intervention to Sustain Viral Suppression Among Women Living With Serious Mental Illness and HIV in Botswana","(A) WOMEN WITH SMI AND HIV\n\nAt Sbrana Psychiatric Hospital, the investigators will recruit women with SMI and HIV who are receiving treatment at that facility. Women with SMI and HIV will be receiving psychiatric care and ART and must:\n\n1. Meet DSM-5 criteria for current psychotic disorder or mood disorders or other disorders causing functional impairment except substance use disorders and developmental disorders, per clinician interview based on the MINI\n2. Have confirmed HIV positive status\n3. Be 18-55 years of age\n4. Be female\n5. Have capacity to provide consent and written informed consent\n6. Speak English or Setswana\n7. Be a Botswana citizen\n\n   The investigators will also recruit 6 to 8 women with SMI and HIV as peer co-leaders to facilitate the intervention. For women who are peer co-leaders, inclusion criteria include #1 to #7 above in addition to:\n8. Remaining adherent to psychiatric medications\n9. Being symptomatically stable for \\>2 years\n10. Maintaining consistent ART adherence.\n\n(B) FAMILY MEMBERS OF WOMEN WITH SMI AND HIV.\n\nIn Botswana, families are usually contacted and engaged in psychiatric treatment planning during inpatient stay or on admission. The involvement of family continues during outpatient follow-ups since most patients are accompanied by some relative or caregiver on such visits. Eligible participants include:\n\n1. Identified by participant and\u002For clinician as the relative 'most involved in the client's care'.\n2. Be 18-65 years of age\n3. English or Setswana speaking\n4. Botswana citizen.\n\n(C) POLICY MAKERS AND OTHER STAKEHOLDERS.\n\nPolicy makers will be\n\n1. Be 18-55 years of age\n2. Include: (a) bureaucratic officials of Botswana, public sector ministries (government) at the national level holding appointment to senior offices that develop, interpret and\u002For implement national mental health and HIV programs (prevention and treatment) or related clinical services; (b) senior bureaucratic officials of the National AIDS and Health Promotion Agency (NAHPA); and (c) senior members of civil society organizations (CSOs), nongovernment organizations (NGOs) or other entities that support the national Botswana government to implement services to People Living With HIV (PLWH) and mental health patients.","65 Years",{"count":392,"type":20},360,[106],"The study goal is to promote viral load suppression among women with serious mental illness (SMI) and HIV in Botswana, given that these women are especially vulnerable to psychiatric medication nonadherence and symptom exacerbation, which are made worse by stigma and threaten antiretroviral therapy (ART) adherence.\n\nThe investigators propose to test an intervention to reduce stigma due to the statuses of SMI and HIV, against an attention control condition, in the high-risk transition period after discharge from an initial psychiatric hospitalization. Specifically, the investigators are conducting a two-arm randomized controlled trial (RCT) with a 4-month follow-up to compare the effectiveness of 1) What Matters Most (WMM)-based intersectional stigma intervention delivered as clients transition from psychiatric hospitalization to outpatient care; and 2) an attention placebo control condition that follows a similar format to isolate the effects of the intervention.\n\nThe investigators will also assess policymaker workshops where peer women with SMI and HIV co-lead the reporting of RCT findings via lived experience to policymakers to initiate structural change.\n\nEnabling women with SMI and HIV to resist stigma has the potential to improve their HIV outcomes and empower these women to elicit broader, structural-level change.",[396,397],"Hiv","Serious Mental Illness",[63,399],"Stigma","2026-04-20",{"date":402,"type":40},"2026-04-23",{"date":404,"type":40},"2024-08-01",{"date":406,"type":20},"2027-12",{"name":408,"class":124},"New York University",{"id":410,"slug":411,"hasResults":11,"nctId":412,"briefTitle":413,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":21,"phases":418,"briefSummary":419,"conditions":420,"keywords":423,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":435,"locationsCount":437},"100334586","phase-3-low-inr-to-minimize-bleeding-with-mechanical-valves-trial-100334586","NCT03636295","Low INR to Minimize Bleeding With Mechanical Valves Trial","LIMIT","Inclusion criteria:\n\n* Age is 18 or older at the time of enrolment\n* Have had a bileaflet mechanical heart valve implant in the aortic position 3 or more months ago\n* Written informed consent from either the patient or substitute decision maker\n\nExclusion criteria:\n\n* Has a second implanted mechanical valve (any position)\n* Lower boundary of planned INR range is less than 2.0\n* Pregnant or expecting to become pregnant during the study follow-up",{"count":417,"type":20},2625,[289],"This study evaluates the use of a lower INR target (1.5 to 2.5) in patients with a mechanical bileaflet heart valve in the aortic position. This study will inform physicians about whether a lower INR target will decrease the risk of bleeding or increase the risk of blood clot formation and stroke. These results have the potential to reduce the burden of bleeding in patients with a mechanical heart valve who require lifelong warfarin (Coumadin) treatment.",[421,422],"Bleeding Post-mechanical Valve Replacement","Thromboembolism Post-mechanical Valve Replacement",[424,425,426,427,428],"Mechanical valve replacement","Vitamin K antagonist","INR targets","Bleeding","Thromboembolism","2025-12-31",{"date":431,"type":40},"2026-01-06",{"date":433,"type":40},"2019-09-05",{"date":156,"type":20},{"name":436,"class":124},"Population Health Research Institute",35,{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":21,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":159},"100395236","assessment-of-a-brief-post-traumatic-stress-disorder-intervention-for-use-in-botswana-100395236","NCT04426448","Assessment of a Brief Post Traumatic Stress Disorder Intervention for Use in Botswana","The Efficacy, Feasibility, and Acceptability of a Culturally Adapted Brief Intervention for Post-Traumatic Stress Disorder in Severe Mental Illness","Inclusion Criteria:\n\n* Able to understand Setswana or English\n* The patient must meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for any SMI as categorized for this study (schizophrenia, schizophreniform disorder, schizoaffective disorder, bipolar mood disorder, and severe depressive disorder)\n* The patient should meet the criteria for Post-Traumatic Stress Disorder as assessed with the Post Traumatic Checklist-5 (PCL-5)\n\nExclusion Criteria:\n\n* Currently engaged in psychotherapy for PTSD\n* On pharmacotherapy management of PTSD (to control for medication effects on PTSD symptoms)\n* Inability to understand informed consent\n* Inability to respond to interview questions\n* Patients who have suicidal ideation and history of a suicide attempt within the past 6 months",{"count":446,"type":20},36,[106],"The purpose of this study is to culturally adapt a brief psychological intervention for Post-Traumatic Stress Disorder (PTSD) and assess its efficacy, feasibility, and acceptability in a pilot trial. The intervention has been shown to be efficacious among individuals with comorbid severe mental illness (SMI) and PTSD.\n\nThe study will be conducted in three phases. The first phase will determine a description of trauma and responses to traumatic experiences among patients with severe mental illness. The first phase of the study will also determine participants' and mental health care providers' perceptions of suitable PTSD interventions in this middle-income context. The findings will then be used to culturally adapt the brief intervention in the second phase. A pilot trial will be conducted in the third phase of the study.\n\nParticipants with comorbid SMI and PTSD will be randomized into two groups (n= 20 intervention group, n= 20 control group). Outcomes of the intervention such as the severity of PTSD symptoms, knowledge about PTSD will be assessed at baseline and at different timelines during the study.\n\nThis study will fill the knowledge gap on trauma and its consequences among individuals with severe mental illness in Botswana, it will also contribute to the improvement of clinical practice in the management of PTSD and SMI.",[450],"Post Traumatic Stress Disorder","2025-07-27",{"date":453,"type":40},"2025-07-30",{"date":455,"type":40},"2020-07-08",{"date":457,"type":20},"2025-08-30",{"name":459,"class":124},"University of Botswana",""]