[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Zambia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":745},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,37,0,25,[9,44,77,110,144,167,194,226,272,303,328,363,393,424,448,474,505,528,558,580,607,633,663,698,723],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100219916","phase-1-very-early-intensive-treatment-of-infants-living-with-hiv-to-achieve-hiv-remission-100219916",false,"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.","ALL","48 Hours",{"count":20,"type":21},1120,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","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.",[28],"HIV Infection",[30],"HIV Remission","RECRUITING","2026-08-17",{"date":34,"type":35},"2026-08-19","ACTUAL",{"date":37,"type":35},"2015-01-23",{"date":39,"type":21},"2031-12-31",{"name":41,"class":42},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",46,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100652307","school-based-prevention-of-teacher-violence-against-children-a-cluster-randomized-controlled-trial-in-zambia-100652307","NCT07773961","School-based Prevention of Teacher Violence Against Children: A Cluster-randomized Controlled Trial in Zambia","ICC-T Zambia","Inclusion Criteria:\n\nSchools:\n\n* public primary school (state owned schools, guided by Zambian education policy)\n* at least 35 students in the selected grade (3th school grade). o if it has less than 35 students in a grade, then it will be combined with nearby selected public primary school which must be within 15 km from the respective and an equal number from each school cluster will be selected to participate in the study.\n* at least 8 but no more than 50 employed teachers. o in case of less than 25 teachers, the selected school will form a school cluster together with another near-by (i.e., within 15 km) public primary school.\n\nAll participants:\n\n• Written informed consent (if underaged by parents (written) \\& minors themselves (orally)\n\nStudents:\n\n* being enrolled in third school grade of public primary school.\n* being of age between 8 and 13 years.\n\nTeachers:\n\n* being employed at an eligible school.\n* being open to participate in the intervention during school holidays.\n\nFacilitators:\n\n* Ideally people holding a BA degree in psychology, social work, social sciences\n* Interest in the work with children\n* Being open minded and motivated\n* Balance of gender in the team of enumerators\n\nExclusion Criteria:\n\nSchools:\n\n• Schools participating in the sponsorship program of Save the Children will be excluded.\n\nStudents:\n\n• severe mental disabilities that make it impossible to follow the interview questions.\n\nTeachers:\n\n• acute intoxication of alcohol, drugs or any other substance which make it impossible to follow the interview questions.",true,"8 Years","80 Years",{"count":55,"type":21},700,[57],"NA","The United Nations Conventions on the Rights of the Child UN General Assembly, 1989), outlawed violence against children worldwide. Yet, 75% of all children worldwide - experience violence while growing up (Know Violence in Childhood, 2017). In Low- and Middle-Income countries prevalence rates at home and at school are higher (Hoeffler, 2017), with particularly high rates in Africa (Hecker et al., 2018; Nkuba, Hermenau, \\& Hecker, 2018; Hillis et al., 2016). Violence against children is related to negative mental health outcomes, lower quality in the child-adult relationship, lower cognitive functioning, and emotional and behavioural problems that begin in childhood and may persist through adolescence until adulthood (Berlin et al., 2009; Gershoff \\& Grogan-Kaylor, 2016; Hecker et al., 2016; Kim \\& Cicchetti, 2010; Majer et al., 2010; Mills et al., 2011; Newbury et al., 2018; Wilson et al., 2009).\n\nThe present study focuses on violent discipline in schools, as (1) many children are subjected to violent discipline at school on a regular basis, and (2) teachers justify violent discipline since they want to encourage better academic performance and maintain children's discipline (Masath et al., 2022). As in other African countries (Hecker et al., 2018; Nkuba, Hermenau, \\& Hecker, 2018; Hillis et al., 2016), violent discipline is prevalent in Zambian schools, despite its prohibition in 2022 (End Corporal Punishment, 2025).\n\nWith this study we test the intervention Interaction Competencies with Children - for Teachers (ICC-T; Kirika \\& Hecker, 2022) to alleviate violence against children. ICC-T is a manualised 5,5 days training workshop focusing on the basic competencies in the work with children, including non-violent action alternatives. Previous cluster randomized controlled trail studies on ICC-T in Tanzania and Uganda showed that teachers who participated in ICC-T, used significantly less violent discipline measures against children compared to teachers in the control group. The transferability of the intervention to and the effectiveness in the Zambian context remains unclear. Evidence from our research may guide policy makers to implement further measures aiming at ending violence against children.",[60],"Violence by Teachers",[62,63,64,65,66],"violence","violence prevention","corporal punishment","emotional violence","physical violence","2026-08-14",{"date":34,"type":35},{"date":70,"type":35},"2026-05-18",{"date":72,"type":21},"2027-12-31",{"name":74,"class":75},"Tobias Hecker, PhD","OTHER",1,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":76},"100649452","reducing-stigma-and-building-employability-skills-for-young-people-with-hiv-in-zambia-100649452","NCT07732660","Reducing Stigma and Building Employability Skills for Young People With HIV in Zambia","Kupambana: A Combined Microeconomic Strengthening and Stigma Reduction Intervention for Young People With HIV in Zambia","Inclusion Criteria:\n\n* Age 18 to 24 years\n* Confirmed HIV-positive status, verified using health records obtained from health facilities with participant consent\n* Residing in the Chipata, Katete, or Lundazi Districts of Zambia's Eastern Province\n* Currently receiving HIV treatment, or previously initiated but disengaged from HIV treatment (stratified purposive sampling will be used to enroll roughly equal proportions of youth currently in care and those who have dropped out of care)\n* Reports at least one indicator of economic vulnerability, defined as any of the following: unemployed or without a regular source of income; not attending school or post-secondary education; or individual income below Zambia's national poverty line\n\nExclusion Criteria:\n\n\\- HIV-negative or unknown status","18 Years","24 Years",{"count":87,"type":21},100,[57],"The goal of this clinical trial is to learn if a program called Kupambana can improve mental health and HIV care outcomes in young people with HIV in Zambia by combining stigma-reduction support with financial and job-skills training. The main questions it aims to answer are whether Kupambana is feasible and acceptable to young people with HIV and whether it improves mental health, reduces stigma, and improves progress along the HIV care continuum, such as staying in care and taking HIV medicine as prescribed. Researchers will compare young people who participate in Kupambana with those who receive a one-time financial literacy training session (usual care) to determine whether Kupambana leads to greater improvements in stigma, mental health, and HIV care outcomes. Participants will complete a baseline questionnaire and then be randomly assigned to either the Kupambana program or the one-time financial literacy training. Those assigned to Kupambana will attend eight weekly peer-led support group sessions focused on reducing HIV- and poverty-related stigma, receive a voucher for technical and vocational education and training, and attend a one-time financial literacy session. Those assigned to the comparison group will attend only the one-time financial literacy session. All participants will complete follow-up surveys at the end of the program and again 3 and 6 months later.",[91,92,93],"HIV","Mental Health","Treatment Adherence",[95,96,97,98,99,100],"HIV Infections","Social Stigma","Poverty","Young Adult","Zambia","Vocational Education","2026-08-11",{"date":103,"type":35},"2026-08-12",{"date":105,"type":21},"2026-09-03",{"date":107,"type":21},"2027-10",{"name":109,"class":75},"University of North Carolina, Chapel Hill",{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":118,"targetDuration":120,"studyType":121,"phases":4,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":76},"100650767","domestication-and-implementation-of-the-pen-plus-clinical-model-in-the-zambian-health-system-100650767","NCT07753681","Domestication and Implementation of the PEN-Plus Clinical Model in the Zambian Health System","PEN-Plus Initiation Grant Opportunity: Domestication and Implementation of the PEN-Plus Clinical Model in the Zambian Health System","PEN Plus","Inclusion Criteria:\n\n* Presenting with chronic NCDs\n\nExclusion Criteria:\n\n* Refusing to be followed up prospectively for routine visits",{"count":119,"type":21},2084,"1 Month","OBSERVATIONAL","Cognizant of the prevalence of complicated non communicable diseases (NCD) and the attendant capacity problems faced by the health workers in primary care settings, we propose to adapt and pilot the Package of Essential Non-communicable Diseases (PEN) Plus intervention using the Interactive Systems Framework (ISF) and then implement and monitor the impact. The ISF framework proposes and organizes several implementation strategies to achieve Evidence Based Implementation (EBI) adaptation. We will apply these strategies at 2 first level hospitals (Peri-Urban and Rural) to ensure local adaptation and work towards scaling up of the WHO-PEN Plus in the rest of Zambia. This process will be inclusive, involving a Stakeholder Consultation Group that shall include the Zambian Non-Communicable diseases and injuries (NCDI) Poverty Commission and shall report bi-annually to a Project Advisory Board (PAB) chaired by the Permanent Secretary of the Ministry of Health.",[124,125,126,127,128,129,130,131,132,133,134],"Cardiac Diseases","Sickle Cell Disease","Hypertension","Diabetes Mellitus","Heart Failure","Congenital Heart Disease","Rheumatic Heart Disease","Epilepsy","Cancer","Mental Health Disorders","Kidney Disease","2026-08-04",{"date":137,"type":35},"2026-08-07",{"date":139,"type":35},"2022-08-08",{"date":141,"type":21},"2027-09-30",{"name":143,"class":75},"Centre for Infectious Disease Research in Zambia",{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},"100595255","surveillance-assessment-and-detection-of-influenza-associated-respiratory-infections-in-hiv-positive-and-negative-individual-in-lusaka-zambia-100595255","NCT07030075","Surveillance, Assessment and Detection of Influenza Associated Respiratory Infections in HIV Positive and Negative Individual in Lusaka, Zambia.","Surveillance, Assessment and Detection of Influenza-Associated Respiratory Infections in HIV-Positive and HIV-Negative Individuals in Lusaka, Zambia","Inclusion Criteria:\n\n* age ≥18 years old\n* presenting with flu-like symptoms or acute respiratory infection with ≥2 to 7 days history of cough and \u002For sore throat and fever, +\u002F- sneezing, +\u002F- congestion, +\u002F- myalgia, +\u002F- fatigue, +\u002F- wheezing, shortness of breath)\\[55-57\\]\n* willing to share their HIV status or be tested\n* willing to share their COVID-19 vaccination status\n* able and willing to give informed consent\n* willing to provide a nasal\u002F nasopharyngeal sample for testing as part of standard of care\n* willing to provide exhaled breath aerosol samples i.e. wear a mask and provide a breath sample\n* willing to fill a symptoms diary card for symptom tracking for 7 days\n* agree to be followed-up and attend study visits up to two weeks after study entry\n\nExclusion Criteria:\n\n* individuals who are unwilling to provide any reference standard samples such as the nasopharyngeal swabs\n* those with symptoms for \\>7 days, or\n* those unwilling or unable to provide informed consent",{"count":152,"type":21},594,"Background and rationale:The World Health Organisation (WHO), estimates influenza global deaths at 290,000 to 650,000 annually. Although influenza is mostly associated with upper respiratory tract infections (URTIs), its role in lower respiratory tract infections (LRTIs) and the associated poor clinical outcomes have been overlooked in sub-Saharan Africa. A study conducted in eight SSA countries estimated that 8.2% of cases and 2.8% of deaths from LRTIs were due to primary infection with influenza. Pneumonia and influenza-associated illness are responsible for 8.5% of respiratory deaths in Zambia. However, in routine practice, testing to distinguish between bacterial and viral etiology of RTIs is seldom done outside sentinel surveillance due to the high cost and lack of available testing options. This consequently underestimates viral RTIs in the population. It is particularly important to diagnose flu early on in vulnerable populations so that they receive timely and appropriate medical care. Although Zambia is a high HIV burden country with a prevalence of 11%, there is presently no study that has described the burden of influenza in the HIV positive population. This research study will address gaps in current scientific knowledge, providing key insights about the prevalence, circulating types, seasonality and associated clinical outcomes of influenza, RSV and SARS-CoV-2 infection in Zambia in the post COVID-19 era.\n\nObjectives Primary To determine the prevalence of influenza (A and\u002For B) infections in a high HIV burden setting in Lusaka, Zambia over one or more influenza seasons.\n\nSecondary\n\n1. To determine the prevalence of influenza co-infection with RSV and\u002For SARS-CoV-2\n2. To determine the clinical outcomes of influenza (A and\u002For B) infection among Zambian adults, with and without co-infection with RSV and COVID-19, by HIV and COVID-19 vaccination status.\n3. To evaluate the accuracy and yield of aerosol-based sampling for diagnosis of respiratory viruses (influenza, SARS-CoV-2, and RSV) compared to nasal\u002F nasopharyngeal swabs, for rapid diagnosis of infection among symptomatic individuals in Zambia.\n4. To evaluate the acceptability of exhaled breath aerosol (XBA) sampling for diagnosis and screening of respiratory infections of pandemic potential.\n\nStudy design and participants:\n\nPrimary objective and secondary objective 1:\n\nCross sectional surveillance study of individuals presenting with flu-like symptoms at two first level hospitals in Lusaka, Zambia. Recruitment of 594 participants will be done over the study period and participants will include both males and females presenting with 2-7 days of flu-like symptoms, able to provide informed consent, aged ≥18 years, with a known HIV status or willing to be tested, with a known COVID 19 vaccination status and available for symptom follow-up.\n\nSecondary objective 2:\n\nProspective follow up of participants enrolled in aim 1 for 14 days will be done to document clinical symptom progression and outcomes. Appropriate care will be provided to all participants within routine care services.\n\nSecondary objective 3 \\& 4:\n\nMixed methods approach. All patients enrolled under aim 1 will be requested to provide in addition to the routine nasopharyngeal sample, an aerosol-based sample for diagnostic accuracy and yield evaluation. We will also conduct an investigator-administered questionnaire to ascertain end-user experience and preferences for either sampling method.\n\nLocation Zambia (Kanyama and Chawama sub-districts) Duration April 2025 to November 2026 (Participant enrolment duration)",[155,156,157],"Influenza","RSV","COVID - 19","2026-08-03",{"date":160,"type":35},"2026-08-05",{"date":162,"type":35},"2025-05-20",{"date":164,"type":21},"2027-01",{"name":143,"class":75},2,{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":51,"sex":17,"minAge":84,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":76},"100601209","phase-1-phase-1b-ascending-dose-study-of-panchol-in-healthy-volunteers-100601209","NCT07107516","Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers","Safety and Immunogenicity of PanChol, a Novel Live Attenuated Oral Cholera Vaccine, in Zambia Adults","PanChol","Inclusion Criteria:\n\n1. Must have given written informed consent (signed and dated) and any other authorizations required by local law and be able to comply with all study requirements.\n2. Healthy adults aged from 18 to 55 years old.\n3. Considered healthy, as judged by the clinical investigator, according to medical history, physical examination, vital signs, screening laboratories, and medication history.\n4. Capable of understanding, consenting, and complying with the entire study protocol including the inpatient period.\n5. Female participants must be non-pregnant and non-lactating and either\n\n   1. surgically sterile (history of bilateral ligation, bilateral salpingectomy, bilateral oophorectomy, total hysterectomy) or postmenopausal (defined as amenorrhea for at least 12 consecutive months before screening without an alternative medical cause)\n   2. be of child-bearing potential and practicing an acceptable method of contraception or abstaining from all activities that could result in pregnancy for at least 28 days before vaccination until 3 months after receiving the investigational product.\n\nAcceptable methods of contraception include barrier methods (such as condom, diaphragm, or cervical cap used in conjunction with spermicide), intrauterine device, hormonal contraception (that may be taken or administered by oral, intravaginal, transdermal, subdermal or IM route), vasectomized partner (the vasectomized partner should be the sole partner for that participant)\n\nExclusion Criteria:\n\n1. Confirmed or suspected immunosuppressive condition, as a result of a disease (e.g., primary immune deficiency, malignancy, HIV infection) or have taken any systemic immunosuppressive therapy within 6 months of enrollment.\n2. Pregnant or lactating women.\n3. History of gastrointestinal (GI) disorder, such as previous major GI surgery, malabsorption, or any chronic GI disorders that would interfere, according to the investigator, with the IP.\n4. Acute GI or febrile illness within 7 days of enrollment.\n5. Have any acute or chronic medical condition that, in the opinion of the investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination.\n6. History of cholera vaccination.\n7. History of cholera infection.\n8. Abnormal stool pattern, defined as \\\u003C 3 or \\>21 stools per week.\n9. Allergy or intolerance to PanChol or placebo component (sodium bicarbonate, lactose, ascorbic acid)\n10. Use of any systemic antibiotics within 1 month of PanChol administration.\n11. Receipt of a live vaccine in the previous 4 weeks or planned in the 4 weeks following enrollment.\n12. Receipt of a killed or subunit (non-live) vaccine in the previous 2 weeks or planned in the 2 weeks following enrollment.\n13. Individuals who do not speak English\n14. Childcare workers with direct contact with children ≤ 2 years of age\n15. Individuals whose occupation involves handling of food\n16. Healthcare workers who have direct contact with patients who are immunodeficient, HIV-positive, or have an unstable medical condition\n17. Use laxatives regularly\n18. Have diarrhea within 48 hours before enrollment\n19. Have a history of hypersensitivity to any of the tetracyclines\n20. Have a history of hypersensitivity to streptomycin or any aminoglycoside due to the known cross-sensitivity of patients to drugs in this class.\n21. Individuals who have a household member who are immunodeficient, HIV-positive, or have an unstable medical condition.","55 Years",{"count":177,"type":21},32,[24],"Cholera is a serious diarrheal disease that can be fatal within hours of onset. The current available cholera vaccines to prevent the disease are not very effective. Panchol is a new oral cholera vaccine that may be an improvement over the currently available vaccines in use. The goal of this study is to learn safety of this new oral cholera vaccine and the body's immune response to the vaccine.\n\nThe researchers will compare the PanChol vaccine to placebo to see the side effects experienced in participants.\n\nThe participants will be adults aged between 18 and 55 years and they will be required to:\n\n1. Be admitted to hospital until they stop passing the cholera vaccine in their stool. During admission, all side effects will be recorded by the researchers.\n2. After discharge, the participants will visit the research site every month for 3 months with an optional visit at the 4th month for the researchers to assess the participants' general health.",[181],"Cholera Vaccination Reaction",[183,184,185],"cholera","vaccine","safety","2026-07-28",{"date":188,"type":35},"2026-07-29",{"date":190,"type":35},"2026-05-20",{"date":192,"type":21},"2027-01-31",{"name":143,"class":75},{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":216,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":76},"100648230","advanced-hiv-re-engagement-in-care-100648230","NCT07720128","Advanced HIV Re-engagement in Care","ARC","Inclusion Criteria:\n\n* Living with HIV\n* Advanced HIV defined as CD4 \\\u003C350 cells\u002Fmm3 or WHO stage 3 or 4 event\n* Currently admitted to study hospital's internal medicine department\n\nExclusion Criteria:\n\n* Planning to reside outside Lusaka after discharge\n* Too sick to provide informed consent\n* Known to have advanced cancer (defined as requiring chemo\u002Fradiation therapy or referred to hospice) other than Kaposi Sarcoma\n* Known to have end stage kidney disease\n* Known to have end stage liver disease\n* No access to a telephone\n* Currently incarcerated",{"count":202,"type":21},724,[57],"Adults who are hospitalized in Lusaka, Zambia, and found to have advanced HIV disease will be enrolled and randomly assigned to receive the ARC intervention or standard of care. All participants will then be followed through the end of the hospitalization and for up to 1 year after discharge from hospital.",[206],"Advanced HIV Disease",[208,209,210,211,212,213,214,215],"HIV\u002FAIDS","Transitions of care","Hospitalization","Community Health Worker","Sub-Saharan Africa","Advanced HIV disease","Tuberculosis","Cryptococcus","NOT_YET_RECRUITING","2026-07-22",{"date":219,"type":35},"2026-07-23",{"date":221,"type":21},"2027-05-01",{"date":223,"type":21},"2031-08-01",{"name":225,"class":75},"University of Alabama at Birmingham",{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":17,"minAge":233,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":22,"phases":237,"briefSummary":239,"conditions":240,"keywords":244,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":269,"locationsCount":271},"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":236,"type":21},860,[238],"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.",[214,241,242,243],"Tuberculosis, Pulmonary","Tuberculosis, Lymph Node","Mycobacterium Tuberculosis",[245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263],"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",{"date":265,"type":35},"2026-07-24",{"date":267,"type":35},"2025-01-15",{"date":141,"type":21},{"name":270,"class":75},"Johns Hopkins University",9,{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":17,"minAge":279,"maxAge":280,"enrollmentInfo":281,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":302},"100648099","a-study-to-characterize-the-clinical-presentation-and-course-of-cryptosporidium-in-pediatric-participants-100648099","NCT07716410","A Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants","A Prospective Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants With Symptomatic Cryptosporidiosis in Endemic Countries","Inclusion criteria:\n\n* Age 6 months to 59 months with diarrhea according to the World Health Organization (WHO) criteria (≥3 loose stools daily for at least 2 days)\n* QuikChek™ and Stool microscopy positive for Cryptosporidium at screening\n* Acute (\\\u003C7 days), prolonged (lasting 7-13 days), persistent (lasting 14-28 days) or chronic (lasting \\>28 days) diarrheal illness (≥3 loose stools daily, as defined by WHO) at screening\n* Normal nutritional status, mildly-to-moderately acutely malnourished, or severely acutely malnourished according to WHO definitions (number of participants with severe acute malnutrition will be capped) at screening\n* Parent or primary caregiver is willing to provide informed consent and to comply with study procedures, including provision of whole stool samples at the scheduled time points and willing to be followed up to 21 days\n\nExclusion criteria:\n\n* Bloody diarrhea, defined as diarrhea with visible blood in stool as observed by the study team member performing the screening or reported by parent\u002Fprimary caregiver\n* Other morbidity requiring emergency medical care in an intensive care setting at the time of screening\n* Coincident non-enteric infection including upper or lower respiratory infection at screening\n* Any participant whose parent or primary caregiver is unwilling or unable to cooperate with study procedures, in the investigator's opinion\n* If the parent\u002Fprimary caregiver managing care of the patient has travel plans out of the study area that would preclude clinic or in-home study visits during the expected study follow-up period\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","6 Months","59 Months",{"count":282,"type":21},30,"This study aims to characterize the pediatric cryptosporidiosis disease profile with respect to clinical presentation.",[285],"Cryptosporidiosis",[287,288,289,290,291],"Cryptosporidium","Observational","Africa","Malaysia","Pediatric Diarrhea","2026-07-15",{"date":294,"type":35},"2026-07-21",{"date":296,"type":35},"2026-01-09",{"date":298,"type":21},"2027-05-19",{"name":300,"class":301},"Novartis Pharmaceuticals","INDUSTRY",4,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":310,"minAge":84,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":327},"100641551","prospective-evaluation-of-an-ai-diagnostic-ultrasound-tool-for-fetal-weight-estimation-100641551","NCT07661433","Prospective Evaluation of an AI Diagnostic Ultrasound Tool for Fetal Weight Estimation","Z 32503 - Prospective Evaluation of an AI Diagnostic Ultrasound Tool for Fetal Weight Estimation","Inclusion Criteria:\n\n* 18 years of age or older\n* Viable intrauterine pregnancy\n* Delivery expected within one week of study procedures between 24 0\u002F7 and 42 6\u002F7 weeks, including participants with a scheduled induction or cesarean delivery on a known date, or those admitted in spontaneous labor\n* Ability and willingness to provide written informed consent\n* Willingness to comply with all study procedures\n\nExclusion Criteria:\n\n* Maternal body mass index ≥ 40 kg\u002Fm\\^2\n* Multiple gestation (i.e., twins or higher order)\n* Known major fetal malformation or anomaly\n* Any maternal condition (medical, psychological, or social) that, in the opinion of the study team, may interfere with study participation or data integrity.","FEMALE",{"count":312,"type":21},1000,"Purpose: The primary objective of this study is to assess the diagnostic accuracy of an AI-enabled ultrasound tool for estimating fetal weight Participants: 1,000 pregnant individuals Procedures (methods): This prospective diagnostic accuracy study will enroll 1,000 pregnant individuals within one week of anticipated delivery. At a single visit, each participant will undergo two ultrasound assessments: (1) standardized sweeps for AI analysis (performed by both specialist and nonspecialist users), (2) specialist-performed fetal biometry.",[315,316,317,318],"Fetal Weight","Pregnancy","Machine Learning","Pregnancy - Prenatal Testing","2026-07-06",{"date":321,"type":35},"2026-07-08",{"date":323,"type":35},"2026-06-29",{"date":325,"type":21},"2026-12",{"name":109,"class":75},5,{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":51,"sex":310,"minAge":84,"maxAge":335,"enrollmentInfo":336,"targetDuration":4,"studyType":22,"phases":338,"briefSummary":339,"conditions":340,"keywords":343,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":166},"100572541","folic-acid-salt-study-fisfa-zambia-100572541","NCT06734611","Folic Acid Salt Study (FISFA Zambia)","Effectiveness Study of Folic Acid Fortified Iodized Salt to Increase Folate Concentrations in Women of Reproductive Age in Zambia, a Non-fortifying Country","Inclusion Criteria:\n\n* Voluntary participation in the study\n* Do not intend to get pregnant\n* Not lactating or pregnant\n* Live alone or with a partner if they can be compliant and not share the study salt.\n* Aged between 18 and 45 years\n\nExclusion Criteria:\n\n* Pregnant or lactating","45 Years",{"count":337,"type":21},250,[57],"Question: How effective is fortified iodized salt with folic acid (FISFA) in increasing serum and red blood cell folate in non-lactating, non-pregnant women of reproductive age in the country of Zambia who do not have active food fortification with a folic acid program?\n\nParticipants will:\n\n* Consume salt with folic acid instead of their regular salt for 6 months\n* Have a blood draw 4 times\n* Fill out surveys",[341,342],"Folate Deficiency","Neural Tube Defects",[344,345,346,347,348,349,350,351,352,353,354,355],"folic acid","iodine","salt","serum folate","red blood cell folate","prevention","folate insufficiency","Malnutrition","Nervous System Malformations","Spinal Dysraphism","Vitamin B9","Micronutrients","2026-06-24",{"date":323,"type":35},{"date":359,"type":35},"2026-04-10",{"date":361,"type":21},"2028-12-31",{"name":225,"class":75},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":371,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":378,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":392},"100581807","phase-3-caffeine-for-hypoxic-ischemic-encephalopathy-100581807","NCT06855108","Caffeine for Hypoxic Ischemic Encephalopathy","Caffeine for Hypoxic Ischemic Encephalopathy (CHIME Trial)","CHIME","Participant Inclusion Criteria:\n\nInfants who meet all the following criteria are eligible for enrollment as study participants:\n\n1. Liveborn infants ≥36 weeks\n2. Birth weight ≥1800 grams\n3. Meets physiologic criteria for moderate to severe HIE, defined as meeting either of the following two criteria:\n\n   1. Criterion #1: Severe acidosis, defined as an umbilical cord sample or neonatal serum sample within one hour after birth demonstrating any of following criteria:\n\n      * pH \\\u003C7.0; or\n      * Base Deficit ≥16 mmol\u002FL; or\n      * Lactate \\>8 mmol\u002FL.\n   2. Criterion #2: Participant must meet all of the following three criteria:\n\n   i. Moderate acidosis, defined as an umbilical cord sample or neonatal serum sample within one hour after birth demonstrating any of following criteria:\n   * POC pH 7.0-7.15; or\n   * Base Deficit 10.0-15.9 mmol\u002FL; or\n   * Lactate 6-8 mmol\u002FL.\n\n   ii. Evidence of an acute perinatal event (i.e., placental abruption, intrapartum hemorrhage, cord prolapse, severe fetal heart rate abnormality, uterine rupture).\n\n   iii. Any of the following criteria:\n   * 10-minute Apgar \\\u003C5; or\n   * Need for assisted ventilation initiated at birth and continued for ≥10 minutes\n4. Meets neurologic criteria for moderate to severe HIE, defined as a physical exam conducted between one and six hours after birth that meets either of the following criteria:\n\n   1. Moderate to severe encephalopathy in at least three out of six modified Sarnat categories (level of consciousness, spontaneous activity, muscle tone, posture, primitive reflexes, autonomic function); or\n   2. A clinical diagnosis of seizure in the first six hours after birth.\n\nParticipant Exclusion Criteria:\n\nInfants who meet any of the following criteria are not eligible for enrollment as study participants:\n\n1. Home births\n2. Infants who cannot be enrolled, randomized and receive study medication within 6 hours post-delivery\n3. Infants with a recognized major congenital anomaly or genetic syndrome that would affect their neurodevelopment.\n4. Infants for whom medical care will not be provided based on the severity of their condition or any other condition that would preclude participation per clinical judgement.\n5. Infant has received therapeutic hypothermia or there is a clinical plan to initiate active or passive hypothermia for the infant.\n6. Infants who will be unavailable to complete follow-up visits.\n7. Infants who have received caffeine after delivery.\n8. Infants whom the health care team deem ineligible for the study based on likelihood to receive caffeine outside of the study protocol.\n9. Enrollment in another trial that will impact participation in this trial.","6 Hours",{"count":373,"type":21},830,[238],"CHIME is a randomized, parallel-arm, double-blind, placebo-controlled trial focused on infants with hypoxic ischemic encephalopathy (HIE). The trial will recruit neonates who are diagnosed with HIE within six hours after birth based on physiologic criteria (acidosis noted on an umbilical cord or early \\[\\\u003C1 hour\\] postnatal blood sample) and neurologic criteria (modified Sarnat exam consistent with encephalopathy). Following informed consent, and by six hours after birth, neonates with HIE will be randomized to one of two treatment arms and subsequently receive one 20 mg\u002Fkg dose of oral caffeine followed by two additional 10 mg\u002Fkg doses at 24-hour intervals or placebo of the same regimen (three total doses).\n\nThe goal of this clinical trial is to compare the incidence of all-cause mortality OR moderate to severe neurodevelopmental impairment (NDI) at 18-22 months between neonates with HIE who are randomized to oral caffeine or placebo. Our hypothesis is that neonates with HIE who receive oral caffeine will have 10% lower incidence of all-cause mortality or moderate to severe NDI at 18-22 months compared to placebo.",[377],"Hypoxic Ischemic Encephalopathy (HIE)",[379,380,381,382],"Caffeine","Hypoxic Ischemic Encephalopathy","HIE","AKI","2026-06-19",{"date":356,"type":35},{"date":386,"type":35},"2026-04-08",{"date":388,"type":21},"2030-07",{"name":390,"class":391},"NICHD Global Network for Women's and Children's Health","NETWORK",7,{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":17,"minAge":401,"maxAge":402,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":413,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":423,"locationsCount":76},"100558026","admission-to-kangaroo-mother-care-kmc-ward-and-maternal-postpartum-depression-100558026","NCT06545760","Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression","Admission to the Kangaroo Mother Care Ward and Maternal Postpartum Depression: A Randomized Controlled Trial","KMC PPD","Inclusion Criteria:\n\n-AIM #1-2 and #5\n\nMothers to newborns who are:\n\n1\\) Birthweight between 1000-2000gm 2) Admitted to the Women and Neonates Hospital-University Teaching Hospital Neonatal Intensive Care Unit (WNH-UTH NICU) (\\>48hrs) 3) Stable preterm eligible for continuing kangaroo mother care (KMC) in the NICU or NICU discharge 4) 16+ years of age (Mother) 5) Residing within Lusaka Province with no intensions to relocate in the coming 18 months\n\n* AIM #3\n\n  1. Parents (mothers and fathers) whose newborn has been enrolled in the study\n  2. Trusted family member or friend of the mother whose newborns is enrolled into the study\n  3. 16+ years of age (mothers and fathers)\n  4. 18+ years of age (family members)\n* AIM # 4:\n\n  1. Fathers whose newborn has been enrolled into the study\n  2. 16+ years of age (father)\n\nExclusion Criteria:\n\n* AIM #1-2 and #5\n\n  1. Mothers who are on treatment for depression and\u002For anxiety\n  2. Mothers who did not consent\n  3. Underage mothers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study\n* AIM #3\n\n  1\\) Family members of parents who do not consent to study participation\n* AIM # 4:\n\n  1. Fathers who are on treatment for depression and\u002For anxiety\n  2. Fathers who did not provide informed consent\n  3. Underage fathers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study","1 Day","89 Years",{"count":404,"type":21},1908,[57],"The goal of this clinical trial is to learn if extended admission to the Kangaroo Mother Care (KMC) ward helps to prevent postpartum depression in mothers of low birthweight infants in a low-resource setting whose newborns were admitted to the neonatal intensive care unit (NICU) more than standard of care KMC. The main questions it aims to answer are:\n\n* Does longer KMC decrease the incidence of postpartum depression in mothers of low birthweight infants in a low-resource setting?\n* Does longer KMC improve neurodevelopmental outcomes of low birthweight infants at 6, 12, and 18 months in a low-resource setting?\n* What are the barriers to practicing KMC in low birthweight infants following hospital discharge in a low-resource setting?\n* What is the prevalence of paternal depression in a low resource setting?\n* Is it cost effective to admit preterm mother-infant dyads to the KMC ward following NICU discharge?\n\nResearchers will compare (extended admission to the KMC ward) to (standard of care KMC) to see if extended KMC decreases PPD in mothers of preterm infants in low-resource settings.\n\nParticipants (infants) will:\n\n* At time of discharge from the NICU, when clinically stable, spend either \\\u003C 2 days in the KMC ward with their mothers or spend longer in the KMC ward until discharge.\n* Return to clinic at routine follow-up visits (at 2 weeks and at 6-8 weeks) where mothers will be screened for postpartum depression and fathers will be screened for depression.\n* Return to clinic for neurodevelopmental screening at 6, 12, and 18 months where mothers will be screened for postpartum depression and perceived social support and fathers will be screened for depression.",[408,409,410,411,412],"Low Birth Weight","Kangaroo Mother Care","Postpartum Depression","Neurodevelopmental Outcome","Pre-Term",[414,409,415,416],"Low resource setting","Paternal depression","Cost-effectiveness","2026-06-18",{"date":419,"type":35},"2026-06-22",{"date":421,"type":35},"2024-12-01",{"date":141,"type":21},{"name":225,"class":75},{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":17,"minAge":233,"maxAge":431,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":434,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":76},"100555939","phase-4-caffeine-citrate-in-preterm-infants-at-risk-of-apnea-in-zambia-100555939","NCT06518603","Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia","Randomized Controlled Trial of Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia","Inclusion Criteria:\n\nNewborns:\n\n1. 29 0\u002F7 to 33 6\u002F7 weeks GA (or with a birth weight 1.0 to 2.0 kg if pregnancy dating is unreliable) admitted to the UTH NICU,\n2. On methylxanthines with plans to discontinue on methylxanthine,\n3. Off oxygen therapy for \\>48 hours at the time of evaluation for eligibility,\n4. Receiving full daily feeds,\n5. Deemed stable and ready to go off caffeine as recommended by the Neonatologist\n6. 18+ years of age (parent)\n\nExclusion Criteria:\n\n1. Newborns with neuromuscular conditions affecting respiration,\n2. Major congenital malformations and genetic disorders,\n3. Unable to obtain parental or guardian consent","12 Months",{"count":433,"type":21},340,[435],"PHASE4","The goal of this clinical trial is to learn if caffeine citrate prevents apneic events that result in sick visits in moderately preterm infants after discharge from the hospital. It will also learn if the use of caffeine leads to better developmental outcomes at 12 months of age.\n\nOur research questions are:\n\n1. Does continued treatment of moderately preterm newborns with caffeine citrate after hospital discharge prevent or decrease apneic events that result in sick visits?\n2. Will the continued use of caffeine citrate lead to improved developmental outcomes among infants at 12 months of age?\n\nResearchers will compare caffeine citrate to a placebo (a look-alike substance that contains no drug) to see if caffeine citrate prevents apneic spells which result in healthcare visits.\n\nParents of participants will:\n\n1. Administer caffeine citrate 20mg\u002Fkg\u002Fday or a placebo (equivalent volume of sterile water) orally every day for up to 28 days after hospital discharge\n2. Keep a diary of symptoms and any apneic events\n3. Check in with researchers via telephone call once a week\n4. Return to clinic for infant physical examination at 28 days\n5. Return to the clinic for infant physical examination at 2 months\n\n5\\. Return to clinic for infant neurodevelopmental examination with Ages and Stages Questionnaire at 12 months of age",[438,439,440],"Premature Infant Disease","Apnea of Prematurity","Development, Infant",{"date":442,"type":35},"2026-06-23",{"date":444,"type":35},"2026-06-17",{"date":446,"type":21},"2027-06-30",{"name":225,"class":75},{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":51,"sex":310,"minAge":456,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":459,"conditions":460,"keywords":462,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":472,"locationsCount":327},"100508724","prisma-maternal-and-newborn-health-study-100508724","NCT05904145","PRISMA Maternal and Newborn Health Study","Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRiSMA) Maternal and Newborn Health (MNH) Study: A Multi-center, Prospective Cohort Study of Maternal, Newborn, and Infant Health","PRiSMA-MNH","A woman who meets the following inclusion criteria during screening may be enrolled:\n\n* Lives within the study catchment area;\n* Meets minimum age requirement in study site country:\n\n  * Ghana: 15 years of age;\n  * Kenya: 18 years of age or those who meet the criteria of emancipated minors;\n  * Pakistan: 15 years of age or those who meet the criteria of emancipated minors;\n  * Zambia: 15 years of age;\n  * India: 18 years of age\n* Intrauterine pregnancy \\\u003C20 weeks gestation verified via ultrasound;\n* Provides informed consent.\n\nA woman who meets the following exclusion criteria during screening may NOT be enrolled:\n\n* Nonviable (e.g. ectopic or molar) pregnancy;\n* Plans to relocate outside of the study catchment area during pregnancy and\u002For postpartum.","15 Years",{"count":458,"type":21},267897,"Access to quality antenatal care (ANC) and postnatal care (PNC), including maternal, newborn, and infant services, is integral to reducing adverse pregnancy-related health outcomes and promoting positive birth experiences. The World Health Organization (WHO) recommends a total of eight ANC visits for pregnant women. However, the ANC coverage rate remains considerably lower among more vulnerable populations, and the quality of care that women receive is inconsistent, often poor, and frequently fails to detect risks in a timely fashion or adequately prepare women for the birth process. While rates of facility-based delivery are on the rise worldwide, disparities persist and the quality of care across facilities remains uneven. Even less information is available on PNC, where services beyond routine immunizations may not be widely available, especially in resource-poor regions.\n\nAdditionally, limited evidence exists on innovative service delivery approaches and how to effectively scale tested maternal and newborn health (MNH) interventions. This coupled with the fragmented datasets from smaller studies limit our ability to advocate for policy change.\n\nThe Pregnancy Risk Stratification Innovation and Measurement Alliance (PRiSMA) is implementing a harmonized open cohort study that seeks to evaluate pregnancy risk factors and their associations with adverse pregnancy outcomes, including stillbirth, neonatal mortality and morbidity, and maternal mortality and severe morbidity. The goals are to develop a harmonized data set to improve understanding of pregnancy risk factors, vulnerabilities, and morbidity and mortality and to estimate the burden of these risk factors and outcomes in LMICs. Ultimately, these data will inform development of innovative strategies to optimize pregnancy outcomes for mothers and their newborns.",[461],"Pregnancy, High Risk",[463,464,465],"Antenatal Care (ANC)","Postnatal Care (PNC)","Maternal Newborn Health","2026-06-09",{"date":468,"type":35},"2026-06-11",{"date":470,"type":35},"2022-08-01",{"date":361,"type":21},{"name":473,"class":75},"George Washington University",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":51,"sex":17,"minAge":84,"maxAge":482,"enrollmentInfo":483,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":485,"conditions":486,"keywords":491,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":76},"100637308","how-gut-health-affects-immune-responses-to-the-oral-rotavirus-vaccine-in-adults-in-zambia-100637308","NCT07626606","How Gut Health Affects Immune Responses to the Oral Rotavirus Vaccine in Adults in Zambia","Temporal and Spatial Immune Profiling of Oral Rotavirus Vaccine Responses in Zambian Adults With Environmental Enteropathy","Rota-Omics","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 50 years.\n* Able and willing to provide written informed consent.\n* Reside within Lusaka district and available for scheduled follow-up.\n* Willing to undergo two endoscopy procedures with serial sample collection.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Active gut disease requiring treatment (e.g., active peptic ulcer disease, gastrointestinal bleeding).\n* Known severe immunodeficiency (HIV with CD4 \\\u003C 200 cells\u002Fmm³, current cancer chemotherapy, systemic corticosteroids equivalent to \\>20 mg\u002Fday prednisolone for \\>2 weeks).\n* Severe comorbidities rendering endoscopy unsafe (e.g., severe cardiopulmonary disease, uncontrolled hypertension, oropharyngeal abnormalities).\n* Use of anticoagulants where suspension is unsafe or unwillingness to withhold anticoagulation when clinically indicated.\n* Receipt of any live vaccine within 30 days prior to enrolment or planned live vaccine within 30 days after Rotarix administration.\n* Any condition judged by the investigator to compromise participant safety or data integrity.\n* Participants who had a recent diarrhoea episode, or who have taken NSAID drugs or antibiotics, will be eligible for re-assessment after a month without this disqualifier.\n\nPregnancy testing and counselling: Women of reproductive potential will require a negative urine pregnancy test within 24 hours prior to endoscopy and vaccination and will be counselled to avoid pregnancy during the first 30 days post-vaccination.","50 Years",{"count":484,"type":21},43,"The Rotavirus SpatioTrasncriptomics (Rota-Omics) study is a multidisciplinary research project aimed at understanding why oral rotavirus vaccines perform less effectively in some low- and middle-income countries, including Zambia. Rotavirus remains one of the leading causes of severe diarrheal disease in infants and young children worldwide, despite the widespread introduction of vaccines such as Rotarix® and Rotavac®. Although these vaccines have greatly reduced childhood deaths in many countries, vaccine effectiveness is often lower in settings where the burden of disease is highest. Understanding the reasons behind this reduced protection is critical for improving child health globally.\n\nA major focus of the study is Environmental Enteropathy (EE), also known as Environmental Enteric Dysfunction (EED), a chronic inflammatory condition of the small intestine that is common in low-resource settings. EE is associated with damage to the intestinal lining, chronic immune activation, poor nutrient absorption, and impaired gut barrier function. These changes are thought to interfere with the body's ability to respond effectively to oral vaccines, which rely on strong intestinal immune responses.\n\nThe RotaOmics study uses a systems biology approach to investigate how the immune system, gut microbiome, nutrition, and intestinal inflammation interact to influence rotavirus vaccine responses. The term \"omics\" refers to advanced technologies that allow researchers to study genes, proteins, microbes, and other biological processes at a large scale. By combining these approaches, the study aims to identify biological markers and immune pathways associated with strong or weak vaccine responses.\n\nThe study involves the collection of samples such as blood, stool, saliva, and breast milk from mothers and infants at different time points before and after vaccination. These samples are analysed using laboratory methods including antibody testing, molecular pathogen detection, microbiome sequencing, and immune profiling. The study also evaluates markers of gut inflammation and intestinal health.\n\nOne important goal of the project is to identify correlates of protection, which are measurable biological indicators that predict whether a vaccine is likely to protect against disease. Identifying these markers could help guide the development of improved vaccines or supportive interventions to enhance vaccine performance in vulnerable populations.\n\nThe study also contributes to a broader understanding of mucosal immunity, which refers to immune responses occurring in the gastrointestinal tract. Since many enteric infections begin in the gut, understanding intestinal immune function is important not only for rotavirus vaccines but also for other oral vaccines and diarrheal diseases.\n\nIn addition to its scientific objectives, RotaOmics includes a strong capacity-building component. The project supports training for local scientists, clinicians, and laboratory personnel in areas such as molecular biology, immunology, genomics, bioinformatics, and data analysis. By strengthening local research expertise and infrastructure, the study aims to support long-term scientific development and improve regional capacity for infectious disease research and outbreak response.\n\nOverall, the RotaOmics study seeks to generate new insights into why oral rotavirus vaccines underperform in some settings and to identify strategies that may improve vaccine effectiveness and child health outcomes in Zambia and similar regions worldwide.",[487,488,489,490],"Feasibility Study","Vaccine Immune Response","Rota Virus Gastroenteritis","Transcriptomics",[490,492,493,494,495,496],"Feasibility","Microbiome","Immunity","Rotavirus","Vaccine","2026-06-02",{"date":499,"type":35},"2026-06-04",{"date":501,"type":35},"2026-03-30",{"date":503,"type":21},"2026-12-31",{"name":143,"class":75},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":514,"conditions":515,"keywords":516,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":76},"100585599","advanced-hiv-disease-during-the-first-six-months-on-antiretroviral-therapy-in-zambia-100585599","NCT06904456","Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia","AHD-Zambia","Cohort 1\n\nInclusion\n\n* ≥18 years old\n* Presenting at a study site clinic for HIV diagnosis or care\n* Not currently on ART (or on ART for up to 1 month if enrolled at next visit after AHD screening)\n* Screened for AHD by clinic, prior to or within 1 month of ART initiation\n* Written informed consent to participate\n\nExclusion\n\n* Pregnant and\u002For presenting for antenatal care\n* Too ill at the time of AHD screening and at the next clinic visit to participate in the study\n* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant\n\nCohort 2\n\nInclusion\n\n* ≥18 years old\n* Living with HIV and screened for AHD at a study site within 12 months of the start of study prospective data collection at that site\n* All inclusion criteria for the full cohort\n* Initiated\u002Fre-initiated ART within the past 6 months\n* Returns to the study site for a clinic visit during the study enrollment period\n* Written informed consent to participate\n\nExclusion\n\n* Pregnant and\u002For presenting for antenatal care as reported in records\n* All exclusion criteria for the full cohort\n* Too ill at the time of study enrollment visit to participate in the study\n* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant\n* Been on ART \\>6 months\n\nCohort 3\n\nInclusion\n\n* ≥18 years old\n* Living with HIV\n* Admitted for inpatient care related to AHD\n* Initiated or re-initiated ART within the last 6 months\n* Written informed consent to participate\n\nExclusion\n\n* Pregnant and\u002For presenting for antenatal care\n* Not physically, mentally, or emotionally able to participate in the study prior to discharge, in the opinion of facility or study staff\n* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant\n* Confined to tuberculosis isolation ward; intensive care unit; or other ward specifically for clients with acute infectious disease.\n\nCohort 4\n\nInclusion\n\n* Employed by or at the study site for at least 6 months\n* Directly interact with clients presenting with AHD\n* Written informed consent to participate\n\nExclusion\n\n* None",{"count":513,"type":21},11800,"In Zambia, an estimated 20% of HIV-positive clients continue to present for first-time antiretroviral therapy (ART) initiation or re-initiation with advanced HIV disease (AHD). The Zambia Ministry of Health (MOH) and other key stakeholders lack information about the characteristics and behaviors of AHD clients, including how they are defined and diagnosed (e.g. low CD4 count v. clinical condition), their demographic and socioeconomic profiles, their HIV care histories, what services they receive, and their short-term outcomes (achieve viral suppression, remain AHD, disengage from care, die) and the timing of these outcomes.\n\nThe Retain6 project aims to improve HIV treatment outcomes during clients' first six months on ART, when disengagement from care and mortality are highest. This protocol, called Advanced HIV disease during the first six months on antiretroviral therapy in Zambia (AHD Zambia), describes an observational study that will describe the experiences of clients who are diagnosed with AHD upon ART initiation (or re-initiation) in Zambia. Data collected will include clinical and socioeconomic characteristics, clinical and non-clinical needs, services delivered and received, and clients' and providers' concerns and preferences. The study's overall goal is to provide information to the Zambia MOH, treatment program partners, providers, and other stakeholders to better understand who is presenting with AHD in Zambia, how they are currently managed, and their treatment outcomes after starting ART. This information will be useful in determining interventions and guideline changes that might improve short- and long-term outcomes for AHD patients.\n\nThe study, which will be conducted in collaboration with the Zambia MOH, will include retrospective file reviews, prospective quantitative surveys with outpatient and inpatient clients, qualitative focus group discussions (FGDs) and interviews with clients, and provider surveys and interviews.",[206],[517,99,518],"Antiretroviral therapy (ART)","Service delivery","2026-05-26",{"date":521,"type":35},"2026-05-27",{"date":523,"type":35},"2025-04-22",{"date":525,"type":21},"2027-06",{"name":527,"class":75},"Boston University",{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":537,"conditions":538,"keywords":540,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":557},"100640344","hep-mec-cohort-in-zambia-100640344","NCT07589985","Hep Mec Cohort in Zambia","Hep Mec","Inclusion Criteria:\n\nMust meet the inclusion criteria for one of 5 groups, as follows:\n\n* Group 1 (rx-naive chronic hbv mono): 18+ years old, HBsAg-positive, HIV-negative, eligible for tenofovir-based therapy, reports taking therapy no more than 7 days (could have previously taken if has stopped \\>1 year ago).\n* Group 2 (acute hbv mono): 18+ years old, HBsAg-positive, HIV-negative, acute\u002Fsubacute onset of hepatitis signs and symptoms and ALT \\>10 times upper limit of normal\n* Group 3 (rx-naive hbv\u002Fhiv coinfection): 18+ years old, HBsAg-positive, HIV-negative, eligible for tenofovir-based therapy, reports taking therapy no more than 7 days (could have previously taken if has stopped \\>1 year ago).\n* Group 4 (rx-experienced coinfection with hbv persistence): 18+ years old, history of chronic HBV infection based on two tests 6 months apart, HIV-positive, at least 4 years of tenofovir-based antiviral therapy, currently HBsAg-positive\n* Group 5 (hbsag loss): 18+ years old, HIV-positive or negative, history of chronic HBV infection based on two tests 6 months apart, Currently HBsAg-negative confirmed by sensitive assay\n\nExclusion Criteria:\n\n* Hepatitis C coinfection (antibody-positive and RNA-positive), current or recent (past 6 weeks) pregnancy, decompensated cirrhosis on physical examination, unlikely to remain in Lusaka for study duration",{"count":536,"type":21},390,"Observational cohort of adults with acute and chronic hepatitis B infection in Zambia, with and without HIV coinfection. Participants join the study at the time of diagnosis and before or at the time when they are starting antiviral treatments and then they are followed up over multiple years to assess changes to their liver and evolution of HBV (and HIV if applicable) infection. All treatments for HBV and HIV are standard per local Ministry of Health guidelines.",[539,91],"Hepatitis B",[541,542,543,289,544,545,546,547,548],"HBV\u002FHIV coinfection","HBV immunology","Liver sampling","Tenofovir","T cell immunology","Omics analysis","Acute HBV infection","Liver immunology","2026-05-09",{"date":551,"type":35},"2026-05-15",{"date":553,"type":35},"2020-09-28",{"date":555,"type":21},"2030-08-31",{"name":225,"class":75},3,{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":22,"phases":566,"briefSummary":567,"conditions":568,"keywords":570,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":578,"locationsCount":76},"100640573","effectiveness-of-implementing-the-adapted-practice-guidelines-for-primary-care-of-acute-abdomen-in-zambia-an-effectiveness-implementation-hybrid-type-2-study-design-100640573","NCT07587190","Effectiveness of Implementing the Adapted Practice Guidelines for Primary Care of Acute Abdomen in Zambia: An Effectiveness-Implementation Hybrid Type 2 Study Design.","Inclusion Criteria:\n\n* Data from all patients 18 year and older with acute abdomen including surgical, gynecological and medical acute abdomen managed at the intervention site and control site will be collected during the study period.\n\nExclusion Criteria:\n\n* All cases of acute abdomen secondary to trauma will be excluded from the study. All patients in the immediate postoperative phase operated from other facilities presenting with acute abdomen.",{"count":565,"type":21},280,[57],"The study aims 1) to adapt, 2) to develop implementation strategies for and 3) to evaluate the effect of implementing a practice guideline for acute abdomen at primary care level in Zambia. We employ a sequential exploratory mixed method study design. Qualitative and quantitative data from health care workers will be used to adapt a practice guideline developed in a high-income into a low- and middle-income (LMIC) context and to develop strategies for successful implementation. The primary outcome of interest is the prospective change in length of stay in hospital among patients presenting with acute abdomen in the intervention site compared to the control site. The study will address the scarcity of literature on practice guidelines for acute abdomen in the LMIC context. The implementation of an adapted guideline may contribute to a reduction of the morbidity and mortality rates associated with acute abdomen in this setting by increasing management capacity at the primary care level.",[569],"Practice Guidelines for Primary Care of Acute Abdomen",[571],"Acute Abdomen, Practice guidelines, Primary Health Care, Adaptation, Implementation Strategies, Effectiveness-Implementation Hybrid Type 2 Study Design","2026-05-08",{"date":574,"type":35},"2026-05-14",{"date":576,"type":35},"2025-09-01",{"date":361,"type":21},{"name":579,"class":75},"University of Bergen",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":17,"minAge":588,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":591,"briefSummary":592,"conditions":593,"keywords":594,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":606},"100433425","rapid-research-in-diagnostics-development-for-tb-network-100433425","NCT04923958","Rapid Research in Diagnostics Development for TB Network","Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) Study","R2D2TB Network","Novel TB triage and diagnostic tests:\n\nWe will include non-hospitalized adults (age ≥ 12 years) with either 1) cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups or 2) risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below:\n\nPositive TB screening definitions by risk factor:\n\n1. PLHIV (Risk Factor), CRP \\>5 mg\u002FdL OR abnormal CXR (Positive TB screening definition)\n2. Self-reported Close Contact (Risk Factor), abnormal CXR (Positive TB screening definition)\n3. History of mining work (Risk Factor), abnormal CXR (Positive TB screening definition)\n\nWe will exclude people who:\n\n1. completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);\n2. have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);\n3. reside \\>20km from the study site or are unwilling to return for follow-up visits; or\n4. are unwilling to provide informed consent\n\nNovel TB rDST assays:\n\nWe will include adults (age ≥12 years) who are positive for TB and RIF resistance according to routine diagnostic testing (based typically on Xpert MTB\u002FRIF, Xpert MTB\u002FRIF Ultra, or Hain MTBDRplus). We will exclude people who:\n\n1. have negative or contaminated results on all baseline (i.e., enrollment) sputum cultures\n2. are unable to provide at least two sputum specimens of 3 mL each within one day of enrollment\n3. are unable or unwilling to provide informed consent\n\nAssessment of the usability of novel TB tests:\n\nWe will include health workers at each clinical site who are 1) aged ≥18 years and 2) involved in routine TB testing (collecting specimens for or performing TB tests). We will exclude staff who are unwilling to provide informed consent.","12 Years",{"count":590,"type":21},26436,[57],"To reduce the burden of TB worldwide through more accurate, faster, simpler, and less expensive diagnosis of TB Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) brings together experts in TB care, technology assessment, diagnostics development, laboratory medicine, epidemiology, health economics and mathematical modeling with highly experienced clinical study sites in 10 countries.",[214],[214,595,596],"Diagnostics","Global Health","2026-05-04",{"date":599,"type":35},"2026-05-06",{"date":601,"type":35},"2021-04-14",{"date":603,"type":21},"2031-05-31",{"name":605,"class":75},"University of California, San Francisco",16,{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":614,"enrollmentInfo":615,"targetDuration":4,"studyType":22,"phases":617,"briefSummary":618,"conditions":619,"keywords":621,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":271},"100587429","phase-3-long-covid-lc-revitalize---a-long-covid-repurposed-drug-study-100587429","NCT06928272","Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study","LC-REVITALIZE - A Long Covid Repurposed Drug Study","Inclusion Criteria:\n\nEligible participants must meet all the following inclusion criteria:\n\n1. Adults ≥ 18 years of age and ≤ 65 years of age\n2. Previous Covid-19 (SARS-CoV-2 infection) within the past four years, as determined by the site investigator using the following certainty scale (based on available clinical history and\u002For serologic data):\n\n3 - Confirmed Infection (PCR or n-Capsid Test): Prior positive nasopharyngeal or salivary PCR test for Covid-19 (documented proof and\u002For verbal confirmation by participant) or has positive nucleocapsid antibodies results.\n\n2 - Probable Infection (Antigen Test): Participant verbally confirms a prior positive rapid antigen test without PCR confirmation.\n\n1 - Possible Infection (Viral Syndrome and Epidemiological Link): Participant verbally confirms experiencing symptoms consistent with Covid-19 infection and has an epidemiological link (i.e., exposure to a confirmed case) without any positive testing.\n\n3\\. Persistent or new symptoms diagnosed as \"Long Covid\" as defined by the World Health Organization; \"the continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection (Covid-19), with these symptoms lasting for at least 2 months with no other explanation\". This diagnosis may come from a healthcare professional experienced in Long Covid diagnosis, or the site investigator. These symptoms must be present for more days than not and must not have been present prior to the onset of SARS-CoV-2 (Covid-19) infection.\n\n4\\. At the time of screening, participants should be experiencing at least one of the following self-reported symptoms or symptom clusters. Participant has self-reported issues with:\n\n1. Fatigue\n2. Breathing\n3. Circulation\n4. Memory, thinking, and\u002For communication\n5. Muscles and\u002For joints\n\n   These five symptoms or symptom clusters were selected based on unpublished data from the National Institutes for Health and Care Research (NIHR, United Kingdom) and their alignment with five validated SBQ scales. The selection was driven by their prevalence and their significant impact on quality of life as reported in symptom assessments.\n\n   5\\. Participant has the ability and is willing to follow study procedures throughout the study\n\n   6\\. Participant can provide informed consent\n\n   Exclusion Criteria:\n\n   Participants who have any one or more of the following criteria at the time of enrollment will be excluded:\n   1. Participants who do not meet the criteria outlined above\n   2. Participants who are unable to provide their informed consent\n   3. Participants who are pregnant, lactating, or plan to become pregnant during the time of the study\n   4. Persons of childbearing potential who are unwilling or unable to abstain from sex or to use at least one acceptable method of contraception from the time of screening through at least 30 days after the end of the study intervention period. Acceptable methods include barrier contraceptives (e.g., condoms or diaphragm) with spermicide, intrauterine devices (IUDs), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. Participants unwilling to be counseled about the risks related to pregnancy or breastfeeding will also be excluded.\n   5. Male participants must take precautions to avoid impregnating a female while participating in this study. If a male participant's partner can become pregnant, she must use an effective and reliable form of birth control, as listed above, during the study and for 30 days after the male participant's last dose of the investigational product. Additionally, male participants must agree to use a latex condom during sexual activity with partners who could become pregnant.\n   6. eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2\n   7. Moderate to severe liver dysfunction, defined as Bilirubin \\> 1.5 x ULN or AST or ALT \\> 2 x ULN\n   8. Hemoglobin (Hbg) \\\u003C 8.0 g\u002FdL\n   9. Absolute neutrophil count (ANC) below 1,000 cells\u002Fmm³, confirmed with repeat testing\n   10. Absolute lymphocyte count (ALC) below 500 cells\u002Fmm³\n   11. Alkaline phosphatase (ALP) levels equal to or greater than three times the upper limit of normal (ULN)\n   12. Creatine phosphokinase (CPK) levels equal to or greater than three times the ULN\n   13. Platelet count below 100,000 cells\u002Fmm³, confirmed with repeat testing\n   14. Platelet count above 500,000 cells\u002Fmm³, confirmed with repeat testing\n   15. Total fasting cholesterol levels of 280 mg\u002FdL or higher, confirmed with repeat testing\n   16. Fasting low-density lipoprotein (LDL) levels of 180 mg\u002FdL or higher, confirmed with repeat testing\n   17. A personal or family history of long QT syndrome or an electrocardiogram (ECG) during screening showing a corrected QT interval (QTc) of 500 milliseconds or greater, calculated using Fridericia's formula\n   18. Participants with HIV diagnosis\n   19. Participants with active hepatitis B or C diagnosis. Note: treated or cleared hepatitis C is not exclusionary.\n   20. Active herpes zoster infection (visible skin lesions) within 3 months prior to screening, or any history of disseminated or complicated herpes zoster or herpes simplex infection (e.g., VZV encephalitis)\n   21. Participants with active or latent tuberculosis\n   22. Immunocompromised status, as determined by the investigator, that places the participant at an unacceptable risk for study participation\n   23. Active malignancy or lymphoproliferative disorder that has not been in remission for at least five years. Localized non-melanoma skin cancers that have been definitively treated are not exclusionary.\n   24. Positive SARS-CoV-2 test in the last 30 days or symptomatic with Covid-19 like illness\n   25. Previous admission to an intensive care unit (ICU) for the treatment of acute COVID-19 infection\n   26. Any history of deep venous thrombosis, pulmonary embolism, unstable angina, atrial fibrillation, ventricular fibrillation, or myocardial infarction or stroke\n   27. History of sepsis or a significant viral, bacterial, fungal, or parasitic infection within 30 days prior to enrollment, as determined by the investigator.\n   28. Use of one or more of the study drugs within 30 days prior to enrollment for the original indication or other purposes\n   29. Known allergic reactions to the components of the study drugs\n   30. Any prior exposure to JAK inhibitors\n   31. Taking any of the listed medications on the prohibited medications list in Appendix A\n   32. Intake or planned consumption of any of the following: Taurine, Curcumin, CoQ10, Creatine, Resveratrol, Fisetin, Nicotinamide mononucleotide (NMN), Nicotinamide adenine dinucleotide (NAD+), Quercetin, Glycine, Spermidine, Arginine alpha-ketoglutarate, Ergothioneine, Alpha Lipoic Acid, Carnitine, Benfotiamine, Carnosine, Crocin, N-acetylcysteine\n   33. Covid vaccinations are prohibited within 30 days prior to enrollment\n   34. Live vaccine within the 30 days before enrollment or plan to receive live vaccines during the study period\n   35. Other vaccines, including influenza vaccine, are prohibited within 14 days of enrollment\n   36. Major surgery within 30 days prior to enrollment or plans for major surgery during the study\n   37. Any other co-existing medical condition or concomitant medication\u002Ftherapy that might in the judgment of the study investigators, potentially impact the participant's safety or ability to adhere to the study protocol or interfere with the meaning of the clinical and research measurements as judged by the study investigators\n   38. Participation in any clinical study within the last 30 days prior to enrollment\n   39. Participants who participated in Phase One of this study (LC-Revitalize) are not eligible to participate in Phase Two\n   40. Currently hospitalized and\u002For incarcerated","65 Years",{"count":616,"type":21},348,[238],"The Long-Covid (LC)-Revitalize clinical study is testing repurposed drug treatments for Long Covid, involving adult participants from Brazil, Canada, Italy, Uganda, the United States, and Zambia. To qualify, participants must have had Covid-19 and experienced Long Covid symptoms for at least three months. The main goal of the study is to determine whether the drug treatments can improve symptoms in five key areas: 1) fatigue, 2) breathing, 3) memory, thinking, and communication, 4) muscle and joint pain, and 5) circulation. A secondary goal is to assess changes in the body, such as reducing inflammation, as well as to confirm the safety and tolerability of the treatments. In the first phase, 348 participants will take either one of two existing medications (upadacitinib or pirfenidone) or a placebo (a pill with no active ingredient) for three months. Although these medications are not yet approved for Long Covid, they are authorized for use in treating other health conditions. This study is adaptive, meaning it may adjust based on early results. In the second phase, the study could continue testing the most effective drug(s) against a placebo with new participants, explore combinations of drugs to see if they improve results, or discontinue the drugs if they prove ineffective or unsafe and test alternative treatments.",[620],"Long COVID",[622,623,624],"Post-Covid-19 Condition","Covid-19","SARS-CoV-2",{"date":626,"type":35},"2026-04-03",{"date":628,"type":35},"2025-09-10",{"date":630,"type":21},"2027-12",{"name":632,"class":75},"Douglas D. Fraser",{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":17,"minAge":279,"maxAge":280,"enrollmentInfo":640,"targetDuration":4,"studyType":22,"phases":641,"briefSummary":642,"conditions":643,"keywords":647,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":302},"100626268","phase-2-the-impact-of-shigellosis-and-recommended-treatment-in-children-100626268","NCT07433426","The Impact of Shigellosis and Recommended Treatment in Children","TrtNDSD","Inclusion Criteria:\n\n* Patients \\>6 and ≤59 months of age seeking care in the study hospitals\n* Patients residing within the study catchment area\n* Present with watery diarrhea and positive for Shigella by RLDT\n* Willing to be available for sample and data collection during the follow up visits\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant's parent\u002Fguardian to give written informed consent or comply with study protocol\n* Diarrhea started more than 96 hours before enrollment\n* Antibiotics related to shigellosis treatment (including the investigational drug azithromycin) taken in the past 5 days\n* More than 2 doses of antidiarrheal drugs taken in the past 24 hours\n* History of allergy to Azithromycin\n* Presence of visible blood in stool\n* Children with severe acute malnutrition (below -3z scores of the median WHO growth standards).\n* History of congenital heart diseases, known gastrointestinal abnormalities, including short bowel syndrome, chronic (inflammatory or irritable) bowel disease, inherited or acquired immune system deficiency rendering the patient immunocompromised, including chronic\u002Flong-term steroid treatment or other immunosuppressive treatment\n* Fever over 39°C (102°F) with other complications that require antibiotic treatment\n* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study",{"count":55,"type":21},[25],"The purpose of this study is to evaluate whether antibiotic treatment of non-dysentery Shigella associated watery diarrhea (NDSD) cases improves clinical outcomes and growth in children.\n\nChildren with NDSD seeking care for diarrhea at the study hospitals in Bangladesh and Zambia will be enrolled and randomized to receive Azithromycin or placebo (a look-alike substance that contains no drug). Enrolled children will be followed for three months with household visits.\n\nThe investigators will determine whether antibiotic treatment of NDSD reduces the duration of diarrhea and time to microbiological cure (shedding of Shigella in stool), and whether it improves growth in children compared with the placebo group.",[644,645,646],"Diarrhea Infectious","Shigella","Growth & Development",[648,649,650,651,652,653,654],"shigella","children","randomized clinical trial","weight for age","growth outcomes","Azithromycin","Diarrhea","2026-03-27",{"date":501,"type":35},{"date":658,"type":35},"2026-03-18",{"date":660,"type":21},"2030-08",{"name":662,"class":75},"Johns Hopkins Bloomberg School of Public Health",{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":668,"acronym":669,"eligibilityCriteria":670,"healthyVolunteers":51,"sex":17,"minAge":234,"maxAge":671,"enrollmentInfo":672,"targetDuration":4,"studyType":22,"phases":674,"briefSummary":675,"conditions":676,"keywords":683,"overallStatus":216,"whyStopped":4,"lastUpdateSubmitDate":689,"lastUpdatePostDateStruct":690,"startDateStruct":692,"completionDateStruct":694,"leadSponsor":696,"locationsCount":76},"100612694","phase-4-a-trial-to-establish-non-inferiority-of-immunogenicity-of-a-single-dose-of-cervavac-quadrivalent-hpv-vaccine-compared-to-the-gardasil-quadrivalent-vaccine-among-girls-and-boys-aged-9-to-14-years-and-in-girlswomen-aged-15-to-20-years-in-zambia-100612694","NCT07256912","A Trial to Establish Non-inferiority of Immunogenicity of a Single-dose of CERVAVAC® Quadrivalent HPV Vaccine Compared to the Gardasil® Quadrivalent Vaccine Among Girls and Boys Aged 9 to 14 Years and in Girls\u002FWomen Aged 15 to 20 Years in Zambia","A Randomized, Active Controlled, Assessors-blind Trial to Establish Non-inferiority of Immunogenicity of a Single-dose of CERVAVAC® Quadrivalent HPV Vaccine Compared to the Gardasil® Quadrivalent Vaccine Among Girls and Boys Aged 9 to 14 Years and in Girls\u002FWomen Aged 15 to 20 Years in Zambia","CervALONE","Inclusion Criteria:\n\n1. Girl\u002Fwoman between 9 and 20 years of age and boy between the age of 9 and 14 years at the time of recruitment.\n2. Participant willing to sign a written informed consent (for participants 18 years of age and above).\n3. Parent (s) willing to provide written informed consent and participant is willing to sign written assent form for participation (for participants below 18 years of age at the time of eligibility assessment).\n4. Participant or parent (s) willing to comply with all study requirements.\n5. Participants who are determined by Medical History (MH), Physical Examination (PE) and clinical judgment of the Investigator to be eligible for inclusion in the study.\n\nExclusion Criteria:\n\n1. Participants who are sexually active and missed their last menstrual period will have a urine pregnancy test and will be excluded if found pregnant.\n2. Participant has a known history of prior vaccination with any HPV vaccine.\n3. Participant known to be HIV positive (no routine HIV testing will be performed unless clinically indicated)\n4. Participant currently enrolled in any other clinical studies of investigational products.\n5. Participant with a current diagnosis or prior history of genital warts or treatment of genital warts.\n6. Participant with a current diagnosis or prior history of cervical intraepithelial neoplasia (CIN) or cervical cancer.\n7. Participant has a history of any allergic diseases or severe allergic reaction to any agent\u002Fvaccine product (e.g., swelling of the mouth and throat, difficulty in breathing, hypotension, or shock).\n8. Participant has had an acute illness (moderate or severe) and\u002For fever (body temperature ≥ 38°C or ≥ 100.4 °F) at the time of vaccination or during the 72 hours prior to the vaccination.\n9. Bleeding diathesis or uncontrolled condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate IM injection.\n10. Participant has history of major congenital defects or illness that requires medical therapy, as determined by MH or clinical assessment.\n11. Participant has had chronic administration (defined as more than 14 days) of high doses of corticosteroids (prednisone or equivalent at a dose of \\>0.5 mg\u002Fkg\u002Fday), cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressants or other immune-modifying drugs in last 3 months or planned at any time during the study.\n12. Participant has history of receiving a blood transfusion or other blood products in three months prior to screening.\n13. Planned administration of a vaccine not foreseen by the study protocol within 14 days before and 14 days after any dose of study vaccine except TT given for emergency use and any vaccine mandated by government program.\n14. Participant has history of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological functional abnormality, mental or physical disability, blood dyscrasia or any condition which in the opinion of the Investigator might interfere with the evaluation of the study objectives.\n15. Participant has history of any cancer, organ transplant or any other immune system disease.\n16. Individuals who, in the opinion of the investigator, are unlikely to be compliant to all study procedures","20 Years",{"count":673,"type":21},1266,[435],"The goal of this study is to compare the immune response of the single dose of the CERVAVAC vaccine with the single dose of Gardasil vaccine in girls\u002Fwomen aged 9 to 20 and boys aged 9 to 14 at 6 months, 12 months and 24 months post vaccination. The vaccine will be given randomly to the boys and girls\u002Fwomen in these age group and they will be followed up to check the immune status developed in them after vaccination. The status of immune response developed by the two differnet vaccines will be compared in these group of participants of the study.",[677,678,679,680,681,682],"Vaccine Effectiveness","HPV Vaccination","Single Dose","Immunogenicity","Cervical Cancer Prevention","Quadrivalent HPV Vaccine",[684,685,686,687,688],"HPV","VACCINE","SINGLE DOSE","cervical cancer prevention","Quadrivalent HPV vaccine","2026-03-23",{"date":691,"type":35},"2026-03-24",{"date":693,"type":21},"2026-04-01",{"date":695,"type":21},"2029-01-15",{"name":697,"class":75},"International Agency for Research on Cancer",{"id":699,"slug":700,"hasResults":12,"nctId":701,"briefTitle":702,"officialTitle":703,"acronym":704,"eligibilityCriteria":705,"healthyVolunteers":51,"sex":17,"minAge":4,"maxAge":706,"enrollmentInfo":707,"targetDuration":4,"studyType":22,"phases":709,"briefSummary":710,"conditions":711,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":714,"lastUpdatePostDateStruct":715,"startDateStruct":716,"completionDateStruct":718,"leadSponsor":720,"locationsCount":722},"100561662","the-decide-tb-trial-validation-of-treatment-decision-algorithms-for-childhood-tuberculosis-100561662","NCT06593080","The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis","Validation of Treatment Decision Algorithms for Childhood Tuberculosis at District Health Care Levels in Mozambique and Zambia - the Decide-TB Cluster-randomized Pragmatic Trial","DTB","Inclusion Criteria:\n\nThe effectiveness assessment will be conducted using aggregated or individual data from direct beneficiaries of the intervention:\n\n* All sick children aged below 15 years entering the selected health facilities (DH and PHC) at either outpatient (OPD) or inpatient (IPD) departments, including children from high-risk groups, as well as children identified as contact of TB cases through community- or facility-based household contact tracing.\n* Children with presumptive TB.\n\nThe WHO definition of presumptive TB will be used, as defined in the 2022 WHO Operational Handbook, namely: children are classified as having presumptive TB if they have unremitting symptoms lasting more than 2 weeks (any one of cough, fever, not eating well or anorexia, weight loss or failure to thrive, fatigue, reduced playfulness or decreased activity) .\n\nThe definitions of presumptive TB have been adapted locally for the programmatic pilot. All children with presumptive TB as defined locally will be considered in the intervention and in secondary effectiveness and sub-group analyses.\n\nHigh-risk group will be defined using the definition in WHO-suggested TDAs A\\&B as children younger than 2 years, CLHIV or children with SAM. CLHIV will be defined per national testing strategy including positive PCR test for children below the age of 18 months. Children will be considered to have SAM (and thereby be eligible for the TB-Speed SAM algorithm) using WHO criteria. These include being \\\u003C5 years with a weight-for-height Z score (WHZ) \\\u003C -3 SDs or mid-upper arm circumference (MUAC) \\\u003C 115 mm (in children over 6 months) or clinical signs of bilateral pitting oedema, and being aged ≥5 years with a body mass index (BMI) for age Z-score \\\u003C -3SD.\n\nExclusion Criteria:\n\nThere will be no exclusion criteria for the programmatic pilot: all children will be offered the intervention.","14 Years",{"count":708,"type":21},30240,[57],"The Decide-TB project aims to generate evidence for the implementation of a comprehensive Treatment Decision Algorithms (TDA) based approach for TB in children living in high TB burden and resource-limited countries, at District Hospital (DH) and Primary Health Centre (PHC) levels, and to facilitate the integration of this evidence within practices and policies.\n\nThis programmatic pilot led by the National TB Programs (NTP) will test a TDA-based approach integrating TB screening, diagnosis, treatment decision-making, and disease severity assessment for shorter treatment eligibility, for use at a lower level of healthcare. This TDA-based approach will be evaluated in a hybrid effectiveness implementation study based on a pragmatic stepped wedge cluster-randomized trial. The Decide TB project will be implemented at the district level, targeting five districts in each country. Each cluster in a district will be made up of one district hospital and six primary health centers. The study will develop a Clinical Decision Support System (CDSS) to operationalize the use of TDAs, and strengthen District Health Information Systems (DHIS2) to collect individual data, which will contribute to monitoring and evaluation, clinical mentoring, and supervision by the country's NTPs.",[214,712,91,713],"Child Health","Severe Acute Malnutrition","2026-03-19",{"date":691,"type":35},{"date":717,"type":35},"2024-06-01",{"date":719,"type":21},"2027-08-31",{"name":721,"class":75},"Chishala Chabala",29,{"id":724,"slug":725,"hasResults":12,"nctId":726,"briefTitle":727,"officialTitle":728,"acronym":729,"eligibilityCriteria":730,"healthyVolunteers":12,"sex":17,"minAge":588,"maxAge":4,"enrollmentInfo":731,"targetDuration":4,"studyType":22,"phases":733,"briefSummary":734,"conditions":735,"keywords":736,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":737,"lastUpdatePostDateStruct":738,"startDateStruct":740,"completionDateStruct":742,"leadSponsor":744,"locationsCount":557},"100511562","assessing-diagnostics-at-point-of-care-for-tuberculosis-100511562","NCT05941052","Assessing Diagnostics At Point-of-care for Tuberculosis","Supporting, Mobilizing and Accelerating Research for Tuberculosis Elimination (SMART4TB)- Technical Area (TA) 1: Diagnostics- Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT)","ADAPT","Novel TB triage and diagnostic tests:\n\nInclusion Criteria-\n\nThe investigators will include non-hospitalized adults (age ≥ 12 years) with either:\n\n1. cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups; OR\n2. risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below:\n\nPositive TB screening definitions by risk factor:\n\n1. People Living with Human Immunodeficiency Virus (PLHIV) (Risk Factor): C Reactive Protein (CRP) \\>5 mg\u002FdL OR abnormal chest x-ray (CXR)\n2. Self-reported Close Contact (Risk Factor): abnormal CXR History of mining work (Risk Factor): abnormal CXR\n\nExclusion Criteria-\n\n1. Completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);\n2. Have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);\n3. Reside \\>20km from the study site or are unwilling to return for follow-up visits; OR\n4. Are unwilling to provide informed consent\n\nAssessment of the usability of novel TB tests:\n\nInclusion Criteria-\n\nThe investigators will include health workers at each clinical site who are:\n\n1. aged ≥18 years; AND\n2. involved in routine TB testing (collecting specimens for or performing TB tests).\n\nExclusion Criteria-\n\nThe investigators will exclude staff who are:\n\n1\\) unwilling to provide informed consent",{"count":732,"type":21},1350,[57],"Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT) study seeks to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests.",[214],[214,595,596],"2026-03-05",{"date":739,"type":35},"2026-03-09",{"date":741,"type":35},"2023-08-28",{"date":743,"type":21},"2028-09-30",{"name":605,"class":75},""]