Search Bar & Filters
Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the intersecting stigmas of HIV, violence, and depression among adolescents and young adults aged 15 to 24 living with HIV in Zambia. The study aims to integrate a World Health Organization (WHO)-endorsed mental health approach into an existing HIV stigma-reducing intervention called Project YES!. The goal is to address internalized and intersecting stigmas that hinder antiretroviral adherence and viral suppression among this population, ultimately improving HIV care and treatment outcomes. The intervention, Project YES+, combines peer mentoring with lay-delivered mental health support adapted from WHO programs such as Project Management Plus and Self Help+. This integrated program offers problem-management skills delivered by trained youth peer mentors. The research includes a randomized controlled trial with 50 participants receiving the intervention and 50 receiving standard care, conducted at a children's hospital in Zambia. The study will assess the feasibility and acceptability of Project YES+ over a 4 to 8 month period. Participants will be involved in attending intervention sessions and completing assessments at baseline and endline. These assessments include measures of stigma, depression, violence, antiretroviral therapy adherence, and blood tests for viral load. Researchers will monitor session attendance and participants' willingness to recommend the program to peers and caregivers. The study will provide data on stigma reduction, psychological distress, and HIV outcomes to inform future larger impact studies.
Actively Recruiting
Researchers are evaluating the effectiveness of whole blood transfusion in children with severe malaria complicated by low platelet counts, a condition known as thrombocytopenia. This study is an open-label randomized controlled trial conducted at a single center. It aims to improve survival rates in children aged 6 months to under 5 years in Zambia who meet modified World Health Organization criteria for severe malaria and have platelet counts of 75,000/uL or less but do not currently require transfusion under existing guidelines. The trial is part of a larger observational study on severe malaria. Participants will be randomly assigned to either receive whole blood transfusion sourced from the Zambia National Blood Transfusion Service or no transfusion. The study will follow children until they are discharged from the hospital or until death occurs. The trial will include 132 children and focuses on comparing survival outcomes between the two groups. During the study, children will be monitored closely with assessments including blood counts and malaria parasite levels to confirm eligibility and track progress. Researchers will measure the incidence of death from any cause up to hospital discharge or for up to 28 days on average. Legal guardians will provide consent and must agree to follow study protocols. Safety monitoring includes watching for any complications from transfusion and maintaining close follow-up during hospitalization.
Actively Recruiting
Researchers are studying drug-susceptible tuberculosis (TB) treatment in children under 10 years old to see if a shorter, 2-month drug regimen is as safe and effective as the standard 4- to 6-month treatment. The shorter treatment uses isoniazid, rifapentine, pyrazinamide, and moxifloxacin (HPZM), while the longer regimen uses isoniazid, rifampin, pyrazinamide, and ethambutol. This study also looks at the safety of the shorter regimen in children with and without HIV. Participants are randomly assigned to receive either the 2-month daily HPZM treatment or the standard daily regimen for 4 to 6 months, depending on disease severity. All drug doses are based on the child's weight. The study focuses on pulmonary and lymph node TB, with treatment plans tailored accordingly. During the study, children will have regular assessments including lab tests to monitor liver function, blood counts, and kidney function. Researchers will track TB disease-free survival over 48 weeks and monitor for serious side effects through week 28. The study includes follow-up visits to evaluate treatment success, safety, and overall health over nearly a year after starting treatment.
Actively Recruiting
Researchers are evaluating whether antibiotic treatment improves outcomes and growth in children aged 6 to 59 months with non-dysentery Shigella-associated watery diarrhea (NDSD). This phase 2B, randomized, double-blind, placebo-controlled study addresses whether treating NDSD with antibiotics, which is not currently standard practice, can reduce diarrhea duration and improve growth compared to placebo. The study is conducted in Bangladesh and Zambia, targeting children seeking care for diarrhea at study hospitals. Participants will be randomly assigned to receive either Azithromycin at 10 mg/kg once daily for 5 days or a placebo that looks identical but contains no drug. All children will receive standard care including oral rehydration or intravenous fluids depending on dehydration level and zinc supplementation. After treatment, children will be followed up for three months with household visits to collect health and growth data. During the study, researchers will measure the time until diarrhea stops and track changes in weight-for-age over 90 days. Additional assessments include linear growth changes and the time to clear Shigella infection. Safety and adherence will be monitored throughout, with data collected through clinical visits and household follow-ups to understand the impact of antibiotic treatment on recovery and growth.