Kampala

Researchers are evaluating a family-centred approach to prevent cardiovascular diseases CVD among adolescents and their families in Uganda. This 5-year study focuses on reducing risk factors like unhealthy diet and physical inactivity that contribute to CVD and other non-communicable diseases NCDs. The study adapts a proven intervention from Asia to the Ugandan context, aiming to support healthier lifestyle behaviors during the critical adolescence period when habits form that affect adult health. The study includes two groups one receiving the FaCe-D intervention, which involves home visits by Village Health Teams delivering diet, physical activity, and health messaging and a control group receiving standard care with usual health promotion activities. The study is divided into three phases adapting the intervention, implementing it, and evaluating its effectiveness and feasibility in 32 villages. Participants will be involved for at least 12 months, during which researchers will assess changes in cardiovascular health and sleep quality. Evaluations include monitoring behavior changes, health outcomes, and implementation costs. The study also considers adoption and feasibility to understand how well the intervention works in real community settings.

Researchers are evaluating whether stopping secondary antibiotic prophylaxis SAP is not worse than continuing SAP in preventing worsening of rheumatic heart disease RHD in children and adolescents. This Phase 3 trial focuses on participants aged 5 to 20 years who have mild RHD and have already received at least two years of SAP. The goal is to see if stopping SAP affects heart disease progression compared to continuing treatment. The study is randomized and controlled with a single masking approach. Participants will be randomly assigned to either stop SAP or continue receiving monthly intramuscular benzathine benzylpenicillin G BPG injections for two years. Dosage is based on weight, with children under 30 kg receiving 600,000 IU and those 30 kg or above receiving 1.2 million IU every 28 days. The control group continues the standard care of monthly BPG injections, while the intervention group receives no prophylaxis for the same period. During the study, participants will be monitored for two years to assess the progression of RHD using echocardiographic evaluations based on the 2023 World Heart Federation criteria. Blinded adjudicators will review heart imaging results to determine disease changes. Researchers will also analyze outcomes for subgroups with either normalized or stable mild RHD and explore differences based on prior prophylaxis routes. The trial spans from enrollment through the end of the 2-year treatment period, with safety and disease progression closely followed.

Researchers are evaluating new medicines to prevent infection with Human Immunodeficiency Virus Type 1 HIV-1. This Phase 3 clinical trial aims to find out if taking MK-8527 once a month is more effective than a daily standard pre-exposure prophylaxis PrEP in preventing HIV-1 infection in women. The study also monitors the safety and tolerability of MK-8527 compared to standard treatment. Participants are randomly assigned to one of two groups one group receives 11 mg of MK-8527 once monthly along with a placebo daily pill resembling EmtricitabineTenofovir Disoproxil Fumarate FTCTDF, and the other group receives the daily FTCTDF pill plus a monthly placebo resembling MK-8527. This treatment phase lasts for up to approximately two years. Afterward, all participants take open-label FTCTDF daily for an additional 28 days. During the study, participants attend regular visits for up to about two years, during which researchers check for new HIV-1 infections, record any adverse events or side effects, and monitor if participants stop the study medication due to side effects. The primary outcomes include the number of participants who acquire HIV-1 infection, those who experience adverse events, and those who discontinue due to adverse events, all tracked over the treatment period.

Researchers are evaluating the effects of etavopivat in adolescents and adults with sickle cell disease. This study aims to confirm whether etavopivat reduces the number of painful vaso-occlusive crises caused by blood vessel blockages. It also examines if the medicine helps reduce organ damage, improve exercise tolerance, and decrease fatigue. The study is a phase 3, randomized, double-blind, placebo-controlled trial lasting about two years. Participants will be randomly assigned to receive either oral etavopivat or a placebo. The treatment is given by mouth, and neither the participants nor the researchers know which treatment is given during the study to ensure impartial results. The primary treatment period is 52 weeks, during which the number of vaso-occlusive crises with medical contact will be measured. Secondary assessments include changes in hemoglobin levels, fatigue scores, walking distance, and other blood markers related to sickle cell disease. During the trial, participants will undergo regular evaluations including blood tests, walking tests, and fatigue assessments from baseline to week 52. Researchers will monitor the safety and effectiveness of etavopivat throughout the study. The total participation time is about two years, with ongoing follow-ups to observe the treatment effects and any side effects. All procedures aim to provide detailed information on how etavopivat affects sickle cell disease symptoms and patient well-being.

Researchers are evaluating the effectiveness and safety of inavolisib combined with Phesgo compared to a placebo combined with Phesgo as maintenance treatment for participants with previously untreated HER2-positive advanced breast cancer that has a PIK3CA mutation. This Phase 3 study focuses on participants with locally advanced or metastatic breast cancer who have completed induction therapy. Participants first receive induction therapy with Phesgo plus taxane-based chemotherapy. Following this, they enter the maintenance phase where they are randomly assigned to receive either inavolisib tablets taken orally once daily for 21 days of each 21-day cycle along with Phesgo administered subcutaneously every 3 weeks, or a matching placebo tablet with Phesgo on the same schedule. Optional endocrine therapy may be given based on the investigators choice according to standard care. Throughout the study, participants undergo regular monitoring including tumor assessments, quality of life questionnaires, and safety evaluations lasting up to approximately 111 months. Key outcomes measured include progression-free survival assessed by investigators, overall survival, response rates, duration of response, and adverse event rates. Plasma concentrations of inavolisib are also measured at specific timepoints. Participants will be followed closely during and after treatment to assess these outcomes over an extended period.

Researchers are investigating the effects of crizanlizumab compared to a placebo in adolescents and adults with Sickle Cell Disease who experience frequent vaso-occlusive crises VOCs. This Phase III, randomized, double-blind study involves patients aged 12 years and older who have had 4 to 12 VOCs managed by healthcare professionals in the past year. The study evaluates the safety and effectiveness of crizanlizumab with or without standard hydroxyureahydroxycarbamide therapy. Participants are randomly assigned in a 21 ratio to receive either crizanlizumab at a dose of 5 mgkg or a placebo, both given alongside standard care. The treatment is administered intravenously as a concentrate for infusion. The study is stratified by hydroxyurea use and geographical region to ensure balanced groups. The main treatment period lasts for one year. During the study, participants will attend regular visits for treatment and monitoring. Researchers will assess the number of healthcare-managed VOCs, including those treated in person or via remote consultation, and measure various other outcomes such as time to first VOC, VOC duration, antibody development to crizanlizumab, adverse events, and changes in hemoglobin levels. Safety and efficacy will be observed over two years, with detailed documentation of VOC events and other health assessments throughout participation.

This research aims to provide continued access to HIV-1 treatment drugs for children and adolescents who have completed relevant prior studies involving Gilead Sciences HIV therapies. It evaluates the safety of these study drugs in participants living with HIV-1, offering a way to maintain their treatment while monitoring for any adverse events. The study is open-label and single-arm, focusing on participants who previously took part in specific parent studies. Participants will continue taking the study drug they received in their parent study, which may include combinations such as emtricitabinetenofovir alafenamide FTAF with a third antiretroviral agent, elvitegravircobicistatemtricitabinetenofovir alafenamide ECFTAF, or other combinations involving cobicistat and protease inhibitors. Dosages are adjusted based on participant weight, and some may switch to bictegraviremtricitabinetenofovir BFTAF depending on their situation. The study drugs are administered orally in various fixed-dose tablets or oral suspension forms. During the study, participants will be monitored for up to 9.5 years to track access to the study drugs and observe any treatment-emergent adverse events. The evaluation includes regular safety monitoring to assess how participants tolerate continued treatment. The long-term observation ensures ongoing assessment of drug safety and participant health throughout the study duration.

This research aims to evaluate the feasibility, sustainability, and public health impact of a district-based program for secondary prevention of Rheumatic Heart Disease RHD in Uganda. It is a non-randomized study testing the implementation of decentralized RHD preventive services, overseen by the Uganda Ministry of Health and District Health Offices in partnership with a technical quality assurance team. The study uses the RE-AIM framework to measure program reach, effectiveness, adoption, implementation, and maintenance while also estimating cost-effectiveness and budget impact. The study involves the ADUNU program, which integrates echocardiographic screening for RHD in children and young adults through community and facility-based testing. The program also includes registry-based secondary prophylaxis injections of Benzathine penicillin G BPG administered at local health centers HCIII and HCIV in the participating districts. This approach is designed to improve access to care and maintain patients linked to treatment. Participants and healthcare providers residing or working in the involved districts will engage with the program over several years. Researchers will assess the proportion of persons reached, enrolled, retained, and adherent to treatment at multiple time points up to five years. They will also evaluate program adoption and implementation at organizational, provider, and patient levels through surveys and interviews, alongside a cost analysis of the program at three years. The study ensures ongoing monitoring of adherence and outcomes to understand the programs public health impact.

Researchers are evaluating the effectiveness of a phone-based tobacco cessation program specifically designed for people living with HIV PLWH in Uganda and Zambia. This study compares this intervention to the standard care, which includes brief advice to quit smoking and nicotine replacement therapy using nicotine patches. The research aims to understand how well this approach works, how feasible it is to deliver, and how affordable it might be in healthcare settings with varying tobacco use, policies, and resources. Participants are assigned to one of four groups standard care with advice to quit, standard care plus nicotine patches, standard care plus supportive text messaging, or a combination of all three. The study uses a previously tested SMS platform to provide tailored support messages. This design allows researchers to see which combination helps maintain tobacco abstinence over six months after starting the program. During the study, participants will be monitored for tobacco use abstinence at several points, including 4 weeks, 8 weeks, 3 months, and especially at 6 months after enrollment, which is the main outcome. The study also tracks feasibility and acceptability of the interventions within HIV treatment centers. Participants will undergo assessments to support these measurements, with ongoing engagement through text messaging and nicotine therapy where applicable, providing insight into the best ways to support quitting tobacco among PLWH in these regions.

Researchers are evaluating a community-based Phase III cluster randomized trial in Uganda involving adults with advanced HIV disease, defined by a CD4 count below 200 cellsL. The study aims to assess 24-week survival with retention in care by comparing an enhanced package of care to the standard of care. This trial focuses on improving prompt screening and treatment of opportunistic infections, which are a major cause of death in this population, while ensuring timely initiation of antiretroviral therapy ART. The intervention group receives an enhanced care package consisting of point-of-care CD4 testing using the Visitect lateral flow assay, screening for tuberculosis with FujiFilm SILVAMP TB LAM, and cryptococcal antigen testing using a semi-quantitative CrAg LFA. They also receive a one-month preemptive therapy with isoniazid and rifapentine for latent tuberculosis and treatment for disseminated CNS cryptococcal infection when indicated. The standard care group undergoes CD4 testing by flow cytometry, WHO-recommended opportunistic infection screening including urine TB LAM and CrAg LFA, and receives longer isoniazid prophylaxis and fluconazole treatment for cryptococcal antigen positivity as per national guidelines. Participants will be monitored over 24 weeks to assess survival while retained in care. Researchers will evaluate the sensitivity and specificity of the tuberculosis point-of-care tests, the incidence of opportunistic infections and related hospitalizations or deaths, and adherence and tolerability to the prophylactic regimens. The study includes regular clinic visits for testing, treatment, and follow-up, with safety and adherence monitoring throughout the trial period. Total participation spans at least 24 weeks from enrollment.