Mbarara

Researchers are evaluating the best way to manage virologic failure in people living with HIV who are taking a combination antiretroviral therapy called TLD, which includes tenofovir, lamivudine, and dolutegravir. This trial takes place in public HIV clinics in Uganda and South Africa and focuses on individuals aged 15 years and older who have experienced two high viral load results despite being on TLD for at least 12 months. The main goal is to see which treatment strategy leads to viral suppression below 50 copiesmL at 48 weeks. Participants will be randomly assigned to one of three groups standard care according to local health guidelines involving genotypic resistance testing and adherence counseling individualized care guided by resistance testing and urine tenofovir adherence tests to tailor treatment or an immediate switch to a protease inhibitor-based second-line therapy. The study includes scheduled visits at enrollment, 24 weeks, and 48 weeks, with ongoing adherence counseling and viral load monitoring throughout. During the study, participants will have viral load tests at weeks 24 and 48, resistance testing, urine tests for medication adherence, and side effect assessments depending on their group. Treatment decisions are made based on test results and participant input. The trial follows each person for one year, monitoring how well the virus is controlled and how the treatments are tolerated, aiming to find the most effective management for virologic failure on TLD in these settings.

Adolescents and young adults with HIV AYWH aged 15 to 24 years are the fastest-growing group living with HIV worldwide and face worse outcomes than adults, with HIVAIDS being a leading cause of death and disability in this group. This research aims to develop and test a youth-friendly mobile health mHealth social media intervention to improve retention in HIV care, which may reduce AIDS-related deaths and new HIV transmissions. The study also supports the investigators training in research and clinical trial skills focused on AYWH in low-resource settings. The study will use a social media-based intervention delivered through WhatsApp modules designed to encourage behaviors that improve retention in care for AYWH. Participants will be randomly assigned either to start receiving the intervention immediately or to a wait-list control group, which will begin the intervention after six months. The intervention targets new or re-engaging AYWH in HIV care and considers different infection routes to tailor support. Participants will take part for at least 12 months during which researchers will assess how feasible and acceptable the intervention is and measure retention in care. Data will be gathered from AYWH who are new or returning to care, including their HIV knowledge, experiences, and challenges. The study includes language fluency assessments and smartphone access for some parts. Safety and consent abilities are monitored, and the study is conducted without blinding, allowing direct observation of participation and outcomes.

Researchers are evaluating a new combination drug therapy called BPaLMZ for treating tuberculous meningitis in adults living with HIV. This Phase 2 study compares participants receiving BPaLMZ to those receiving the standard care regimen of rifampicin, isoniazid, pyrazinamide, and ethambutol RHZE. The study aims to assess treatment outcomes including survival and functional status over 24 weeks. Participants are randomly assigned to receive either the BPaLMZ regimen, which includes bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide, or the standard care regimen with rifampicin, isoniazid, pyrazinamide, and ethambutol. The study follows a parallel design without masking. Both treatment groups are monitored closely for up to 28 weeks to assess safety and efficacy markers. During the study, participants undergo evaluations of survival time, functional status, serious adverse events, clinical adverse events, laboratory abnormalities, neuropathy, and drug-induced liver injury. Researchers also measure inflammatory markers in cerebrospinal fluid and blood, neurocognitive performance, mental status changes, and corticosteroid use. Follow-up assessments occur at various time points up to 28 weeks, with a primary focus on outcomes at 24 weeks, providing comprehensive monitoring throughout the study period.

Researchers are evaluating new diagnostic technologies designed to detect upper and lower respiratory tract infections in both children and adults presenting with respiratory symptoms in Uganda, Ethiopia, and Senegal. This observational study aims to assess whether the novel lateral flow tests and microfluidic point-of-care platforms have sufficient accuracy and whether they are practical for use in low-resource clinical settings. The study is conducted across multiple sites and includes participants with suspected respiratory infections, such as fever, cough, or difficulty breathing. The study consists of two sub-studies. The first focuses on upper respiratory infections and evaluates a multiplex lateral flow test detecting influenza, RSV, and COVID-19 from nasal swabs, with results read visually and via an Android tablet. The second sub-study assesses a point-of-care instrument using microfluidic technology to detect bacterial and fungal pathogens in lower respiratory infections, comparing results with standard laboratory methods. Participants provide respiratory and blood samples, and some adults and community members complete surveys about sample biobanking and diagnostic acceptance. Participants attend a single study visit during which respiratory and blood samples are collected for testing and future research. Clinical and demographic information is gathered, and some participants complete surveys or interviews about biobanking acceptability. The study measures diagnostic accuracy and feasibility of the new tests compared to reference methods. Routine medical care continues unchanged, and the study includes participants aged 6 months and older. The trial aims to complete in mid-2026.

This research aims to evaluate several low-cost behavioral strategies designed with user input to encourage adults at higher risk of HIV exposure in rural Kenya and Uganda to retest for HIV. Enrolling 30,000 to 40,000 participants aged 15 and older, the study focuses on improving early disease detection and preventing further transmission by promoting repeat HIV testing. Participants will be randomly assigned to one of up to 12 groups receiving different interventions, such as video messages and SMS reminders based on various motivational themes like risk assessment, community benefits, social norms, and goal-setting. One group will receive a small financial incentive to encourage retesting, while another will receive standard care messaging. The interventions are delivered at baseline and followed up with reminders around 8 and 11 weeks later. Throughout the study, participants will be monitored for HIV retesting uptake measured 3 to 6 months after enrollment. Researchers will collect data to assess which strategies most effectively increase retesting rates and also track secondary outcomes like PrEP uptake. Participation includes initial visits, message delivery, and follow-up assessments, with the total involvement spanning at least 3 to 6 months.

The ICU-related Out-of-Pocket Expenses ICOPE study is a multinational, prospective observational study conducted in African and Asian countries to understand the financial impact of ICU care on patients and their families. The study focuses on measuring out-of-pocket expenses and the occurrence of catastrophic health expenditure among patients who stay in the ICU for more than 24 hours, including those who receive mechanical ventilation and those who do not. The study addresses the rising cost burden related to ICU care in low- and middle-income countries LMICs and aims to identify factors contributing to financial hardship. Participants include all patients admitted to participating ICUs during a 14-day recruitment period, with a planned sample size of at least 354 patients. The study compares groups of patients receiving invasive mechanical ventilation with those who do not, tracking their ICU-related expenses. The follow-up period extends from ICU admission to discharge, with additional assessments at 30 days and 6 months, spanning a total study duration of 18 months. During the study, researchers will collect detailed information about direct and indirect costs associated with ICU care, including medical and non-medical expenses. They will also examine how families cope with these costs and identify risk factors for catastrophic health expenditure. The primary outcomes include out-of-pocket cost per patient episode and the relative risk of catastrophic health expenditure by ICU discharge. Secondary outcomes include risk factors for catastrophic expenditure and the frequency of various coping strategies used by families.

Researchers are evaluating if HIV screening can be effectively conducted for children aged 18 months to 5 years by traditional healers in Southwestern Uganda. The study aims to determine whether caretakers accept HIV testing offered by traditional healers compared to acceptance and follow-through after referral to nearby health centers. The investigation also explores how factors like HIV-related stigma and caregiver knowledge influence testing decisions. The study involves training five traditional healers to provide pediatric-specific HIV counseling and rapid oral swab testing, while another five healers offer enhanced standard care by referring children to health facilities after education about community HIV resources. A total of 400 children will be enrolled over nine months, with half receiving testing through the healers and half referred for testing. Caregivers will complete health histories, surveys on HIV knowledge and stigma, and be offered rapid HIV testing or referral depending on the group. Participants caregivers will be contacted monthly for three months to track follow-up testing, confirmatory testing, and treatment initiation if HIV positive. The study includes thorough monitoring of counseling and testing quality, collection of demographic and behavioral data, and exit interviews with traditional healers and caregivers to assess acceptability and sustainability. The main outcome measured is the number of children completing HIV testing within three months of enrollment.

Researchers are conducting a phase III randomized controlled trial called INTENSE-TBM to evaluate treatments aimed at reducing death rates in adolescents and adults with tuberculous meningitis, including those with or without HIV infection in sub-Saharan Africa. The trial compares intensified tuberculosis meningitis treatment using high-dose rifampicin and linezolid against the World Health Organizations standard treatment, and also examines the effects of aspirin compared to a placebo. This study is carried out across multiple countries including Cte dIvoire, Madagascar, Uganda, and South Africa. Participants are randomly assigned to one of four groups standard WHO tuberculosis meningitis treatment with aspirin placebo, standard treatment with aspirin, intensified treatment with aspirin placebo, or intensified treatment with aspirin. The intensified treatment includes high doses of rifampicin and linezolid for the first eight weeks, followed by standard doses of rifampicin and isoniazid until week 40. Aspirin or placebo is taken daily during the first eight weeks. After week 8, all participants continue with standard treatment until week 40. During the 40-week follow-up, participants undergo regular assessments to monitor survival, neurological events, adverse effects, and disability. Laboratory tests, including culture and drug resistance evaluations, as well as pharmacokinetic studies in subsets of patients, are conducted. HIV-infected participants will have additional monitoring of AIDS-related illnesses, viral load, and immune cell counts. The primary outcome measures the rate of death from any cause up to 40 weeks, with secondary outcomes assessing safety, effectiveness, and quality of life related factors.

High maternal mortality remains a major health challenge in many areas, including Uganda, where low use of antenatal care ANC and skilled birth services contribute to high rates of maternal and perinatal deaths. Researchers are studying the Support-Moms mobile health intervention, designed to share targeted health information and engage social support networks through scheduled reminders to encourage pregnant women in rural Uganda to use maternity care services. This trial aims to evaluate the feasibility, effectiveness, and cost-effectiveness of this intervention in improving maternal health outcomes. The study compares three groups one receiving routine care with standard information, one receiving scheduled SMS-audio messages from the Support-Moms app, and another receiving scheduled messages plus engagement with social supporters via SMS. The intervention delivers health education and appointment reminders to pregnant women and their social supporters to promote ANC attendance and skilled births. The study will be conducted as a randomized controlled trial and includes implementation evaluations to explore broader adoption and cost assessments. Participants will be pregnant individuals in their first trimester who have not yet started ANC and who live within the study area. They will be monitored over 15 months for outcomes including the proportion of births attended by healthcare providers and other maternal, service, and client outcomes. Data collection includes interviews and assessments of implementation success, with ongoing monitoring of study participation and intervention use. The trial will provide insights into how mobile health tools can support maternal care in resource-limited settings.

Researchers are evaluating a new approach to support people living with HIV in rural Uganda by training traditional healers to provide counseling, testing, and help with starting antiretroviral therapy quickly. This study aims to see if this additional support can help more people achieve viral suppression compared to standard clinic care. The study is interventional and randomized, focusing on improving health outcomes for people living with HIV in rural areas. Participants are divided into two groups one receives standard clinic care plus additional support from trained traditional healers using a tailored curriculum for medication adherence, one-on-one counseling, social support, and personalized adherence strategies. The other group receives standard clinic care with no extra linkage or psychosocial support. Both groups are referred to government-run HIV clinics for care. During the study, participants will have visits at baseline, 12 months, and 24 months with a study nurse and agree to attend one of five designated HIV clinics for care. Researchers will monitor viral load suppression at 12 months as the main outcome. Secondary outcomes include linkage to care, ART initiation within 7 days, adherence, retention in care, and quality of life measured at 12 months. The total study duration extends with follow-ups at 24 months and beyond to assess long-term effects.