Mbarara

Researchers are conducting the RESOLVE trial, an open, randomized clinical study in Uganda and South Africa, to find the best way to manage virologic failure in people with HIV taking the antiretroviral therapy combination of tenofovir, lamivudine, and dolutegravir (TLD). The study focuses on individuals aged 15 and older who have experienced two viral load results above 1,000 copies/mL while on TLD for at least one year. The main goal is to see which management strategy leads to viral suppression below 50 copies/mL after 48 weeks. Participants will be randomly assigned to one of three groups: the Standard of Care group, which uses genotypic resistance tests and follows national guidelines; the Individualized Care group, which bases treatment on resistance test results and urine adherence tests; or the Immediate Switch group, which switches directly to a protease inhibitor-based second-line therapy. The randomization considers clinic location, previous exposure to certain HIV drugs, and history of virologic failure. The study includes visits at enrollment, 24 weeks, and 48 weeks. During the year-long follow-up, participants will have their viral load monitored to assess suppression status. The primary outcome is viral suppression at 48 weeks post-enrollment, using the FDA snapshot definition. The study involves assessments at each visit and collects data on treatment response and adherence. Pregnant women can participate, and the study excludes those planning to move away or with prior failure on specific HIV drugs.

Adolescents and young adults with HIV (AYWH) aged 15 to 24 years are the fastest-growing group living with HIV globally and face poorer care outcomes compared to adults. HIV/AIDS is a leading cause of death and disability in this group. This research aims to develop a youth-friendly mobile health (mHealth) social media intervention to improve retention in HIV care, reduce AIDS-related deaths, and decrease new HIV transmissions among AYWH, especially in low-resource settings. The intervention uses WhatsApp-based behavioral modules designed to positively influence retention in care behaviors among AYWH. The study will focus on AYWH who are new to care or re-engaging after being lost to follow-up. It also includes training the investigator in qualitative research, behavioral science, and clinical trial methods. The goal is to tailor the intervention to address neurodevelopmental challenges and knowledge gaps specific to AYWH. Participants will be assessed over a 12-month period to measure how acceptable and feasible the social media intervention is. Researchers will collect information on participants' experiences, retention in care, and viral suppression. The study includes language fluency checks, smartphone access for some participants, and informed consent. The overall aim is to improve outcomes for AYWH and support efforts to end the HIV/AIDS pandemic.

Researchers are evaluating the effectiveness of gabapentin compared to a placebo in helping people with HIV who also have heavy alcohol use to achieve undetectable HIV viral load. This Phase 2 randomized controlled trial includes 300 participants who have had a detectable viral load at least 6 months after their HIV diagnosis. The study aims to see if gabapentin can reduce alcohol consumption, improve pain management, increase adherence to antiretroviral therapy (ART), and enhance engagement in HIV care, all of which support viral load suppression. Participants will be randomly assigned to one of two groups: one group will receive gabapentin with a target dose of 1800 mg per day, and the other will receive a placebo. The gabapentin dose will be gradually increased over three weeks before maintaining the target dose for nearly three months, followed by a tapering period in the final week. Both groups will also receive counseling focused on reducing alcohol use during the 3-month treatment period. Throughout the study, HIV viral load will be measured via laboratory tests at 3, 6, and 12 months after starting treatment, with the primary outcome assessed at 3 months. Participants will be closely monitored for alcohol use, pain severity, ART adherence, and engagement in care. The total duration of participation includes the treatment phase and follow-up assessments to evaluate the longer-term effects of the intervention.

Researchers are evaluating various low-cost behavioral interventions designed with input from the target users to encourage adults at higher risk of HIV exposure in rural Kenya and Uganda to retest for HIV. This large study aims to enroll between 30,000 and 40,000 individuals aged 15 years and older from eight HIV testing sites. The goal is to identify which strategies best promote repeat HIV testing and understand for whom these interventions are most effective. Participants will be randomly assigned to receive one of up to 12 different messaging strategies, each delivered through a brief video at their initial visit. These messages focus on themes such as risk assessment, U=U (Undetectable = Untransmittable), community benefits, fresh start effect, education, default appointment, reserved for you messaging, social norms, goal-setting, or a small financial incentive. Following the baseline visit, participants will receive follow-up SMS reminders at about 8 and 11 weeks to encourage returning for repeat HIV testing. During the study, researchers will monitor participants' HIV retesting uptake 3 to 6 months after their baseline visit. Data collected will be used to compare how effective each intervention is at encouraging retesting. Participants will need daily access to a mobile phone to receive messages, and their HIV status will be confirmed negative at enrollment. The total duration of participation will cover this retesting period and follow-up assessments.

Researchers are conducting a multinational, prospective observational study called the ICU-related Out-of-Pocket Expenses (ICOPE) study in African and Asian countries. This study aims to measure the financial burden on patients and families related to ICU care, focusing on out-of-pocket expenses and catastrophic health expenditure. The study includes both ventilated and non-ventilated patients admitted to participating ICUs during a 14-day recruitment period, with a planned sample size of at least 354 patients. Participants are followed during their ICU stay, which averages about 7 days, and additional follow-ups occur at 30 days and 6 months after admission. The study compares costs between patients receiving invasive mechanical ventilation and those who are not ventilated. It also investigates risk factors for catastrophic health expenditure and documents how families cope with the financial demands of ICU care. Throughout the study, researchers collect data on patient expenses, including direct medical and non-medical costs, as well as indirect costs such as income loss. The main outcomes measured are the out-of-pocket cost per patient episode until ICU discharge and the relative risk of catastrophic health expenditure. The total study duration spans 18 months, allowing for comprehensive assessment of financial impact and coping strategies over time.

Researchers are evaluating a digital-first, multi-component care strategy to improve self-care for patients with Heart Failure (HF) at six Regional Referral Hospital outpatient departments in Uganda. This stepped wedge, cluster-randomized trial will assess both implementation and clinical outcomes, including the effectiveness of an enhanced standard-of-care clinical bundle and a digital health intervention called Medly Uganda. The study focuses on improving HF self-care and reducing mortality and hospitalization rates over time. The study involves training healthcare providers in an enhanced HF clinical care bundle (Core-HF) that includes a treatment protocol, patient and provider self-care training, and medication stock management. After this, the digital health intervention Medly Uganda will be introduced, offering a mobile app for patients to report symptoms and receive self-care guidance, alongside a clinician dashboard for monitoring and nurse-guided management. This phased approach supports standardized care and digital monitoring for better management of HF. Participants will be assessed regularly at baseline and every six months up to 36 months for self-care using the Self-Care of Heart Failure Index and clinical effectiveness including mortality and hospitalizations. The study will also collect qualitative and quantitative data to guide ongoing improvements. Patients must have access to a mobile phone and basic reading skills in specific local languages or English. Continuous monitoring and evaluation throughout the study aim to optimize care delivery and patient outcomes in this setting.

Researchers are investigating whether traditional healers in Southwestern Uganda can effectively offer HIV screening tests to children aged 18 months to 5 years. The study aims to understand if caretakers will accept HIV testing for their children from traditional healers and how factors like HIV stigma and knowledge influence this decision. The study compares the acceptance and follow-up rates between children tested by traditional healers and those referred to nearby health centers for testing. In this study, five traditional healers will be trained to provide pediatric HIV counseling and rapid oral swab testing, while another five will offer enhanced standard care by referring children to health facilities. A total of 400 children will be enrolled over nine months, with half receiving testing from traditional healers and the other half referred to health centers. The study uses Oraquick4 oral swab test kits for rapid HIV testing, which provide results in 15 minutes. Caretakers receive counseling before and after testing, and those with reactive results are referred for confirmatory testing and care. Testing can be performed by healers or supervised caretakers in a private setting. Participants will complete health and social surveys at enrollment, including questions about HIV knowledge and stigma. Caretakers will be contacted monthly for three months to track follow-up testing and treatment initiation for those diagnosed with HIV. Researchers will verify treatment information through clinic visits if consent is given. Exit interviews with traditional healers and caretakers will assess the program's acceptability, sustainability, and safety. The main outcome measured is the number of participants who complete HIV testing during the study period.

This research aims to improve maternal health in rural Uganda by increasing the use of antenatal care (ANC) and skilled births, which are critical to preventing maternal and perinatal deaths. Due to low usage of these services, maternal and perinatal mortality rates remain high in this region. The study evaluates a mobile health intervention called the Support-Moms app, designed to share targeted health information and engage social support networks through scheduled reminders to encourage pregnant women to use maternity services. Participants will be randomly assigned to one of three groups: routine care, scheduled SMS-audio messages alone, or scheduled messages plus engagement of social supporters via SMS. The Support-Moms app sends health messages and appointment reminders and involves social supporters to help pregnant women attend ANC visits and deliver with skilled healthcare providers. The study includes a randomized controlled trial with 824 participants to test the effectiveness and cost-effectiveness of this intervention. Participants will be involved throughout their pregnancy, starting in the first trimester before ANC begins. Researchers will monitor healthcare provider-led skilled births over 15 months, assess implementation outcomes through interviews, and evaluate costs. Women and their social supporters must have access to cell phones and be able to receive SMS messages. The study will measure maternity care utilization, including the number of ANC visits and skilled delivery rates, to understand how well the Support-Moms app supports maternal health.

Researchers are evaluating My Mobile Wallet, a behavioral and economic intervention designed to support tuberculosis medication adherence in rural southwestern Uganda. Tuberculosis remains a deadly public health issue, with poor medication adherence contributing to treatment failure, increased transmission, and drug resistance. This trial aims to determine the best design for My Mobile Wallet and assess its initial feasibility and acceptability compared to standard care in improving tuberculosis medication adherence. Participants are divided into three groups: one receiving daily SMS reminders and mobile money incentives for transport and adherence during the first two months, followed by weekly SMS reminders and monthly incentives for the next four months; a second group receiving only SMS reminders on the same schedule without financial incentives; and a control group receiving only a Wisepill device to monitor medication without SMS or mobile money support. All participants use the Wisepill device to monitor adherence over six months. Participants will be monitored for medication adherence over six months using the Wisepill device. Researchers will collect data through SMS reminders, mobile money transactions, and hair sampling at months 2 and 4 to measure adherence. The primary outcome is medication adherence rates at six months. The study includes a variety of assessments to understand the intervention's impact on adherence and participant experience with the My Mobile Wallet system.

Researchers are studying a new way to support people living with HIV in rural Uganda by involving traditional healers. These healers will be trained to provide counseling, HIV testing, help patients start antiretroviral therapy quickly, and guide them on medication use and staying in care. The goal is to see if this additional support can help more people achieve viral suppression compared to standard clinic care. The study includes two groups: one receiving the new support approach called Omuyambi, which involves traditional healers offering HIV testing, referrals, care linkage, and medication adherence support; and a control group receiving standard HIV testing and referral. Participants will receive care at one of five pre-determined HIV clinics if they choose to engage in HIV treatment. Participants will be involved in study procedures including baseline, 12-month, and 24-month in-person visits with a study nurse. Researchers will measure viral load suppression at 12 months to evaluate the effectiveness of the intervention. Participants' adherence and viral loads will be monitored, with a focus on improving health outcomes over two years.