Gaborone

People living with HIV rely on antiretroviral therapy (ART) to prevent the virus from multiplying and becoming detectable in the blood. However, HIV can hide in cells and start multiplying again when ART is stopped. This study evaluates two new laboratory-made antibodies, 10-1074-LS and 3BNC117-LS, designed to attach to HIV and block it from infecting cells and spreading. The main goals are to see how these antibodies affect HIV levels in the blood during ART and after stopping ART and to assess their safety and possible side effects. Participants will receive either the two antibodies or placebo through intravenous infusions at the start of the study (Step 1). The doses are 30 mg/kg for 3BNC117-LS and 10 mg/kg for 10-1074-LS. After initial treatment, participants will stop ART (Step 2) to observe changes in HIV levels over time. The study includes multiple steps with specific criteria for continuing or restarting ART, with total monitoring extending up to 56 weeks for safety and up to 84 weeks depending on individual responses. Throughout the study, participants will undergo regular blood tests to measure HIV RNA levels and immune cell counts. Researchers will track any side effects or serious adverse events from Day 0 through Week 56. They will also monitor how long it takes for HIV to rebound after stopping ART. Participants must attend scheduled visits, follow study guidelines on contraception and sexual activity to prevent HIV transmission, and provide informed consent. This research aims to understand the potential of these antibodies as part of HIV treatment and cure strategies.

Researchers are evaluating an unconditional cash transfer intervention to improve mental bandwidth, adherence to antiretroviral therapy (ART), and postpartum retention among pregnant women with HIV in Botswana. The study addresses how poverty, which affects many in Botswana and burdens mental capacity, may impact health outcomes during pregnancy and postpartum, particularly among women living with HIV. It also explores the feasibility and acceptability of delivering cash transfers via mobile money in public antenatal clinics. The study enrolls 100 pregnant women with HIV in their second trimester from clinics in Gaborone and Mogoditsane-Thamaga District. Participants are randomly assigned to either usual care or an intervention group receiving 1,000 Botswana Pula (BWP) monthly through 6 months postpartum. Study visits occur at baseline, late pregnancy before delivery, and 3-6 months postpartum. Data collected include surveys, mental bandwidth assessments, and clinical records. A subset of participants will be interviewed qualitatively after delivery to evaluate the intervention's acceptability and implementation. Participants undergo mental bandwidth tests and ART adherence assessments from baseline through 6 months postpartum. Researchers also assess the intervention's feasibility and acceptability at late pregnancy and postpartum visits, complemented by qualitative interviews 3-8 months after delivery. These findings will inform future larger trials aimed at improving clinical outcomes such as postpartum viral suppression among pregnant women with HIV.

Neonatal jaundice is a common condition in newborns characterized by high levels of bilirubin, which can cause serious brain damage if not detected and treated. This research evaluates a new smartphone app called Picterus designed to provide a more affordable and user-friendly way to detect jaundice in newborns, especially those with darker skin tones in Botswana. The study aims to collect data from newborns with various bilirubin levels to test how well the app estimates bilirubin compared to traditional blood tests. The study involves taking digital images of newborns' skin using the Picterus app along with other bilirubin measurements such as blood samples and transcutaneous bilirubinometer readings. The app uses a calibration card fixed on the infant's chest to capture images both with and without flash. Blood samples are taken within one hour of the images for laboratory bilirubin analysis. Additional devices like a spectrophotometer and a Neo-Bil Plus analyzer are used to adjust and verify bilirubin estimates. The study is conducted in a hospital setting with up to 150 newborns participating. During the study, researchers collect background information about each newborn, including birth weight, age, gestational age, skin type, and feeding type. They perform various bilirubin measurements and compare the results from the Picterus app to the laboratory tests. The study measures how closely the app's estimates correlate with blood bilirubin levels and assesses its accuracy as a screening tool. Results will be analyzed statistically and shared through publications and seminars. Participants are involved from birth up to 14 days old, with all measurements and blood samples taken within one hour of each other for accuracy.

Researchers are evaluating the use of a lower INR target range (1.5 to 2.5) in patients who have a mechanical bileaflet heart valve in the aortic position. The study aims to determine whether this lower INR target can reduce the risk of bleeding without increasing the risk of blood clot formation or stroke. This is important because patients with mechanical heart valves need lifelong warfarin treatment, and finding the right INR balance could lessen bleeding complications. Participants will continue warfarin therapy after their mechanical valve replacement, but with different INR target ranges depending on their study group. The study compares the standard higher INR targets to the lower 1.5 to 2.5 range to assess safety and effectiveness. This is a Phase 3 clinical trial focusing on patients who had their bileaflet mechanical heart valve implanted at least three months prior. During the study, participants will be monitored for thrombosis or thromboembolism and major bleeding events over a period expected to last 2 to 3 years. Researchers will regularly measure INR levels to guide warfarin dosing and track outcomes related to bleeding and clotting. The results are intended to help doctors better manage warfarin dosing to reduce bleeding risks while preventing clots in this patient group.

Researchers are evaluating the safety and effectiveness of pramipexole extended release (ER) compared to escitalopram for treating major depressive disorder (MDD) and MDD with mild neurocognitive disorder (MND) in people living with HIV. This phase II, randomized, open-label trial includes an optional sub-study with 36 participants to assess treatment effects on cerebrospinal fluid (CSF) profiles. Participants will be carefully monitored to track treatment response and any side effects. Participants will take either pramipexole ER tablets or escitalopram tablets, both taken orally. The study includes scheduled visits for detailed and brief assessments throughout treatment to check for toxicity, response, and dose adjustments as needed. The sub-study for CSF evaluation is optional and involves a smaller group of participants. During the study, participants will undergo evaluations including the Beck Depression Inventory-II to measure changes in depression symptoms from the start to week 24. Researchers will also monitor for any severe or neuropsychiatric adverse events related to the study drugs throughout the 24 weeks. Participants will be assessed regularly to ensure safety and to observe treatment effects over the study period.

Researchers are evaluating a culturally tailored stigma intervention to help women living with serious mental illness (SMI) and HIV in Botswana maintain viral load suppression. These women face challenges such as psychiatric medication nonadherence and symptom worsening due to stigma, which can impact their adherence to HIV treatment. The study is a two-arm randomized controlled trial comparing a 'What Matters Most' (WMM) based intersectional stigma intervention to an attention placebo control, focusing on the period after discharge from psychiatric hospitalization. The study also includes family members and policymakers to address stigma at multiple levels and promote structural change. The intervention includes psychoeducation, cognitive restructuring to challenge stigma-related stereotypes, and coping skills to handle discrimination, delivered as women transition from inpatient to outpatient care. Family members receive a parallel group stigma intervention to support treatment adherence. The control group receives a similar format without the stigma content. The study also pilots policymaker workshops co-led by women with lived experience to encourage systemic changes. The intervention and control sessions occur during and after psychiatric hospitalization, with some sessions in community settings. Participants will be assessed over a 4-month follow-up period after the intervention to measure changes in viral load as the primary outcome. Secondary outcomes include adherence to antiretroviral and psychiatric treatments, mental health status such as depression, and social integration. Evaluations involve interviews, adherence tracking, and social assessments. The study also involves monitoring family-level stigma and its impact on participants. The overall study duration includes baseline assessment, intervention delivery, and follow-up evaluations totaling approximately 16 months from baseline to primary outcome measurement.

Researchers are conducting a Phase 3 trial in Botswana to evaluate if offering testing for sexually transmitted infections (STIs) alongside expanded HIV prevention options helps increase the start and continued use of pre-exposure prophylaxis (PrEP) among pregnant women. The study focuses on pregnant women without HIV seeking antenatal care, comparing standard care involving symptom-based STI assessment with an approach that includes STI testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The goal is to see whether providing STI testing with PrEP offers improves initiation and persistence of PrEP use during pregnancy and postpartum. Participants will be randomly assigned to one of two groups: standard of care with syndromic STI management or co-offer of STI testing using Xpert CT/NG and TV assays during pregnancy and postpartum. Pregnant women will be offered a choice of oral PrEP pills or a dapivirine vaginal ring (DPV-VR) and may start, stop, or switch PrEP methods at any time during the study. Follow-up will continue until 9 months after delivery. During the study, women will be monitored for PrEP initiation within the first month, continued use up to 9 months postpartum, and adherence measured by drug levels in hair samples. Secondary outcomes include PrEP method choice, rates of STIs, and birth outcomes by group. Additional exploratory outcomes cover HIV incidence, quality of care, factors affecting adherence, and antimicrobial resistance. Participants will provide informed consent and receive antenatal and postnatal care in the city or town where they enroll.

Researchers are evaluating adaptive strategies to improve the timely start of cervical cancer treatment in Botswana. This trial uses a pragmatic Sequential Multiple Assignment Randomized Trial (SMART) design, focusing on overcoming delays caused by communication issues, patient and system barriers, and poor coordination between clinics. The study applies behavioral economics and nudge techniques, which have shown effectiveness in preventive care, HIV, and cancer treatment, aiming for sustainable and scalable improvements. Participants may receive different behavioral interventions including Clinic Outreach, where pathology staff contact referring clinics to share results; Enhanced Outreach, involving direct communication with both clinics and patients; Low-Touch Strategy with asynchronous text message reminders about timely care; and High-Touch Strategy combining text reminders with live telephone patient navigation. These adaptive approaches are tested to find the best method for increasing timely treatment adoption. During the study, researchers will monitor how quickly participants begin treatment within 90 days after randomization. Data collection includes communication tracking and patient navigation activities. The study focuses on biological females aged 18 or older diagnosed with invasive cervical cancer confirmed at Botswana's National Health Laboratory. The goal is to measure the effectiveness of these strategies in improving treatment adoption rates and coordination over the study period.

Researchers are evaluating the safety, tolerability, acceptability, and pharmacokinetics of oral and long-acting injectable Cabotegravir (CAB) and Rilpivirine (RPV) in children aged two to less than twelve years living with HIV-1 who are virologically suppressed. This Phase I/II, multicenter, open-label, non-comparative study aims to propose appropriate weight-band dosing and assess the injectable regimen with and without an oral lead-in period in this population. The study also includes a safety extension period to monitor for toxicities if participants cannot access the injections after the study ends. Participants will first receive daily oral tablets of CAB and RPV, followed by long-acting injectable CAB and RPV. The study involves an oral lead-in phase followed by an injection phase for eligible participants. If injections are not accessible post-study, participants may enter a safety extension period for ongoing monitoring. The treatments are monitored through various pharmacokinetic measures at multiple time points, including weeks 2, 5, 8, 12, and 24. Throughout the study, children will undergo laboratory tests, electrocardiograms, and safety assessments to evaluate drug levels, side effects, and tolerability. Researchers will monitor for adverse events, serious adverse events, and reasons for discontinuation during both the oral and injectable phases. Caregivers may also participate in behavioral surveys or interviews. The total participation duration includes the initial treatment phases and a possible extended safety monitoring period.

Researchers are evaluating the impact of a combination of three broadly neutralizing antibodies (bNAbs) or analytic treatment interruption (ATI) on viral reservoir, immune function, and maintenance of HIV suppression in early-treated children living with HIV-1 in Botswana. This phase I/II trial aims to advance pediatric HIV treatment and cure research by studying these effects in young participants who started antiretroviral therapy early. Participants receive intravenous infusions of the antibodies PGDM1400LS, VRC07-523LS, and PGT121.414.LS based on their weight. They continue their existing effective antiretroviral therapy (ART) during initial study steps. Later study phases include periods of antibody immunotherapy alone after stopping ART, and some participants may undergo analytic treatment interruption where all anti-HIV treatments are paused. The study monitors safety and treatment effects through these various steps and durations. During the study, participants undergo regular assessments including viral load measurements, CD4 cell counts, and safety evaluations over periods lasting up to 48 weeks. Researchers track the maintenance of HIV suppression, immune function, and safety of the antibody therapies alone or combined with ART. Participants will be followed through multiple steps, including periods of antibody treatment with ART, antibody treatment alone, and treatment interruption, to understand long-term effects and safety.