Gaborone

Researchers are evaluating two new laboratory-made antibodies, 10-1074-LS and 3BNC117-LS, for adults living with HIV-1 in Sub-Saharan Africa. These antibodies are designed to attach to HIV and block it from infecting cells and spreading. The study aims to see if these antibodies affect the amount of HIV that remains in blood cells while on antiretroviral therapy ART and after stopping ART, as well as to assess their safety and any side effects. Participants will be randomly assigned to receive either the two antibodies or placebo infusions combined with ART at the start of the study. The antibodies and placebos are given intravenously on the first day of the initial treatment period. The study includes multiple steps, including starting ART with antibody or placebo infusions, stopping ART under close monitoring, and following participants to observe the return of the virus and any need to restart ART. During the study, participants will attend scheduled visits for blood tests to measure HIV levels, immune cell counts, and safety labs. Researchers will track side effects and monitor how long it takes for the virus to rebound after stopping ART. Participants will also be asked to use contraception methods if of child-bearing potential and follow precautions to prevent HIV transmission during treatment interruption. The study duration includes at least 56 weeks of safety and efficacy monitoring after infusion and follow-up for up to 72 weeks after ART discontinuation.

Researchers are evaluating the impact of unconditional cash transfers on mental bandwidth, antiretroviral therapy ART adherence, and postpartum retention among pregnant women with HIV in Botswana. This pilot trial explores if providing monthly cash support improves these outcomes compared to usual care, while also assessing the feasibility and acceptability of delivering cash transfers via mobile money at public antenatal clinics. The study addresses the challenge of poverty as a barrier to sustained ART engagement during pregnancy and postpartum periods. Participants are pregnant women with HIV in their second trimester, randomly assigned to either receive the usual care plus a monthly unconditional cash transfer of 1,000 Botswana Pula BWP through six months postpartum or usual care alone. The study enrolls 100 women, with 50 in each group. Study visits occur at baseline, late pregnancy before delivery, and 3 to 6 months postpartum, including surveys, bandwidth assessments, and clinical data collection. A subset of participants will be interviewed qualitatively to explore intervention feasibility and acceptability. During the study, participants complete questionnaires and mental bandwidth tests at three key time points baseline, late pregnancy, and postpartum. Researchers will measure ART adherence from baseline through six months postpartum and evaluate food security, psychological distress, and other related outcomes. Safety and acceptability are monitored through interviews conducted 3 to 8 months postpartum. The entire participation spans from the second trimester through six months after delivery, with data collected at three visits.

Researchers are investigating whether routine screening and treatment for two common sexually transmitted infections, chlamydia and gonorrhoea, during pregnancy can reduce the risk of preterm birth and other poor birth outcomes in Botswana. The study also assesses if this screening approach is affordable and cost-effective for the health system. Approximately 2,000 pregnant women attending their first antenatal care visit at several government clinics will be invited to participate. Participants will be randomly assigned to either receive routine antenatal care or additional screening and treatment for chlamydia and gonorrhoea during pregnancy. Participants in the intervention group will be screened for chlamydia and gonorrhoea using self-collected vaginal swabs at their first antenatal care visit and again in the third trimester between 28 and 32 weeks. Women who test positive will receive treatment following recommended guidelines, counseling on partner notification, and a test-of-cure about four weeks after treatment. The standard of care group will receive routine antenatal care, with urine specimens collected and tested retrospectively after delivery to assess infection prevalence. Both groups will undergo routine health checks, HIV and syphilis testing, ultrasounds, and other standard antenatal procedures. Throughout the study, participants will complete questionnaires about their health, socio-economic status, and pregnancy progress. Researchers will review medical records after birth to collect data on birth outcomes like preterm birth, birth weight, and maternal health conditions such as hypertension and preeclampsia. Study staff will support participant retention by providing reimbursements for time and travel and maintaining contact through multiple communication methods. The study will monitor outcomes until delivery and conduct detailed cost and cost-effectiveness analyses to evaluate the impact of screening and treatment on health and healthcare expenses.

This research aims to evaluate the use of a lower international normalized ratio INR target range of 1.5 to 2.5 in patients with a mechanical bileaflet heart valve placed in the aortic position. The study seeks to determine whether lowering the INR target can reduce bleeding risks without increasing the chance of blood clots or stroke. This is important because patients with mechanical heart valves require lifelong warfarin Coumadin treatment to prevent clot formation, but managing the right balance between clot prevention and bleeding risk remains challenging. Participants will be randomly assigned to one of two groups. One group will receive warfarin therapy adjusted to a lower INR target range of 1.5 to 2.5, while the other group will have warfarin adjusted to a standard INR target range as currently recommended. Both groups will receive warfarin after their mechanical valve implant, but the INR targets for blood thinning will differ. The study includes follow-up over an expected mean of 2 to 3 years to monitor outcomes. During the study, participants will be regularly monitored for blood clot events such as thrombosis or stroke, as well as bleeding episodes, including major and minor bleeding. Researchers will track various outcomes like mortality, different types of stroke, heart attacks, pulmonary embolism, and kidney function over the study period. Time in the therapeutic INR range and occurrences of extreme INR values will also be recorded. Participants will be followed through the study duration, which will help determine the safety and risk balance of using a lower INR target in this patient group.

Chronic respiratory diseases such as chronic obstructive pulmonary disease COPD cause millions of deaths globally, with many occurring in low- and middle-income countries LMICs. These regions also have high rates of abnormal lung function, including restrictive spirometric pattern RSP, which can precede chronic respiratory diseases and is linked to overall mortality. Sub-Saharan Africa has a large population of people with HIV PWH, and HIV increases the risk of COPD and related deaths, though the mechanisms are not fully understood. This research involves a prospective cohort study in Botswana to describe patterns of abnormal lung function and explore how interactions between the body and microbiome relate to COPD and lung function decline in adults with and without HIV. The study aims to fill knowledge gaps by generating data from Batswana adults, a population disproportionately affected by COPD but underrepresented in research, thus supporting the development of more equitable COPD treatments. Participants aged 35 and older will be observed over five years with assessments including the Duke Activity Status Index DASI and the six-minute walk test to evaluate lung health and function. Data collection will include clinical evaluations, spirometry, and multi-omics analyses to understand host-microbiome relationships. The study involves regular monitoring and follow-up to assess respiratory health outcomes and activity status over time.

Researchers are evaluating an intervention aimed at supporting women living with both serious mental illness SMI and HIV in Botswana. These women face challenges with stigma that affect their adherence to psychiatric and antiretroviral treatments, which can worsen their health outcomes. The study tests a culturally tailored stigma reduction program called What Matters Most WMM during the critical transition from psychiatric hospitalization to outpatient care. The study also includes family members and policymakers to address stigma on multiple levels and encourage structural change. The trial has two main groups one receiving the WMM-based stigma intervention and another receiving an attention control focusing on general health education without stigma content. Women participants will attend eight group sessions led by a clinician and a peer with lived experience, starting during inpatient care and continuing in community settings after discharge. Family members will receive a parallel stigma intervention with three group sessions. Policymaker workshops will share findings through peer co-leaders to promote broader policy changes. Participants will be followed for four months after intervention completion, with assessments including viral load measurements, psychiatric and antiretroviral treatment adherence, mental health status, and social integration outcomes. Researchers will monitor changes from baseline to evaluate the interventions impact on viral suppression and related health factors. The study also tracks family stigma as a mechanism for change and includes safety monitoring throughout the study period, which is expected to last approximately 16 months from baseline to final follow-up.

Researchers are conducting a study in Botswana to see if offering testing for sexually transmitted infections STIs along with expanded HIV prevention options, specifically pre-exposure prophylaxis PrEP, helps more pregnant women start and continue using PrEP during pregnancy and after giving birth. The study involves 600 pregnant women without HIV who are seeking antenatal care. The purpose is to compare the usual care, which includes standard STI assessment without testing, to an approach that includes STI testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Participants are randomly assigned to one of two groups the intervention group receives STI testing using Xpert CTNG and TV assays during pregnancy and postpartum at three time points enrollment, 32 weeks gestation, and 9 months after delivery or two time points if enrolled in the third trimester. Women in this group learn to self-collect vaginal swabs. The standard care group receives STI symptom assessment per national guidelines during pregnancy and STI testing only at 9 months postpartum. All women are offered PrEP and can choose between oral pills or a dapivirine vaginal ring, with the option to start, stop, or switch methods at any time. Participants are followed through pregnancy and up to nine months after delivery. The study includes regular monitoring of PrEP use, including initiation, continued use, and adherence measured by drug levels in hair samples. Other assessments include STI rates, choice of PrEP method, birth outcomes, HIV incidence, quality of care, factors influencing adherence, and antimicrobial resistance. The total duration of participation includes antenatal care and postpartum follow-up visits.

Researchers are evaluating adaptive strategies to improve the timely adoption of cervical cancer treatment in Botswana. This pragmatic trial uses a Sequential Multiple Assignment Randomized Trial SMART design to address patient- and system-level barriers such as delayed communication of results, challenges in accessing treatment, and poor coordination between referring clinics and cancer treatment centers. The strategies are based on behavioral economics principles and nudge techniques proven effective in preventive, HIV, and cancer care settings. The goal is to enhance coordination, communication, and navigation to increase timely treatment adoption in a scalable and sustainable way. Participants receive different combinations of outreach and reminder strategies. Initially, all receive direct clinic outreach to communicate when pathology results are ready. Those who do not attend the clinic within 30 days receive either asynchronous text message reminders alone or combined with telephone-based patient navigation. Some participants receive enhanced outreach, where both the clinic and patient are contacted directly, while others receive standard outreach. These adaptive strategies are tested in four experimental groups combining low-touch and high-touch reminder approaches. Throughout the study, participants attendance and treatment adoption are monitored, focusing on whether they receive treatment within 90 days of randomization. Researchers also assess the fidelity and reach of the interventions at 12 months. The study involves tracking communication effectiveness and care coordination through outreach and reminder methods. This trial is sponsored by the Abramson Cancer Center at Penn Medicine and runs from September 2023 to August 2027.

Researchers are studying the safety, tolerability, acceptability, and how the body processes pharmacokinetics oral and long-acting injectable forms of Cabotegravir and Rilpivirine in children living with HIV-1 who are virologically suppressed and aged between two to less than 12 years. This Phase III, multicenter, open-label study aims to propose appropriate weight-based dosing and to evaluate the injectable regimen with or without an oral lead-in period in these children. Participants are grouped into three cohorts Cohort 1 receives daily oral Cabotegravir and Rilpivirine tablets for about four weeks followed by intramuscular injections every four or eight weeks Cohort 2A also starts with daily oral doses followed by injections Cohort 2B receives only the injections on the same schedules. If participants cannot access the injections after the study, they may join a Study Safety Extension period to continue safety monitoring. During the study, children will have multiple assessments including blood tests to measure drug levels and monitor immune cell counts, safety evaluations for side effects, and questionnaires for children and caregivers about side effects and injection site reactions. The study tracks safety events and HIV viral load at key timepoints up to 72 weeks. Caregivers may also participate by completing behavioral surveys. The total participation may include up to the extension period for ongoing safety monitoring.

Researchers are investigating new ways to improve HIV treatment and explore potential cures in children who started treatment early. The study focuses on testing a combination of three broadly neutralizing antibodies bNAbs or a planned break from antiretroviral therapy ART to see how these approaches affect the viral reservoir, immune system function, and the ability to keep the virus under control in children living with HIV in Botswana. The study includes several steps with different treatment approaches. Initially, children receive one of the three bNAbs alone to assess safety, followed by a rotating schedule of all three antibodies alongside their regular ART. Later steps involve stopping ART while continuing bNAbs, or stopping both ART and antibody treatments to observe effects. The study measures how long the virus remains suppressed and monitors immune health during these phases. Participants will have regular visits for safety checks, blood tests to measure viral levels and immune cell counts, and pharmacokinetic assessments to understand how the antibodies behave in the body. Researchers will also monitor the size of the viral reservoir and time to viral rebound if it occurs. Study participation includes up to 48 weeks of treatment and follow-up, with careful monitoring to ensure participant safety throughout.