Harare

Researchers are evaluating a lab-made antibody called ePGT121v1-LS designed to target a specific part of HIV. This Phase 1 clinical trial also studies this antibody alone and in combination with two other antibodies, VRC07-523LS and PGDM1400LS, which target different parts of the virus. The study aims to assess the safety, side effects, proper dosing, how the body processes these antibodies, and their ability to neutralize HIV in the blood. The trial includes about 83 generally healthy adults without HIV-1, aged 18 to 55. Participants are divided into two parts. In Part A, six groups receive ePGT121v1-LS by intravenous IV infusion at various doses, either alone or combined with the other two antibodies, given at two visits 24 weeks apart over 48 weeks. In Part B, two groups receive subcutaneous SC injections either of ePGT121v1-LS alone or combined with the other antibodies, given at two visits 12 weeks apart over 24 weeks. Each dose and administration schedule is carefully studied in these groups. Throughout the study, participants attend scheduled clinic visits for up to 48 weeks depending on their group. They will be monitored for local and systemic side effects, laboratory safety tests, and the levels of antibodies in their blood. Researchers will track how the antibodies are absorbed, distributed, and cleared, along with their neutralizing activity against HIV. Safety, tolerability, and antibody interactions are key outcomes during the follow-up period.

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.

Researchers are conducting a Phase 1 trial to study the GRAdHIVNE1 vaccine, which uses a gorilla adenovirus vector to target HIV. The study aims to evaluate the vaccines safety, tolerability, and ability to stimulate immune responses in healthy adults both living with and without HIV. This trial builds on earlier vaccine research and preclinical studies that highlighted the importance of broad T-cell responses for controlling HIVs diversity and immune evasion. Participants living without HIV will be randomly assigned to receive either one or two doses of the GRAdHIVNE1 vaccine at two possible dose levels or a placebo. Those living with HIV will receive either two doses of the vaccine or placebo. The vaccine doses studied are 5x1010 or 2x1011 units. The study uses a double-blind design to compare vaccine effects with placebo. Throughout the study, participants will be closely monitored for safety and side effects over several timeframes including 7 days, 28 days, and up to 19 months. Immune responses will be measured repeatedly for up to 19 months to assess the vaccines impact. Participants will complete follow-up visits to evaluate adverse events, immune function, and overall health status during the trial period.

Researchers are evaluating the safety, tolerability, and immune responses of two experimental mRNA HIV vaccines in adults living with HIV who are generally healthy. This phase 1 clinical trial aims to determine if these vaccines can initiate or boost antibody responses against HIV. The study also examines how a closely monitored planned pause in antiretroviral therapy ATI influences these immune responses. Participants will receive a series of vaccine injections one group receives DV700P-RNA at weeks 0 and 8, followed by DV701B1.1-RNA at week 16 another group receives DV700P-RNA at week 0 and DV701B1.1-RNA at week 8. Each vaccine is given by intramuscular injection. The trial uses a sequential design with no randomization or masking. During the study, participants will undergo assessments of local and systemic reactions following vaccinations, monitoring for serious and medically attended adverse events through up to 88 weeks. Immune responses will be measured by analyzing antibody levels and B-cell activity at baseline, after vaccinations, and after restarting antiretroviral therapy. The study involves multiple visits for vaccinations and monitoring, lasting approximately up to 88 weeks in total.

This research aims to develop a multi-level intervention called TENDAI4PrEP, adapted from the TENDAI program, to improve uptake and persistence of oral pre-exposure prophylaxis PrEP among pregnant persons in Zimbabwe. The study addresses the urgent public health need due to Zimbabwes high HIV prevalence, especially among cisgender women of reproductive age, and aims to overcome barriers such as psychological distress, stigma, low partner support, and limited provider knowledge. The intervention involves 4-5 problem-solving sessions including one with a partner and an optional postpartum booster, incorporating PrEP education, psychoeducation, and a culturally adapted Life Steps approach. Participants are randomized to either the TENDAI4PrEP intervention or enhanced treatment as usual ETAU, which includes monthly antenatal care visits and educational pamphlets. Providers at the clinics also receive training to improve PrEP knowledge and reduce stigma. Participants will be involved in assessments over approximately five months post-baseline, including evaluations of feasibility and acceptability of the intervention and provider training. Measurements include self-reported PrEP adherence, psychological distress, PrEP persistence, and changes in provider knowledge and stigma. Qualitative interviews with providers and administrators will explore implementation outcomes to prepare for larger-scale testing.

Malnutrition among women of reproductive age is a significant health issue in Sub-Saharan Africa, including Zimbabwe, affecting both mothers and their infants. This research investigates how maternal malnutrition and poor water, sanitation, and hygiene WASH conditions influence infant growth, intestinal microbiota development, immune system maturation, and the risk of intestinal inflammation and malnutrition. The study also considers maternal stress and mental health as factors potentially impacting infant care and health outcomes. The study follows pregnant women from at least 20 weeks gestation, divided into groups based on nutritional status and WASH living conditions. Four groups include malnourished and well-nourished women living in improved or poor WASH environments. Researchers will observe maternal and infant microbiota, breast milk composition, infant gut function, and immune responses from pregnancy through the infants first three years. The study includes detailed bio-sample collection and analysis at multiple time points to understand the role of environmental and biological factors in infant malnutrition. Participants will undergo regular assessments including maternal and infant stool, blood, and breast milk samples, alongside questionnaires on maternal stress and empowerment. Infant growth and health will be monitored through measures like mid-upper arm circumference, weight, height, and diarrhea episodes. The study aims to track infant intestinal inflammation, permeability, and immune cell populations, with follow-up visits continuing until the child reaches three years old. This comprehensive approach seeks to clarify how maternal and environmental factors contribute to infant malnutrition and development.

People in Zimbabwe who have both cancer and HIV often face challenges staying connected to their HIV care while undergoing cancer treatment. This is mainly because HIV and cancer treatments are provided at different health facilities, creating barriers to care. The goal of this research is to understand these barriers and develop ways to support patients in continuing their HIV care throughout their cancer treatment. Researchers will observe two groups of people with cancer and HIV to study these challenges and improvements. The study involves two main groups. The first group will receive standard care, and their experiences with HIV care barriers during cancer treatment will be documented. Based on these findings, researchers will develop and implement strategies at Parirenyatwa Hospitals Radiotherapy Centre to improve HIV care engagement. These strategies may include better documentation, improved referral and prescription processes, and enhanced communication between cancer and HIV care teams. After these changes, a second group of patients starting cancer treatment will be observed to assess the impact and acceptability of the new strategies. Participants will be monitored over six months or until completion of their cancer treatment. Researchers will evaluate how acceptable the new strategies are to patients and staff and track missed HIV clinical visits, antiretroviral therapy ART adherence, and missed ART prescription refills. This detailed observation will help determine if the new health system changes support patients in maintaining their HIV care during cancer treatment.

Researchers are evaluating a new artificial intelligence AI system designed to improve cervical cancer screening, triage, and treatment decisions, particularly in low- and middle-income countries. This study focuses on detecting high-risk human papillomavirus hr-HPV through infrared spectroscopy of urine samples and interpreting cervical images using AI to identify high-grade precancers and cancers. The project aims to address the high burden of cervical cancer in these regions and support global efforts to eliminate the disease. The study is conducted in two parts over five years. In the first two years, the technology for urine spectroscopy and AI image analysis will be refined using samples and images collected from women in Zimbabwe. The second part will validate the improved AI system by screening 2100 women with the AI-supported urine test and a validated HPV test, comparing their ability to detect cervical precancers and cancers. The AI will also be assessed for its accuracy in determining the cervical transformation zone type to assist treatment decisions. Participants will provide self-collected urine and vaginal samples for HPV testing and undergo cervical imaging and colposcopy if positive for HPV. Cervical biopsies will be taken when abnormalities are detected, and women with lesions will be treated or referred as appropriate. The study will measure the accuracy of AI in detecting cervical disease and transformation zone type compared to expert assessments. Safety, cost analysis, and data management will be overseen by international and local research teams. The study lasts approximately five years from recruitment start with ongoing monitoring and management of participants.

Researchers are studying how individual health behaviors and broader societal factors like environment, policies, and health system quality affect health outcomes such as death and the development of chronic diseases. This study also explores genetic influences on non-communicable diseases through both a cross-sectional and a prospective cohort approach. It aims to understand these relationships across different socioeconomic and health resource settings worldwide. Participants are adults aged 35 to 70 years at enrollment. The study involves observing various health-related behaviors, societal determinants including built environment, food and nutrition policies, psychosocial and socioeconomic factors, and tobacco use. Researchers will track the incidence of chronic diseases like cardiovascular disease, cancer, respiratory conditions, diabetes, kidney disease, obesity, hypertension, and injuries over time, without administering any specific treatments. Participants will be followed for an average of 10 years, during which researchers will monitor health events such as new cases of cardiovascular disease and other illnesses, hospitalizations, and mortality. Data will be collected on genetic factors and changes in risk factors like smoking and diet. The study measures the impact of health systems and environmental influences on outcomes. Participants will be involved through regular assessments but will not receive interventions as this is an observational study.

Researchers are evaluating the safety and how the body processes two potent, broadly neutralizing anti-HIV monoclonal antibodies, PGT121.414.LS and VRC07-523LS, in newborn infants exposed to HIV-1. This open-label, phase I study focuses on newborns at increased risk of HIV infection and aims to understand the safety and drug levels of these antibodies when given alone or together soon after birth. Participants receive one or two subcutaneous injections of PGT121.414.LS alone or combined with VRC07-523LS. Doses are given at birth based on the infants weight, with a possible second dose at Week 12 if the infant is still breastfeeding. The study includes different groups based on feeding method and antibody combinations, with drug levels and safety assessed through Week 24. During the study, infants undergo medical evaluations including laboratory tests for blood counts and liver enzymes, physical exams, and monitoring for adverse events. Researchers measure drug concentrations and antibody levels up to Week 48 or Week 60, checking for any side effects or signs of HIV infection. Participation lasts up to about two years, allowing thorough safety and pharmacokinetic monitoring.