Harare

Researchers are evaluating a lab-made antibody called ePGT121v1-LS that targets a specific part of HIV. This study is testing how safe it is, its side effects, the right dosage, how the body processes it, and how well it neutralizes HIV in the blood. The antibody is studied alone and in combination with two others, VRC07-523LS and PGDM1400LS, which target different parts of the virus. The study involves generally healthy adults without HIV. Participants are divided into two parts. In Part A, six groups receive ePGT121v1-LS by intravenous (IV) infusion at varying doses, either alone or combined with the other two antibodies, with infusions at the start and after 24 weeks. Part B has two groups receiving subcutaneous (SC) injections; one group gets ePGT121v1-LS alone, and the other receives all three antibodies, given twice 12 weeks apart. The study durations are 48 weeks for Part A and 24 weeks for Part B. During the study, participants attend scheduled clinic visits for monitoring. Researchers check for local and systemic side effects, safety lab tests, and measure antibody levels and how they neutralize HIV. They record any adverse events and study how the antibodies behave in the body over time. Participants are observed throughout the study period to assess safety and drug levels.

This research aims to provide ongoing access to HIV treatment drugs for children and adolescents who have finished participating in previous Gilead clinical studies for HIV-1 infection. The main goals are to allow these participants to continue their study medication or switch to a specific combination drug called bictegravir/emtricitabine/tenofovir (B/F/TAF) and to monitor the safety of these drugs in young people living with HIV-1. Participants will either continue taking the study drug they used in their previous parent study or switch to B/F/TAF based on their weight. The study drugs include various doses of emtricitabine/tenofovir alafenamide (F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), combinations including cobicistat, darunavir, atazanavir, lopinavir, and other third antiretroviral agents. Dosing varies according to the participant's weight and the combination of drugs used. During the study, participants will be closely monitored for adverse events and safety concerns over up to 9.5 years. The research team will track how many eligible participants receive access to the study drugs and the percentage experiencing treatment-emergent adverse events. Participants will have regular assessments to ensure continued safety while on the study medication, supporting long-term monitoring of treatment effects and tolerability.

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 vaccine's 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 HIV's 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 5x10^10 or 2x10^11 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 vaccine's impact. Participants will complete follow-up visits to evaluate adverse events, immune function, and overall health status during the trial period.

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 Zimbabwe's 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.

This research aims to improve treatment outcomes for cervical pre-cancer in women living with HIV (WLWH), with a focus on those in low and middle income countries like Zimbabwe. It seeks to understand the risk of disease coming back or persisting after treatment and to evaluate the effectiveness of various HPV and DNA methylation tests for monitoring these outcomes. The study responds to the need for better post-treatment monitoring guidelines to support global efforts in cervical cancer elimination. Participants are women aged 18 to 65 treated for cervical pre-cancer. Researchers will collect cervical biopsies for tissue analysis and samples for HPV genotyping and DNA methylation testing. The study will follow these women every six months for two years to track disease persistence or recurrence and assess the predictive value of different testing methods using both cervical and urine samples. During the study, women will attend visits every six months for up to 24 months. At each visit, samples will be collected and tested to monitor cervical disease status. Researchers will measure outcomes including the rate of persistent or recurrent disease (CIN2+) at 6, 12, 18, and 24 months and examine how well HPV and DNA methylation tests predict disease status. The study also evaluates the agreement between test results from cervical and urine samples, with ongoing monitoring to better understand post-treatment outcomes in this population.

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 infant's 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.

Researchers are establishing a prospective registry to study patients diagnosed with inflammatory bowel disease (IBD) at a hospital in Harare, Zimbabwe. This observational study will gather data on disease types, progression, and treatment, while also biobanking stool samples and germline DNA. A nested case-control study will recruit one relative and one neighbor of each patient to explore risk factors for IBD in this population. The study will enroll confirmed IBD cases from various clinics and hospitals, along with two controls per case: a sibling or cousin of similar age and a neighbor matched by age. Data collection will include demographic and clinical information at baseline, six months, and annually afterward. Participants will complete questionnaires about IBD risk factors and diet. Biological samples will be stored for future analysis. Participants will undergo regular assessments including clinical data collection and questionnaire responses over time. The research team will analyze demographic and disease characteristics, estimate IBD incidence in Harare, and study risk factors using statistical methods. The study plans preliminary analysis after recruiting at least 100 patients and will continue monitoring participants for several years to gather comprehensive information about IBD in this population.

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 Hospital's 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.

This research aims to evaluate the long-term use of long-acting injectable cabotegravir (CAB LA) for preventing HIV infection in participants who have completed previous related studies (HPTN 083 and HPTN 084) sponsored by the Division of AIDS. The study focuses on those at risk for HIV and monitors new HIV infections, serious adverse events, and injection site reactions over an extended period. Participants in this study will continue receiving CAB LA at a dose of 600 mg administered by gluteal intramuscular injections every eight weeks. All enrolled individuals have previously received CAB LA in the parent studies or their sub-studies and will maintain this treatment schedule throughout the study period. During the study, participants will be regularly monitored for new HIV infections, serious adverse events, and any adverse reactions related to the injections or treatment that could lead to withdrawal. Follow-up will occur for up to approximately three years, with researchers collecting clinical and laboratory data to assess safety and effectiveness. Participants will have ongoing access to CAB LA under medical supervision during this long-term follow-up period.

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.