Thika

Researchers are evaluating new medicines to prevent infection with Human Immunodeficiency Virus Type 1 HIV-1. This Phase 3 clinical trial aims to find out if taking MK-8527 once a month is more effective than a daily standard pre-exposure prophylaxis PrEP in preventing HIV-1 infection in women. The study also monitors the safety and tolerability of MK-8527 compared to standard treatment. Participants are randomly assigned to one of two groups one group receives 11 mg of MK-8527 once monthly along with a placebo daily pill resembling EmtricitabineTenofovir Disoproxil Fumarate FTCTDF, and the other group receives the daily FTCTDF pill plus a monthly placebo resembling MK-8527. This treatment phase lasts for up to approximately two years. Afterward, all participants take open-label FTCTDF daily for an additional 28 days. During the study, participants attend regular visits for up to about two years, during which researchers check for new HIV-1 infections, record any adverse events or side effects, and monitor if participants stop the study medication due to side effects. The primary outcomes include the number of participants who acquire HIV-1 infection, those who experience adverse events, and those who discontinue due to adverse events, all tracked over the treatment period.

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

Cervical cancer is a major health concern, especially in low- and middle-income countries like Kenya, where it remains the second most common cancer and leading cause of cancer death among women. Despite being largely preventable through early detection and treatment of pre-cancerous lesions, screening and treatment rates are low due to challenges such as equipment shortages and costs. This research aims to evaluate the implementation and cost of introducing thermal ablation, a safer and easier treatment alternative to cryotherapy, in reproductive health clinics in Kenya to improve cervical cancer prevention efforts. The study involves delivering the single visit screen-and-treat approach using thermal ablation SVA-SATTA at 10 reproductive health clinics in central Kenya. Thermal ablation uses local heating to destroy abnormal cervical tissue and can be powered by electricity, batteries, or solar energy. The research employs a stepped-wedge, cluster randomized design over five years to introduce and evaluate this approach using the RE-AIM framework, which assesses reach, effectiveness, adoption, implementation, and maintenance of the intervention. The study also includes cost and budget impact analyses comparing thermal ablation to cryotherapy. Participants include women seeking cervical cancer screening, women who test positive for pre-cancerous lesions, health care providers, and health managers. The study collects data through interviews, training records, treatment completion rates, HPV clearance tests, and clinic adoption measures. Outcomes include barriers and facilitators to implementation, the number of trained providers delivering treatment, sustained use of thermal ablation, and the impact on treatment uptake. Participant involvement spans up to four years with additional monitoring six months post-treatment for HPV clearance.

Researchers are evaluating whether offering multiple HIV prevention products, starting with the dapivirine vaginal ring, alongside daily oral pre-exposure prophylaxis PrEP increases the initiation and continued use of PrEP among adolescent girls and young women seeking reproductive health services in Kenya. This Phase 4 study uses a stepped wedge cluster randomized design involving 12 clinics and approximately 1400 participants aged 18 to 30 years. During the study, participating clinics will first provide the standard daily oral PrEP program as the active comparator. Then, clinics will introduce a multi-product PrEP program that includes daily oral PrEP plus other available PrEP options such as the dapivirine vaginal ring, with additional products added as they become accessible. This approach allows researchers to compare the standard oral PrEP program with the expanded multi-product offering. Participants will be monitored from enrollment up to six months to assess how often they start using PrEP and how well they persist with it at three months. The study includes counseling about PrEP options at reproductive health visits. Researchers will collect data on PrEP initiation and persistence while ensuring participants can communicate in Kiswahili or English and are able to consent to participate. The study is expected to complete by the end of 2029.

This research aims to improve care for youth living with HIV in Kenya by scaling up an evidence-based Adolescent Transition Package ATP. The study evaluates how well a youth-led, data-driven implementation strategy ATP-YES supports the transition from pediatric to adult HIV care compared to the standard of care. It focuses on improving youth readiness to transition, viral suppression, retention in care, and overall health outcomes using a cluster randomized controlled trial design involving 32 clinics across four counties. The study compares two approaches standard of care implementation using a trainer of trainers ToT method and an enhanced ATP-YES strategy that includes youth-led data audits, feedback, and collaborative learning cycles. Existing healthcare workers at clinics will deliver the ATP during routine visits over a 36-month intervention period. Youth aged 10-24 will be offered the ATP, with those aged 15-24 invited to participate in surveys and focus groups. Clinics are randomized 11 to either intervention or control arms. Participants will be involved in surveys, focus groups, and routine medical record reviews. Healthcare workers will provide feedback through interviews and continuous quality improvement activities. The study tracks outcomes such as ATP reach, adoption by providers, fidelity of implementation, viral suppression, retention, and transition readiness over 42 months. Costs and budget impacts of the ATP-YES strategy will also be evaluated. The project includes youth advisory boards and collaboration with Kenyan health authorities to ensure alignment with national priorities.