Ongoing Studies

Title: A savings intervention to reduce men’s engagement in HIV risk behaviors A collaborative study between Impact Research and Development Organization and the University of Pennsylvania in the USA in partnership with Equity bank, Kenya Purpose: To test the impact of a “prize-linked savings” intervention on men’s engagement in high-risk behaviors (transactional sex and alcohol use), by reducing their spending on these behaviors Objectives:   To determine the effect of the savings intervention on the following on the composite incidence of HIV and other STIs over 24 months To determine the intervention’s effect on the following health and economic outcomes The total amount of savings and investment ­Total formal savings, and total household assets ­Investment behavior such as housing improvements, and schooling expenditures Expenditures on food and household needs ­Expenditures on alcohol and transactional sex ­Expenditures on gambling ­Self-reported sexual behavior, including number of transactional sex partners, total number of sexual partners and condom use. ­Alcohol use   Design: Randomized Control Trial Population: Men ages 18-39 years with access to regular cash income and who are at high risk of HIV and STI infection Coverage: Siaya County Duration: 5 years Funding/Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development Local IRB Approval: Maseno University Ethics Review Committee – MUERC 1022/2 Current activities: Participant recruitment

Title: Self-Test Strategies and Linkage Incentives to Improve ART and PrE-Exposure Prophylaxis Uptake in Men Purpose: To test a social networks strategy to increase men’s HIV testing uptake, linkage to, and uptake of ART and PrEP among men living/working in beach communities Objectives: Determine whether providing training and HIVST to select fishermen to distribute to other men in their close social networks increases men’s HIV testing uptake Determine whether network-central promoters and small incentives can improve ART and PrEP uptake among men in their close social networks Test the impact of interventions on ART or PrEP retention and adherence Design: Randomized Control Trial Population: Men aged 18 years and above primarily working in the fishing industry or related activities   Coverage: Siaya County   Duration:  5 years Funding:  National Institute of Health, USA   Sponsor: University of California, San Francisco, USA Local IRB Approval: Kenya Medical Research Institute – Non-KEMRI 677 Updates: Participant recruitment is completed Current activities: Participant follow up

DiSC Study 2 Title: Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3): A cluster randomized trial on a Data-informed Stepped Care intervention to improve retention among adolescents living with HIV Purpose:  To develop, pilot, and test a Data informed Stepped Care Intervention in a cluster randomized controlled trial Objectives: Develop, adapt, pilot, and optimize implementation of data-informed stepped care (DiSC) intervention for ALHIV HIV treatment management Evaluate the effectiveness of the DiSC intervention on ALHIV retention in up to 24 high-volume HIV clinics in Homa bay, Kisumu, and Migori counties in Western Kenya Determine acceptability, feasibility, adaptability, and fidelity of the DiSC intervention Evaluate the effectiveness of the DiSC intervention on ALHIV cascade outcomes (adherence, viral suppression) and adolescent self-efficacy, health service outcomes, and implementation outcomes in high-volume HIV clinics in Homabay, Kisumu, and Migori Counties Design: Randomized Control Trial Population: Adolescents and young adults aged 10-24 years enrolled in HIV care, caregivers of HIV-positive adolescents and young adults, policymakers, and stakeholders in adolescent HIV care Coverage: Kisumu, Homa bay, and Migori Counties Duration: 2 years Funding: National Institute of Health, USA Sponsor: University of Washington, USA Local IRB Approval: Maseno University Ethics Review Committee – MUERC 917/20 Updates: Participant recruitment is completed Current activities:  Participant follow up

Title: Jitegemee (rely on yourself): Designing and piloting a savings intervention to reduce HIV risk behaviours among female sex workers in western Kenya Purpose: Determine if economic independence could reduce HIV risk among female sex workers in Kisumu, Kenya Design: Mixed methods approach comprising of focus group discussions and quantitative survey Population: Women who self-report being sex workers Coverage: Kisumu Duration: 6 months Sponsor: Impact Research and Development Organization Funding: Impact Research and Development Organization. Local IRB Approval: Maseno University Ethics Review Committee – MUERC 1033/21 Updates: Data collection underway Current Activities: Data collection on going

Title: A Formative Research to Inform Gonococcal Vaccine Implementation in Kenya Purpose: To collect views from stakeholders about a vaccine under development that can prevent gonorrhea infection in the future Objectives: Among potential recipients of a gonorrhea vaccine (target populations) – learn about their thoughts on what is important to them for a vaccine to prevent gonorrhea Among professionals who work in the promotion of vaccines (e.g., MOH, MOE) – seek their advice on factors to be considered in planning for the eventual rollout of a gonorrhea vaccine Design: A sequential mixed-method study conducted in three phases Population: Phase 1: Key informants (e.g., representatives from the Ministry of Health & Ministry of Education, Healthcare Providers) & potential future vaccine recipients (e.g., Men who have sex with men, male and female sex workers, & individuals with recent or current STI) Phase 2: Adolescents and parents/caregivers of adolescents (all genders) Phase 3: Key Informants, potential future vaccine recipients, and parents/caregivers of adolescents Coverage:  Kisumu, Siaya, and Nairobi Counties Duration: 3 years (2021-2023) Funding: National Institute of Health, USA Sponsor: Duke University, USA IRB Approval: Maseno University Ethics Review Committee – MUERC 1023/21 Current Activities: Qualitative data collection for Phase 1, and preparation for Phase 2

Title: Solidarity Trial Vaccines: An international randomized trial of candidate vaccines against SARS-CoV-2 (COVID-19)   Purpose: To coordinate a prompt, efficient, and reliable evaluation of the many preventive candidate SARS-CoV-2 vaccines under development Objective: To assess the safety and efficacy of the preventive candidate SARS-CoV-2 vaccines and to identify those that are likely to be appropriate for deployment to influence the course of the pandemic Design: Randomized Controlled Clinical Trial Population: Individuals (all gender) 16 years and above Coverage: Kisumu County Site: Kenya Impact Research and Development Organization Clinical Research Site (K- IRDO-CRS)   Duration: 1 ½ year Funding: World Health Organization through Kenya Aids Vaccine Initiative (KAVI) Institute of Clinical Research Local IRB Approval: Kenyatta National Hospital/University of Nairobi Ethics Review Committee – P258/03/2022

Title: A relationship-focused intervention to reduce gender-based violence (GBV) and increase pre-exposure prophylaxis (PrEP) uptake and adherence among Kenyan adolescent girls and young women (AGYW) Purpose: To test the effectiveness of a youth-designed multilevel intervention to increase PrEP use and reduce Intimate Partner Violence (IPV) among Kenyan AGYW, and to identify implementation challenges and strategies to facilitate future scale-up in programmatic settings to maximize public health impact. Objectives: Test the effectiveness of the Tu’Washindi intervention to increase effective PrEP use Test the effectiveness of the Tu’Washindi intervention to reduce IPV  Conduct a prospective process evaluation to assess the implementation processes and theorized mechanisms of change influencing intervention effectiveness Design:  Cluster Randomized Controlled Trial (CRCT) Study Site: Bondo – Siaya County Duration : 5 Years Population : AGYW aged 15-24 years, AGYW’s male partners aged 15 years and above, and healthcare providers working with AGYW Sponsor : RTI Internantional Funding : National Institute of Health (NIH) IRB Approval : Maseno University Ethics Review Committee – MUERC 991/21