Demonstration study to assess HIV-1 incidence and retention among HIV-negative men who have sex with men and transgender women in Kisumu, Nairobi, Kilifi and Mombasa


Start: February 2020
Status: Follow ups ongoing
Design: Observational study
Study Sites: Anza Mapema Centre of Excellence, Kisumu
SWOP Clinic, Nahrobi
KEMRI clinic at HAPA Kenya offices in Nyali and KEMRI-MARPS-office at Malindi sub-county Hospital;
Sponsor: International AIDS Vaccines Initiative (IAVI)
Purpose: The overall aim of this study is to estimate HIV-1 incidence, retention, uptake and adherence to PrEP, and the prevalence of acute HIV infection among at-risk MSM and TGW participating in studies or programmes at 3 MSM Health Research Consortium (MHRC) clinics in Kisumu, Nairobi, and Kilifi.
Design: This is an observational study that will enrol HIV-negative MSM and TGW from ongoing studies or HIV prevention programmes in Kisumu, Nairobi, and Kilifi. MSM and TGW will be engaged and explained about the study purpose, and asked if they are willing to do audio computer-assisted self-interviewing (ACASI), make 4 quarterly study visits, and have their biometrical data (i.e. iris scan) collected at each visit. All participants will remain co-enrolled in HIV prevention programmes or study protocols at their site, and will receive risk reduction counselling, PrEP (as standard of care in Kenya and provided by NASCOP), and treatment for minor illnesses as per programme or protocol. All participants should be HIV-uninfected at study start. A 4ml blood sample will be collected at enrolment, at each quarterly visit, and when indicated at an interim visit when AHI is suspected. Participants who have seroconverted or who have AHI detected will be referred for immediate ART. Initial assessment of the objectives will occur after six months and after one year. Study participation will continue thereafter should funding permit.
Population: Men who report oral or anal sex with a man in the past 3 months, are 18-29 years of age, HIV uninfected, and are residents of the respective study sites.
Study Size: A total of approximately 900 men will be enrolled.
Study Aims: To determine the HIV-1 incidence and retention, and correlates of HIV-1 acquisition among 900 MSM and TGW in Kilifi, Kisumu and Nairobi.
To assess uptake and adherence to PrEP administered per NASCOP guidelines.
To determine the prevalence of acute HIV infection in participants reporting symptoms compatible with acute retroviral syndrome at scheduled or interim visits.