For phase III vaginal microbicide trials in Rwanda and Kenya: Preparedness studies, capacity building and strengthening of medical referral systems


The main aim is to conduct cross-sectional HIV incidence surveys in Kigali and Mombasa using BED and Avidity Index (AI) testing, to estimate HIV incidence in potential microbicide trial target populations. Secondly, this project aims to establish cohorts of high-risk women in Kigali and Mombasa, after expanding community outreach into high-risk populations, to measure incidence of HIV, reproductive tract infections (RTIs) and pregnancy. A third objective is to improve the microbicide trial capacity in Kigali and Mombasa by strengthening the clinical, laboratory, and data management infrastructure, local ethics committees and reproductive health referral systems and staff development.


Additional HIV prevention methods are urgently needed, especially those that women can use such as vaginal microbicides. Phase III effectiveness trials of microbicides have to be conducted in female populations with high incidence of heterosexually-acquired HIV. This project aims to prepare two research sites: one in Kigali, Rwanda and one in Mombasa, Kenya. During the site preparation HIV incidence will be estimated by cross sectional and longitudinal cohort studies. The cohort studies will also evaluate the sites’ recruitment and retention strategies, and will assess other relevant outcomes for microbicides studies such as reproductive tract infections and pregnancy rates.


Gent University
Prince Leopold Institute of Tropical Medicine (ITM)
International Centre for Reproductive Health (ICRH), Kenya
Projet Ubuzima, Rwanda