Preparing for Phase III vaginal microbicide trials in Rwanda and Kenya

Conduct cross-sectional HIV incidence surveys in Kigali and Mombasa (year 1) using BED and
Avidity Index (AI) testing, to estimate HIV incidence in potential microbicide trial target
populations, and to validate BED/AI testing in African settings
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, and to evaluate recruitment and retention strategies
Improve microbicide trial capacity in Kigali and Mombasa (year 1-3) by strengthening the clinical,
laboratory, and data management infrastructure, local ethics committees, and reproductive health
referral systems and by staff development at the sites as well as the wider research communities
A combination of cross-sectional surveys and longitudinal cohort studies to estimate HIV incidence, depending on the situation at each site
BED assays will be carried out in local labs and for AI testing, collaboration with Dr.
Barbara Suligoi of the Instituto Superiore di Sanità in Rome, who is one of the pioneers of the AI
method for HIV has been built.
Activities Mombasa: A cross-sectional HIV incidence survey of 800 sex workers (using the BED and AI
assays) is currently ongoing in Mombasa with IPM-funding. EDCTP funding will be used to conduct
another survey of 500 postpartum women. 400 HIV-negative non-pregnant sex workers will be selected for a preparedness cohort. EDCTP funding will be used to expand community outreach into high-risk populations, expand testing for RTIs in the preparedness cohort, and optimize RTI management procedures.
Activities Kigali: Two cross-sectional HIV incidence surveys will be conducted: one with 800 high-risk
women and one with 1,250 female VCT clients. 400 HIV-negative high-risk women will subsequently be enrolled in the preparedness cohort. These studies are co-funded by IPM and will start in October 2006 (using IPM funding). EDCTP funding will be used to expand community outreach into high-risk populations, expand testing for RTIs in the surveys and cohort (to determine prevalence and incidence of these infections, but also to evaluate diagnostic and treatment procedures), improve medical referral systems for reproductive health problems, and allow referral of HIV-positive women to the TRAC HIV clinic cohort
To prepare both sites for Phase I, II and III clinical microbicide trials

Funding agencies

European Commission


ICRH, University of Ghent, Belgium; ITM, Antwerp, Belgium; Projet Ubuzima, Kigali, Rwanda;


March 01, 2007 - February 28, 2010

Project status

Project closed

Team members

Ms. Patricia Claeys
Mr. Peter Gichangi
Mr. Stanley Luchters
Mr. Kishor Mandaliya
Ms. Marleen Temmerman