ICRH Kenya

Preparing for Phase III vaginal microbicide trials in Rwanda and Kenya

Team members:
Patricia Claeys; Stanley Luchters; Kishor Mandalya; Peter Gichangi; Marleen Temmerman


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



  • 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