HIV prevalence and incidence among sexually active females in two districts of South Africa to determine microbicide trial feasibility. PLoS One 2011;6:e21528

Background: The suitability of populations of sexually active women in Madibeng (North-West Province) and Mbekweni (Western Cape), South Africa, for a Phase III vaginal microbicide trial was evaluated. Methods: Sexually active women 18–35 years not known to be HIV-positive or pregnant were tested cross-sectionally to determine HIV and pregnancy prevalence (798 in Madibeng and 800 in Mbekweni). Out of these, 299 non-pregnant, HIV-negative women were subsequently enrolled at each clinical research center in a 12-month cohort study with quarterly study visits. Results: HIV prevalence was 24 % in Madibeng and 22 % in Mbekweni. HIV incidence rates based on seroconversions over 12 months were 6.0/100 person-years (PY) (95 % CI 3.0, 9.0) in Madibeng and 4.5/100 PY (95 % CI 1.8, 7.1) in Mbekweni and those estimated by cross-sectional BED testing were 7.1/100 PY (95 % CI 2.8, 11.3) in Madibeng and 5.8/100 PY (95 % CI 2.0, 9.6) in Mbekweni. The 12-month pregnancy incidence rates were 4.8/100 PY (95 % CI 2.2, 7.5) in Madibeng and 7.0/100 PY (95 % CI 3.7, 10.3) in Mbekweni; rates decreased over time in both districts. Genital symptoms were reported very frequently, with an incidence of 46.8/100 PY (95 % CI 38.5, 55.2) in Madibeng and 21.5/100 PY (95 % CI 15.8, 27.3) in Mbekweni. Almost all (.99%) participants said that they would be willing to participate in a microbicide trial. Conclusion: These populations might be suitable for Phase III microbicide trials provided that HIV incidence rates over tim