title: HIV prevalence and incidence among sexually active females in two districts of South Africa to determine microbicide trial feasibility.
abstract: 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.
  
  
  CONCLUSIONS
  These populations might be suitable for Phase III microbicide trials provided that HIV incidence rates over time remain sufficiently high to support endpoint-driven trials.
authors.affiliation: International Partnership for Microbicides, Silver Spring, Maryland, United States of America.
authors.forename: Annaléne
authors.initials: A
authors.lastname: Nel
authors.forename: Cheryl
authors.initials: C
authors.lastname: Louw
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Hellstrom
authors.forename: Sarah L
authors.initials: SL
authors.lastname: Braunstein
authors.forename: Ina
authors.initials: I
authors.lastname: Treadwell
authors.forename: Melanie
authors.initials: M
authors.lastname: Marais
authors.forename: Martie
authors.initials: M
authors.lastname: de Villiers
authors.forename: Jannie
authors.initials: J
authors.lastname: Hugo
authors.forename: Inge
authors.initials: I
authors.lastname: Paschke
authors.forename: Chrisna
authors.initials: C
authors.lastname: Andersen
authors.forename: Janneke
authors.initials: J
authors.lastname: van de Wijgert
mesh_terms: D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000494:pharmacology*; D002986:Clinical Trials as Topic; D003430:Cross-Sectional Studies; D003710:Demography; D005240:Feasibility Studies; D005260:Female; D015658:HIV Infections / Q000453:epidemiology*; D006801:Humans; D015994:Incidence; D011247:Pregnancy; D015995:Prevalence; D011446:Prospective Studies; D012725:Sexual Behavior; D013019:South Africa / Q000453:epidemiology; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents