title: Microbicide trials for preventing HIV/AIDS in South Africa: phase II trial partricipants' experiences and psychological needs.
abstract: The Microbicide Division of the Department of Medical Microbiology at MEDUNSA, South Africa, recently completed a phase II expanded safety trial of the candidate microbicide Carraguard. A microbicide is a vaginal product that women might use, if proven safe and effective, to protect themselves from HIV and possibly other sexually transmitted infections (STIs). The study participants were from Ga-Rankuwa and its neighbouring areas, an historically disadvantaged residential township near Pretoria. We conducted six focus group discussions with phase II trial participants to evaluate their experiences with trial participation and their psychological needs. Participants spontaneously talked about their experiences with the study gel and speculum examinations. They felt that they had received high quality medical care. They indicated that their personal hygiene and knowledge of the female reproductive system, HIV and other STIs had improved, which helped their familie and empowered them as women. Participants valued being able to discuss their anxiety about HIV/AIDS wit study staff. They felt that the study provided them with a supportive environment in which their personal problems (not necessarily restricted to HIV/AIDS) could be addressed. Some recommended that the study staf improve their professionalism and punctuality. They suggested the formation of participant support groups, an expressed a preference to remain involved in the trial. Some participants appeared to have become dependent o services provided during the trial. We have taken the results of these focus group discussions into account during planning for a phase III efficacy trial of Carraguard to be conducted in the same and other similar communities.
authors.affiliation: Health Professions Council of South Africa. annalie@medunsa.ac.za
authors.forename: A G
authors.initials: AG
authors.lastname: Pistorius
authors.forename: J H H M
authors.initials: JH
authors.lastname: van de Wijgert
authors.forename: M
authors.initials: M
authors.lastname: Sebola
authors.forename: B
authors.initials: B
authors.lastname: Friedland
authors.forename: E
authors.initials: E
authors.lastname: Nagel
authors.forename: C
authors.initials: C
authors.lastname: Bokaba
authors.forename: A A
authors.initials: AA
authors.lastname: Hoosen
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000517:prevention & control / Q000635:transmission*; D000900:Anti-Bacterial Agents / Q000506:poisoning / Q000627:therapeutic use*; D002351:Carrageenan; D005260:Female; D015658:HIV Infections / Q000517:prevention & control / Q000635:transmission*; D006801:Humans; D006920:Hygiene; D011209:Power, Psychological; D013019:South Africa; D014622:Vaginal Creams, Foams, and Jellies; D016387:Women's Health
chemical_list: D000900:Anti-Bacterial Agents; D014622:Vaginal Creams, Foams, and Jellies; D002351:Carrageenan