title: Phase III microbicide trial methodology: opinions of experienced expanded safety trial participants in South Africa.
abstract: In preparation for effectiveness trials of candidate vaginal microbicides, scientists are debating trial design and implementation challenges, including choice of control arm(s), product-sharing across arms, and visit schedules. This study involved a survey of South African women participating in an expanded safety trial of the candidate microbicide Carraguard gel. The first 100 consenting women who attended the study clinics in Ga-Rankuwa and Gugulethu (total N = 200) were interviewed; all women had been using a study gel for at least 6 months at the time of the interview. The study found that many participants thought that including a condoms-only arm would result in increased product-sharing, male partner resistance to trial participation and decreased enrollment; no clear patterns emerged regarding the potential effect on condom use and cohort retention. The majority of women preferred a monthly visit schedule, would be willing to use a product for 2 years, and thought that their product use would not decrease over time. Thus flexibility in trial design and implementation strategies is needed until evidence-based decisions can be made. When including a condoms-only arm, extra efforts should be made to explain the importance of all study arms to potential participants and to measure adherence and product-sharing.
authors.affiliation: IATEC Foundation, Pietersbergweg 9, 1105 BM Amsterdam, The Netherlands. j.vandewijgert@iatec.com
authors.forename: Janneke
authors.initials: J
authors.lastname: van de Wijgert
authors.forename: Heidi
authors.initials: H
authors.lastname: Jones
authors.forename: Annalie
authors.initials: A
authors.lastname: Pistorius
authors.forename: Alana
authors.initials: A
authors.lastname: de Kock
authors.forename: Mohlatlego
authors.initials: M
authors.lastname: Sebola
authors.forename: Barbara
authors.initials: B
authors.lastname: Friedland
authors.forename: Anwar
authors.initials: A
authors.lastname: Hoosen
authors.forename: Nicol
authors.initials: N
authors.lastname: Coetzee
mesh_terms: D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D017280:Condoms; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D007407:Interviews as Topic; D008875:Middle Aged; D012107:Research Design; D012747:Sexual Partners; D013019:South Africa; D014622:Vaginal Creams, Foams, and Jellies / Q000627:therapeutic use*
chemical_list: D000890:Anti-Infective Agents; D014622:Vaginal Creams, Foams, and Jellies