Details

Autor(en) / Beteiligte

• Hoosen, A.
• Jones, H.
• Sebola, M.
• Coetzee, N.
• Friedland, B.
• Pistorius, A.
• Van de Wijgert, J.
• De Kock, A.

Titel

Phase III microbicide trial methodology : opinions of experienced expanded safety trial participants in South Africa : original article

Ist Teil von

• SAHARA J : journal of Social Aspects of HIV/AIDS Research Alliance, 2005-11, Vol.2 (3), p.311-319

Ort / Verlag

Taylor & Francis

Erscheinungsjahr

2005

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• 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.