13th International AIDS Conference Durban, South Africa - July 9-July 14, 2000

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. WeOrA600)

Magwaza S, Coetzee N, McGrory E
S.Magwaza, CApe Town University, Public Health Dept. Anzio Rd, Observatory 7925, South Africa, Tel.: +27-21-406-6485/3, Fax: +27-21-406-6163, E-mail: spin@ant.uct.ac.za

BACKGROUND: In 1998, the staff from the Population Council and the University of Cape Town tested the informed consent forms preparing for the Population Council Phase II microbicide expanded safety trial in South Africa. The interview explored their understanding of the purpose of the trial, the steps involved, the risks and benefits, and the responsibilities of the researchers and participants. The main findings were that many women understood that the study gel would be tested for effectiveness instead of safety. After revising the forms, researchers tested these again with the women who have been enrolled in the pilot study of this Phase II microbicide trial. Specific Objectives Were: to determine women's understanding of: - The main purpose of the study (safety vs. effectiveness); Key concepts (trial, randomisation, placebo, microbicide, double-blind, risks and benefits) included in the informed consent document; and their understanding of the ethical principles such as: confidentiality, autonomy, distribution justice, and beneficence. - The overall perception of the trial from the recruitment process, informed consent form, and as the steps and conditions as participants based on actually being in the trial.

METHODS: In-depth interviews were conducted with the 10 women enrolled in the PC-515 pilot study. Women were interviewed post enrolment and post-pilot phase.

RESULTS: The second part of the study is still in progress, however, the first set of interviews conducted with women suggest that half of the women still believe that the gel was being tested for effectiveness. Women were able to define most terms used in research such as eligibility, confidentiality, privacy, and voluntary participation. Participants mentioned that one to one discussions they held with staff about the trial helped them to understand better, and the informed consent document was complimentary to the discussions and also useful to friends or neighbours who showed interest.

CONCLUSION: Other findings will be presented in detail at the conference.

BACKGROUND: In 1998, the staff from the Population Council and the University of Cape Town tested the informed consent forms preparing for the Population Council Phase II microbicide expanded safety trial in South Africa. The interview explored their understanding of the purpose of the trial, the steps involved, the risks and benefits, and the responsibilities of the researchers and participants. The main findings were that many women understood that the study gel would be tested for effectiveness instead of safety Tthe main purpose of the study needed to be clearer. After revising the forms, researchers tested these again with the women who have been enrolled in the pilot study of this Phase II microbicide trial. Specific Objectives Were: to determine women's understanding of: - The main purpose of the study; key concepts of trials, and their understanding of the ethical principles such as: confidentiality, autonomy, distribution justice, and beneficence. - Their role as trial participants, and the role of the researchers, particularly with regard to adverse events, compensation, and liability; - The overall perception of the trial from the recruitment process, informed consent form, and as the steps and conditions as participants based on actually being in the trial.

METHODS: In-depth interviews were conducted with the 10 women enrolled in the PC-515 pilot study. Women were interviewed post enrolment and post-pilot phase Women received R30 as an incentive after the interviews which were conducted in Xhosa, and later transcribed and then translated into English.

RESULTS: The second part of the study is still in progress, however, the first set of interviews conducted with the women suggest that out of ten participants interviewed, half still believe that the gel was tested for effectiveness. Participants were able to define most terms used in research such as eligibility, confidentiality, privacy, and voluntary participation. Other findings will be presented in detailed at the conference. It is hoped that the findings will inform the recommendations needed to further improve the informed consent forms and process for the Phase II safety study of PC-515.

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