PROJECT
Evaluation of the Informed Consent Process in the Phase 3 Study of the Microbicide Carraguard®

The Population Council is committed to improving the informed consent process in microbicide clinical trials. As part of its Phase 3 trial of the efficacy and safety of the candidate microbicide Carraguard in preventing HIV seroconversion in women, the Council is conducting evaluations of the trial’s informed consent process.

In the Phase 3 efficacy trial, information sessions were held at the study clinics or at venues in the communities. All sessions were guided by a standard operating procedure outlining how the various educational materials—video, study booklet, and informed consent form—were to be used to ensure that all of the requisite information was covered in a standardized manner. Whenever possible, information sessions began with a screening of the video. The video was shown at all sessions which occurred at the study clinics, but  for logistical reasons, could not be shown at all sessions taking place at community sites.

The evaluation involved both quantitative and qualitative components. The quantitative portion of the evaluation focused on comprehension and willingness to participate.

The first objective was to determine among the recruitment population whether the addition of the video: (1) improved comprehension of the aims, procedures, risks, and benefits of the Phase 3 trial; (2) increased willingness to participate in the trial; and (3) increased the number of women who come for screening for the trial when compared to use of the study booklet alone.

The second objective was to assess the level of comprehension regarding aims, risks, and benefits among women enrolled in the Phase 3 trial after they had gone through the full informed consent process. The comprehensive informed consent process included the information session, viewing the video (at information session or screening), group review of the informed consent form, and a one-on-one discussion of comprehension questions at which the informed consent form was signed.

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Population Council researchers

Barbara Friedland, Sharon Abbott, Lauren Katzen

Non-Council collaborators

Nela Williams, Vu Mtimkulu (University of Limpopo/Medunsa campus, Soshanguve)

Alana de Kock, Vuyelwa Mehlomakulu (University of Cape Town)

Donors

International Partnership for Microbicides

US Agency for International Development

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