PROJECT
Evaluation of the Informed Consent Process . . . (continued)

The quantitative evaluation was implemented in 2005 at the Soshanguve and Gugulethu study sites. Two hundred women at each site were interviewed before and after information sessions; 150 women per site were interviewed at their enrollment visit. Interviews were conducted by field workers employed by the Community Agency for Social Enquiry, a social science research organization based in Johannesburg. Final data analysis is underway, with results expected by February 2008.

The qualitative component of the evaluation used in-depth interviews and focus group discussions with study participants at various stages in their trial participation and with study staff. Focus groups were conducted with study participants and their willing male partners, both in single gender and mixed gender groups. The interviews and focus group discussions were conducted by local field workers at each of the three study sites.

Researchers conducted more than 100 interviews with participants, partners, and study staff. Preliminary findings indicate that the desire to know one’s HIV status and to receive quality care were primary motivations for joining the trial, and that partners, social networks, and staff played key roles in participants’ decisions to join and remain in a clinical trial. While most women disclosed trial participation to their partners, there was variation in how and when this information was disclosed, and how it was received by their social networks. Many volunteers articulated a sense of empowered gained by their participation in the trial, which they suggested served to improve communication about HIV risk reduction (e.g., condom use) with their sexual partners.

In-depth interviews with counselors, nurses, and recruiters conducted at the end of the trial highlighted the importance for staff training and high-quality materials. Study staff stressed the importance of their role in ensuring that women understood their rights within the trial. While many of the staff members stated that the informed consent process and materials were comprehensive, they often felt pressured for time because many volunteers lacked fundamental health and clinical research knowledge. Several recommended additional community programs to foster a sense of health literacy prior to the start of a clinical trial. Final data analysis is underway, with results expected by June 2008.

This evaluation builds on previous efforts to develop, test, and adapt the informed consent forms and processes to ensure that women are truly informed and participate voluntarily. The findings of this evaluation will provide valuable information that can be applied to future clinical trials.

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