852 Trust Me, I'm a Doctor: Issues Related to Study Participation, Adherence, and Informed Consent in a Clinical Trial to Prevent Mother-to-Child Transmission of HIV through Breastfeeding A. Corneli1, E. Piwoz2, M. Bentley1, A. Moses3, Y. Ahmed4, A. Duerr4, C. van der Horst*1 1Univ of North Carolina, Chapel Hill; 2Academy for Ed Development, Washington, DC; 3Univ of North Carolina Project, Lilongwe, Malawi; and 4CDC, Atlanta, GA
Background: A qualitative study was conducted in 2002 in Lilongwe, Malawi, with the aim of informing the design of a clinical trial on the safety and efficacy of antiretroviral and nutrition interventions to reduce mother-to-child transmission of HIV during breastfeeding. The objective was to gather data from the community on issues related to participation in a clinical trial, recruitment and consent, and adherence to treatment regimens.
Methods: In-depth interviews were conducted with 22 HIV-infected women with infants, and 12 focus groups were conducted with 25 pregnant women, 26 men, and 26 grandmothers. Content analysis was used to identify cultural, social, and behavioral themes related to the research topics.
Results: All 22 of the HIV-infected women said they would be willing to participate in the research study, although many stressed that women need to consult with their husbands before giving consent, a finding that was confirmed in the focus groups. All but 2 of the women interviewed felt they would be able to adhere to the daily treatment regimen (2 pills, twice daily). Forgetfulness, lack of food (medications are to be taken with food), unclear instructions, and the need to share pills with their husbands were cited as likely constraints to adherence. About half of the study participants expressed concern about drawing blood, especially from young infants. Although study participants appeared to understand individual study procedures, they had more trouble grasping less concrete issues, such as the reasons for randomizing and comparing drug regimens. Study participants strongly believed that any medicine provided by a doctor is already proven safe and effective, otherwise it would not be provided. The community’s "blind faith" in the medical system may be a barrier to obtaining informed consent for the clinical trial.
Conclusions: The clinical trial protocol was modified to take into account these research findings. Important modifications include a reduction in the amount of blood to be drawn; additional training for study nurses on the importance of adherence and dangers of sharing medicines; and referrals for HIV-infected husbands. Additional research is being carried out on how to explain the concepts of testing safety and efficacy without violating the faith and trust of the community. Comprehension of these study concepts is crucial in order for participants to give consent that is truly informed.