The Role of Community Engagement in Novel HIV Research in Infants.

The proposed study would be a single-arm interventional trial in a community where HIV is endemic. Beginning with a high-dose triple-drug treatment right after birth, treatment would continue in those who test HIV positive for the next two years and then stop to see if HIV has been eradicated. While we believe the general approach can be justified, and some important questions about this study have already been raised in the literature, three additional questions need to be addressed to determine an ethically sound study design. First is whether this study will be perceived by the community as an opportunity or a burden. A second question regards the ideal permission process and whether permission should be obtained by someone who is not involved in clinical care. A third question regards the implications of withdrawing from a study that involves treatment discontinuation and the expectations of the participants and community about subsequent obligations of the researchers. For these questions, there may be more than one acceptable approach, and the critical issue is to work with the community respectfully and as a partner in the study design process.