Exploring the community response to a randomized controlled HIV/AIDS intervention trial in rural Uganda.

Investigators need, both for ethical and methodological reasons, to consider the acceptability of their intervention to the study population. We explored the response to a community-based randomized controlled trial (RCT) of an HIV/AIDS behavioral change intervention in rural Uganda. The views of field-workers, trial community, nongovernment organization representatives, and religious leaders were explored via focus groups (13) and interviews (45). The results suggest that the components of the intervention valued by the community are not necessarily those prioritised by trial implementers. Specifically, prevention activities appear to be valued less than material assistance. Furthermore, universal acceptance of the trial is probably unattainable. For these reasons, sensitive mobilization, respect for community members and their appointed leaders, and ongoing communication is essential. We suggest that evaluations of process be regarded as essential to the conduct of community-based RCTs and highlight the need for appropriate evaluation indicators to facilitate this.