Recruitment challenges and strategies in the phase II extended safety trial of tenofovir (TDF) HIV chemoprophylaxis in three US cities among men who have sex with men (MSM)
L. Grohskopf1, C. Alinsung2, S. Buchbinder3, A. Liu3, K. Mayer2, J. Maynard2, L. Miller4, G. Mustaafaa4, D. Teague4, M. Thompson4, B. Collins1, L. Paxton1, M. Ackers1, K. Chillag1
1Centers for Disease Control and Prevention, Atlanta, United States, 2Fenway Community Health, Boston, United States, 3San Francisco Department of Public Health, San Francisco, United States, 4AIDS Research Consortium of Atlanta, Atlanta, United States
Issues: Design and implementation of this placebo-controlled safety trial of once daily TDF for HIV preexposure prophylaxis (PrEP) was predicated on completing enrollment of 400 MSM in two sites (Atlanta and San Francisco) between February and November 2005. Enrollment was ultimately completed in July 2007. Because this was the first MSM PrEP trial, accurate projections were difficult. Assumptions based on other biomedical and behavioral prevention or treatment trials proved inadequate. Resource constraints and institutional factors, e.g., lengthy protocol and recruitment material approval processes, contributed to accrual challenges.
Description: This presentation describes lessons learned during trial implementation. Additionally, after trial completion, a structured debriefing was held with staff from each site. Topics included: why recruitment approaches changed; comparison with other HIV prevention trials; and impact of site and sponsor characteristics.
Lessons learned: Initial resources were insufficient to meet original recruitment goals for this complex trial. Assumptions about the utility of specific recruitment strategies (e.g., direct street outreach, palm cards, internet) were sometimes erroneous, particularly among specific subpopulations. Creative solutions emerged, capitalizing on personalities of recruitment staff. In addition to adding another site (Boston) 20 months into enrollment, study staff modified recruitment paradigms and strategies. Contributing to eventual success was focus on active recruitment, e.g., building trust with club owners and patrons; addressing message fatigue and misperceptions, e.g., that the trial was only recruiting persons of color; and ongoing evaluation.
Next steps: Successful recruitment is resource intensive, and ongoing capacity to modify strategies is essential. While not all challenges can be anticipated, activities such as community engagement, sociobehavioral studies, formal evaluation, and staff debriefings enhance the likelihood of success. Prompt human subjects and sponsor review processes are critical. Prudent resource planning should consider that studies may require more or different resources over time.