Recruitment of minority women and their main sexual partners in an HIV/STI prevention trial

Recruiting heterosexual couples into randomized clinical trials (RCTs) to test the efficacy of HIV/sexually transmitted infection (STI) prevention interventions is a challenge that requires innovative strategies and consideration of ethical issues, including participant safety and confidentiality. Methods: This paper provides a brief review of the literature on minority and couple RCT recruitment and describes the development (preparation phase and protocol development) and implementation (strategies employed and barriers) of a recruitment protocol that safely enrolled 217 predominantly African American and Latino heterosexual couples into a relationship-based, HIV/STI prevention study. Results: The success of this recruitment protocol with no reported adverse events demonstrates the feasibility of engaging urban minority women and men in RCTs. This study builds on a small literature base articulating specific couple recruitment strategies. Conclusion: More research delineating and testing specific strategies for recruiting defined populations into clinical trials is needed to advance the science of study recruitment and improve generalizability of research findings.