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.


CONCLUSIONS
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.
Witte
Susan S
SS
Social Intervention Group, Columbia University School of Social Work, New York, New York 10027, USA. ssw12@columbia.edu
El-Bassel
Nabila
N
Gilbert
Louisa
L
Wu
Elwin
E
Chang
Mingway
M
Steinglass
Peter
P
D000328:Adult; D001741:Black or African American / Q000706:statistics & numerical data*; D001294:Attitude to Health / Q000208:ethnology; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000208:ethnology / Q000517:prevention & control*; D006630:Hispanic or Latino / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008913:Minority Groups / Q000706:statistics & numerical data; D009518:New York; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000706:statistics & numerical data; D012747:Sexual Partners / Q000523:psychology; D013997:Time Factors; D016387:Women's Health / Q000208:ethnology