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Strategies and ethical considerations for the recruitment of young men who have sex with men: challenges of a vaccination trial in MexicoCenter for Population Health Research, National Institute of Public Health. Cuernavaca, Morelos, Mexico
Center for Population Health Research, National Institute of Public Health. Cuernavaca, Morelos, Mexico, aangelica{at}insp.mx
Center for Health Systems Research, National Institute of Public Health. Cuernavaca, Morelos, Mexico
Department of Medical Psychology, Psychiatry and Mental Health, School of Medicine, UNAM, Mexico City, Mexico
Center for Population Health Research, National Institute of Public Health. Cuernavaca, Morelos, Mexico
Gynecological Oncology Department, National Institute of Perinatology, Mexico City
Director PPD, Mexico City, Mexico
Center for Population Health Research, National Institute of Public Health. Cuernavaca, Morelos, Mexico Background The importance of recruiting and retaining study participants from minority groups is well recognized; however, there are no established rules for recruitment as its success depends on the setting and population. Purpose To describe and analyze recruitment strategies, ethical considerations, and recruitment outcomes from a study to evaluate the efficacy the Human Papilloma Virus vaccine in young men who have sex with men (MSM). Methods The recruitment settings were university and community sites in the state of Morelos, Mexico. Eligibility requirement were men between 18 and 23 years old, who were free of anal-genital lesions as confirmed by clinical exploration, HIV negative, with no history of sexual relations with female partners and with fewer than five male lifetime sexual partners. Recruitment goals were 25 study participants in a four and a half month period. In addition to traditional recruitment strategies (flyers and media advertising, specific training of the recruitment team and adequate choice of recruitment sites)—engagement of local leaders in the MSM community formed a crucial part of the strategy. Special consideration was given to confidentiality and respect for study participants and a Bill of Participant Rights was developed as an explicit commitment to respect and acceptance. Results In total 723 MSM were initially contacted, 243 filled out the recruitment questionnaire, of which 151 met the criteria to be invited to the clinical examination. After clinical examination and interviews with the recruitment team, 131 fulfilled the inclusion criteria, of whom 73 were enrolled in the study — nearly triple the recruitment goal. Among the initial recruitment strategies (application of the screening questionnaire) attending meetings with MSM activist organizations was the most successful (326), followed by recruitment at bars and dance clubs (107). Limitations The recruitment strategies should be formally evaluated for their effectiveness to identify those which are most successful. In addition, future studies should consider the evaluation of study participants’ perceptions of the recruitment strategies. Conclusions Recruiting MSM in a developing country such as Mexico presented multiple challenges. We recommend that future studies actively engage the local MSM community and pay special attention to designing recruitment strategies that guarantee the confidentiality of and respect for participants.
This version was published on August
1, 2009 Clinical Trials, Vol. 6, No. 4,
365-372 (2009) |
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