Despite many successful clinical trials to test HIV-prevention interventions for sexual minority men (SMM), not all SMM are reached by these trials. Identifying factors associated with non-participation in these trials could help to ensure the benefits of research extend to all SMM. Prospective participants in New York City and Miami were screened to determine eligibility for a baseline assessment for a mental health/HIV-prevention trial (N = 633 eligible on screen). Logistic regression and classification and regression tree (CART) analysis identified predictors of non-participation in the baseline, among those who were screened as eligible and invited to participate. Individuals who reported unknown HIV status were more likely to be non-participators than those who reported being HIV-negative (OR = 2.39; 95% CI 1.41, 4.04). In New York City, Latinx SMM were more likely to be non-participators than non-Latinx white SMM (OR = 1.81; 95% CI, 1.09, 2.98). A CART model pruned two predictors of non-participation: knowledge of HIV status and age, such that SMM with unknown HIV status and SMM ages 18–19 were less likely to participate. Young SMM who did not know their HIV status, and thus are more likely to acquire and transmit HIV, were less likely to participate. Additionally, younger SMM (18–19 years) and Latinx SMM in New York City were less likely to participate. The findings suggest the importance of tailored recruitment to ensure HIV-prevention/mental health trials reach all SMM.
A pesar de muchos ensayos clínicos exitosos para probar intervenciones de prevención del VIH para hombres de minorías sexuales (HMS), no todos los HMS son alcanzados por estos ensayos. La identificación de factores asociados con la no participación en estos ensayos podría ayudar a asegurar que los beneficios de la investigación se extiendan a todos los HMS. Se realizaron evaluaciones de teléfono para determinar la elegibilidad para la visita inicial para un ensayo de salud mental/prevención del VIH (N = 633 elegibles en las evaluaciones). La regresión logística y el análisis de arboles de regresión y clasificación (ARC) identificaron predictores de no participación en la visita inicial, entre aquellos que fueron evaluados como elegibles e invitados a participar. Los individuos que reportaron estado desconocido de VIH fueron más probables a ser no participantes que aquellos que reportaron ser VIH negativos (RP = 2.39; IC 95% 1.41, 4.04). En la ciudad de Nueva York, HMS latinx eran más probable a no participar que los HMS blancos no latinx (RP = 1.81; IC 95%, 1.09, 2.98). Un modelo de ARC podó dos predictores de no participación: el conocimiento del estado de VIH y la edad, tal que los HMS con estado desconocido del VIH y las HMS de 18–19 años eran menos probables a participar. Los HMS jóvenes que no conocían su estado de VIH, y por lo tanto eran más probables a adquirir y transmitir el VIH, tenían menos probabilidades de participar. Además, las HMS más jóvenes (18–19 años) y los HMS latinx en la ciudad de Nueva York eran menos probables a participar. Los resultados sugieren la importancia de un reclutamiento personalizado para garantizar que los ensayos de prevención del VIH y salud mental lleguen a todos los SMM.
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We use the term “sexual minority men” to refer to men who identify as gay, bisexual, or another non-heterosexual identity. Some sources referenced use the term “men who have sex with men” (MSM) to refer to men who engage in sexual behavior with men, regardless of their sexual orientation identity; therefore, we use the term MSM to describe these groups, consistent with the cited research.
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Data collection for this study was supported by R01MH109413 (Pachankis). Additional support came from P30MH116867 and K24DA040489 (Safren) and K23MD015690 (Harkness). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Data collection for this study was supported by R01MH109413 (Pachankis). Additional support came from P30MH116867 and K24DA040489 (Safren) and K23MD015690 (Harkness).
Conflict of interest
Dr. Pachankis receives royalties from Oxford University Press for books related to LGBTQ-affirmative mental health treatments. Dr. Safren receives royalties from Oxford University Press, Guilford Publications, and Springer/Humana press for books on cognitive behavioral therapy. The authors have no other relevant financial or non-financial interests to disclose.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Institutional Review Boards at Yale University and University of Miami.
Informed consent was obtained from all individual participants included in the study.
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Harkness, A., Rogers, B.G., Balise, R. et al. Who Aren’t We Reaching? Young Sexual Minority Men’s Non-participation in an HIV-Prevention and Mental Health Clinical Trial. AIDS Behav (2021). https://doi.org/10.1007/s10461-020-03148-x
- HIV prevention
- Sexual minority men
- Mental health
- Recruitment and outreach