Abstract
This is a 2-arm pilot randomized controlled trial (N = 96) of a behavioral intervention (4 group and 4 individual sessions) integrating risk reduction counseling with counseling to foster self-acceptance in MSM in India compared to enhanced standard of care (ESOC). Both conditions involved HIV and STI testing and counseling at baseline and 6-months, and assessments of condomless sex at baseline, 3-, and 6-months. A significant condition by time interaction suggested a difference in the rate of change in number of anal sex acts without condoms in the intervention versus ESOC (p < 0.0001). Post hoc contrasts suggested that the overall difference was due to intervention-response at 3-months. The incidence of bacterial STIs was 17.5 % in the intervention condition and a 28.6 % in ESOC. Addressing self-acceptance and related psychosocial concerns in the context sexual risk reduction counseling for MSM in India was feasible and acceptable. Testing the intervention for efficacy is justified.
Resumen
Esto es un estudio piloto de un ensayo clínico aleatorizado (N = 96) que fue proveído en la India con hombres que tienen relaciones sexuales con otros hombres (HSH). El estudio compara una intervención conductual—cual integra consejería para desminuir riesgo con consejería para desarrollar auto-aceptación—con tratamiento estándar y realzado (ESOC en inglés). Ambas condiciones incluyen examen y consejería para el VIH y otras enfermedades transmitidas sexualmente. Estas se llevaron a cabo en las evaluaciones de línea base y de 6 meses, con entrevistas sobre el riesgo sexual completadas durante las evaluaciones de línea base, 3 y 6 meses. Una interacción de condición y tiempo indicaron una diferencia en la tasa de cambio entre la condición conductual comparada con ESOC (p < 0.0001) en la cantidad de actos de sexo anal sin protección. Analices post hoc de contraste indicaron que la diferencia fue a causa de la reacción a la intervención a los 3 meses. La incidencia de enfermedades transmitidas sexualmente fue 17.5 % en la condición conductual y 28.6 % en la condición ESOC. Con este grupo de HSH en la India, se demostró factibilidad y aceptación de poder abordar la auto-aceptación y factores psicosociales como parte de consejería para desminuir el riesgo del VIH. Es justo examinar la intervención para demostrar su efectividad.
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Acknowledgments
Funding from this project is from a joint Indo-U.S. mechanism. Accordingly, Grant NIMH R-21 MH085314 was awarded to Dr. Steven Safren from the National Institute of Mental Health (NIMH) and Dr. Beena Thomas was awarded a Grant from the India Council of Medical Research (ICMR). Dr. Safren was also supported by Grant 5K24MH094214 with respect to investigator time after the R21 funding ended. We would like to thank Jocelyn Remmert for helping prepare the manuscript for submission, and Dr. C. Andres Bedoya for writing the Resumen. We would also like to thank the study participants, and the staff of Sahodaran for their contribution to the project.
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Safren, S.A., Thomas, B.E., Mayer, K.H. et al. A Pilot RCT of an Intervention to Reduce HIV Sexual Risk and Increase Self-acceptance Among MSM in Chennai, India. AIDS Behav 18, 1904–1912 (2014). https://doi.org/10.1007/s10461-014-0773-4
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DOI: https://doi.org/10.1007/s10461-014-0773-4