TY - JOUR
T1 - A randomized clinical efficacy trial of a psychosocial intervention to strengthen self-acceptance and reduce HIV risk for MSM in India
T2 - Study protocol
AU - Mimiaga, Matthew J.
AU - Thomas, Beena
AU - Mayer, Kenneth H.
AU - Regenauer, Kristen S.
AU - Dange, Alpana
AU - Andres Bedoya, C.
AU - Rawat, Shruta
AU - Balu, Vinoth
AU - O'Cleirigh, Conall
AU - Biello, Katie B.
AU - Anand, Vivek
AU - Swaminathan, Soumya
AU - Safren, Steven A.
N1 - Funding Information:
This study is funded by the National Institute of Mental Health of the National Institutes of Health (NIH) under Award Number R01MH100627. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Publisher Copyright:
© 2018 The Author(s).
PY - 2018/7/18
Y1 - 2018/7/18
N2 - Background: Men who have sex with men (MSM) in India are a key group at risk for HIV acquisition and transmission. They are also an extremely marginalized and stigmatized population, facing immense psychosocial stressors including, but not limited to, stigma, homophobia, discrimination, criminalization, low self-esteem, low self-acceptance, distress, and, as a result, high rates of mental health problems. Although these multi-level psychosocial problems may put MSM at high risk for HIV acquisition and transmission, currently HIV prevention interventions in India do not address them. This paper describes the design of a psychosocial intervention to reduce HIV risk for MSM in India. Methods: Funded by the National Institute of Mental Health, this study is a two-arm randomized clinical efficacy trial of a self-acceptance based psychosocial HIV prevention intervention, informed by the minority stress model and syndemic theory, that was developed with extensive community-based formative work and input from the Indian MSM community and key informants who are knowledgeable about the experiences faced by MSM in India. Participants are MSM in Chennai and Mumbai who endorsed recent sexual behaviors placing them at high risk for HIV/sexually transmitted infection (STI) acquisition and transmission. Enrolled participants are equally randomized to either 1) the experimental condition, which consists of four group and six individual counseling sessions and includes standard of care HIV/STI testing and counseling, or 2) the standard of care condition, which includes HIV/STI testing and counseling alone. The primary outcomes are changes in the frequency of condomless anal sex acts and STI incidence (syphilis seropositivity and urethral, rectal, and pharyngeal gonorrhea and chlamydia infection. Major study assessment visits occur at baseline, 4-, 8-, and 12-months. Discussion: HIV prevention interventions that address the psychosocial stressors faced by MSM in India are needed; this study will examine the efficacy of such an intervention. If the intervention is successful, it may be able to reduce the national HIV/AIDS burden in India while empowering a marginalized and highly stigmatized group. Trial registration: ClinicalTrials.gov Identifier: NCT02556294, registered 22 September 2015.
AB - Background: Men who have sex with men (MSM) in India are a key group at risk for HIV acquisition and transmission. They are also an extremely marginalized and stigmatized population, facing immense psychosocial stressors including, but not limited to, stigma, homophobia, discrimination, criminalization, low self-esteem, low self-acceptance, distress, and, as a result, high rates of mental health problems. Although these multi-level psychosocial problems may put MSM at high risk for HIV acquisition and transmission, currently HIV prevention interventions in India do not address them. This paper describes the design of a psychosocial intervention to reduce HIV risk for MSM in India. Methods: Funded by the National Institute of Mental Health, this study is a two-arm randomized clinical efficacy trial of a self-acceptance based psychosocial HIV prevention intervention, informed by the minority stress model and syndemic theory, that was developed with extensive community-based formative work and input from the Indian MSM community and key informants who are knowledgeable about the experiences faced by MSM in India. Participants are MSM in Chennai and Mumbai who endorsed recent sexual behaviors placing them at high risk for HIV/sexually transmitted infection (STI) acquisition and transmission. Enrolled participants are equally randomized to either 1) the experimental condition, which consists of four group and six individual counseling sessions and includes standard of care HIV/STI testing and counseling, or 2) the standard of care condition, which includes HIV/STI testing and counseling alone. The primary outcomes are changes in the frequency of condomless anal sex acts and STI incidence (syphilis seropositivity and urethral, rectal, and pharyngeal gonorrhea and chlamydia infection. Major study assessment visits occur at baseline, 4-, 8-, and 12-months. Discussion: HIV prevention interventions that address the psychosocial stressors faced by MSM in India are needed; this study will examine the efficacy of such an intervention. If the intervention is successful, it may be able to reduce the national HIV/AIDS burden in India while empowering a marginalized and highly stigmatized group. Trial registration: ClinicalTrials.gov Identifier: NCT02556294, registered 22 September 2015.
KW - HIV prevention
KW - India
KW - MSM
KW - Psychosocial intervention
KW - Randomized controlled trial
KW - STI prevention
KW - Self-acceptance
UR - http://www.scopus.com/inward/record.url?scp=85050369685&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85050369685&partnerID=8YFLogxK
U2 - 10.1186/s12889-018-5838-2
DO - 10.1186/s12889-018-5838-2
M3 - Article
C2 - 30021566
AN - SCOPUS:85050369685
VL - 18
JO - BMC Public Health
JF - BMC Public Health
SN - 1471-2458
IS - 1
M1 - 890
ER -