PLoS Medicine: An Intervention to Reduce HIV Risk Behavior of Substance-Using Men Who Have Sex with Men: A Two-Group Randomized Trial with a Nonrandomized Third Group

An Intervention to Reduce HIV Risk Behavior of Substance-Using Men Who Have Sex with Men: A Two-Group Randomized Trial with a Nonrandomized Third Group
In a randomized trial of a behavioral intervention among substance-using men who have sex with men, aimed at reducing sexual risk behavior, Mansergh and colleagues fail to find evidence of a reduction in risk from the intervention.

Gordon Mansergh1*, Beryl A. Koblin2, David J. McKirnan3, Sharon M. Hudson4, Stephen A. Flores1, Ryan E. Wiegand1, David W. Purcell1, Grant N. Colfax5, for the Project MIX Study Team¶
1 Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America, 2 New York Blood Center, New York, New York, United States of America, 3 University of Illinois at Chicago and Howard Brown Health Center, Chicago, Illinois, United States of America, 4 Health Research Association, Los Angeles, California, United States of America, 5 San Francisco Department of Public Health, San Francisco, California, United States of America

Abstract
Background
Substance use during sex is associated with sexual risk behavior among men who have sex with men (MSM), and MSM continue to be the group at highest risk for incident HIV in the United States. The objective of this study is to test the efficacy of a group-based, cognitive-behavioral intervention to reduce risk behavior of substance-using MSM, compared to a randomized attention-control group and a nonrandomized standard HIV-testing group.

Methods and Findings
Participants (n = 1,686) were enrolled in Chicago, Los Angeles, New York City, and San Francisco and randomized to a cognitive-behavioral intervention or attention-control comparison. The nonrandomized group received standard HIV counseling and testing. Intervention group participants received six 2-h group sessions focused on reducing substance use and sexual risk behavior. Attention-control group participants received six 2-h group sessions of videos and discussion of MSM community issues unrelated to substance use, sexual risk, and HIV/AIDS. All three groups received HIV counseling and testing at baseline. The sample reported high-risk behavior during the past 3 mo prior to their baseline visit: 67% reported unprotected anal sex, and 77% reported substance use during their most recent anal sex encounter with a nonprimary partner. The three groups significantly (p<0.05) reduced risk behavior (e.g., unprotected anal sex reduced by 32% at 12-mo follow-up), but were not different (p>0.05) from each other at 3-, 6-, and 12-mo follow-up. Outcomes for the 2-arm comparisons were not significantly different at 12-mo follow-up (e.g., unprotected anal sex, odds ratio = 1.14, confidence interval = 0.86–1.51), nor at earlier time points. Similar results were found for each outcome variable in both 2- and 3-arm comparisons.

Conclusions
These results for reducing sexual risk behavior of substance-using MSM are consistent with results of intervention trials for other populations, which collectively suggest critical challenges for the field of HIV behavioral interventions. Several mechanisms may contribute to statistically indistinguishable reductions in risk outcomes by trial group. More explicit debate is needed in the behavioral intervention field about appropriate scientific designs and methods. As HIV prevention increasingly competes for behavior-change attention alongside other “chronic” diseases and mental health issues, new approaches may better resonate with at-risk groups.

Trial Registration
ClinicalTrials.gov NCT00153361

Please see later in the article for the Editors' Summary

Citation: Mansergh G, Koblin BA, McKirnan DJ, Hudson SM, Flores SA, et al. (2010) An Intervention to Reduce HIV Risk Behavior of Substance-Using Men Who Have Sex with Men: A Two-Group Randomized Trial with a Nonrandomized Third Group. PLoS Med 7(8): e1000329. doi:10.1371/journal.pmed.1000329

Academic Editor: Seth C. Kalichman, University of Connecticut, United States of America


Received: January 27, 2010; Accepted: July 14, 2010; Published: August 24, 2010

This is an open-access article distributed under the terms of the Creative Commons Public Domain declaration which stipulates that, once placed in the public domain, this work may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose.

Funding: This work was funded by cooperative agreements from the Division of HIV/AIDS Prevention, CDC, USA (http://www.cdc.gov), award numbers: U65/CCU522209 (Chicago); U65/CCU922215 (Los Angeles); U65/CCU222309 (New York); U65/CCU922213 (San Francisco). As a cooperative agreement award, the funders had an active role in study design, data analysis, decision to publish, and preparation of the manuscript. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the US Centers for Disease Control and Prevention.

Competing interests: The authors have declared that no competing interests exist.

Abbreviations: ACASI, audio computer-assisted self-interview; CI, confidence interval; DUA, discordant unprotected anal sex; MSM, men who have sex with men; OR, odds ratio; UA, unprotected anal sex

* E-mail: gmansergh@cdc.gov
¶ Membership of the Project MIX Study Team is provided in the Acknowledgments.

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PLoS Medicine: An Intervention to Reduce HIV Risk Behavior of Substance-Using Men Who Have Sex with Men: A Two-Group Randomized Trial with a Nonrandomized Third Group