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.
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.


RESULTS
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.


BACKGROUND
ClinicalTrials.gov NCT00153361. Please see later in the article for the Editors' Summary.
Mansergh
Gordon
G
Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America. gmansergh@cdc.gov
Koblin
Beryl A
BA
McKirnan
David J
DJ
Hudson
Sharon M
SM
Flores
Stephen A
SA
Wiegand
Ryan E
RE
Purcell
David W
DW
Colfax
Grant N
GN
D000293:Adolescent; D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000379:methods; D005500:Follow-Up Studies; D015658:HIV Infections / Q000150:complications / Q000523:psychology* / Q000628:therapy; D018451:Homosexuality, Male / Q000523:psychology; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D040242:Risk Reduction Behavior; D012309:Risk-Taking; D012725:Sexual Behavior / Q000523:psychology*; D019966:Substance-Related Disorders / Q000150:complications / Q000523:psychology* / Q000628:therapy; D047568:Unsafe Sex / Q000517:prevention & control / Q000523:psychology / Q000528:radiation effects; D055815:Young Adult
J Urban Health. 2006 Nov;83(6):1151-7
17111217
Am J Public Health. 2003 Jun;93(6):939-42
12773359
AIDS Behav. 2009 Aug;13(4):757-82
18236149
AIDS. 2007 Sep 12;21(14):1923-32
17721100
J Stud Alcohol. 1999 Nov;60(6):837-45
10606497
Cochrane Database Syst Rev. 2006 Oct 18;(4):CD001561
17054138
JAMA. 1998 Oct 7;280(13):1161-7
9777816
Am J Epidemiol. 2004 May 15;159(10):1002-12
15128613
Drug Alcohol Depend. 2007 Mar 16;87(2-3):249-57
17182196
JAMA. 2008 Aug 6;300(5):520-9
18677024
Sex Transm Infect. 2008 Nov;84(6):509-11
19028957
J Acquir Immune Defic Syndr. 2004 Oct 1;37 Suppl 2:S110-8
15385907
Am J Public Health. 2010 Apr;100(4):590-5
20167880
Stat Med. 2007 Mar 15;26(6):1368-82
16810713
Alcohol Clin Exp Res. 2007 Aug;31(8):1380-91
17550361
Psychol Methods. 2001 Dec;6(4):330-51
11778676
AIDS. 2006 Mar 21;20(5):731-9
16514304
J Addict Dis. 1998;17(4):19-32
9848029
J Acquir Immune Defic Syndr. 2005 Jun 1;39(2):228-41
15905741
AIDS. 2005 Apr;19 Suppl 1:S99-109
15838199
Drug Alcohol Depend. 2005 May 9;78(2):125-34
15845315
Lancet. 2004 Jul 3-9;364(9428):41-50
15234855
Sex Transm Dis. 2000 Sep;27(8):456-7
10987451
Sex Transm Dis. 2006 Apr;33(4):265-71
16434886
AIDS Educ Prev. 2005 Dec;17(6):568-89
16398578
Alcohol Alcohol. 2006 Sep-Oct;41(5):580; author reply 581
16751218
Subst Use Misuse. 2006;41(10-12):1551-601
17002993
Sex Transm Dis. 2004 Aug;31(8):492-8
15273583
Am Psychol. 2000 Jan;55(1):5-14
11392865
AIDS Educ Prev. 2002 Dec;14(6):482-95
12512849
J Allergy Clin Immunol. 2007 Nov;120(5):1023-30
17904625