HIV Prevention in Very High Risk Men Who Have Sex With Men

Phase 1

Completed

• Conditions: Risk Reduction Behavior
• Interventions: Behavioral: Cognitive-behavioral therapy

• Registration Number: NCT01291589
• Lead Sponsor: Fenway Community Health

Brief Summary

The purpose of this study is to pilot test an innovative program development project in an open trial format an 8-session, individual, cognitive-behavioral therapy based, intervention on ten (10) HIV-infected men who have sex with men who report very high levels (\>10 episodes) of sexual transmission risk behavior (unprotected anal intercourse with serodiscordant partners).

Detailed Description

This is an innovative program development project that will, over the next year, pilot test, in an open trial format an 8-session, individual, cognitive-behavioral therapy based, intervention on ten (10) HIV-infected men who have sex with men who report very high levels (\>10 episodes) of sexual transmission risk behavior (unprotected anal intercourse with serodiscordant partners). That is, to pilot test a novel prevention intervention designed to effect reductions in sexual transmission risk behavior among the riskiest men in the largest HIV risk group in the US. Effecting even modest reductions in the mean number of risk acts in this group will likely have substantial public health significance through the number of averted new HIV infections. Traditional secondary HIV intervention strategies (e.g., Information, Motivation, Behavior change (IMB)) models only have modest effects for HIV-positive MSM and there is evidence to suggest that these effects tend to diminish over time.

Study Timeline

• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Study Start: 2011-11
• Primary Completion: 2012-04
• Study Completion: 2012-09
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

• Age 18 years old or older
• Self-reports as a man who has sex with men (MSM)
• Self-reports being HIV-infected
• Reports engaging in 10 episodes or more of unprotected anal intercourse (receptive or insertive) in the past three months with male partners who are not HIV-infected or whose serostatus is unknown.
• Is capable of completing and fully understanding the informed consent process and the study procedures and assessments in English

Exclusion Criteria

• Unable or unwilling to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive-behavioral counseling	Cognitive-behavioral therapy	-

Primary Outcome Measures

Name	Time	Method
Decrease in self-reported sexual risk taking	Measured at baseline, 3 months post baseline (12 weeks) and again at 3 months post treatment (up to 24 weeks)	The potential for an effect will determine the magnitude of the change in self-reported unprotected anal intercourse acts with HIV-uninfected and HIV-unknown status partners in the previous 3 months from baseline assessment to post treatment and follow-up.

Trial Locations

Locations (1)

Fenway Community Health; 🇺🇸 Boston, Massachusetts, United States