Clinical trial NCT01291589: HIV Prevention in Very High Risk Men Who Have Sex With Men
Official title: HIV Prevention in Very High Risk Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Risk Reduction Behavior
Keywords: HIV-infected
MSM
HIV prevention
Lead sponsor: Fenway Community Health
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Harvard University
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2011-02-08
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decrease in self-reported sexual risk taking
timeFrame: Measured at baseline, 3 months post baseline (12 weeks) and again at 3 months post treatment (up to 24 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
Study officials:
affiliation: Fenway Community Health
name: Conall M. O'Cleirigh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fenway Community Health
name: Wade Taylor, PhD
role: STUDY_DIRECTOR
References: