HIV Prevention in Very High Risk Men Who Have Sex With Men (ENGAGE)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Risk Reduction Behavior |
Behavioral: Cognitive-behavioral therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | HIV Prevention in Very High Risk Men Who Have Sex With Men |
- Decrease in self-reported sexual risk taking [ Time Frame: Measured at baseline, 3 months post baseline (12 weeks) and again at 3 months post treatment (up to 24 weeks) ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cognitive-behavioral counseling |
Behavioral: Cognitive-behavioral therapy
Treatment will include elements from effective interventions for reducing risky sexual behaviors
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Massachusetts | |
| Fenway Community Health | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Conall M. O'Cleirigh, PhD | Fenway Community Health |
| Study Director: | Wade Taylor, PhD | Fenway Community Health |
More Information
No publications provided
| Responsible Party: | Conall O'Cleirigh, Instructor, Harvard Medical School, Associate Director, Behavioral Medicine, Department of Psychiatry Massachusetts General Hospital, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01291589 History of Changes |
| Other Study ID Numbers: | 2P30AI060354-07 |
| Study First Received: | February 1, 2011 |
| Last Updated: | May 7, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fenway Community Health:
|
HIV-infected MSM HIV prevention |
ClinicalTrials.gov processed this record on June 18, 2013