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

Risk Reduction Behavior Clinical Trial

— ENGAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291589
• Other study ID #: 2P30AI060354-07
• Status: Completed
• Phase: Phase 1
• First received: February 1, 2011
• Last updated: August 8, 2016
• Start date: November 2011
• Est. completion date: September 2012

Study information

• Verified date: August 2016
• Source: Fenway Community Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Risk Reduction Behavior

Intervention

Behavioral:
• Cognitive-behavioral therapy
Treatment will include elements from effective interventions for reducing risky sexual behaviors

Locations

Country	Name	City	State
United States	Fenway Community Health	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Fenway Community Health	Harvard University, Massachusetts General Hospital, National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in self-reported sexual risk taking	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.	Measured at baseline, 3 months post baseline (12 weeks) and again at 3 months post treatment (up to 24 weeks)	No