HIV Prevention in Very High Risk Men Who Have Sex With Men (ENGAGE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Fenway Community Health.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Massachusetts General Hospital
Harvard University
Information provided by (Responsible Party):
Conall O'Cleirigh, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01291589
First received: February 1, 2011
Last updated: May 7, 2012
Last verified: May 2012

February 1, 2011
May 7, 2012
September 2011
September 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01291589 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
HIV Prevention in Very High Risk Men Who Have Sex With Men
HIV Prevention in Very High Risk Men Who Have Sex With Men

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).

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Risk Reduction Behavior
Behavioral: Cognitive-behavioral therapy
Treatment will include elements from effective interventions for reducing risky sexual behaviors
Experimental: Cognitive-behavioral counseling
Intervention: Behavioral: Cognitive-behavioral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01291589
2P30AI060354-07
Yes
Conall O'Cleirigh, Massachusetts General Hospital
Fenway Community Health
  • Massachusetts General Hospital
  • Harvard University
  • National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Conall M. O'Cleirigh, PhD Fenway Community Health
Study Director: Wade Taylor, PhD Fenway Community Health
Fenway Community Health
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP