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
  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

Resource links provided by NLM:


Further study details as provided by Fenway Community Health:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291589

Locations
United States, Massachusetts
Fenway Community Health
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Fenway Community Health
Massachusetts General Hospital
Harvard University
Investigators
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 October 29, 2014