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

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ClinicalTrials.gov Identifier: NCT01291589
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : August 9, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Risk Reduction Behavior Behavioral: Cognitive-behavioral therapy Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: HIV Prevention in Very High Risk Men Who Have Sex With Men
Study Start Date : November 2011
Primary Completion Date : April 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cognitive-behavioral counseling Behavioral: Cognitive-behavioral therapy
Treatment will include elements from effective interventions for reducing risky sexual behaviors


Outcome Measures

Primary Outcome Measures :
  1. 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) ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291589


Locations
United States, Massachusetts
Fenway Community Health
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Fenway Community Health
Massachusetts General Hospital
Harvard University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Conall M. O'Cleirigh, PhD Fenway Community Health
Study Director: Wade Taylor, PhD Fenway Community Health
More Information

Responsible Party: Conall O'Cleirigh, Assistant Professor, Harvard Medical School, 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 ( U.S. NIH Grant/Contract )
First Posted: February 8, 2011    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016

Keywords provided by Conall O'Cleirigh, Massachusetts General Hospital:
HIV-infected
MSM
HIV prevention