HIV Prevention in Very High Risk Men Who Have Sex With Men
ENGAGE
1 other identifier
interventional
14
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2011
CompletedFirst Posted
Study publicly available on registry
February 8, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedAugust 9, 2016
August 1, 2016
5 months
February 1, 2011
August 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
Cognitive-behavioral counseling
EXPERIMENTALInterventions
Treatment will include elements from effective interventions for reducing risky sexual behaviors
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unable or unwilling to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fenway Community Healthlead
- Massachusetts General Hospitalcollaborator
- Harvard Universitycollaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
Study Sites (1)
Fenway Community Health
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Conall M. O'Cleirigh, PhD
Fenway Community Health
- STUDY DIRECTOR
Wade Taylor, PhD
Fenway Community Health
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Harvard Medical School, Director, Behavioral Medicine, Department of Psychiatry Massachusetts General Hospital
Study Record Dates
First Submitted
February 1, 2011
First Posted
February 8, 2011
Study Start
November 1, 2011
Primary Completion
April 1, 2012
Study Completion
September 1, 2012
Last Updated
August 9, 2016
Record last verified: 2016-08