Enhancing HIV Prevention by Using Behavioral Intervention Among HIV-Infected Men
Enhance
Enhancing HIV Prevention Among HIV Infected Men
2 other identifiers
interventional
201
1 country
1
Brief Summary
This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management in promoting safer sex practices in HIV-infected men.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
Started Dec 2003
Longer than P75 for not_applicable hiv-infections
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
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedApril 8, 2011
February 1, 2011
4.6 years
September 30, 2005
April 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up
Measured at Months 3, 6, 9, and 12
Secondary Outcomes (4)
Incidence of sexually transmitted diseases
Measured at Months 3, 6, 9, and 12
Higher risk-reduction self-efficacy
Measured at Months 3, 6, 9, and 12
Increased behavioral intentions to engage in safer behaviors
Measured at Months 3, 6, 9, and 12
Increased risk-reduction strategies (other than condom use)
Measured at Months 3, 6, 9, and 12
Study Arms (2)
Project Enhance
EXPERIMENTALParticipants will receive the risk reduction program, Project Enhance
Active Comparison Condition
ACTIVE COMPARATORParticipants will receive standard prevention case management
Interventions
The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.
Participants will receive standard PCM for HIV prevention.
Eligibility Criteria
You may qualify if:
- HIV infected
- Receives primary health care at Fenway Community Health
- Identifies as a man who has sex with men
- Has engaged in unprotected anal or vaginal intercourse within 3 months of study enrollment
You may not qualify if:
- All episodes of unprotected anal intercourse occurred with only a single primary partner who is also HIV infected
- Plans to relocate over the upcoming year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fenway Community Health
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Mayer, MD
Fenway Community Health and Brown University
- PRINCIPAL INVESTIGATOR
Steven Safren, PhD
Fenway Community Health and Harvard Medical School
- STUDY DIRECTOR
Conall O'Cleirigh, PhD
Fenway Community Health and Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
December 1, 2003
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
April 8, 2011
Record last verified: 2011-02