Specialized Cognitive-Behavioral Counseling Intervention to Reduce HIV Transmission Risk Behavior in HIV-Infected Men
Reducing HIV Transmission Risk Behavior: a Trial of a Two Session Risk-Reduction Intervention With HIV-Positive Men Who Have Sex With Men
2 other identifiers
interventional
488
1 country
2
Brief Summary
This study will evaluate the effectiveness of a specialized cognitive-behavioral counseling intervention in reducing sexual risk behaviors in men who are HIV-infected and report having unprotected sex with male partners who are either not HIV-infected or do not know if they are HIV-infected.
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 Sep 2005
Longer than P75 for not_applicable hiv-infections
2 active sites
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
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMay 2, 2012
April 1, 2012
5.3 years
September 16, 2005
April 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in HIV transmission risk behavior; measured 6 and 12 months following the initial counseling intervention
Measured at Months 6 and 12
Study Arms (2)
1
EXPERIMENTALParticipants will receive personalized cognitive counseling
2
ACTIVE COMPARATORParticipants will receive standard counseling
Interventions
Cognitive behavioral intervention will include personalized cognitive counseling. All participants will attend two counseling sessions: the first will occur at study entry and the second will occur 6 months later.
Participants will receive standard counseling. All participants will attend two counseling sessions: the first will occur at study entry and the second will occur 6 months later.
Eligibility Criteria
You may qualify if:
- HIV-infected
- Currently receiving HIV-specific primary medical care or mental health care
- Reports at least one episode of unprotected sex (receptive or insertive) with a male partner who is either not infected or does not know if he is infected with HIV (within 12 months prior to study enrollment)
- Plans to live in the San Francisco Bay Area for the next 12 months
You may not qualify if:
- History of intercourse on a regular basis with only one person
- Insufficient understanding of English
- Cognitive disorder that may affect ability to give informed consent
- Currently enrolled in any other behavioral or clinical HIV trials that could affect participation in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UCSF AIDS Health Project
San Francisco, California, 94102, United States
SFDPH San Francisco City Clinic
San Francisco, California, 94103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James W. Dilley, MD
UCSF AIDS Health Project
- PRINCIPAL INVESTIGATOR
Sandra Schwarcz, MD, MPH
SFDPH-AIDS Office
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
September 1, 2005
Primary Completion
December 1, 2010
Study Completion
March 1, 2011
Last Updated
May 2, 2012
Record last verified: 2012-04