HIV Prevention Counseling for Men Who Have Sex With Men
NCT ID: NCT00000931
Last Updated: 2008-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
4350 participants
INTERVENTIONAL
Brief Summary
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In standard pre- and post-test counseling, everyone is told the same things about how to prevent HIV. The behavioral intervention used in this study is designed to help each individual prevent HIV according to his specific problems and needs.
Detailed Description
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Participants are randomly assigned to receive either the behavioral intervention or the control risk-reduction counseling. The same counseling staff provides the two types of treatment. The behavioral intervention consists of 10 counseling sessions within a 4-month period followed by quarterly maintenance sessions for the remainder of the 3-year follow-up. The intervention is conducted on a one-to-one basis and targets condom use, change in sexual practices associated with HIV risk, and change in sexual practices in the context of alcohol and drug use. Participants in the control group receive pre- and post-test counseling at enrollment, then semiannually through Month 36. Beginning at Month 6, all participants complete routine semiannual visits. At each visit, Risk Assessment and phlebotomy for specimen collection for HIV antibody tests are administered. As is routine in most public counseling and testing venues, participants in the control condition do not see the same counselor consistently.
Conditions
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Keywords
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Study Design
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PARALLEL
PREVENTION
Interventions
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Behavioral intervention
Risk-reduction counseling
Eligibility Criteria
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Inclusion Criteria
* Are an HIV-negative man who has had anal sex with another man in the 12 months prior to study entry.
* Are able to attend all scheduled study visits.
* Are able to provide information for locator purposes (address, phone number, etc.).
* Are at least 18 years old.
Exclusion Criteria
* Have been in a monogamous relationship for 2 years or more with an HIV-negative man. (Monogamous is defined as a relationship in which the members of the couple engage in sexual activities with only each other.)
* Have an obvious mental disorder or any another condition that would prevent them from completing the study.
* Are currently enrolled in any Phase III HIV vaccine trial, including the AIDSVAX Phase III trial sponsored by VaxGen, Inc.
* Are currently enrolled in HIVNET Protocol 014.
* Were enrolled in the HIVNET 015 Pilot Study.
18 Years
MALE
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Chesney M, Coates T
Role: STUDY_CHAIR
Koblin B
Role: STUDY_CHAIR
Locations
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San Francisco Dept of Hlth / AIDS Office
San Francisco, California, United States
Denver Dept of Public Health / HIVNET
Denver, Colorado, United States
Howard Brown Health Ctr
Chicago, Illinois, United States
Fenway Community Health Ctr
Boston, Massachusetts, United States
New York Blood Ctr
The Bronx, New York, United States
Univ of Washington
Seattle, Washington, United States
Countries
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References
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Koblin B, Chesney M, Coates T; EXPLORE Study Team. Effects of a behavioural intervention to reduce acquisition of HIV infection among men who have sex with men: the EXPLORE randomised controlled study. Lancet. 2004 Jul 3-9;364(9428):41-50. doi: 10.1016/S0140-6736(04)16588-4.
Other Identifiers
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HIVNET 015
Identifier Type: -
Identifier Source: org_study_id