HIV Prevention Counseling for Men Who Have Sex With Men
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00000931|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : September 9, 2008
The purpose of this study is to see if a behavioral intervention, a special kind of counseling, can reduce the risk of HIV infection in men who have sex with men. The behavioral intervention will be compared to the standard risk reduction counseling that is given before and after getting an HIV test.
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: Behavioral intervention Behavioral: Risk-reduction counseling||Phase 3|
The intervention being evaluated in this trial is based on the extensive literature on behavioral approaches to risk reduction in MSM. These reviews recommend an intervention that, unlike the current standard HIV pre-test and post-test risk-reduction counseling, is tailored to an individual's unique problems and needs, lifestyle, and situations that contribute to high-risk behavior. Furthermore, there is a need for HIV-prevention intervention trials using biological endpoints (e.g., HIV seroconversion) in addition to behavioral change indices.
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||4350 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Clinical Trial of the Efficacy of a Behavioral Intervention to Prevent Acquisition of HIV Among Men Who Have Sex With Men|
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): NCT00000931
|United States, California|
|San Francisco Dept of Hlth / AIDS Office|
|San Francisco, California, United States, 94102|
|United States, Colorado|
|Denver Dept of Public Health / HIVNET|
|Denver, Colorado, United States, 80204|
|United States, Illinois|
|Howard Brown Health Ctr|
|Chicago, Illinois, United States, 60613|
|United States, Massachusetts|
|Fenway Community Health Ctr|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|New York Blood Ctr|
|Bronx, New York, United States, 10456|
|United States, Washington|
|Univ of Washington|
|Seattle, Washington, United States, 98104|
|Study Chair:||Chesney M, Coates T|
|Study Chair:||Koblin B|