NCT00000931

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,350

participants targeted

Target at P75+ for phase_3 hiv-infections

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

September 9, 2008

Status Verified

November 1, 2006

First QC Date

November 2, 1999

Last Update Submit

September 8, 2008

Conditions

Keywords

Homosexuality, MaleRisk-TakingBehavior TherapyHIV Seronegativity

Interventions

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants may be eligible for this study if they:
  • 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.

You may not qualify if:

  • Participants will not be eligible for this study if they:
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

San Francisco Dept of Hlth / AIDS Office

San Francisco, California, 94102, United States

Location

Denver Dept of Public Health / HIVNET

Denver, Colorado, 80204, United States

Location

Howard Brown Health Ctr

Chicago, Illinois, 60613, United States

Location

Fenway Community Health Ctr

Boston, Massachusetts, 02115, United States

Location

New York Blood Ctr

The Bronx, New York, 10456, United States

Location

Univ of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

HIV InfectionsHomosexuality, MaleRisk-Taking

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHomosexualitySexualitySexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Chesney M, Coates T

    STUDY CHAIR
  • Koblin B

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

September 9, 2008

Record last verified: 2006-11

Locations