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Pre-HIV Test Counseling Intervention to Reduce HIV Infection Risk Behavior in Men Who Are Not HIV Infected

NCT ID: NCT00218699

Last Updated: 2013-08-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2005-09-30

Brief Summary

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This study will evaluate the effectiveness of a single specialized pre-test counseling session in reducing HIV infection risk behavior in men who are not HIV infected.

Detailed Description

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In San Francisco, HIV infection rates among men who have tested for HIV three or more times is almost triple the HIV infection rates of all other testers. Past research has shown that HIV uninfected gay and bisexual men who receive counseling are less likely to engage in high-risk sexual behavior. Counseling provided by trained mental health professionals within a clinical study setting helped individuals identify and re-evaluate their "self-justifications," which are their thoughts, attitudes, and beliefs when deciding to engage in unprotected sex. This study will focus on implementing a "real-world" counseling intervention designed specifically for men who are at the greatest risk of becoming infected with HIV: men who engage in high-risk sexual activity with other men and who repeatedly test for HIV. This specialized intervention will be administered by trained paraprofessional counselors during a pre-test counseling session prior to an HIV test. The purpose of this study is to evaluate the effectiveness of the specialized pre-test counseling intervention versus a standard pre-test counseling intervention in promoting safer sexual activity among HIV uninfected men. The men will have reported having unprotected sex with males of unknown HIV status or known HIV infection.

This 12-month study will enroll 300 men who will be recruited upon scheduling an anonymous HIV test at the participating clinic. Participants will be randomly assigned to receive either the enhanced pre-test counseling session or a standard pre-test counseling session prior to an HIV test. Outcome measurements will be assessed 6 and 12 months after the counseling session and will include self-reports of unprotected anal sex with non-primary partners and reported satisfaction levels with the pre-test counseling.

Conditions

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HIV Infections

Keywords

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HIV MSM Men Who Have Sex with Men Men Who Have Sex With Men Cognitive-Behavioral HIV Counseling and Testing HIV Seronegativity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Cognitive-Behavioral Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* History of two or more HIV antibody tests prior to study entry
* History of at least one episode of unprotected anal intercourse (receptive or insertive) within 12 months prior to study entry

Exclusion Criteria

* History of injection drug use within 12 months of study enrollment
* Insufficient proficiency in English
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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University of California, San Francisco - Department of Psychiatry

Principal Investigators

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James W. Dilley, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF AIDS Health Project

William J. Woods, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSF Center for AIDS Prevention Studies

Locations

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UCSF AIDS Health Project

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH065138

Identifier Type: NIH

Identifier Source: secondary_id

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DAHBR AZ-Q

Identifier Type: -

Identifier Source: secondary_id

R01MH065138

Identifier Type: NIH

Identifier Source: org_study_id

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