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

Basic Information

• 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

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

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

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Cognitive-Behavioral Intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

University of California, San Francisco - Department of Psychiatry

Principal Investigators

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

UCSF AIDS Health Project

San Francisco, California, United States

Countries

United States

Other Identifiers

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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