Clinical Trials


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

This study has been completed
University of California, San Francisco

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party)
University of California, San Francisco Identifier

First received: September 16, 2005
Last updated: August 2, 2013
Last Verified: August 2013
History of Changes


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.

Condition Intervention
HIV Infections

Behavioral : Cognitive-Behavioral Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Changing Sexual Behavior in Gay Male Repeat HIV Testers: A Randomized Trial of a Single Session Counseling Intervention

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures

  • Reduction in HIV infection risk behavior; measured at Months 6 and 12 [ Time Frame: 6 and 12 months ]

Enrollment: 300
Study Start Date: August 2002
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)

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.



Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  


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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00218699


United States, California
UCSF AIDS Health Project
San Francisco, California, United States, 94102

Sponsors and Collaborators

University of California, San Francisco
National Institute of Mental Health (NIMH)


Principal Investigator: James W. Dilley, MD UCSF AIDS Health Project
Principal Investigator: William J. Woods, PhD UCSF Center for AIDS Prevention Studies
More Information

More Information

Responsible Party: James W. Dilley, MD/Principal Investigator, University of California, San Francisco - Department of Psychiatry Identifier: NCT00218699   History of Changes  
Other Study ID Numbers: R01MH065138  
Study First Received: September 16, 2005  
Last Updated: August 2, 2013  

Keywords provided by University of California, San Francisco:

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome processed this data on May 24, 2020
This information is provided by