Clinical trial NCT00218699: Pre-HIV Test Counseling Intervention to Reduce HIV Infection Risk Behavior in Men Who Are Not HIV Infected
Official title: Changing Sexual Behavior in Gay Male Repeat HIV Testers: A Randomized Trial of a Single Session Counseling Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
MSM Men Who Have Sex with Men
Men Who Have Sex With Men
Cognitive-Behavioral
HIV Counseling and Testing
HIV Seronegativity
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-22
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Reduction in HIV infection risk behavior; measured at Months 6 and 12
timeFrame: 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF AIDS Health Project
state: California
Study officials:
affiliation: UCSF AIDS Health Project
name: James W. Dilley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF Center for AIDS Prevention Studies
name: William J. Woods, PhD
role: PRINCIPAL_INVESTIGATOR
References: