- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00218699
Pre-HIV Test Counseling Intervention to Reduce HIV Infection Risk Behavior in Men Who Are Not HIV Infected
Changing Sexual Behavior in Gay Male Repeat HIV Testers: A Randomized Trial of a Single Session Counseling Intervention
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94102
- UCSF AIDS Health Project
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in HIV infection risk behavior; measured at Months 6 and 12
Time Frame: 6 and 12 months
|
6 and 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: James W. Dilley, MD, UCSF AIDS Health Project
- Principal Investigator: William J. Woods, PhD, UCSF Center for AIDS Prevention Studies
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- R01MH065138 (U.S. NIH Grant/Contract)
- DAHBR AZ-Q
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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