Pre-HIV Test Counseling Intervention to Reduce HIV Infection Risk Behavior in Men Who Are Not HIV Infected
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00218699 |
Recruitment Status
:
Completed
First Posted
: September 22, 2005
Last Update Posted
: August 5, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Behavioral: Cognitive-Behavioral Intervention | Not Applicable |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 300 participants |
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 |
Study Start Date : | August 2002 |
Actual Primary Completion Date : | September 2005 |
Actual Study Completion Date : | September 2005 |

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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218699
United States, California | |
UCSF AIDS Health Project | |
San Francisco, California, United States, 94102 |
Principal Investigator: | James W. Dilley, MD | UCSF AIDS Health Project | |
Principal Investigator: | William J. Woods, PhD | UCSF Center for AIDS Prevention Studies |
Responsible Party: | James W. Dilley, MD/Principal Investigator, University of California, San Francisco - Department of Psychiatry |
ClinicalTrials.gov Identifier: | NCT00218699 History of Changes |
Other Study ID Numbers: |
R01MH065138 ( U.S. NIH Grant/Contract ) DAHBR AZ-Q |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | August 5, 2013 |
Last Verified: | August 2013 |
Keywords provided by University of California, San Francisco:
HIV MSM Men Who Have Sex with Men Men Who Have Sex With Men |
Cognitive-Behavioral HIV Counseling and Testing HIV Seronegativity |
Additional relevant MeSH terms:
Infection HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |