Specialized Cognitive-Behavioral Counseling Intervention to Reduce HIV Transmission Risk Behavior in HIV-Infected Men
|ClinicalTrials.gov Identifier: NCT00218712|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: Cognitive behavioral intervention Behavioral: Standard counseling||Not Applicable|
Past research has shown that HIV-uninfected men who receive counseling regarding high-risk sexual behavior are less likely to engage in such behavior with other men. The rising rates of HIV infection among gay men suggest that some HIV-infected men are still engaging in high-risk sexual activity. There are several existing counseling interventions that focus on reducing high-risk sexual behavior, but the need exists for an intervention specifically targeted to HIV-infected men. This study will focus on the development of a specialized counseling intervention to help HIV-infected men identify and re-evaluate their "self-justifications," which are their thoughts, attitudes, and beliefs when deciding to engage in high-risk sexual activity with other men. In turn, this counseling may decrease the incidence of high-risk sexual behaviors, thereby reducing HIV infection rates among gay men. This study will evaluate the effectiveness of the specialized counseling intervention versus a standard risk-reduction counseling intervention in promoting safer sexual activity among HIV-infected men.
This study will consist of two phases. In Year 1, interviews will be conducted with 30 HIV-infected men who have engaged in high-risk unprotected sex within the previous 12 months with HIV-uninfected partners or partners with an unknown HIV status. The data resulting from these interviews will aid in the development of a specialized counseling intervention that is specifically geared for HIV-infected men. In Years 2 through 4, approximately 400 HIV-infected men will be randomly assigned to receive either the specialized counseling intervention or a standard counseling intervention. All participants will attend two counseling sessions: the first will occur at study entry and the second will occur 6 months later. Outcome measurements will be assessed at the second counseling session and again 6 months later, and will include self-reports of unprotected sex and laboratory testing for the presence of sexually transmitted diseases.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||488 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Reducing HIV Transmission Risk Behavior: a Trial of a Two Session Risk-Reduction Intervention With HIV-Positive Men Who Have Sex With Men|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||March 2011|
Participants will receive personalized cognitive counseling
Behavioral: Cognitive behavioral intervention
Cognitive behavioral intervention will include personalized cognitive counseling. All participants will attend two counseling sessions: the first will occur at study entry and the second will occur 6 months later.
Active Comparator: 2
Participants will receive standard counseling
Behavioral: Standard counseling
Participants will receive standard counseling. All participants will attend two counseling sessions: the first will occur at study entry and the second will occur 6 months later.
- Reduction in HIV transmission risk behavior; measured 6 and 12 months following the initial counseling intervention [ Time Frame: Measured at Months 6 and 12 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218712
|United States, California|
|UCSF AIDS Health Project|
|San Francisco, California, United States, 94102|
|SFDPH San Francisco City Clinic|
|San Francisco, California, United States, 94103|
|Principal Investigator:||James W. Dilley, MD||UCSF AIDS Health Project|
|Principal Investigator:||Sandra Schwarcz, MD, MPH||SFDPH-AIDS Office|