Specialized Cognitive-Behavioral Counseling Intervention to Reduce HIV Transmission Risk Behavior in HIV-Infected Men

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218712
• Other study ID #: R01MH073425
• Secondary ID: R01MH073425DAHBR
• Status: Completed
• Phase: N/A
• First received: September 16, 2005
• Last updated: April 30, 2012
• Start date: September 2005
• Est. completion date: March 2011

Study information

• Verified date: April 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effectiveness of a specialized cognitive-behavioral counseling intervention in reducing sexual risk behaviors in men who are HIV-infected and report having unprotected sex with male partners who are either not HIV-infected or do not know if they are HIV-infected.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV-infected

• Currently receiving HIV-specific primary medical care or mental health care

• Reports at least one episode of unprotected sex (receptive or insertive) with a male partner who is either not infected or does not know if he is infected with HIV (within 12 months prior to study enrollment)

• Plans to live in the San Francisco Bay Area for the next 12 months

Exclusion Criteria:

• History of intercourse on a regular basis with only one person

• Insufficient understanding of English

• Cognitive disorder that may affect ability to give informed consent

• Currently enrolled in any other behavioral or clinical HIV trials that could affect participation in this study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	SFDPH San Francisco City Clinic	San Francisco	California
United States	UCSF AIDS Health Project	San Francisco	California

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in HIV transmission risk behavior; measured 6 and 12 months following the initial counseling intervention		Measured at Months 6 and 12	No