Expired Study
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San Francisco, California 94102


Purpose:

The purpose of this study is to determine if persons randomized to receive adapted Personalized Cognitive Risk-reduction Counseling (PCC) will report greater reductions in unprotected anal sex behavior compared with persons who do not receive Personalized Cognitive Risk-reduction Counseling (PCC).


Study summary:

In the U.S., men who have sex with men (MSM) continue to constitute the greatest number of HIV/AIDS cases compared with other risk groups. Furthermore, many episodic substance using men who have sex with men (SUMSM) report that sex and substance use "always" or "often" go together. Studies have shown that substance use just before or during sex substantially increases HIV risk. The randomized controlled trial (RCT) phase of this study will enroll 326 ethnically-diverse, HIV-negative episodic SUMSM to receive standard HIV rapid testing plus adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC) or standard HIV counseling and rapid testing only. Specific Aims: 1. To conduct formative research through individual interviews and pilot testing among a sample of episodic substance-using men who have sex with men (SUMSM) to develop and adapt the key elements of the Personal Risk-Reduction Cognitive Counseling intervention, with a focus on eliciting and intervening on the thoughts, attitudes, and behaviors that episodic SUMSM employ when using substances and engaging in concurrent sexual risk. 2. To determine the efficacy of the adapted intervention in reducing unprotected anal sex, as compared to routine HIV testing control condition, in a randomized trial of 326 episodic SUMSM. We will also determine the efficacy of the intervention in reducing substance use.


Criteria:

Inclusion Criteria: 1. Reports within the past 6 months unprotected anal intercourse (UAI) with another man while under the influence of at least one or any combination of the following substance: methamphetamine, poppers, crack or powder cocaine, or alcohol if binge drinking (5 or more drinks) within 2 hours before or during sex. 2. Identifies as male. 3. HIV-negative or unknown serostatus by self-report 4. Willing and able to participate in an intervention that addresses episodic substance use and sexual risk behavior 5. Not currently in substance use treatment, a self-help program, or an HIV prevention study 6. Has not injected any substances in prior 6 months. 7. ≥ 18 years old 8. Planning to remain in the San Francisco Bay Area for the duration of study activities 9. Willing and able to provide full informed consent. Able to speak, read, and understand English. Exclusion Criteria: 1. Reports within the past 6 months UAI with only one partner AND identifies that individual as a primary partner. 2. In the prior three months, weekly or more use of any of the targeted substances (meth, poppers, crack or powder cocaine), with the exception of alcohol 3. For alcohol, more than an average of 3 alcoholic drinks daily, or binge drinking more than twice weekly.


NCT ID:

NCT01279044


Primary Contact:

Principal Investigator
Phillip O Coffin, MD, MIA
Director of Substance Use Research, HIV Prevention, San Francisco Department of Public Health


Backup Contact:

N/A


Location Contact:

San Francisco, California 94102
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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