Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM)

Study Overview
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Brief Summary
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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).

Detailed Description
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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 formative phase of this research enrolled 59 HIV-negative episodic substance using MSM to participate in interviews to inform the adaptation of the Self-Justification Elicitation Instrument (SJEI) used during Personalized Cognitive Counseling (PCC) and to subsequently, pilot the adapted SJEI. The randomized controlled trial (RCT) phase of this study enrolled 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: To conduct formative research through individual interviews and pilot testing among a sample (n=59) 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. 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.

Official Title
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Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM): Adaptation of the Personalized Cognitive Counseling (PCC) Intervention

Conditions
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HIV Infections, Episodic Substance Use

Intervention / Treatment
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* Behavioral: Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)
* Behavioral: Standard HIV testing with information only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Identifies as male. HIV-negative or unknown serostatus by self-report Willing and able to participate in an intervention that addresses episodic substance use and sexual risk behavior Not currently in substance use treatment, a self-help program, or an HIV prevention study Has not injected any substances in prior 6 months. ≥ 18 years old Planning to remain in the San Francisco Bay Area for the duration of study activities Willing and able to provide full informed consent. Able to speak, read, and understand English. Exclusion Criteria: Reports within the past 6 months UAI with only one partner AND identifies that individual as a primary partner. 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 For alcohol, more than an average of 3 alcoholic drinks daily, or binge drinking more than twice weekly.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>HIV testing with adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC) | Behavioral: Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)<br>* The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.<br>|
| Placebo Comparator: 2<br>HIV testing with information only | Behavioral: Standard HIV testing with information only<br>* Standard HIV testing with information only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner) | The outcome measure data shows the rate of change in the mean value in the number of total unprotected anal intercourse events over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints. | Self-reported behavior during past 3 months | 
| Total Unprotected Anal Intercourse Partners | The outcome measure data shows the rate of change in the mean value of total unprotected anal intercourse partners over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints. | Self-reported behavior during past 3 months | 
| Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners. | The outcome measure data shows the rate of change in the mean value of total unprotected anal intercourse episodes with three most recent sex partners over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints. | Self-reported behavior during past 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events | The outcome measure data shows the rate of change in the mean value of number of serodiscordant unprotected anal intercourse events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints. Serodiscordant defined as having partner of discordant or of unknown HIV serostatus. | Self-reported behavior during past 3 months | 
| Number of Instertive UAI Events | The outcome measure data shows the rate of change in the mean value of number of instertive unprotected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints. | Self-reported behavior during past 3 months | 
| Number of Receptive UAI Events | The outcome measure data shows the rate of change in the mean value of the number of receptive unprotected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints. | Self-reported behavior during past 3 months | 
| Number of Condom-protected Anal Intercourse Events | The outcome measure data shows the rate of change in the mean value of the number of condom-protected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints. Serodiscordant defined as having partner of discordant or of unknown HIV serostatus. | Self-reported behavior during past 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, MSM, SUMSM