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

Phase 1

Completed

• Conditions: Episodic Substance Use; HIV Infections
• Interventions: Behavioral: Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC); Behavioral: Standard HIV testing with information only

• Registration Number: NCT01279044
• Lead Sponsor: San Francisco Department of Public Health

Brief Summary

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

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:

1. 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.

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2014-03-18
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-30
• Last Update Submitted: 2014-09-30
• Results First Posted: 2014-10-07
• Last Update Posted: 2014-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 385

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)	HIV testing with adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)
2	Standard HIV testing with information only	HIV testing with information only

Primary Outcome Measures

Name	Time	Method
Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)	Self-reported behavior during past 3 months	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.
Total Unprotected Anal Intercourse Partners	Self-reported behavior during past 3 months	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.
Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.	Self-reported behavior during past 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Instertive UAI Events	Self-reported behavior during past 3 months	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.
Number of Receptive UAI Events	Self-reported behavior during past 3 months	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.
Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events	Self-reported behavior during past 3 months	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.
Number of Condom-protected Anal Intercourse Events	Self-reported behavior during past 3 months	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.

Trial Locations

Locations (1)

San Francisco Department of Public Health, AIDS Office; 🇺🇸 San Francisco, California, United States