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

San Francisco Department of Public Health

Status and phase

Completed

Phase 2

Phase 1

Conditions

HIV Infections

Episodic Substance Use

Treatments

Behavioral: Standard HIV testing with information only

Behavioral: Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT01279044

1UR6PS000684-01

Details and patient eligibility

About

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).

Full 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:

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.

Enrollment

385 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.