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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Project MIX: Behavioral Intervention to Reduce Risk Among Substance-Using MSM

NCT00153361

HIV Infections

COMPLETED NA

Risk Reduction for Urban Substance Using Men Who Have Sex With Men (MSM)

NCT01327898

HIV Infection Substance Abuse

COMPLETED PHASE2

Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use Intervention

NCT02945436

HIV Substance Use

COMPLETED NA

Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected MSM in the United States

NCT02663219

HIV

COMPLETED NA

A Behavioral Intervention to Reduce Sexual Risk Among African-American Men Who Have Sex With Men

NCT00691496

HIV Infections

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections Episodic Substance Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

HIV testing with adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)

Group Type ACTIVE_COMPARATOR

Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)

Intervention Type BEHAVIORAL

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.

2

HIV testing with information only

Group Type PLACEBO_COMPARATOR

Standard HIV testing with information only

Intervention Type BEHAVIORAL

Standard HIV testing with information only

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)

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.

Intervention Type BEHAVIORAL

Standard HIV testing with information only

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes