Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM) - Full Text View

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).

Condition	Intervention	Phase
HIV Infections Episodic Substance Use	Behavioral: Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC) Behavioral: Standard HIV testing with information only	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM): Adaptation of the Personalized Cognitive Counseling (PCC) Intervention

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by San Francisco Department of Public Health:

Primary Outcome Measures:

Total unprotected anal intercourse events (exclusive of those events with a primary HIV-negative partner) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Total unprotected anal intercourse partners [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Unprotected anal intercourse episodes with two most recent sex partners at each follow-up visit, exclusive of primary HIV-negative partners. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reported frequency of substance use with two most recent sex partners at each follow-up visit [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Overall frequency of substance use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
STI incidence (urethral and rectal gonorrhea and chlamydia) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Cost-effectiveness analyses [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	385
Study Start Date:	September 2007
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 HIV testing with adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)	Behavioral: 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.
Placebo Comparator: 2 HIV testing with information only	Behavioral: Standard HIV testing with information only Standard HIV testing with information only

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 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:

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.
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 cost-effectiveness of the intervention in reducing sexual risk.
Determine the efficacy of the intervention in reducing substance use.
Explore whether the intervention reduces sexually transmitted infection incidence compared with the control arm.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279044

Locations

United States, California
San Francisco Department of Public Health, AIDS Office
San Francisco, California, United States, 94102

Sponsors and Collaborators

San Francisco Department of Public Health

Centers for Disease Control and Prevention

Investigators

Principal Investigator:	Phillip O Coffin, MD, MIA	Director of Substance Use Research, HIV Prevention, San Francisco Department of Public Health
Study Director:	Jeffrey H Herbst, PhD	Centers for Disease Control and Prevention

More Information

No publications provided

Responsible Party:	Phillip Coffin, MD, MIA, Director of Substance Use Research, HIV Prevention, San Francisco Department of Public Health
ClinicalTrials.gov Identifier:	NCT01279044 History of Changes
Other Study ID Numbers:	1UR6PS000684-01
Study First Received:	January 18, 2011
Last Updated:	April 9, 2013
Health Authority:	United States: Federal Government

Keywords provided by San Francisco Department of Public Health:

HIV
MSM
SUMSM

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases

Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013