Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users

NCT00432926 | Completed Phase 2 DMC

• 1 other identifier: R01DA021115
• Study Type: interventional
• Target: 429
• Locations: 1 country
• Sites: 1

Brief Summary

This study tests the effectiveness of a behavioral intervention to reduce sexual risk behavior in HIV-positive, methamphetamine-using men who have sex with men (MSM). It builds on the findings of a previous study (R01 DA012116, "Promoting safer sex in HIV+ homosexual and bisexual men who use methamphetamine"). That study achieved significant short-term results that eroded over time. Accordingly, this study hypothesizes that the addition of a maintenance component to the already proven counseling and educational components of the treatment model will result in longer-lasting positive effects.

Conditions

HIV Infections; Substance Abuse; Sexually Transmitted Diseases

Keywords

HIV; STDs; Methamphetamine abuse; MSM; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• Reduction of defined sexual risk behaviors

  18 months

Study Arms (3)

1

EXPERIMENTAL

Five-session behavior change intervention that combines client-centered motivational interviewing and structured behavioral counseling (to address context of unsafe sex/drug use; condom use, safer sex negotiation; disclosure; and enhancement of social supports).

Behavioral: EDGE counseling, no maintenance

2

EXPERIMENTAL

Five-session behavior change intervention (identical to Arm 1) that combines client-centered motivational interviewing and structured behavioral counseling (to address context of unsafe sex/drug use; condom use, safer sex negotiation; disclosure; and enhancement of social supports) PLUS eight group-format safer sex maintenance counseling sessions, which utilize clinical strategies from relapse prevention to identify high risk situations and develop effective coping strategies.

Behavioral: EDGE counseling, plus maintenance

3

ACTIVE COMPARATOR

An attention-control condition that is time-equivalent to Arm 2, and addresses diet, exercise, and HIV.

Behavioral: Attention control

Interventions

EDGE counseling, no maintenance BEHAVIORAL

Five-session behavior change intervention that combines client-centered motivational interviewing and structured behavioral counseling (to address context of unsafe sex/drug use; condom use, safer sex negotiation; disclosure; and enhancement of social supports).

1

EDGE counseling, plus maintenance BEHAVIORAL

Five-session behavior change intervention (identical to Arm 1) that combines client-centered motivational interviewing and structured behavioral counseling (to address context of unsafe sex/drug use; condom use, safer sex negotiation; disclosure; and enhancement of social supports) PLUS eight group-format safer sex maintenance counseling sessions, which utilize clinical strategies from relapse prevention to identify high risk situations and develop effective coping strategies.

2

Attention control BEHAVIORAL

An attention-control condition that is time-equivalent to Arm 2, and addresses diet, exercise, and HIV.

3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV+
• Used methamphetamine at least twice in last two months
• At least some recent sexual partners were male
• At least some recent sexual activity has been high-risk for transmission of HIV

You may not qualify if:

• Current major psychiatric diagnosis
• Only HIV+ sex partners in past two months
• Consistently protected sex with HIV- or serostatus-unknown partners in last two months
• Sexually inactive in last two months
• Found out about HIV+ status less than two months ago

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Webster Building, 3500 Fifth Ave., Suite 102

San Diego, California, 92103, United States

Location

Related Publications (1)

• Semple SJ, Strathdee SA, Zians J, Patterson TL. Factors associated with sex in the context of methamphetamine use in different sexual venues among HIV-positive men who have sex with men. BMC Public Health. 2010 Apr 1;10:178. doi: 10.1186/1471-2458-10-178.

  PMID: 20359362 DERIVED

MeSH Terms

Conditions

HIV Infections; Substance-Related Disorders; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas L. Patterson, Ph.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2007
• First Posted: February 8, 2007
• Study Start: February 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: September 28, 2012

Record last verified: 2012-09

Locations

US (1)