Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas L. Patterson, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00432926
First received: February 6, 2007
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Substance Abuse
Sexually Transmitted Diseases
Behavioral: EDGE counseling, no maintenance
Behavioral: EDGE counseling, plus maintenance
Behavioral: Attention control
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: Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Reduction of defined sexual risk behaviors [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 429
Study Start Date: February 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
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).
Experimental: 2
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
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.
Active Comparator: 3
An attention-control condition that is time-equivalent to Arm 2, and addresses diet, exercise, and HIV.
Behavioral: Attention control
An attention-control condition that is time-equivalent to Arm 2, and addresses diet, exercise, and HIV.

Detailed Description:

Methamphetamine use by MSM has been consistently associated with increased HIV transmission. In the previous funding period we demonstrated reductions in transmission risk behavior associated with participation in our behavioral intervention; however, these improvements eroded over time, underscoring the need to develop and test interventions designed to enhance longer-term behavior change. The objective of this study is to evaluate the efficacy of an intervention designed to maintain reductions in high-risk sexual practices achieved by methamphetamine-using HIV+ MSM. Three major questions addressed are: 1) Can methamphetamine-using HIV+ MSM modify their high-risk sexual practices over an extended (16-month) period? 2) Do "group maintenance sessions" result in less erosion of behavioral improvements? 3) Are the underlying mechanisms the same for acquisition and maintenance of behavior change? We will assign 450 sexually active HIV+ MSM who regularly use methamphetamine and who have had unprotected sex with an HIV-negative or unknown-status partner to one of three conditions: 1) an eight-session intervention, combining client-centered motivational interviewing and structured behavioral counseling to address five intervention domains (context of unsafe sex/drug use; condom use; safer sex negotiation; disclosure; and enhancement of social supports); 2) the same eight counseling sessions (i.e., identical to condition 1 above), plus eight group-format safer sex maintenance sessions, which utilize clinical strategies from relapse prevention to identify high-risk situations and develop effective coping strategies; or 3) an attention-control condition that is time-equivalent to condition 2 above, and addresses diet, exercise, and HIV. Thus we will determine whether longer-term maintenance of safer sex behaviors is possible among HIV+ methamphetamine-using MSM, a population that remains at very high risk of HIV transmission, and for which substitution therapies to promote cessation and risk reduction are not yet available.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432926

Locations
United States, California
Webster Building, 3500 Fifth Ave., Suite 102
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Thomas L. Patterson, Ph.D. University of California, San Diego
  More Information

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas L. Patterson, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00432926     History of Changes
Other Study ID Numbers: R01 DA021115, R01DA021115
Study First Received: February 6, 2007
Last Updated: September 27, 2012
Health Authority: United States: Federal Government

Keywords provided by University of California, San Diego:
HIV
STDs
Methamphetamine abuse
MSM
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014