Full Text View
Tabular View
No Study Results Posted
Related Studies
Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), October 2008
First Received: February 6, 2007   Last Updated: October 24, 2008   History of Changes
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00432926
  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 II

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

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

Estimated Enrollment: 450
Study Start Date: September 2006
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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).
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
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.
3: Active Comparator
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432926

Contacts
Contact: Jim Zians, Ph.D. 619-543-5086 jzians@ucsd.edu

Locations
United States, California
Webster Building, 3900 Fifth Ave., Suite 102 Recruiting
San Diego, California, United States, 92103
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas L. Patterson, Ph.D. University of California, San Diego
  More Information

Publications:
Responsible Party: University of California, San Diego ( Thomas L. Patterson, Professor of Psychiatry )
Study ID Numbers: R01 DA021115
Study First Received: February 6, 2007
Last Updated: October 24, 2008
ClinicalTrials.gov Identifier: NCT00432926     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
HIV
STDs
Methamphetamine abuse
MSM
HIV Seronegativity

Study placed in the following topic categories:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Sexually Transmitted Diseases, Viral
Adrenergic Agents
Acquired Immunodeficiency Syndrome
Disorders of Environmental Origin
Central Nervous System Stimulants
Genital Diseases, Male
Immunologic Deficiency Syndromes
Virus Diseases
Genital Diseases, Female
Methamphetamine
Dopamine
HIV Infections
Mental Disorders
Sexually Transmitted Diseases
Substance-Related Disorders
Dopamine Agents
Amphetamine
Peripheral Nervous System Agents
Retroviridae Infections

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

ClinicalTrials.gov processed this record on July 06, 2009