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Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users

Primary Purpose

HIV Infections, Substance Abuse, Sexually Transmitted Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EDGE counseling, no maintenance
EDGE counseling, plus maintenance
Attention control
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, STDs, Methamphetamine abuse, MSM, HIV Seronegativity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Webster Building, 3500 Fifth Ave., Suite 102

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

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).

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.

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

Outcomes

Primary Outcome Measures

Reduction of defined sexual risk behaviors

Secondary Outcome Measures

Full Information

First Posted
February 6, 2007
Last Updated
September 27, 2012
Sponsor
University of California, San Diego
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00432926
Brief Title
Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users
Official Title
Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Substance Abuse, Sexually Transmitted Diseases
Keywords
HIV, STDs, Methamphetamine abuse, MSM, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
429 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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).
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Arm Title
3
Arm Type
Active Comparator
Arm Description
An attention-control condition that is time-equivalent to Arm 2, and addresses diet, exercise, and HIV.
Intervention Type
Behavioral
Intervention Name(s)
EDGE counseling, no maintenance
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
EDGE counseling, plus maintenance
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention control
Intervention Description
An attention-control condition that is time-equivalent to Arm 2, and addresses diet, exercise, and HIV.
Primary Outcome Measure Information:
Title
Reduction of defined sexual risk behaviors
Time Frame
18 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas L. Patterson, Ph.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Webster Building, 3500 Fifth Ave., Suite 102
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20359362
Citation
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.
Results Reference
derived

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Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users

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