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Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users

NCT ID: NCT00432926

Last Updated: 2012-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

429 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2012-04-30

Brief Summary

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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

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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.

Conditions

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HIV Infections Substance Abuse Sexually Transmitted Diseases

Keywords

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HIV STDs Methamphetamine abuse MSM HIV Seronegativity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

EDGE counseling, no maintenance

Intervention Type 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).

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.

Group Type EXPERIMENTAL

EDGE counseling, plus maintenance

Intervention Type 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.

3

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

Group Type ACTIVE_COMPARATOR

Attention control

Intervention Type BEHAVIORAL

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

Interventions

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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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Attention control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Thomas L. Patterson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas L. Patterson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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Webster Building, 3500 Fifth Ave., Suite 102

San Diego, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20359362 (View on PubMed)

Other Identifiers

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R01DA021115

Identifier Type: NIH

Identifier Source: secondary_id

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R01DA021115

Identifier Type: NIH

Identifier Source: org_study_id

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