Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Substance Abuse; Sexually Transmitted Diseases
Intervention: EDGE counseling, no maintenance (Behavioral); EDGE counseling, plus maintenance (Behavioral); Attention control (Behavioral)
Phase: Phase 2
Status: Recruiting
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s):
Thomas L. Patterson, Ph.D., Principal Investigator, Affiliation: University of California, San Diego
Overall contact:
Jim Zians, Ph.D., Phone: 619-543-5086, Email: jzians@ucsd.edu
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.
Clinical Details
Official title: Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Reduction of defined sexual risk behaviors
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Jim Zians, Ph.D., Phone: 619-543-5086, Email: jzians@ucsd.edu
Webster Building, 3900 Fifth Ave., Suite 102, San Diego, California 92103, United States; Recruiting
Additional Information
Starting date: September 2006
Ending date: April 2011
Last updated: October 24, 2008
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