Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men (ACE)

NCT ID: NCT01122186

Last Updated: 2013-06-03

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

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-01-31

Brief Summary

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The primary aim is to test an innovative 8-session intervention, based on Motivational Interviewing and Cognitive Behavioral Skills-Training for the co-occurrence of methamphetamine use and highly active antiretroviral therapy (HAART) non-adherence among methamphetamine using HIV+ MSM in NYC, compared to an 8-session educational (ED) condition. Participants in the intervention condition will report greater reductions in the number of days of methamphetamine use and viral load, and greater increases in CD4 counts and self-reported and objectively measured adherence than those in the education condition.

Detailed Description

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Conditions

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HIV Medication Adherence Methamphetamine Use Sexual Risk Poly-substance Use HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Condition

Eight sessions of Motivational Interviewing and Cognitive Behavioral Skills Training, adapted to target both MA use and medication adherence, as well as sexual risk behaviors and polydrug use.

Group Type EXPERIMENTAL

Motivational Interviewing + Cognitive Behavioral Skills Training

Intervention Type BEHAVIORAL

The first two sessions will be primarily Motivational Interviewing and begin with an introduction to the nature of treatment, emphasizing the client's autonomy, and explain that the purpose of the sessions is to explore feelings about their medication adherence, meth use, and any other issues, with the eventual goal of working towards any changes the client may wish to make. During the third session, the client will complete an individualized functional analysis of recent occasions when the client missed medication, used MA and/or other substances, and engaged in risky sex (not necessarily all at the same time). Sessions four through seven will focus on Cognitive Behavioral Skills Training for adherence, reducing or stopping meth use, reducing or stopping the combination of meth and other drug use, and avoiding risky sexual behavior. The final session emphasizes maintenance of behavior change and relapse prevention.

Education Condition

Eight sessions of education with content designed to mirror the information covered in the intervention condition. The content will be as follows: 3 sessions focusing on medication adherence; 3 sessions focusing on the dangers of methamphetamine use; 1 session addressing sexual risk; and 1 session addressing poly-substance use.

Group Type ACTIVE_COMPARATOR

Education Attention Control

Intervention Type BEHAVIORAL

During the first two sessions participants watch the documentary "Rock bottom" to receive information on Crystal Methamphetamine, and the possible interactions between HIV medications and recreational substances. Sessions 3 and 4 focus on the importance of medication adherence, viral replication and mutation, and resistance. Session 5 focuses on the negative effects of several recreational substances as well as the negative effects of mixing substances. Session six discusses HIV stigma, transmission risk sexual behavior, and HIV disclosure. Session 7 revisits medication adherence, focusing on dealing with medication side effects and communicating with health care providers. The final session uses part of the documentary "Meth" which highlights issues of methamphetamine use through interviews with men in various stages of recovery.

Interventions

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Motivational Interviewing + Cognitive Behavioral Skills Training

The first two sessions will be primarily Motivational Interviewing and begin with an introduction to the nature of treatment, emphasizing the client's autonomy, and explain that the purpose of the sessions is to explore feelings about their medication adherence, meth use, and any other issues, with the eventual goal of working towards any changes the client may wish to make. During the third session, the client will complete an individualized functional analysis of recent occasions when the client missed medication, used MA and/or other substances, and engaged in risky sex (not necessarily all at the same time). Sessions four through seven will focus on Cognitive Behavioral Skills Training for adherence, reducing or stopping meth use, reducing or stopping the combination of meth and other drug use, and avoiding risky sexual behavior. The final session emphasizes maintenance of behavior change and relapse prevention.

Intervention Type BEHAVIORAL

Education Attention Control

During the first two sessions participants watch the documentary "Rock bottom" to receive information on Crystal Methamphetamine, and the possible interactions between HIV medications and recreational substances. Sessions 3 and 4 focus on the importance of medication adherence, viral replication and mutation, and resistance. Session 5 focuses on the negative effects of several recreational substances as well as the negative effects of mixing substances. Session six discusses HIV stigma, transmission risk sexual behavior, and HIV disclosure. Session 7 revisits medication adherence, focusing on dealing with medication side effects and communicating with health care providers. The final session uses part of the documentary "Meth" which highlights issues of methamphetamine use through interviews with men in various stages of recovery.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* HIV+ (confirmed at baseline through documentation)
* Biologically male
* report sex with another man at least once
* report methamphetamine use at least three times in the past three months
* report less than 90% HAART medication adherence, as measured by the total number of days a participant missed an HIV medication in the last 30
* able to communicate with staff and complete a survey that is in English.

Exclusion Criteria

* Unstable, serious psychiatric symptoms
* Currently suicidal/homicidal
* Evidence of gross cognitive impairment
* Self-reported current enrollment in a drug or HIV-related intervention or research study.
* Methadone use
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hunter College of City University of New York

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey T. Parsons

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.hunter.cuny.edu/chest/

Center for HIV/AIDS Educational Studies and Training website

Other Identifiers

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1R01DA023395

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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