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

Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01122186
Acronym
ACE
Enrollment
210
Registered
2010-05-13
Start date
2007-09-30
Completion date
2012-01-31
Last updated
2013-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Medication Adherence, Methamphetamine Use, Sexual Risk, Poly-substance Use, HIV, Treatment, Motivational Interviewing, Cognitive Behavioral Skills Training, Men Who Have Sex With Men

Brief summary

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.

Interventions

BEHAVIORALMotivational 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.

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.

Sponsors

Hunter College of City University of New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adherence to HIV medicationevery three months over the course of a yearParticipants in the intervention condition will report greater reductions in viral load, and greater increases in CD4 counts and self-reported adherence than those in the education comparison at at the end of the intervention period (3 months). Those in the intervention condition will also maintain greater reductions in viral load, and greater increases in CD4 counts and self-reported adherence than those in the education comparison condition at the three follow-up assessments (6, 9, and 12 months).
Methamphetamine use.every three months over the course of a yearParticipants in the intervention condition will report greater reductions in self-reported days of methamphetamine use than those in the education comparison at at the end of the intervention period (3 months). Those in the intervention condition will also maintain greater reductions in self-reported days of methamphetamine use than those in the education comparison condition at the three follow-up assessments (6, 9, and 12 months).

Secondary

MeasureTime frameDescription
Sexual Riskevery three months over the course of a yearParticipants in the intervention condition will report greater reductions in high-risk sexual behavior compared to participants in the educational comparison condition.
Polysubstance useevery three months over the course of a yearParticipants in the intervention condition will report greater reductions in the use of substances other than methamphetamine, compared to participants in the educational comparison condition.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026