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

Not Applicable

Completed

• Conditions: HIV Medication Adherence; Methamphetamine Use; Sexual Risk; Poly-substance Use; HIV Infections
• Interventions: Behavioral: Motivational Interviewing + Cognitive Behavioral Skills Training; Behavioral: Education Attention Control

• Registration Number: NCT01122186
• Lead Sponsor: Hunter College of City University of New York

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-13
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-30
• Last Update Posted: 2013-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Condition	Motivational Interviewing + Cognitive Behavioral Skills Training	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.
Education Condition	Education Attention Control	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.

Primary Outcome Measures

Name	Time	Method
Adherence to HIV medication	every three months over the course of a year	Participants 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 year	Participants 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 Outcome Measures

Name	Time	Method
Sexual Risk	every three months over the course of a year	Participants in the intervention condition will report greater reductions in high-risk sexual behavior compared to participants in the educational comparison condition.
Polysubstance use	every three months over the course of a year	Participants in the intervention condition will report greater reductions in the use of substances other than methamphetamine, compared to participants in the educational comparison condition.

Trial Locations

Locations (1)

Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY; 🇺🇸 New York, New York, United States