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

HIV Infections Clinical Trial

— ACE  

Official title:

Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122186
• Other study ID #: 1R01DA023395
• Status: Completed
• Phase: N/A
• First received: May 11, 2010
• Last updated: May 30, 2013
• Start date: September 2007
• Est. completion date: January 2012

Study information

• Verified date: May 2013
• Source: Hunter College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hunter College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to HIV medication	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).	every three months over the course of a year	No
Primary	Methamphetamine use.	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).	every three months over the course of a year	No
Secondary	Sexual Risk	Participants in the intervention condition will report greater reductions in high-risk sexual behavior compared to participants in the educational comparison condition.	every three months over the course of a year	No
Secondary	Polysubstance use	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.	every three months over the course of a year	No

External Links

•   Center for HIV/AIDS Educational Studies and Training website