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Completed

NCT Number: NCT01122186

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

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.

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Key information

Conditions

HIV Medication Adherence Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Homosexuality Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Medication Adherence Methamphetamine Use Patient Acceptance of Health Care Patient Compliance Poly-substance Use RNA Virus Infections Retroviridae Infections Sexual Behavior Sexual Risk Sexuality Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

New York, 10018, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing + Cognitive Behavioral Skills Training

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 Attention Control

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.

Primary outcomes

  1. Adherence to HIV medication

    Time frame: 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).

  2. Methamphetamine use.

    Time frame: 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 outcomes

  1. Sexual Risk

    Time frame: 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.

  2. Polysubstance use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hunter College of City University of New York

Other

Registry information

Official study title

Intervention Targeting Medication Adherence and Methamphetamine Use in HIV Positive Men

Acronym: ACE

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
May 13, 2010
Registry last updated
Jun 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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