Comparing the Effectiveness of Two Alcohol+Adherence Interventions for HIV+ Youth

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Wayne State University
Sponsor:
Collaborators:
Westat
The City University of New York
University of California, San Diego
Medical University of South Carolina
University of California, Los Angeles
Columbia University
University of Alabama at Birmingham
Information provided by (Responsible Party):
Sylvie Naar-King, Wayne State University
ClinicalTrials.gov Identifier:
NCT01969461
First received: October 17, 2013
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

Alcohol use among persons with HIV exacerbates health problems and accelerates HIV disease progression. Antiretroviral therapy (ART) is the single most important treatment for people living with HIV. However, ART adherence is suboptimal among adolescents and young adults living with HIV, the age group with the fastest growing rates of HIV infection, and great risk of engaging in risky behaviors such as alcohol use. The proposed study will compare the effectiveness of home-based versus clinic-based "Healthy Choices", a brief, 4- session intervention using Motivational Enhancement Therapy (MET) to address alcohol use, medication adherence, and health outcomes in youth living with HIV (YLH) using a repeated measures design. Unlike previous trials, Healthy Choices will be tested in a "real world" clinical setting and be delivered by community health workers (CHW: already members of the HIV care team). The study population will consist of YLH, ages 16-24, who are current patients at 5 ATN sites. Site staff will recruit potential participants. Youth will be randomized to receive Healthy Choices, either clinic-based or home-based delivered by the same CHW in both conditions. Outcomes are measured at baseline, 4-, 7-, and 13-months. Data collection for biological measures will be through medical record extraction, and self-reported measures will occur using a brief Web-based CASI (computer-administered self-interviewing) survey on an iPad. All intervention sessions will be audio-recorded for MITI fidelity coding, and investigators will support local supervisors during the active intervention phase. We will conduct qualitative interviews with CHWs, supervisors and organization leaders at the end of the trial to obtain information about barriers and facilitators of implementation. Thus, the proposed trial will allow us to use a Type 1 Effectiveness-implementation hybrid design to pilot a sustainable model of MI implementation in real-world youth care settings towards the goals of 1) examining the effectiveness, cost-effectiveness, and scalability of an efficacious behavioral intervention when delivered by CHWs in real-world adolescent HIV care settings; 2) gathering information about who responds under what contexts; and 3) increasing our understanding of the barriers and facilitators for future implementation. The primary hypothesis is that YLH receiving home-based MET will have greater improvements in alcohol use and viral load than YLH receiving clinic-based MET.


Condition Intervention
HIV
Behavioral: Motivational Enhancement Therapy (MET)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Effectiveness of Two Alcohol+Adherence Interventions for HIV+ Youth

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Change in Alcohol Use from Baseline to 9 months post intervention [ Time Frame: Baseline, 4-, 7-, and 13-months ] [ Designated as safety issue: No ]
    We will use multiple methods of assessing use including calendar-based interview, biomarker, and self-report questionnaire.

  • Change in Viral Load from Baseline to 9 months post intervention [ Time Frame: Baseline, 4-, 7-, and 13-months ] [ Designated as safety issue: No ]
    Viral load will be extracted from medical records, though we have budgeted to collect a percentage of viral loads for youth who drop out of care or transfer to a care setting where records are not available.


Secondary Outcome Measures:
  • Change in Medication Adherence from Baseline to 9 months post intervention [ Time Frame: Baseline, 4-, 7-, and 13-months ] [ Designated as safety issue: No ]
    We will use self-report and interviews that have been successful in our previous trials.

  • Change in Sexual Risk from Baseline to 9 months post intervention [ Time Frame: Baseline, 4-, 7-, and 13-months ] [ Designated as safety issue: No ]
    We will use self-report and interviews that have been successful in our previous trials.

  • Change in Other Substance Use (not alcohol use) from Baseline to 9 months post intervention [ Time Frame: Baseline, 4-, 7-, and 13-months ] [ Designated as safety issue: No ]
    Objective measures are cost prohibitive (e.g., MEMS, hair assays, STI tests, urine screens) for these secondary outcomes; thus we will use self-report and interviews that have been successful in our previous trials.


Other Outcome Measures:
  • Barriers and Facilitators of the MI Implementation Process [ Time Frame: 4 months post baseline ] [ Designated as safety issue: No ]
    The qualitative interview guide (with input from Dr. Norton, consultant) will focus on barriers and facilitators of implementation experienced at the individual, clinic, protocol team, and organizational level. Both positive and potentially negative outcomes will be elicited. Interviews will be conducted at the end of the MET intervention phase to assess sustainability.

  • Barriers and Facilitators of the MI Implementation Process [ Time Frame: 13 months post Baseline ] [ Designated as safety issue: No ]
    The qualitative interview guide (with input from Dr. Norton, consultant) will focus on barriers and facilitators of implementation experienced at the individual, clinic, protocol team, and organizational level. Both positive and potentially negative outcomes will be elicited. Interviews will be conducted at the end of the trial to assess sustainability.


Estimated Enrollment: 500
Study Start Date: July 2014
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy Choices: MET CHW Clinic
The 4-session Motivational Enhancement Therapy (MET) intervention will address alcohol use and HIV medication (ART) adherence. Sessions will be delivered in the CLINIC by a CHW (outreach worker, etc) already providing services in the clinic. The intervention is based on Motivational Interviewing (MI) techniques, building motivation for change by eliciting and reinforcing change talk.
Behavioral: Motivational Enhancement Therapy (MET)
The 4-session MET intervention will address alcohol use and HIV medication (ART) adherence. Sessions will be delivered in the clinic or the home by a CHW (outreach worker, etc) already providing services in the clinic. In sessions 1 and 2 (each behavior will get its own session), CHW will elicit the client's view of the problem using MI techniques, building motivation for change by eliciting and reinforcing change talk. The CHW will deliver feedback and discuss the consideration of a behavior change plan option, and the client sets the change plan goal and consolidates commitment. In the last two sessions, the CHW will review the change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change.
Other Name: Motivational Interviewing
Active Comparator: Healthy Choices: MET CHW Home
The 4-session Motivational Enhancement Therapy (MET) intervention will address alcohol use and HIV medication (ART) adherence. Sessions will be delivered in the HOME by a CHW (outreach worker, etc) already providing services in the clinic. The intervention is based on Motivational Interviewing (MI) techniques, building motivation for change by eliciting and reinforcing change talk.
Behavioral: Motivational Enhancement Therapy (MET)
The 4-session MET intervention will address alcohol use and HIV medication (ART) adherence. Sessions will be delivered in the clinic or the home by a CHW (outreach worker, etc) already providing services in the clinic. In sessions 1 and 2 (each behavior will get its own session), CHW will elicit the client's view of the problem using MI techniques, building motivation for change by eliciting and reinforcing change talk. The CHW will deliver feedback and discuss the consideration of a behavior change plan option, and the client sets the change plan goal and consolidates commitment. In the last two sessions, the CHW will review the change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change.
Other Name: Motivational Interviewing

  Eligibility

Ages Eligible for Study:   16 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-infected
  • Ability to speak and understand English
  • Prescribed antiretroviral therapy
  • Detectable viral load in the last month

Exclusion Criteria:

  • Not fluent in English
  • History of sever learning disability, mental retardation, major psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depression with psychotic features, etc).
  • Participation in another adherence intervention trial
  • On ART due to pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969461

Contacts
Contact: Sylvie Naar-King, PhD 3137454875 snaarkin@med.wayne.edu
Contact: Phebe Lam, PhD 3135776994 plam@med.wayne.edu

Locations
United States, Alabama
Adolescent Trials Network (ATN) Sites within ATN to be determined Not yet recruiting
Birmingham, Alabama, United States, 35215
Principal Investigator: Sylvie Naar-King, PhD         
Sponsors and Collaborators
Wayne State University
Westat
The City University of New York
University of California, San Diego
Medical University of South Carolina
University of California, Los Angeles
Columbia University
University of Alabama at Birmingham
Investigators
Principal Investigator: Sylvie Naar-King, PhD Wayne State University
  More Information

No publications provided

Responsible Party: Sylvie Naar-King, Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT01969461     History of Changes
Other Study ID Numbers: 1R01AA022891-01
Study First Received: October 17, 2013
Last Updated: October 21, 2013
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Wayne State University:
HIV positive
Adolescents
Adolescent Trials Network
Comparative Effectiveness Trial
Implementation
Adherence Intervention
Alcohol Intervention

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 28, 2014