Recruiting

Healthy Choices

Sponsor:

Wayne State University

Code:

NCT01969461

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 16 - 24

Healthy Volunteers: Not accepted

Interventions

Motivational Enhancement Therapy (MET)

Study Details

Brief summary:

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.

Conditions

HIV

Study ID

NCT01969461

Start date

Jul, 2014

Status verified date

Jan, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 24

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Change in Alcohol Use from Baseline to 9 months post intervention [ Time Frame: Baseline, 4-, 7-, and 13-months ]
  • Change in Viral Load from Baseline to 9 months post intervention [ Time Frame: Baseline, 4-, 7-, and 13-months ]

Central Contacts and Locations

Central contacts

Locations

Adolescent Trials Network (ATN) Sites

Recruiting

Birmingham, Alabama, United States, 35215

Contacts

Sylvie Naar, PhD

snaarkin@med.wayne.edu

Principal Investigator:

Sylvie Naar-King, PhD

More Information

Sponsor

Wayne State University

Last update posted

Jan 9, 2017

Last verified

Jan, 2017

Keywords

  • HIV positive
  • Adolescents
  • Adolescent Trials Network
  • Comparative Effectiveness Trial
  • Implementation
  • Adherence Intervention
  • Alcohol Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2017-01-09.