- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01969461
Comparing the Effectiveness of Two Alcohol+Adherence Interventions for HIV+ Youth
January 6, 2017 updated by: Sylvie Naar-King, Wayne State University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sylvie Naar-King, PhD
- Phone Number: 3137454875
- Email: snaarkin@med.wayne.edu
Study Contact Backup
- Name: Phebe Lam, PhD
- Phone Number: 3135776994
- Email: plam@med.wayne.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35215
- Recruiting
- Adolescent Trials Network (ATN) Sites
-
Contact:
- Sylvie Naar, PhD
- Email: snaarkin@med.wayne.edu
-
Principal Investigator:
- Sylvie Naar-King, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 24 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Alcohol Use from Baseline to 9 months post intervention
Time Frame: Baseline, 4-, 7-, and 13-months
|
We will use multiple methods of assessing use including calendar-based interview, biomarker, and self-report questionnaire.
|
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
|
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.
|
Baseline, 4-, 7-, and 13-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Medication Adherence from Baseline to 9 months post intervention
Time Frame: Baseline, 4-, 7-, and 13-months
|
We will use self-report and interviews that have been successful in our previous trials.
|
Baseline, 4-, 7-, and 13-months
|
Change in Sexual Risk from Baseline to 9 months post intervention
Time Frame: Baseline, 4-, 7-, and 13-months
|
We will use self-report and interviews that have been successful in our previous trials.
|
Baseline, 4-, 7-, and 13-months
|
Change in Other Substance Use (not alcohol use) from Baseline to 9 months post intervention
Time Frame: Baseline, 4-, 7-, and 13-months
|
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.
|
Baseline, 4-, 7-, and 13-months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Barriers and Facilitators of the MI Implementation Process
Time Frame: 4 months post baseline
|
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.
|
4 months post baseline
|
Barriers and Facilitators of the MI Implementation Process
Time Frame: 13 months post Baseline
|
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.
|
13 months post Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (ANTICIPATED)
December 1, 2018
Study Completion (ANTICIPATED)
December 1, 2018
Study Registration Dates
First Submitted
October 17, 2013
First Submitted That Met QC Criteria
October 21, 2013
First Posted (ESTIMATE)
October 25, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
January 9, 2017
Last Update Submitted That Met QC Criteria
January 6, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1R01AA022891-01 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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