HIVNCT01969461
Comparing the Effectiveness of Two Alcohol+Adherence Interventions for HIV+ Youth
A study testing Motivational Enhancement Therapy (MET) in people with HIV, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- HIV
- What is being tested?
- Motivational Enhancement Therapy (MET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV-infected
- Ability to speak and understand English
- Prescribed antiretroviral therapy
- Detectable viral load in the last month
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Adolescent Trials Network (ATN) Sites
Birmingham, Alabama, 35215
Sylvie Naar, PhD, snaarkin@med.wayne.edu
Sylvie Naar-King, PhD
About this study
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
- Being tested
- Motivational Enhancement Therapy (MET)
- Keywords
- HIV positive, Adolescents, Adolescent Trials Network, Comparative Effectiveness Trial, Implementation, Adherence Intervention, Alcohol Intervention
- Medical subject headings
- HIV Seropositivity, Adherence Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Enhancement Therapy (MET)Behavioural
Also called Motivational Interviewing
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Choices: MET CHW Clinic | Experimental | 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. Receives: Behavioral: Motivational Enhancement Therapy (MET) |
| Healthy Choices: MET CHW Home | Active comparator | 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. Receives: Behavioral: Motivational Enhancement Therapy (MET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Use from Baseline to 9 months post intervention
We will use multiple methods of assessing use including calendar-based interview, biomarker, and self-report questionnaire.
Measured: Baseline, 4-, 7-, and 13-months
Change in Viral Load from Baseline to 9 months post intervention
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.
Measured: Baseline, 4-, 7-, and 13-months
Secondary outcomes (3)
Change in Medication Adherence from Baseline to 9 months post intervention
We will use self-report and interviews that have been successful in our previous trials.
Measured: Baseline, 4-, 7-, and 13-months
Change in Sexual Risk from Baseline to 9 months post intervention
We will use self-report and interviews that have been successful in our previous trials.
Measured: Baseline, 4-, 7-, and 13-months
Change in Other Substance Use (not alcohol use) from Baseline to 9 months post intervention
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.
Measured: Baseline, 4-, 7-, and 13-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startJul 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Westat, City University of New York, School of Public Health, University of California, San Diego, Medical University of South Carolina, University of California, Los Angeles, Columbia University, University of Alabama at Birmingham
- Responsible party
- Principal investigator, Sylvie Naar-King, Wayne State University
- Investigators
- Sylvie Naar-King, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969461
- Sponsor's protocol ID
- 1R01AA022891-01
- Status last verified
- Jan 2017
- First submitted
- 17 Oct 2013
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Naar S, Robles G, MacDonell KK, Dinaj-Koci V, Simpson KN, Lam P, Parsons JT, Sizemore KM, Starks TJ. Comparative Effectiveness of Community-Based vs Clinic-Based Healthy Choices Motivational Intervention to Improve Health Behaviors Among Youth Living With HIV: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2014650. doi: 10.1001/jamanetworkopen.2020.14650.
PubMed 32845328
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Two Alcohol+Adherence Interventions for HIV+ Youth
- ClinicalTrials.gov ID
- NCT01969461
- Acronym / sponsor ID
- 1R01AA022891-01
- Conditions
- HIV
- Keywords
- HIV positive, Adolescents, Adolescent Trials Network, Comparative Effectiveness Trial, Implementation, Adherence Intervention, Alcohol Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Westat, City University of New York, School of Public Health, University of California, San Diego, Medical University of South Carolina, University of California, Los Angeles, Columbia University, University of Alabama at Birmingham
- Study start
- Jul 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Choices: MET CHW Clinic | Experimental | Behavioral: Motivational Enhancement Therapy (MET)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. |
| Healthy Choices: MET CHW Home | Active comparator | Behavioral: Motivational Enhancement Therapy (MET)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. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- HIV-infected
- Ability to speak and understand English
- Prescribed antiretroviral therapy
- Detectable viral load in the last month
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Enhancement Therapy (MET)Also: Motivational InterviewingThe 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. | Behavioural | Healthy Choices: MET CHW Clinic, Healthy Choices: MET CHW Home |
Primary outcome
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.
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.
3 secondary outcomes
Change in Medication Adherence from Baseline to 9 months post intervention
Time frame: 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
Change in Other Substance Use (not alcohol use) from Baseline to 9 months post intervention
Time frame: Baseline, 4-, 7-, and 13-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Derived from this study: PubMed 32845328Naar S, Robles G, MacDonell KK, Dinaj-Koci V, Simpson KN, Lam P, Parsons JT, Sizemore KM, Starks TJ. Comparative Effectiveness of Community-Based vs Clinic-Based Healthy Choices Motivational Intervention to Improve Health Behaviors Among Youth Living With HIV: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2014650. doi: 10.1001/jamanetworkopen.2020.14650.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Naar-King, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Enhancement Therapy (MET) in people with HIV, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvie Naar-King, PhD (3137454875, snaarkin@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alcohol Use from Baseline to 9 months post intervention (time frame: Baseline, 4-, 7-, and 13-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01969461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.