Clinical trial NCT01969461: Comparing the Effectiveness of Two Alcohol+Adherence Interventions for HIV+ Youth
Official title: Comparing the Effectiveness of Two Alcohol+Adherence Interventions for HIV+ Youth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Keywords: HIV positive
Adolescents
Adolescent Trials Network
Comparative Effectiveness Trial
Implementation
Adherence Intervention
Alcohol Intervention
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: Westat
name: City University of New York, School of Public Health
name: University of California, San Diego
name: Medical University of South Carolina
name: University of California, Los Angeles
name: Columbia University
name: University of Alabama at Birmingham
First posted: 2013-10-25
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Alcohol Use from Baseline to 9 months post intervention
timeFrame: Baseline, 4-, 7-, and 13-months
measure: Change in Viral Load from Baseline to 9 months post intervention
timeFrame: Baseline, 4-, 7-, and 13-months
Secondary outcomes:
measure: Change in Medication Adherence from Baseline to 9 months post intervention
timeFrame: Baseline, 4-, 7-, and 13-months
measure: Change in Sexual Risk from Baseline to 9 months post intervention
timeFrame: Baseline, 4-, 7-, and 13-months
measure: Change in Other Substance Use (not alcohol use) from Baseline to 9 months post intervention
timeFrame: Baseline, 4-, 7-, and 13-months
Other outcomes:
measure: Barriers and Facilitators of the MI Implementation Process
timeFrame: 4 months post baseline
measure: Barriers and Facilitators of the MI Implementation Process
timeFrame: 13 months post Baseline
Locations:
city: Birmingham
country: United States
facility: Adolescent Trials Network (ATN) Sites
state: Alabama
Study officials:
affiliation: Wayne State University
name: Sylvie Naar-King, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.