Supporting Adolescent Adherence in Vietnam (SAAV) There an urgent need to 1) gain understanding of challenges faced by HIV-infected adolescents in maintaining high adherence to antiretroviral treatment (ART), including in low-resource settings; 2) measure ART adherence rigorously among youth in these contexts; and 3) identify and test interventions designed to help adolescents achieve and maintain high ART adherence levels. Emerging technologies, including electronic drug monitors (EDM), have demonstrated potential as adherence supports in adults; we propose to extend this to adolescents. In Vietnam, more than 4300 HIV-positive children and adolescents are currently on ART, and the first surviving cohorts of pediatric ART recipients are transitioning to adult care. Over 10% of these patients are already on second line therapy, raising concerns regarding adherence, drug resistance, and the ultimate effectiveness of Vietnam's HIV treatment program. SAAV's overall goal is to increase understanding of interventions that are feasible and effective in supporting high adherence among adolescent ART patients.
The specific aims are to: 1) Examine facilitators of and challenges to adherence among adolescent ART patients and their caregivers; 2) Tailor an EDM-based real-time adherence support intervention package for adolescent patients, using input from adolescents in development of the package; 3) Assess feasibility and acceptability of this innovative, personalized approach to improving adherence among adolescents; and 4) Generate preliminary data regarding efficacy of the personalized real-time feedback package on adherence and clinical outcomes in this patient population by implementing a small randomized controlled trial (RCT). SAAV will achieve these aims over 2 years via formative research and implementation of the RCT. In formative work, we will query challenges to adherence, discuss strategies for improving adherence, and refine options for the intervention package offered to RCT participants; we will also explore with clinicians their experiences caring for youth and managing the transition to adult care. For the RCT, 80 adolescent patients will be enrolled in a HIV clinic in Hanoi. The core intervention will make use of wireless pill containers (WPCs) to provide, over 6- months, 2 layers of tailored adherence feedback: 1) continuous feedback via phone or bottle-based reminders when doses are missed; and 2) monthly feedback via counseling sessions with a clinician informed by the real- time data. Intervention subjects may tailor their individual intervention package. Comparison subjects will provide adherence data via WPC and receive usual care and an offer of counseling at monthly clinic visits. In addition to adherence and clinical data, quantitative and qualitative dat will be collected using survey instruments and in-depth interviews. Analysis of these data will enable achievement of the specific aims and contribute to the scientific evidence base on ART adherence-support strategies in adolescents. The study's Boston-Hanoi team of experienced researchers has exceptional capacity to conduct the study. With strong support from Vietnamese officials and clinicians, our results have high potential for policy and program impact.

Public Health Relevance

Supporting Adolescent Adherence in Vietnam (SAAV) A major priority in HIV care and treatment is identifying effective interventions for adolescent patients, including those that make use of new technologies, to help them achieve and maintain high levels of adherence to antiretroviral treatment (ART), particularly as they take responsibilit for their own medication-taking in the transition to adult care. The research proposed here will contribute to the scientific evidence base on approaches to support ART adherence effectively among youth by 1) conducting formative research on adherence challenges among adolescents and refining options for a personalized adherence intervention package; and 2) implementing a small randomized controlled trial (RCT) to assess the feasibility, acceptability, and efficacy of a novel real-time feedback intervention that permits adolescent patients to tailor intervention features to suit their individual preferences. Due to the focus on adolescent ART adherence and interest in SAAV at high decision-making levels in Vietnam, this study has potential to influence clinical practice and further research on useful interventions for adolescent patients affected by HIV-and possibly other chronic diseases-in Vietnam and elsewhere.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21MH109381-01
Application #
9064941
Study Section
Behavioral and Social Consequences of HIV/AIDS Study Section (BSCH)
Program Officer
Allison, Susannah
Project Start
2016-08-24
Project End
2018-08-31
Budget Start
2016-08-24
Budget End
2017-08-31
Support Year
1
Fiscal Year
2016
Total Cost
$199,633
Indirect Cost
$26,708
Name
University of New England
Department
Type
Schools of Arts and Sciences
DUNS #
071735252
City
Biddeford
State
ME
Country
United States
Zip Code
04005