The Supporting Adolescent Adherence in Vietnam (SAAV) Study

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 DESCRIPTION (provided by applicant): 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.