The Supporting Adolescent Adherence in Vietnam (SAAV) study: study protocol for a randomized controlled trial assessing an mHealth approach to improving adherence for adolescents living with HIV in Vietnam

Abstract Background The overall goal of the Supporting Adolescent Adherence in Vietnam (SAAV) study is to improve understanding of an adherence feedback mHealth intervention designed to help adolescents living with HIV (ALHIV) maintain high adherence to antiretroviral therapy (ART), critical to effective treatment. Specifically, we aim to: (1) conduct formative research with Vietnamese ALHIV and their caregivers to better understand adherence challenges and refine the personalized mHealth intervention package; and (2) assess the feasibility, acceptability, and efficacy of the intervention to improve ART adherence by implementing a randomized controlled trial (RCT). Methods The study will utilize mixed methods. The formative phase will include 40 in-depth interviews (IDIs) with 20 adolescent (12–17 years)/caregiver dyads and eight focus group discussions with adolescents, caregivers, and clinicians at the National Hospital for Pediatrics (NHP) in Hanoi, Vietnam. We will also conduct 20 IDIs with older adolescents (18–21 years) who have transitioned to adult care at outpatient clinics in Hanoi. We will then implement a seven-month RCT at NHP. We will recruit 80 adolescents on ART, monitor their adherence for one month to establish baseline adherence using a wireless pill container (WPC), and then randomize participants to intervention versus control within optimal (≥ 95% on-time doses) versus suboptimal (