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

Mary DeSilva, Cong Nguyen Vu, Rachael Bonawitz, Le Thanh Hai, Nguyen Van Lam, Le Thi Yen, Allen L Gifford, Jessica Haberer, Dang Thuy Linh, Lora Sabin, Mary DeSilva, Cong Nguyen Vu, Rachael Bonawitz, Le Thanh Hai, Nguyen Van Lam, Le Thi Yen, Allen L Gifford, Jessica Haberer, Dang Thuy Linh, Lora Sabin

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 (< 95% on-time doses) baseline adherence strata. Intervention participants will receive a reminder of their choice (cellphone text message/call or bottle-based flash/alarm), triggered when they miss a dose, and engage in monthly counseling informed by their adherence data. Comparison participants will receive usual care and offer of counseling at routine monthly clinic visits. After six months, we will compare ART adherence, CD4 count, and HIV viral suppression between arms, in addition to acceptability and feasibility of the intervention.

Discussion: Findings will contribute valuable information on perceived barriers and facilitators affecting adolescents' ART adherence, mHealth approaches as adherence support tools for ALHIV, and factors affecting adolescents' ART adherence. This information will be useful to researchers, medical personnel, and policy-makers as they develop and implement adherence programs for ALHIV, with potential relevance to other chronic diseases during transition from adolescent to adult care.

Trial registration: ClinicalTrials.gov, NCT03031197 . Registered on 21 January 2017.

Keywords: Adherence; Adolescents; Antiretroviral therapy; Dose histories; HIV; Real-time feedback; Vietnam; mHealth.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Institutional Review Boards of the University of New England (reference 071316–001), the Institute for Population Health and Development (reference PHAD-2016/SAAV-01), and the Ethics Committee of the National Hospital for Pediatrics in Hanoi (reference VNCH-RICH-16-015). Any protocol modifications will be submitted to the IRB for review and participants will be informed if warranted. After eligibility screening, we will request signed consent from caregivers before seeking assent from their adolescent children. Clinician participants in the FGD will also be requested to provide consent. The study coordinator will administer the consent process in all cases. For the RCT, consent and assent will be reviewed at each study visit so that participants have an opportunity to stop participation if they desire.

Consent for publication

Not applicable.

Competing interests

JH has been a consultant for Merck and owns stock in Natera. The remaining authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schedule of enrolment, interventions, and assessments
Fig. 2
Fig. 2
Study profile

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