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Published in: Trials 1/2019

Open Access 01-12-2019 | Human Immunodeficiency Virus | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2019

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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.
Appendix
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Metadata
Title
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
Authors
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
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3239-1

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