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.
Adolescent
Adolescent Behavior
Age Factors
Anti-HIV Agents
/ therapeutic use
Caregivers
/ psychology
Child
Child Behavior
Feasibility Studies
Female
HIV Infections
/ diagnosis
Health Knowledge, Attitudes, Practice
Humans
Male
Medication Adherence
Randomized Controlled Trials as Topic
Telemedicine
/ methods
Time Factors
Treatment Outcome
Vietnam
Adherence
Adolescents
Antiretroviral therapy
Dose histories
HIV
Real-time feedback
Vietnam
mHealth
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
28 Feb 2019
28 Feb 2019
Historique:
received:
15
08
2017
accepted:
31
01
2019
entrez:
2
3
2019
pubmed:
2
3
2019
medline:
27
6
2019
Statut:
epublish
Résumé
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). 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. 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. ClinicalTrials.gov, NCT03031197 . Registered on 21 January 2017.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov, NCT03031197 . Registered on 21 January 2017.
Identifiants
pubmed: 30819228
doi: 10.1186/s13063-019-3239-1
pii: 10.1186/s13063-019-3239-1
pmc: PMC6394014
doi:
Substances chimiques
Anti-HIV Agents
0
Banques de données
ClinicalTrials.gov
['NCT03031197']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
150Subventions
Organisme : NIMH NIH HHS
ID : R21 MH109381
Pays : United States
Organisme : NIMH NIH HHS
ID : R21 MH109381-01
Pays : United States
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