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Published in: Trials 1/2020

01-12-2020 | Human Immunodeficiency Virus | Study protocol

The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi

Authors: Maria H. Kim, Tapiwa A. Tembo, Alick Mazenga, Xiaoying Yu, Landon Myer, Rachael Sabelli, Robert Flick, Miriam Hartig, Elizabeth Wetzel, Katie Simon, Saeed Ahmed, Rose Nyirenda, Peter N. Kazembe, Mtisunge Mphande, Angella Mkandawire, Mike J. Chitani, Christine Markham, Andrea Ciaranello, Elaine J. Abrams

Published in: Trials | Issue 1/2020

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Abstract

Background

Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs. There is an urgent need for evidence-based, cost-effective, and scalable interventions to improve maternal adherence and retention that can be feasibly implemented in overburdened health systems. Brief video-based interventions are a promising but underutilized approach to this crisis. We describe a trial protocol to evaluate the effectiveness and implementation of a standardized educational video-based intervention targeting HIV-infected pregnant women that seeks to optimize their ART retention and adherence by providing a VITAL Start (Video intervention to Inspire Treatment Adherence for Life) before committing to lifelong ART.

Methods

This study is a multisite parallel group, randomized controlled trial assessing the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant women living with HIV in Malawi. A total of 892 pregnant women living with HIV and not yet on ART will be randomized to standard-of-care pre-ART counseling or VITAL Start. The primary outcome is a composite of retention and adherence (viral load < 1000 copies/ml) 12 months after starting ART. Secondary outcomes include assessments of behavioral adherence (self-reported adherence, pharmacy refill, and tenofovir diphosphate concentration), psychosocial impact, and resource utilization. We will also examine the implementation of VITAL Start via surveys and qualitative interviews with patients, partners, and health care workers and conduct cost-effectiveness analyses.

Discussion

This is a robust evaluation of an innovative facility-based video intervention for pregnant women living with HIV, with the potential to improve maternal and infant outcomes.

Trial registration

ClinicalTrials.gov, NCT03654898. Registered on 31 August 2018.
Appendix
Available only for authorised users
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Metadata
Title
The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi
Authors
Maria H. Kim
Tapiwa A. Tembo
Alick Mazenga
Xiaoying Yu
Landon Myer
Rachael Sabelli
Robert Flick
Miriam Hartig
Elizabeth Wetzel
Katie Simon
Saeed Ahmed
Rose Nyirenda
Peter N. Kazembe
Mtisunge Mphande
Angella Mkandawire
Mike J. Chitani
Christine Markham
Andrea Ciaranello
Elaine J. Abrams
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4131-8

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