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

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

doi:10.1186/s13063-020-4131-8

Abstract

BackgroundImproving 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.MethodsThis 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT03654898. Registered on 31 August 2018.

Highlights

Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs
Kim et al Trials (2020) 21:207 (Continued from previous page). 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
We aim to rigorously evaluate the effect of VITAL Start compared to standard of care (SOC) on the primary composite outcome of retention and adherence in a multisite randomized controlled trial

Summary

Introduction

Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs. Maternal ART uptake increased sevenfold, the proportion of pregnant women receiving ART increased from 49% in the pre-B+ era to 89% in 2016, and vertical transmission rates declined [1,2,3,4,5,6]. Recognizing these benefits, the World Health Organization endorsed B+, and the majority of highprevalence countries are implementing B+. Drops in retention shortly after ART initiation have been reported from other high-prevalence settings in the developing world [9,10,11,12,13,14]

Objectives

Methods

Findings

Conclusion