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.

Details

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
Author
Kim, Maria H. 1   VIAFID ORCID Logo  ; Tembo, Tapiwa A. 2 ; Mazenga, Alick 2 ; Yu, Xiaoying 3 ; Myer, Landon 4 ; Sabelli, Rachael 5 ; Flick, Robert 1 ; Hartig, Miriam 1 ; Wetzel, Elizabeth 1 ; Simon, Katie 1 ; Ahmed, Saeed 1 ; Nyirenda, Rose 6 ; Kazembe, Peter N. 1 ; Mphande, Mtisunge 2 ; Mkandawire, Angella 2 ; Chitani, Mike J. 2 ; Markham, Christine 7 ; Ciaranello, Andrea 8 ; Abrams, Elaine J. 9 

1  Baylor College of Medicine International Pediatric AIDS Initiative, Texas Children’s Hospital, Houston, USA (GRID:grid.416975.8) (ISNI:0000 0001 2200 2638); Baylor College of Medicine Children’s Foundation Malawi, Lilongwe, Malawi (GRID:grid.416975.8) 
2  Baylor College of Medicine Children’s Foundation Malawi, Lilongwe, Malawi (GRID:grid.416975.8) 
3  University of Texas Medical Branch at Galveston, Galveston, USA (GRID:grid.176731.5) (ISNI:0000 0001 1547 9964) 
4  University of Cape Town, Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, Cape Town, South Africa (GRID:grid.7836.a) (ISNI:0000 0004 1937 1151) 
5  Baylor College of Medicine Children’s Foundation Malawi, Lilongwe, Malawi (GRID:grid.7836.a) 
6  HIV Unit, Malawi Ministry of Health, Lilongwe, Malawi (GRID:grid.415722.7) 
7  The University of Texas School of Public Health, Health Promotion & Behavioral Sciences, Houston, USA (GRID:grid.267308.8) (ISNI:0000 0000 9206 2401) 
8  Division of Infectious Diseases, Department of Medicine; Medical Practice Evaluation Center; both at Massachusetts General Hospital, Boston, USA (GRID:grid.2515.3) (ISNI:0000 0004 0378 8438) 
9  Columbia University, ICAP at Columbia, Mailman School of Public Health and Vagelos College of Physicians and Surgeons, New York, USA (GRID:grid.21729.3f) (ISNI:0000000419368729) 
Pages
207
Publication year
2020
Publication date
Dec 2020
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-020-4131-8
ProQuest document ID
2730340763
Copyright
© The Author(s). 2020. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.