Cargando…
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
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...
Autores principales: | , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7031891/ https://www.ncbi.nlm.nih.gov/pubmed/32075677 http://dx.doi.org/10.1186/s13063-020-4131-8 |
_version_ | 1783499462752075776 |
---|---|
author | Kim, Maria H. Tembo, Tapiwa A. Mazenga, Alick Yu, Xiaoying Myer, Landon Sabelli, Rachael Flick, Robert Hartig, Miriam Wetzel, Elizabeth Simon, Katie Ahmed, Saeed Nyirenda, Rose Kazembe, Peter N. Mphande, Mtisunge Mkandawire, Angella Chitani, Mike J. Markham, Christine Ciaranello, Andrea Abrams, Elaine J. |
author_facet | Kim, Maria H. Tembo, Tapiwa A. Mazenga, Alick Yu, Xiaoying Myer, Landon Sabelli, Rachael Flick, Robert Hartig, Miriam Wetzel, Elizabeth Simon, Katie Ahmed, Saeed Nyirenda, Rose Kazembe, Peter N. Mphande, Mtisunge Mkandawire, Angella Chitani, Mike J. Markham, Christine Ciaranello, Andrea Abrams, Elaine J. |
author_sort | Kim, Maria H. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7031891 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-70318912020-02-25 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 Kim, Maria H. Tembo, Tapiwa A. Mazenga, Alick Yu, Xiaoying Myer, Landon Sabelli, Rachael Flick, Robert Hartig, Miriam Wetzel, Elizabeth Simon, Katie Ahmed, Saeed Nyirenda, Rose Kazembe, Peter N. Mphande, Mtisunge Mkandawire, Angella Chitani, Mike J. Markham, Christine Ciaranello, Andrea Abrams, Elaine J. Trials Study Protocol 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. BioMed Central 2020-02-19 /pmc/articles/PMC7031891/ /pubmed/32075677 http://dx.doi.org/10.1186/s13063-020-4131-8 Text en © The Author(s). 2020 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Kim, Maria H. Tembo, Tapiwa A. Mazenga, Alick Yu, Xiaoying Myer, Landon Sabelli, Rachael Flick, Robert Hartig, Miriam Wetzel, Elizabeth Simon, Katie Ahmed, Saeed Nyirenda, Rose Kazembe, Peter N. Mphande, Mtisunge Mkandawire, Angella Chitani, Mike J. Markham, Christine Ciaranello, Andrea Abrams, Elaine J. 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7031891/ https://www.ncbi.nlm.nih.gov/pubmed/32075677 http://dx.doi.org/10.1186/s13063-020-4131-8 |
work_keys_str_mv | AT kimmariah thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT tembotapiwaa thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT mazengaalick thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT yuxiaoying thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT myerlandon thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT sabellirachael thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT flickrobert thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT hartigmiriam thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT wetzelelizabeth thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT simonkatie thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT ahmedsaeed thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT nyirendarose thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT kazembepetern thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT mphandemtisunge thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT mkandawireangella thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT chitanimikej thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT markhamchristine thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT ciaranelloandrea thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT abramselainej thevideointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT kimmariah videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT tembotapiwaa videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT mazengaalick videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT yuxiaoying videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT myerlandon videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT sabellirachael videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT flickrobert videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT hartigmiriam videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT wetzelelizabeth videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT simonkatie videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT ahmedsaeed videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT nyirendarose videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT kazembepetern videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT mphandemtisunge videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT mkandawireangella videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT chitanimikej videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT markhamchristine videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT ciaranelloandrea videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi AT abramselainej videointerventiontoinspiretreatmentadherenceforlifevitalstartprotocolforamultisiterandomizedcontrolledtrialofabriefvideobasedinterventiontoimproveantiretroviraladherenceandretentionamonghivinfectedpregnantwomeninmalawi |