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

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dc.contributor.authorKim, Maria H
dc.contributor.authorTembo, Tapiwa A
dc.contributor.authorMazenga, Alick
dc.contributor.authorYu, Xiaoying
dc.contributor.authorMyer, Landon
dc.contributor.authorSabelli, Rachael
dc.contributor.authorFlick, Robert
dc.contributor.authorHartig, Miriam
dc.contributor.authorWetzel, Elizabeth
dc.contributor.authorSimon, Katie
dc.contributor.authorAhmed, Saeed
dc.contributor.authorNyirenda, Rose
dc.contributor.authorKazembe, Peter N
dc.contributor.authorMphande, Mtisunge
dc.contributor.authorMkandawire, Angella
dc.contributor.authorChitani, Mike J
dc.contributor.authorMarkham, Christine
dc.contributor.authorCiaranello, Andrea
dc.contributor.authorAbrams, Elaine J
dc.date.accessioned2020-03-02T12:22:09Z
dc.date.available2020-03-02T12:22:09Z
dc.date.issued2020-02-19
dc.date.updated2020-02-23T04:31:49Z
dc.description.abstractAbstract 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.
dc.identifier.apacitationKim, M. H., Tembo, T. A., Mazenga, A., Yu, X., Myer, L., Sabelli, R., ... Abrams, E. J. (2020). 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. http://hdl.handle.net/11427/31443en_ZA
dc.identifier.chicagocitationKim, Maria H, Tapiwa A Tembo, Alick Mazenga, Xiaoying Yu, Landon Myer, Rachael Sabelli, Robert Flick, et al "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." (2020) http://hdl.handle.net/11427/31443en_ZA
dc.identifier.citationTrials. 2020 Feb 19;21(1):207
dc.identifier.ris TY - Journal Article AU - Kim, Maria H AU - Tembo, Tapiwa A AU - Mazenga, Alick AU - Yu, Xiaoying AU - Myer, Landon AU - Sabelli, Rachael AU - Flick, Robert AU - Hartig, Miriam AU - Wetzel, Elizabeth AU - Simon, Katie AU - Ahmed, Saeed AU - Nyirenda, Rose AU - Kazembe, Peter N AU - Mphande, Mtisunge AU - Mkandawire, Angella AU - Chitani, Mike J AU - Markham, Christine AU - Ciaranello, Andrea AU - Abrams, Elaine J AB - 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. DA - 2020-02-19 DB - OpenUCT DP - University of Cape Town KW - HIV KW - ART (antiretroviral therapy) KW - Retention KW - Adherence KW - PMTCT (prevention of mother-to-children transmission) KW - Video LK - https://open.uct.ac.za PY - 2020 T1 - 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 TI - 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 UR - http://hdl.handle.net/11427/31443 ER - en_ZA
dc.identifier.urihttps://doi.org/10.1186/s13063-020-4131-8
dc.identifier.urihttp://hdl.handle.net/11427/31443
dc.identifier.vancouvercitationKim MH, Tembo TA, Mazenga A, Yu X, Myer L, Sabelli R, et al. 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. 2020; http://hdl.handle.net/11427/31443.en_ZA
dc.language.rfc3066en
dc.rights.holderThe Author(s).
dc.subjectHIV
dc.subjectART (antiretroviral therapy)
dc.subjectRetention
dc.subjectAdherence
dc.subjectPMTCT (prevention of mother-to-children transmission)
dc.subjectVideo
dc.titleThe 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
dc.typeJournal Article
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