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Systems analysis and improvement to optimize pMTCT (SAIA): a cluster randomized trial

BACKGROUND: Despite significant increases in global health investment and the availability of low-cost, efficacious interventions to prevent mother-to-child HIV transmission (pMTCT) in low- and middle-income countries with high HIV burden, the translation of scientific advances into effective delive...

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Autores principales: Sherr, Kenneth, Gimbel, Sarah, Rustagi, Alison, Nduati, Ruth, Cuembelo, Fatima, Farquhar, Carey, Wasserheit, Judith, Gloyd, Stephen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4019370/
https://www.ncbi.nlm.nih.gov/pubmed/24885976
http://dx.doi.org/10.1186/1748-5908-9-55
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author Sherr, Kenneth
Gimbel, Sarah
Rustagi, Alison
Nduati, Ruth
Cuembelo, Fatima
Farquhar, Carey
Wasserheit, Judith
Gloyd, Stephen
author_facet Sherr, Kenneth
Gimbel, Sarah
Rustagi, Alison
Nduati, Ruth
Cuembelo, Fatima
Farquhar, Carey
Wasserheit, Judith
Gloyd, Stephen
author_sort Sherr, Kenneth
collection PubMed
description BACKGROUND: Despite significant increases in global health investment and the availability of low-cost, efficacious interventions to prevent mother-to-child HIV transmission (pMTCT) in low- and middle-income countries with high HIV burden, the translation of scientific advances into effective delivery strategies has been slow, uneven and incomplete. As a result, pediatric HIV infection remains largely uncontrolled. A five-step, facility-level systems analysis and improvement intervention (SAIA) was designed to maximize effectiveness of pMTCT service provision by improving understanding of inefficiencies (step one: cascade analysis), guiding identification and prioritization of low-cost workflow modifications (step two: value stream mapping), and iteratively testing and redesigning these modifications (steps three through five). This protocol describes the SAIA intervention and methods to evaluate the intervention’s impact on reducing drop-offs along the pMTCT cascade. METHODS: This study employs a two-arm, longitudinal cluster randomized trial design. The unit of randomization is the health facility. A total of 90 facilities were identified in Côte d’Ivoire, Kenya and Mozambique (30 per country). A subset was randomly selected and assigned to intervention and comparison arms, stratified by country and service volume, resulting in 18 intervention and 18 comparison facilities across all three countries, with six intervention and six comparison facilities per country. The SAIA intervention will be implemented for six months in the 18 intervention facilities. Primary trial outcomes are designed to assess improvements in the pMTCT service cascade, and include the percentage of pregnant women being tested for HIV at the first antenatal care visit, the percentage of HIV-infected pregnant women receiving adequate prophylaxis or combination antiretroviral therapy in pregnancy, and the percentage of newborns exposed to HIV in pregnancy receiving an HIV diagnosis eight weeks postpartum. The Consolidated Framework for Implementation Research (CFIR) will guide collection and analysis of qualitative data on implementation process. DISCUSSION: This study is a pragmatic trial that has the potential benefit of improving maternal and infant outcomes by reducing drop-offs along the pMTCT cascade. The SAIA intervention is designed to provide simple tools to guide decision-making for pMTCT program staff at the facility level, and to identify low cost, contextually appropriate pMTCT improvement strategies. TRIAL REGISTRATION: ClinicalTrials.gov NCT02023658
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spelling pubmed-40193702014-05-27 Systems analysis and improvement to optimize pMTCT (SAIA): a cluster randomized trial Sherr, Kenneth Gimbel, Sarah Rustagi, Alison Nduati, Ruth Cuembelo, Fatima Farquhar, Carey Wasserheit, Judith Gloyd, Stephen Implement Sci Study Protocol BACKGROUND: Despite significant increases in global health investment and the availability of low-cost, efficacious interventions to prevent mother-to-child HIV transmission (pMTCT) in low- and middle-income countries with high HIV burden, the translation of scientific advances into effective delivery strategies has been slow, uneven and incomplete. As a result, pediatric HIV infection remains largely uncontrolled. A five-step, facility-level systems analysis and improvement intervention (SAIA) was designed to maximize effectiveness of pMTCT service provision by improving understanding of inefficiencies (step one: cascade analysis), guiding identification and prioritization of low-cost workflow modifications (step two: value stream mapping), and iteratively testing and redesigning these modifications (steps three through five). This protocol describes the SAIA intervention and methods to evaluate the intervention’s impact on reducing drop-offs along the pMTCT cascade. METHODS: This study employs a two-arm, longitudinal cluster randomized trial design. The unit of randomization is the health facility. A total of 90 facilities were identified in Côte d’Ivoire, Kenya and Mozambique (30 per country). A subset was randomly selected and assigned to intervention and comparison arms, stratified by country and service volume, resulting in 18 intervention and 18 comparison facilities across all three countries, with six intervention and six comparison facilities per country. The SAIA intervention will be implemented for six months in the 18 intervention facilities. Primary trial outcomes are designed to assess improvements in the pMTCT service cascade, and include the percentage of pregnant women being tested for HIV at the first antenatal care visit, the percentage of HIV-infected pregnant women receiving adequate prophylaxis or combination antiretroviral therapy in pregnancy, and the percentage of newborns exposed to HIV in pregnancy receiving an HIV diagnosis eight weeks postpartum. The Consolidated Framework for Implementation Research (CFIR) will guide collection and analysis of qualitative data on implementation process. DISCUSSION: This study is a pragmatic trial that has the potential benefit of improving maternal and infant outcomes by reducing drop-offs along the pMTCT cascade. The SAIA intervention is designed to provide simple tools to guide decision-making for pMTCT program staff at the facility level, and to identify low cost, contextually appropriate pMTCT improvement strategies. TRIAL REGISTRATION: ClinicalTrials.gov NCT02023658 BioMed Central 2014-05-08 /pmc/articles/PMC4019370/ /pubmed/24885976 http://dx.doi.org/10.1186/1748-5908-9-55 Text en Copyright © 2014 Sherr et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. 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
Sherr, Kenneth
Gimbel, Sarah
Rustagi, Alison
Nduati, Ruth
Cuembelo, Fatima
Farquhar, Carey
Wasserheit, Judith
Gloyd, Stephen
Systems analysis and improvement to optimize pMTCT (SAIA): a cluster randomized trial
title Systems analysis and improvement to optimize pMTCT (SAIA): a cluster randomized trial
title_full Systems analysis and improvement to optimize pMTCT (SAIA): a cluster randomized trial
title_fullStr Systems analysis and improvement to optimize pMTCT (SAIA): a cluster randomized trial
title_full_unstemmed Systems analysis and improvement to optimize pMTCT (SAIA): a cluster randomized trial
title_short Systems analysis and improvement to optimize pMTCT (SAIA): a cluster randomized trial
title_sort systems analysis and improvement to optimize pmtct (saia): a cluster randomized trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4019370/
https://www.ncbi.nlm.nih.gov/pubmed/24885976
http://dx.doi.org/10.1186/1748-5908-9-55
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