Systems Analysis and Improvement Approach for Prevention of MTC HIV Transmission (SAIA-SCALE)
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ClinicalTrials.gov Identifier: NCT03425136 |
Recruitment Status :
Completed
First Posted : February 7, 2018
Last Update Posted : May 17, 2022
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Sponsor:
University of Washington
Collaborators:
Ministry of Health, Mozambique
Health Alliance International
Fred Hutchinson Cancer Center
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kenneth Sherr, University of Washington
Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | January 26, 2018 | ||||||||||||||
First Posted Date ICMJE | February 7, 2018 | ||||||||||||||
Last Update Posted Date | May 17, 2022 | ||||||||||||||
Actual Study Start Date ICMJE | February 1, 2018 | ||||||||||||||
Actual Primary Completion Date | September 30, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Maternal retention in care, evaluated using clinic registry data [ Time Frame: 6-months post ART initiation ] Women retained in care (picked up their 6-month pharmacy refill within 15 days of scheduled pickup)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Systems Analysis and Improvement Approach for Prevention of MTC HIV Transmission | ||||||||||||||
Official Title ICMJE | Scaling up the Systems Analysis and Improvement Approach for Prevention of Mother-to-Child HIV Transmission in Mozambique | ||||||||||||||
Brief Summary | Optimizing the prevention of mother-to-child HIV transmission cascade minimizes drop offs from one step to the next to maximize the benefits of antiretroviral therapy on maternal health and pediatric survival, growth, and development. This proposal scales-up a health systems intervention (the systems analysis and improvement approach - SAIA) that packages systems engineering methods (including cascade analysis, flow mapping, and continuous quality improvement) and was previously shown to be effective in improving the prevention of mother-to-child HIV transmission cascade. By spreading the SAIA through routine district management structures, and studying the implementation process, this study will build evidence on how to achieve rapid, sustainable and scalable improvements in services that can dramatically improve population health in resource limited countries. | ||||||||||||||
Detailed Description | Despite significant increases in global health investment and the availability of low-cost, efficacious interventions designed to prevent mother to child HIV transmission (PMTCT) in low and middle income countries with high HIV burden, the translation of these scientific advances into effective delivery strategies has been slow, uneven and incomplete. As a result, pediatric HIV infection remains largely uncontrolled. The introduction of the Option B+ strategy - where HIV-infected pregnant women rapidly initiate lifelong antiretroviral therapy (ART) independent of disease status - has the potential to dramatically reduce HIV transmission during pregnancy, birth and the breastfeeding period, and as a result, it has been scaled up throughout high HIV burden countries in sub-Saharan Africa. Despite these significant investments to scale-up Option B+, results have been poor, with high rates of loss to follow-up and low viral suppression, leading to continued HIV transmission to children and HIV-associated morbidity among mothers. A previous research project (the Systems Analysis and Improvement Approach - or SAIA - cluster randomized trial) demonstrated that a package of systems engineering tools including cascade analysis, process mapping, and continuous quality improvement, was effective at improving flow through the PMTCT cascade across three sub-Saharan African countries. The overall goal of this application is to develop a model to deliver the SAIA intervention (SAIA-SCALE) that is led by district maternal and child health (MCH) supervisors (rather than research nurses), to serve as a foundation for national scale-up. We propose to implement the SAIA intervention in all districts in one province in Mozambique using MCH supervisors as disseminating agents, who will implement SAIA in subordinate health facilities. Using a three-year phased-in design, 12 districts will be randomly allocated into three implementation waves, and a mixed-methods evaluation will be used to assess the impact of the intervention. Our specific aims are to: Aim 1: Develop an effective district-based dissemination and implementation strategy for the SAIA intervention (SAIA-SCALE), using the RE-AIM model to evaluate the program's Reach, Effectiveness, Adoption, Implementation, and Maintenance; and Aim 2: Using activity based micro-costing and mathematical models of HIV transmission, estimate the budget and program impact from the payer perspective to scale-up the SAIA intervention compared to the standard of care. The results of this implementation research are expected to generate knowledge of global health significance, and by providing a real-world implementation model for the SAIA intervention and programmatically relevant information, is designed to lead to rapid policy translation for future scale-up in countries with high burden of HIV and weak PMTCT delivery systems. | ||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Intervention Model Description: A three-wave stepped-wedge (phased-in) cluster randomized trial, with districts as the unit of randomization (and outcomes assessed at the clinic/individual level within each district) Masking: None (Open Label)Primary Purpose: Health Services Research |
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Condition ICMJE | HIV | ||||||||||||||
Intervention ICMJE | Other: Systems Analysis and Improvement Approach (SAIA)
Five-step systems analysis and iterative improvement cycles applied by district maternal and child health supervisors to subordinate health facilities providing prevention of mother-to-child HIV transmission services at the facility level.
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||
Actual Enrollment ICMJE |
36 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Actual Study Completion Date ICMJE | March 31, 2022 | ||||||||||||||
Actual Primary Completion Date | September 30, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria • Woman/infant pair attending pMTCT and linked pediatric HIV screening and treatment services at a public sector health facility Exclusion Criteria • None |
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Sex/Gender ICMJE |
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Ages ICMJE | 15 Years and older (Child, Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | Mozambique | ||||||||||||||
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Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT03425136 | ||||||||||||||
Other Study ID Numbers ICMJE | STUDY00000645 1R01MH113435 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Kenneth Sherr, University of Washington | ||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||
Current Study Sponsor ICMJE | University of Washington | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Washington | ||||||||||||||
Verification Date | May 2022 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |