Systems Analysis and Improvement Approach for Prevention of MTC HIV Transmission

NCT03425136 | Completed

• 2 other identifiers: STUDY000006451R01MH113435
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Prevention of Mother-to-Child HIV Transmission; HIV; PMTCT

Outcome Measures

Primary Outcomes (1)

• Maternal retention in care, evaluated using clinic registry data

  Women retained in care (picked up their 6-month pharmacy refill within 15 days of scheduled pickup)

  6-months post ART initiation

Secondary Outcomes (6)

• Maternal viral load assessment, evaluated using clinic registry data

  Within 1 month of delivery (birth)

• Early Infant Diagnosis for HIV, evaluated using clinic registry data

  within 8 weeks of birth

• Facility Delivery, evaluated using clinic registry data

  At birth

• Maternal ART Adherence, evaluated using clinic registry data

  At 3 and 6 months post ART initiation

• Viral Suppression, evaluated using clinic registry data

  Within 1 months of delivery

Study Arms (2)

SAIA (Systems Analysis & Improvement)

EXPERIMENTAL

Intervention is a five-step package of industrial engineering methods known as SAIA (the systems analysis and improvement approach) delivered by district maternal and child health managers to subordinate health facilities that provide prevention of mother-to-child HIV services.

Other: Systems Analysis and Improvement Approach (SAIA)

Control

NO INTERVENTION

Routine provision of prevention of mother-to-child HIV transmission services and routine support from district maternal and child health managers to subordinate facilities.

Interventions

Systems Analysis and Improvement Approach (SAIA) OTHER

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.

SAIA (Systems Analysis & Improvement)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• None

Sponsors & Collaborators

• University of Washington: lead
• Ministry of Health, Mozambique: collaborator
• Health Alliance International: collaborator
• Fred Hutchinson Cancer Center: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Manica Province

Chimoio, Manica Province, Mozambique

Location

Related Publications (7)

• Gimbel S, Voss J, Rustagi A, Mercer MA, Zierler B, Gloyd S, Coutinho Mde J, Cuembelo Mde F, Sherr K. What does high and low have to do with it? Performance classification to identify health system factors associated with effective prevention of mother-to-child transmission of HIV delivery in Mozambique. J Int AIDS Soc. 2014 Mar 24;17(1):18828. doi: 10.7448/IAS.17.1.18828. eCollection 2014.

  PMID: 24666594 BACKGROUND

• Gimbel S, Rustagi AS, Robinson J, Kouyate S, Coutinho J, Nduati R, Pfeiffer J, Gloyd S, Sherr K, Granato SA, Kone A, Cruz E, Manuel JL, Zucule J, Napua M, Mbatia G, Wariua G, Maina M; with input from the SAIA study team. Evaluation of a Systems Analysis and Improvement Approach to Optimize Prevention of Mother-To-Child Transmission of HIV Using the Consolidated Framework for Implementation Research. J Acquir Immune Defic Syndr. 2016 Aug 1;72 Suppl 2(Suppl 2):S108-16. doi: 10.1097/QAI.0000000000001055.

  PMID: 27355497 BACKGROUND

• Rustagi AS, Gimbel S, Nduati R, Cuembelo Mde F, Wasserheit JN, Farquhar C, Gloyd S, Sherr K; with input from the SAIA Study Team. Implementation and Operational Research: Impact of a Systems Engineering Intervention on PMTCT Service Delivery in Cote d'Ivoire, Kenya, Mozambique: A Cluster Randomized Trial. J Acquir Immune Defic Syndr. 2016 Jul 1;72(3):e68-76. doi: 10.1097/QAI.0000000000001023.

  PMID: 27082507 BACKGROUND

• Gimbel S, Voss J, Mercer MA, Zierler B, Gloyd S, Coutinho Mde J, Floriano F, Cuembelo Mde F, Einberg J, Sherr K. The prevention of mother-to-child transmission of HIV cascade analysis tool: supporting health managers to improve facility-level service delivery. BMC Res Notes. 2014 Oct 21;7:743. doi: 10.1186/1756-0500-7-743.

  PMID: 25335783 BACKGROUND

• Sherr K, Gimbel S, Rustagi A, Nduati R, Cuembelo F, Farquhar C, Wasserheit J, Gloyd S; With input from the SAIA Study Team. Systems analysis and improvement to optimize pMTCT (SAIA): a cluster randomized trial. Implement Sci. 2014 May 8;9:55. doi: 10.1186/1748-5908-9-55.

  PMID: 24885976 BACKGROUND

• Inguane C, Gimbel S, Soi C, Tavede E, Murgorgo F, Isidoro X, Sidat Y, Nassiaca R, Coutinho J, Cruz M, Agostinho M, Amaral F, Dinis A, Absjornsdottir K, Crocker J, Manaca N, Ramiro I, Pfeiffer J, de Fatima Cuembelo M, Sherr K. Assessing drivers of implementing "Scaling-up the Systems Analysis and Improvement Approach" for Prevention of Mother-to-Child HIV Transmission in Mozambique (SAIA-SCALE) over implementation waves. Implement Sci Commun. 2023 Jul 24;4(1):84. doi: 10.1186/s43058-023-00422-6.

  PMID: 37488632 DERIVED

• Sherr K, Asbjornsdottir K, Crocker J, Coutinho J, de Fatima Cuembelo M, Tavede E, Manaca N, Ronen K, Murgorgo F, Barnabas R, John-Stewart G, Holte S, Weiner BJ, Pfeiffer J, Gimbel S. Scaling-up the Systems Analysis and Improvement Approach for prevention of mother-to-child HIV transmission in Mozambique (SAIA-SCALE): a stepped-wedge cluster randomized trial. Implement Sci. 2019 Apr 27;14(1):41. doi: 10.1186/s13012-019-0889-z.

  PMID: 31029171 DERIVED

Study Officials

• Kenneth Sherr, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 7, 2018
• Study Start: February 1, 2018
• Primary Completion: September 30, 2021
• Study Completion: March 31, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After a manuscript with primary study results is accepted for publication.
• Access Criteria: User registration will be required in order to access or download files. As part of the registration process, users must agree to the conditions of use governing access to the public release data, including destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource. The information provided to users will not be used for commercial purposes, and will not be redistributed to third parties.

Locations

MO (1)