Systems Analysis and Improvement Approach for Prevention of MTC HIV Transmission

HIV Clinical Trial

— SAIA-SCALE  

Official title:

Scaling up the Systems Analysis and Improvement Approach for Prevention of Mother-to-Child HIV Transmission in Mozambique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03425136
• Other study ID #: STUDY00000645
• Secondary ID: 1R01MH113435
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 31, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria • Woman/infant pair attending pMTCT and linked pediatric HIV screening and treatment services at a public sector health facility Exclusion Criteria

• None

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
Mozambique	Manica Province	Chimoio	Manica

Sponsors (5)

Lead Sponsor	Collaborator
University of Washington	Fred Hutchinson Cancer Center, Health Alliance International, Ministry of Health, Mozambique, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Mozambique, 

References & Publications (5)

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:S108-16. doi: 10.1097/QAI.0000000000001055. — View Citation

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. — View Citation

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;17:18828. doi: 10.7448/IAS.17.1.18828. eCollection 2014. — View Citation

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 Côte 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maternal viral load assessment, evaluated using clinic registry data	Proportion of women on ART with viral load assessment	Within 1 month of delivery (birth)
Secondary	Early Infant Diagnosis for HIV, evaluated using clinic registry data	Proportion of HIV-exposed infants tested for HIV (PCR) within 8 weeks of birth	within 8 weeks of birth
Secondary	Facility Delivery, evaluated using clinic registry data	Proportion of HIV-infected women enrolled in antenatal care with a facility delivery	At birth
Secondary	Maternal ART Adherence, evaluated using clinic registry data	Proportion of expected ART medicines picked up at study clinics	At 3 and 6 months post ART initiation
Secondary	Viral Suppression, evaluated using clinic registry data	Proportion of viral load samples with undetectable viral load (<20 copies/mL)	Within 1 months of delivery
Secondary	Mother-to-Child HIV Transmission Rate, evaluated using clinic registry data	Proportion of HIV-exposed infants testing positive for HIV	6 months postpartum