- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03425136
Systems Analysis and Improvement Approach for Prevention of MTC HIV Transmission (SAIA-SCALE)
May 16, 2022 updated by: Kenneth Sherr, University of Washington
Scaling up the Systems Analysis and Improvement Approach for Prevention of Mother-to-Child HIV Transmission in Mozambique
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manica
-
Chimoio, Manica, Mozambique
- Manica Province
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria • Woman/infant pair attending pMTCT and linked pediatric HIV screening and treatment services at a public sector health facility
Exclusion Criteria
• None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SAIA (Systems Analysis & Improvement)
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.
|
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.
|
No Intervention: Control
Routine provision of prevention of mother-to-child HIV transmission services and routine support from district maternal and child health managers to subordinate facilities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
6-months post ART initiation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal viral load assessment, evaluated using clinic registry data
Time Frame: Within 1 month of delivery (birth)
|
Proportion of women on ART with viral load assessment
|
Within 1 month of delivery (birth)
|
Early Infant Diagnosis for HIV, evaluated using clinic registry data
Time Frame: within 8 weeks of birth
|
Proportion of HIV-exposed infants tested for HIV (PCR) within 8 weeks of birth
|
within 8 weeks of birth
|
Facility Delivery, evaluated using clinic registry data
Time Frame: At birth
|
Proportion of HIV-infected women enrolled in antenatal care with a facility delivery
|
At birth
|
Maternal ART Adherence, evaluated using clinic registry data
Time Frame: At 3 and 6 months post ART initiation
|
Proportion of expected ART medicines picked up at study clinics
|
At 3 and 6 months post ART initiation
|
Viral Suppression, evaluated using clinic registry data
Time Frame: Within 1 months of delivery
|
Proportion of viral load samples with undetectable viral load (<20 copies/mL)
|
Within 1 months of delivery
|
Mother-to-Child HIV Transmission Rate, evaluated using clinic registry data
Time Frame: 6 months postpartum
|
Proportion of HIV-exposed infants testing positive for HIV
|
6 months postpartum
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenneth Sherr, PhD, University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
March 31, 2022
Study Registration Dates
First Submitted
January 26, 2018
First Submitted That Met QC Criteria
February 6, 2018
First Posted (Actual)
February 7, 2018
Study Record Updates
Last Update Posted (Actual)
May 17, 2022
Last Update Submitted That Met QC Criteria
May 16, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00000645
- 1R01MH113435 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient- and aggregate facility-level data will be made available to users who request access to the data after a manuscript based on the primary study results is accepted for publication.
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.
Registered users will receive user support, as well as information related to errors in the data, future releases, workshops, and publication lists.
The information provided to users will not be used for commercial purposes, and will not be redistributed to third parties.
Data from focus group discussions and key informant interviews will not be available because of human subjects protections constraints.
IPD Sharing Time Frame
After a manuscript with primary study results is accepted for publication.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRecruitingHIV | HIV Testing | HIV Linkage to Care | HIV TreatmentUnited States
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationCompletedPartner HIV Testing | Couple HIV Counseling | Couple Communication | HIV IncidenceCameroon, Dominican Republic, Georgia, India
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement and other collaboratorsUnknownHIV | HIV-uninfected Children | Children Exposed to HIVCameroon
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
CDC FoundationGilead SciencesUnknownHIV Preexposure Prophylaxis | HIV ChemoprophylaxisUnited States
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... and other collaboratorsRecruiting
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH); Fenway Community Health; Tuberculosis...CompletedHIV/STI Risk | HIV/STI IncidenceUnited States, India
-
Erasmus Medical CenterNot yet recruitingHIV Infections | Hiv | HIV-1-infection | HIV I InfectionNetherlands
-
University of WashingtonNational Institute of Mental Health (NIMH)RecruitingHIV Prevention | HIV Preexposure Prophylaxis | ImplementationKenya
-
University of Maryland, BaltimoreWithdrawnHiv | Kidney Transplant | HIV Reservoir | CCR5United States
Clinical Trials on Systems Analysis and Improvement Approach (SAIA)
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...Not yet recruiting
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
Boston CollegeBoston University; National Institute of Nursing Research (NINR); National Institutes... and other collaboratorsNot yet recruitingTuberculosis | TB - Tuberculosis | TPTSouth Africa
-
University of WashingtonNational Institute of Mental Health (NIMH); Ministry of Health, Mozambique; Comité...RecruitingMental Health DisorderMozambique
-
University of WashingtonNational Cancer Institute (NCI)Active, not recruiting
-
University of WashingtonNational Heart, Lung, and Blood Institute (NHLBI)RecruitingHypertension | HIV/AIDSMozambique
-
Eduardo Mondlane UniversityNational Heart, Lung, and Blood Institute (NHLBI); University of Washington; Instituto... and other collaboratorsRecruiting
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
Inova Health Care ServicesCity of Hope Medical CenterRecruitingBreast Cancer | Estrogen Receptor-positive Breast Cancer | HER2-negative Breast CancerUnited States
-
Gustave Roussy, Cancer Campus, Grand ParisUnknownMelanoma (Skin)France