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Systems Analysis and Improvement Approach for Prevention of MTC HIV Transmission (SAIA-SCALE)

16 maj 2022 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

36

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Manica
      • Chimoio, Manica, Moçambique
        • Manica Province

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

15 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Exclusion Criteria

• None

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maternal retention in care, evaluated using clinic registry data
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maternal viral load assessment, evaluated using clinic registry data
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 6 months postpartum
Proportion of HIV-exposed infants testing positive for HIV
6 months postpartum

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2018

Primärt slutförande (Faktisk)

30 september 2021

Avslutad studie (Faktisk)

31 mars 2022

Studieregistreringsdatum

Först inskickad

26 januari 2018

Först inskickad som uppfyllde QC-kriterierna

6 februari 2018

Första postat (Faktisk)

7 februari 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 maj 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 maj 2022

Senast verifierad

1 maj 2022

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • STUDY00000645
  • 1R01MH113435 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

After a manuscript with primary study results is accepted for publication.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ANALYTIC_CODE

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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