Systems Analysis and Improvement Approach for Prevention of MTC HIV Transmission (SAIA-SCALE)
Scaling up the Systems Analysis and Improvement Approach for Prevention of Mother-to-Child HIV Transmission in Mozambique
Studieöversikt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Studietyp
Inskrivning (Faktisk)
Inskrivning
Fas
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Manica
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Chimoio, Manica, Moçambique
- Manica Province
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-
Deltagandekriterier
Urvalskriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Antal vapen
Vapen och interventioner
Deltagargrupp / ArmDeltagargrupp / Arm |
Intervention / BehandlingIntervention / Behandling |
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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.
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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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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.
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Vad mäter studien?
Primära resultatmått
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Maternal retention in care, evaluated using clinic registry data
Tidsram: 6-months post ART initiation
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Women retained in care (picked up their 6-month pharmacy refill within 15 days of scheduled pickup)
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6-months post ART initiation
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Sekundära resultatmått
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Maternal viral load assessment, evaluated using clinic registry data
Tidsram: Within 1 month of delivery (birth)
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Proportion of women on ART with viral load assessment
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Within 1 month of delivery (birth)
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Early Infant Diagnosis for HIV, evaluated using clinic registry data
Tidsram: within 8 weeks of birth
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Proportion of HIV-exposed infants tested for HIV (PCR) within 8 weeks of birth
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within 8 weeks of birth
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Facility Delivery, evaluated using clinic registry data
Tidsram: At birth
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Proportion of HIV-infected women enrolled in antenatal care with a facility delivery
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At birth
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Maternal ART Adherence, evaluated using clinic registry data
Tidsram: At 3 and 6 months post ART initiation
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Proportion of expected ART medicines picked up at study clinics
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At 3 and 6 months post ART initiation
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Viral Suppression, evaluated using clinic registry data
Tidsram: Within 1 months of delivery
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Proportion of viral load samples with undetectable viral load (<20 copies/mL)
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Within 1 months of delivery
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Mother-to-Child HIV Transmission Rate, evaluated using clinic registry data
Tidsram: 6 months postpartum
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Proportion of HIV-exposed infants testing positive for HIV
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6 months postpartum
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Samarbetspartners och utredare
Sponsor
Sponsor
Samarbetspartners
Samarbetspartners
Utredare
Utredare
- Huvudutredare: Kenneth Sherr, PhD, University of Washington
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Studiestart
Primärt slutförande (Faktisk)
Primärt slutförande
Avslutad studie (Faktisk)
Avslutad studie
Studieregistreringsdatum
Först inskickad
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Första postat
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste uppdatering publicerad
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
Andra studie-ID-nummer
- STUDY00000645
- 1R01MH113435 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ANALYTIC_CODE
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