- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02023658
Systems Analysis and Improvement to Optimize pMTCT
24. januar 2017 opdateret af: Kenneth Sherr, University of Washington
Systems Analysis and Improvement to Optimize pMTCT: A Cluster Randomized Trial
Despite significant increases in global health investment and the availability of low-cost, efficacious interventions designed to reduce mother to child HIV transmission 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.
Enhancing the implementation of pMTCT interventions through contextually appropriate systems analysis and improvement approaches can potentially reduce drop-offs along the pMTCT cascade, leading to dramatic improvements in infant and maternal outcomes.
The goal of this proposal is to develop a model for systematic assessment and improvement of pMTCT services in sub-Saharan Africa.
In specific aim 1, we will identify health system factors and service delivery approaches associated with high and low performing pMTCT services in Côte d'Ivoire, Kenya and Mozambique.
In specific aim 2 we will adapt evaluate the feasibility and impact of a systems analysis tool and associated performance enhancement approach for pMTCT services in Côte d'Ivoire, Kenya and Mozambique.
This systems analysis tool and associated performance enhancement approach is currently being developed and piloted for pMTCT services in Mozambique.
The results of this implementation research are expected to generate knowledge of global health significance, and by disseminating the study results and intervention tools through the broad PEPFAR network, can rapidly impact pMTCT service delivery enhancements across the highest need countries.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
36
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Bouake, Côte D'Ivoire
- Ministry of Health
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Nairobi, Kenya
- Ministry of Health
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Sofala
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Beira, Sofala, Mozambique
- Ministry of Health
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- health facility with pMTCT services in central Mozambique, northern Cote d'Ivoire or western Kenya
- health facility with at least 20 HIV-infected women identified in antenatal care per year
Exclusion Criteria:
- health facility over 20 kilometers from a main transport corridor
- health facility with an ongoing prospective study or systems analysis and improvement approach in place
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Systems analysis and improvement
pMTCT systems analysis and improvement
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Five-step systems analysis and iterative improvement cycles carried out over a six-month period in intervention facilities.
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Ingen indgriben: Control
No systems analysis and improvement intervention for prevention of mother to child HIV transmission services in place.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Uptake of HIV counseling and testing at first antenatal care visit
Tidsramme: Patients will be assessed at first antenatal care visit (average of 25 weeks gestational age)
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# women counseled and tested for HIV in their first ANC visit/# first ANC visits
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Patients will be assessed at first antenatal care visit (average of 25 weeks gestational age)
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Uptake of CD4 testing at antenatal care
Tidsramme: Patients will be assessed during the antenatal care period (average of 25-40 weeks gestational age)
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# CD4 counts of HIV-infected pregnant women/# HIV-infected women newly identified in ANC
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Patients will be assessed during the antenatal care period (average of 25-40 weeks gestational age)
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Use of appropriate ARVs in pregnancy for prophylaxis or initiation of ART during pregnancy
Tidsramme: Patients will be assessed during the antenatal care period (average of 25-40 weeks gestational age)
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# HIV-infected pregnant women starting AZT prophylaxis or ART /# women testing HIV-positive in ANC 3 months previously
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Patients will be assessed during the antenatal care period (average of 25-40 weeks gestational age)
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Infant HIV determination
Tidsramme: 6 weeks post-partum
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# infants <6 weeks of age receiving a PCR test/# women testing HIV-positive in ANC 5 months previously
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6 weeks post-partum
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kenneth Sherr, PhD, University of Washington
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle 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.
- 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.
- 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, 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2014
Primær færdiggørelse (Faktiske)
1. marts 2015
Studieafslutning (Faktiske)
1. marts 2015
Datoer for studieregistrering
Først indsendt
9. december 2013
Først indsendt, der opfyldte QC-kriterier
23. december 2013
Først opslået (Skøn)
30. december 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. januar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. januar 2017
Sidst verificeret
1. januar 2017
Mere information
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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