Systems Analysis and Improvement to Optimize pMTCT

NCT ID: NCT02023658

Last Updated: 2017-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Systems analysis and improvement

pMTCT systems analysis and improvement

Group Type EXPERIMENTAL

pMTCT systems analysis and improvement

Intervention Type OTHER

Five-step systems analysis and iterative improvement cycles carried out over a six-month period in intervention facilities.

Control

No systems analysis and improvement intervention for prevention of mother to child HIV transmission services in place.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pMTCT systems analysis and improvement

Five-step systems analysis and iterative improvement cycles carried out over a six-month period in intervention facilities.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Network of AIDS Researchers of Eastern and Southern Africa

UNKNOWN

Sponsor Role collaborator

Centro de Investigacao Operacional da Beira

UNKNOWN

Sponsor Role collaborator

Health Alliance International

OTHER

Sponsor Role collaborator

Eduardo Mondlane University

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Sherr

Study Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth Sherr, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Ministry of Health

Bouaké, , Côte d’Ivoire

Site Status

Ministry of Health

Nairobi, , Kenya

Site Status

Ministry of Health

Beira, Sofala, Mozambique

Site Status

Countries

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Côte d’Ivoire Kenya Mozambique

References

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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.

Reference Type BACKGROUND
PMID: 24885976 (View on PubMed)

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.

Reference Type RESULT
PMID: 27355497 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27082507 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25335783 (View on PubMed)

Other Identifiers

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R01HD075057

Identifier Type: NIH

Identifier Source: secondary_id

View Link

44167-EG

Identifier Type: -

Identifier Source: org_study_id

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