- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02023658
Systems Analysis and Improvement to Optimize pMTCT
January 24, 2017 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
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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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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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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No Intervention: Control
No systems analysis and improvement intervention for prevention of mother to child HIV transmission services in place.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Uptake of HIV counseling and testing at first antenatal care visit
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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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.
- 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.
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)
January 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
December 9, 2013
First Submitted That Met QC Criteria
December 23, 2013
First Posted (Estimate)
December 30, 2013
Study Record Updates
Last Update Posted (Estimate)
January 26, 2017
Last Update Submitted That Met QC Criteria
January 24, 2017
Last Verified
January 1, 2017
More Information
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.
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