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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02023658
Date of registration: 09/12/2013
Prospective Registration: Yes
Primary sponsor: University of Washington
Public title: Systems Analysis and Improvement to Optimize pMTCT
Scientific title: Systems Analysis and Improvement to Optimize pMTCT: A Cluster Randomized Trial
Date of first enrolment: January 2014
Target sample size: 36
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02023658
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Côte D'Ivoire Kenya Mozambique
Contacts
Name:     Kenneth Sherr, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Washington
Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
HIV
Intervention(s)
Other: pMTCT systems analysis and improvement
Primary Outcome(s)
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)]
Infant HIV determination [Time Frame: 6 weeks post-partum]
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)]
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)]
Secondary Outcome(s)
Secondary ID(s)
44167-EG
R01HD075057
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Universidade Eduardo Mondlane
Centro de Investigacao Operacional da Beira
Health Alliance International
Network of AIDS Researchers of Eastern and Southern Africa
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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