Systems Analysis and Improvement to Optimize pMTCT

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by University of Washington
Sponsor:
Collaborators:
Network of AIDS Researchers of Eastern and Southern Africa
Centro de Investigacao Operacional da Beira
Health Alliance International
Eduardo Mondlane University
Information provided by (Responsible Party):
Kenneth Sherr, University of Washington
ClinicalTrials.gov Identifier:
NCT02023658
First received: December 9, 2013
Last updated: December 23, 2013
Last verified: December 2013

December 9, 2013
December 23, 2013
January 2014
July 2014   (final data collection date for primary outcome measure)
  • 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) ] [ Designated as safety issue: No ]
    # women counseled and tested for HIV in their first ANC visit/# first ANC visits
  • 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) ] [ Designated as safety issue: No ]
    # CD4 counts of HIV-infected pregnant women/# HIV-infected women newly identified in ANC
  • 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) ] [ Designated as safety issue: No ]
    # HIV-infected pregnant women starting AZT prophylaxis or ART /# women testing HIV-positive in ANC 3 months previously
  • Infant HIV determination [ Time Frame: 6 weeks post-partum ] [ Designated as safety issue: No ]
    # infants <6 weeks of age receiving a PCR test/# women testing HIV-positive in ANC 5 months previously
Same as current
Complete list of historical versions of study NCT02023658 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Systems Analysis and Improvement to Optimize pMTCT
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
HIV
Other: pMTCT systems analysis and improvement
Five-step systems analysis and iterative improvement cycles carried out over a six-month period in intervention facilities.
  • Experimental: Systems analysis and improvement
    pMTCT systems analysis and improvement
    Intervention: Other: pMTCT systems analysis and improvement
  • No Intervention: Control
    No systems analysis and improvement intervention for prevention of mother to child HIV transmission services in place.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
12
October 2014
July 2014   (final data collection date for primary outcome measure)

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
Female
Not Provided
Yes
Contact: Sarah O Gimbel, RN, PhD 206-291-4223 sgimbel@uw.edu
Contact: Kenneth Sherr, PhD 206-543-8382 ksherr@uw.edu
Côte D'Ivoire,   Kenya,   Mozambique
 
NCT02023658
44167-EG, R01HD075057
No
Kenneth Sherr, University of Washington
University of Washington
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Network of AIDS Researchers of Eastern and Southern Africa
  • Centro de Investigacao Operacional da Beira
  • Health Alliance International
  • Eduardo Mondlane University
Principal Investigator: Kenneth Sherr, PhD University of Washington
University of Washington
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP