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
  Purpose

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.


Condition Intervention
HIV
Other: pMTCT systems analysis and improvement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Systems Analysis and Improvement to Optimize pMTCT: A Cluster Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 12
Study Start Date: January 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Systems analysis and improvement
pMTCT systems analysis and improvement
Other: pMTCT systems analysis and improvement
Five-step systems analysis and iterative improvement cycles carried out over a six-month period in intervention facilities.
No Intervention: Control
No systems analysis and improvement intervention for prevention of mother to child HIV transmission services in place.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02023658

Contacts
Contact: Sarah O Gimbel, RN, PhD 206-291-4223 sgimbel@uw.edu
Contact: Kenneth Sherr, PhD 206-543-8382 ksherr@uw.edu

Locations
Côte D'Ivoire
Ministry of Health Not yet recruiting
Bouake, Côte D'Ivoire
Contact: Stephen Gloyd, MD, MPH         
Kenya
Ministry of Health Not yet recruiting
Nairobi, Kenya
Contact: Ruth Nduati, MBChB, MPH         
Mozambique
Ministry of Health Not yet recruiting
Beira, Sofala, Mozambique
Contact: Sherr       ksherr@uw.edu   
Sub-Investigator: Fatima Cuembelo, MBChB, MPH         
Sponsors and Collaborators
University of Washington
Network of AIDS Researchers of Eastern and Southern Africa
Centro de Investigacao Operacional da Beira
Health Alliance International
Eduardo Mondlane University
Investigators
Principal Investigator: Kenneth Sherr, PhD University of Washington
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kenneth Sherr, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT02023658     History of Changes
Other Study ID Numbers: 44167-EG, R01HD075057
Study First Received: December 9, 2013
Last Updated: December 23, 2013
Health Authority: Kenya: Ethical Review Committee
Mozambique: Ministry of Health (MISAU)
Cote d'Ivoire: National Research and Ethics Committee

Keywords provided by University of Washington:
HIV
pMTCT

ClinicalTrials.gov processed this record on September 16, 2014