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NCT Number: NCT02023658

Systems Analysis and Improvement to Optimize pMTCT

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.

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Key information

Conditions

HIV

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ministry of Health, Bouaké, Côte d’Ivoire

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pMTCT systems analysis and improvement

Other

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

Primary outcomes

  1. 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)

    # women counseled and tested for HIV in their first ANC visit/# first ANC visits

  2. 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)

    # CD4 counts of HIV-infected pregnant women/# HIV-infected women newly identified in ANC

  3. 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)

    # HIV-infected pregnant women starting AZT prophylaxis or ART /# women testing HIV-positive in ANC 3 months previously

  4. Infant HIV determination

    Time frame: 6 weeks post-partum

    # infants <6 weeks of age receiving a PCR test/# women testing HIV-positive in ANC 5 months previously

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Centro de Investigacao Operacional da Beira
  • Eduardo Mondlane University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Health Alliance International
  • Network of AIDS Researchers of Eastern and Southern Africa

Registry information

Official study title

Systems Analysis and Improvement to Optimize pMTCT: A Cluster Randomized Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 30, 2013
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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