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Systems Analysis and Improvement to Optimize pMTCT

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02023658
Enrollment
36
Registered
2013-12-30
Start date
2014-01-31
Completion date
2015-03-31
Last updated
2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, pMTCT

Brief summary

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.

Interventions

OTHERpMTCT systems analysis and improvement

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Uptake of HIV counseling and testing at first antenatal care visitPatients 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
Uptake of CD4 testing at antenatal carePatients 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
Use of appropriate ARVs in pregnancy for prophylaxis or initiation of ART during pregnancyPatients 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
Infant HIV determination6 weeks post-partum\# infants \<6 weeks of age receiving a PCR test/# women testing HIV-positive in ANC 5 months previously

Countries

Côte d’Ivoire, Kenya, Mozambique

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026