Systems Analysis and Improvement to Optimize pMTCT

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Other: pMTCT systems analysis and improvement


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systems analysis and improvement<br>pMTCT systems analysis and improvement | Other: pMTCT systems analysis and improvement<br>* Five-step systems analysis and iterative improvement cycles carried out over a six-month period in intervention facilities.<br>|
| No Intervention: Control<br>No systems analysis and improvement intervention for prevention of mother to child HIV transmission services in place. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of HIV counseling and testing at first antenatal care visit | # women counseled and tested for HIV in their first ANC visit/# first ANC visits | Patients will be assessed at first antenatal care visit (average of 25 weeks gestational age) | 
| Uptake of CD4 testing at antenatal care | # CD4 counts of HIV-infected pregnant women/# HIV-infected women newly identified in ANC | Patients will be assessed during the antenatal care period (average of 25-40 weeks gestational age) | 
| Use of appropriate ARVs in pregnancy for prophylaxis or initiation of ART during pregnancy | # HIV-infected pregnant women starting AZT prophylaxis or ART /# women testing HIV-positive in ANC 3 months previously | Patients will be assessed during the antenatal care period (average of 25-40 weeks gestational age) | 
| Infant HIV determination | # infants <6 weeks of age receiving a PCR test/# women testing HIV-positive in ANC 5 months previously | 6 weeks post-partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, pMTCT