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Clinical Trials/NCT02191527
NCT02191527
Completed
Not Applicable

Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services and Their Impact on Mother and Child Health Outcomes in Cabo Delgado Province, Mozambique

Elizabeth Glaser Pediatric AIDS Foundation0 sites1,673 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
Elizabeth Glaser Pediatric AIDS Foundation
Enrollment
1673
Primary Endpoint
The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The general goal of the proposed study is to evaluate the cost-effectiveness of POC technologies for diagnosis of syphilis, quantitative analysis for hemoglobin and CD4 counting performed within MCH services to improve maternal and infant health.

A prospective, quasi-experimental study will be done in Cabo Delgado province, where health facilities will be randomized in an intervention or comparison arm. Outcomes on maternal and infant health will be measured.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
February 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • First antenatal care visit
  • Able to provide informed consent and signed consent form
  • Minimum 18 years of age
  • Diagnosed HIV positive at antenatal care visit
  • Living in the catchment area of the health facility

Exclusion Criteria

  • Age \<18 years
  • No consent form signed
  • Being on ART at time of first antenatal care visit

Outcomes

Primary Outcomes

The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women.

Time Frame: Within 1 month

Number of HIV positive pregnant women initiating antiretroviral therapy divided by the number of eligible HIV positive pregnant women

Secondary Outcomes

  • The proportion of pregnant women tested and treated for anemia(Within 1 month)
  • Number of HIV infections in infants averted(1-3 months of age)
  • Proportion of women at first ANC visit tested and treated for syphilis(Within 1 month)

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