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Clinical Trials/NCT03023033
NCT03023033
Completed
Not Applicable

Enhancing Retention in PMTCT/MNCH Services and Facility Delivery in Tabora, Tanzania

Elizabeth Glaser Pediatric AIDS Foundation1 site in 1 country1,505 target enrollmentOctober 2014
ConditionsHIVAIDS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
Elizabeth Glaser Pediatric AIDS Foundation
Enrollment
1505
Locations
1
Primary Endpoint
Early identification of HEI at Reproductive and Child Health (RCH) Clinic
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The goal of this proposed intervention study is to increase the proportion of HIV positive and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing within 8 weeks of age.

Detailed Description

Following a formative phase I, we propose in phase II to implement a three-group cluster-randomized study to test the effectiveness of short message service (SMS) reminders and notifications, \[mobile health or mhealth\] (group 1) and the combined effectiveness of SMS reminders/notifications and cash transfers (group 2) compared to the standard prevention of mother-to-child transmission (of HIV)/maternal, neonatal and child health, (PMTCT/MNCH) practices (group 3).

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
November 2016
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Known or recently diagnosed HIV-positive in ANC or; Tested HIV-negative at ANC
  • Plans to deliver in facility catchment area
  • 18 years or older
  • Able and willing to provide consent

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Early identification of HEI at Reproductive and Child Health (RCH) Clinic

Time Frame: 1 year

Proportion of HEI identified early (48 hours,3 and 7 days) at RCH clinic

Antenatal care (ANC) visits

Time Frame: 1 year

Proportion of pregnant women attending at least 4 ANC visits

Facility delivery

Time Frame: 1 year

Proportion of pregnant women delivering in a health facility

Post natal care (PNC) visits

Time Frame: 1 year

Proportion of post partum women attending PNC 48 hours, 3 and 7 days post delivery

Nevirapine (NVP) at delivery

Time Frame: 1 year

Proportion of HEI given NVP at delivery

Attendance for Early infant diagnosis (EID) of HIV

Time Frame: 1 year

Proportion of HIV-exposed infants (HEI) attending for early infant diagnosis of HIV (DBS collected) by 8 weeks

Secondary Outcomes

  • Receipt of EID results(1 year)
  • Time to receipt of EID results(1 year)
  • Time to treatment(! year)
  • HIV infected infants initiated on antiretroviral therapy (ART)(1 year)
  • Time to EID(1 year)

Study Sites (1)

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