Supporting Attendance for Facility Delivery and Infant Health

Not Applicable

Completed

• Conditions: AIDS; HIV
• Interventions: Behavioral: Transport Payments; Behavioral: mHealth messaging

• Registration Number: NCT03023033
• Lead Sponsor: Elizabeth Glaser Pediatric AIDS Foundation

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).

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-02-27
• Primary Completion: 2016-03
• Study Completion: 2016-11
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-18
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1505

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinic group 2	Transport Payments	Clinics using SMS health promotion and reminder messages + Clinics providing payment scaled to reflect typical transport costs to facility (transport payments)
Clinic group 1	mHealth messaging	Clinics using SMS health promotion and reminder messages (mhealth messaging)

Primary Outcome Measures

Name	Time	Method
Early identification of HEI at Reproductive and Child Health (RCH) Clinic	1 year	Proportion of HEI identified early (48 hours,3 and 7 days) at RCH clinic
Antenatal care (ANC) visits	1 year	Proportion of pregnant women attending at least 4 ANC visits
Facility delivery	1 year	Proportion of pregnant women delivering in a health facility
Post natal care (PNC) visits	1 year	Proportion of post partum women attending PNC 48 hours, 3 and 7 days post delivery
Nevirapine (NVP) at delivery	1 year	Proportion of HEI given NVP at delivery
Attendance for Early infant diagnosis (EID) of HIV	1 year	Proportion of HIV-exposed infants (HEI) attending for early infant diagnosis of HIV (DBS collected) by 8 weeks

Secondary Outcome Measures

Name	Time	Method
Receipt of EID results	1 year	Proportion of HEI who received EID results by 12 weeks
Time to receipt of EID results	1 year	Time (days/weeks) from date of birth to receipt of EID results
Time to treatment	! year	Time (days/weeks) from date of birth to initiation of ART
HIV infected infants initiated on antiretroviral therapy (ART)	1 year	Proportion of HIV infected infants initiated on ART by 12 weeks of age
Time to EID	1 year	Time (days/weeks) from date of birth to attendance for EID

Trial Locations

Locations (1)

Elizabeth Glaser Pediatric AIDS Foundation; 🇹🇿 Dar es Salaam, Tanzania