Supporting Attendance for Facility Delivery and Infant Health (SAFI)

Elizabeth Glaser Pediatric AIDS Foundation

Status: Completed

Conditions: AIDS; HIV

Treatments: Behavioral: mHealth messaging; Behavioral: Transport Payments

Study type: Interventional

Funder types: Other

Identifiers

NCT03023033

EG0130

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,505 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,505 participants in 3 patient groups

Clinic group 1

Experimental group

Description:

Clinics using SMS health promotion and reminder messages (mhealth messaging)

Treatment:

Behavioral: mHealth messaging

Clinic group 2

Experimental group

Description:

Clinics using SMS health promotion and reminder messages + Clinics providing payment scaled to reflect typical transport costs to facility (transport payments)

Treatment:

Behavioral: Transport Payments

Clinic group 3

No Intervention group

Description:

Services provided under the Ministry of Health standard care