Supporting Attendance for Facility Delivery and Infant Health (SAFI)

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

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.

Study Overview

• Status: Completed
• Conditions: HIV; AIDS
• Intervention / Treatment: Behavioral: mHealth messaging; Behavioral: Transport Payments

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 Type: Interventional
• Enrollment (Actual): 1505
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Dar es Salaam, Tanzania
    • Elizabeth Glaser Pediatric AIDS Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinic group 1; Clinics using SMS health promotion and reminder messages (mhealth messaging)	Behavioral: mHealth messaging; SMS appointment reminders and health messaging via mobile phones
Experimental: Clinic group 2; Clinics using SMS health promotion and reminder messages + Clinics providing payment scaled to reflect typical transport costs to facility (transport payments)	Behavioral: Transport Payments; A payment scaled to reflect the cost of typical return transport fare for residents of the clinic catchment area
No Intervention: Clinic group 3; Services provided under the Ministry of Health standard care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation
• Collaborators: Population Council; Ministry of Health, Tanzania
• Investigators: Principal Investigator: Godfrey Woelk, MCOMMH, PhD, Elizabeth Glaser Pediatric AIDS Foundation

Publications and helpful links

General Publications

• Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: PMTCT; MNCH
• Other Study ID Numbers: EG0130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The dataset has been given to the USAID, the study sponsor. There is a plan to made these data publically available from 2018
• IPD Sharing Time Frame: The plan is for the data to become available in 2018
• IPD Sharing Access Criteria: Access criteria will be defined by USAID
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)