SAFI: Supporting Attendance for Facility Delivery and Infant Health

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT03023033

Collaborator

Population Council (Other), Ministry of Health, Tanzania (Other)

1,505

Enrollment

Location

Arms

Duration (Months)

60.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV AIDS	Behavioral: mHealth messaging Behavioral: Transport Payments	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

1505 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

Receipt of EID results [1 year]
Proportion of HEI who received EID results by 12 weeks
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Elizabeth Glaser Pediatric AIDS Foundation	Dar es Salaam		Tanzania

Sponsors and Collaborators

Elizabeth Glaser Pediatric AIDS Foundation
Population Council
Ministry of Health, Tanzania

Investigators

Principal Investigator: Godfrey Woelk, MCOMMH, PhD, Elizabeth Glaser Pediatric AIDS Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elizabeth Glaser Pediatric AIDS Foundation

ClinicalTrials.gov Identifier:

NCT03023033

Other Study ID Numbers:

EG0130

First Posted:

Jan 18, 2017

Last Update Posted:

Feb 8, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Elizabeth Glaser Pediatric AIDS Foundation

PMTCT

MNCH

Study Results

No Results Posted as of Feb 8, 2021