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Supporting Attendance for Facility Delivery and Infant Health

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03023033
Acronym
SAFI
Enrollment
1505
Registered
2017-01-18
Start date
2014-10-31
Completion date
2016-11-30
Last updated
2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS, HIV

Keywords

PMTCT, MNCH

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).

Interventions

BEHAVIORALmHealth messaging

SMS appointment reminders and health messaging via mobile phones

BEHAVIORALTransport Payments

A payment scaled to reflect the cost of typical return transport fare for residents of the clinic catchment area

Sponsors

Population Council
CollaboratorOTHER
Ministry of Health, Tanzania
CollaboratorOTHER_GOV
Elizabeth Glaser Pediatric AIDS Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

\-

Design outcomes

Primary

MeasureTime frameDescription
Nevirapine (NVP) at delivery1 yearProportion of HEI given NVP at delivery
Attendance for Early infant diagnosis (EID) of HIV1 yearProportion 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) Clinic1 yearProportion of HEI identified early (48 hours,3 and 7 days) at RCH clinic
Antenatal care (ANC) visits1 yearProportion of pregnant women attending at least 4 ANC visits
Facility delivery1 yearProportion of pregnant women delivering in a health facility
Post natal care (PNC) visits1 yearProportion of post partum women attending PNC 48 hours, 3 and 7 days post delivery

Secondary

MeasureTime frameDescription
HIV infected infants initiated on antiretroviral therapy (ART)1 yearProportion of HIV infected infants initiated on ART by 12 weeks of age
Time to EID1 yearTime (days/weeks) from date of birth to attendance for EID
Time to receipt of EID results1 yearTime (days/weeks) from date of birth to receipt of EID results
Time to treatment! yearTime (days/weeks) from date of birth to initiation of ART
Receipt of EID results1 yearProportion of HEI who received EID results by 12 weeks

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026