Supporting Attendance for Facility Delivery and Infant Health

HIV Clinical Trial

— SAFI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023033
• Other study ID #: EG0130
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: November 2016

Study information

• Verified date: February 2021
• Source: Elizabeth Glaser Pediatric AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1505
• Est. completion date: November 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• AIDS
• HIV

Intervention

Behavioral:
• mHealth messaging
SMS appointment reminders and health messaging via mobile phones
• Transport Payments
A payment scaled to reflect the cost of typical return transport fare for residents of the clinic catchment area

Locations

Country	Name	City	State
Tanzania	Elizabeth Glaser Pediatric AIDS Foundation	Dar es Salaam

Sponsors (3)

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

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Antenatal care (ANC) visits	Proportion of pregnant women attending at least 4 ANC visits	1 year
Primary	Facility delivery	Proportion of pregnant women delivering in a health facility	1 year
Primary	Post natal care (PNC) visits	Proportion of post partum women attending PNC 48 hours, 3 and 7 days post delivery	1 year
Primary	Nevirapine (NVP) at delivery	Proportion of HEI given NVP at delivery	1 year
Secondary	Receipt of EID results	Proportion of HEI who received EID results by 12 weeks	1 year
Secondary	HIV infected infants initiated on antiretroviral therapy (ART)	Proportion of HIV infected infants initiated on ART by 12 weeks of age	1 year
Secondary	Time to EID	Time (days/weeks) from date of birth to attendance for EID	1 year
Secondary	Time to receipt of EID results	Time (days/weeks) from date of birth to receipt of EID results	1 year
Secondary	Time to treatment	Time (days/weeks) from date of birth to initiation of ART	! year