Supporting Attendance for Facility Delivery and Infant Health

NCT ID: NCT03023033

Last Updated: 2021-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1505 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-11-30

Brief Summary

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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

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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).

Conditions

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HIV AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Clinic group 1

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

Group Type EXPERIMENTAL

mHealth messaging

Intervention Type BEHAVIORAL

SMS appointment reminders and health messaging via mobile phones

Clinic group 2

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

Group Type EXPERIMENTAL

Transport Payments

Intervention Type BEHAVIORAL

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

Clinic group 3

Services provided under the Ministry of Health standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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mHealth messaging

SMS appointment reminders and health messaging via mobile phones

Intervention Type BEHAVIORAL

Transport Payments

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Population Council

OTHER

Sponsor Role collaborator

Ministry of Health, Tanzania

OTHER_GOV

Sponsor Role collaborator

Elizabeth Glaser Pediatric AIDS Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Godfrey Woelk, MCOMMH, PhD

Role: PRINCIPAL_INVESTIGATOR

Elizabeth Glaser Pediatric AIDS Foundation

Locations

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Elizabeth Glaser Pediatric AIDS Foundation

Dar es Salaam, , Tanzania

Site Status

Countries

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Tanzania

References

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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.

Reference Type DERIVED
PMID: 32813276 (View on PubMed)

Other Identifiers

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EG0130

Identifier Type: -

Identifier Source: org_study_id

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