NCT03161184

Brief Summary

This study investigates whether training Community Health Workers (CHW) to use a smartphone-based prenatal counseling application as a "job aid" instead of the existing paper based standard is associated with increased women's use of maternal health services in Singida region, Tanzania.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
572

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2014

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

May 1, 2017

Last Update Submit

May 18, 2017

Conditions

Keywords

maternal healthcommunity healthhealth servicesTanzaniaevaluationcluster randomized trial

Outcome Measures

Primary Outcomes (2)

  • Delivery in a facility

    Participant delivered at or on the way to a health facility, measured by retrospective report at time of interview, after delivery

    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)

  • Antenatal care attendance

    Whether participant attended 4 ANC visits or more during their most recent pregnancy

    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)

Secondary Outcomes (15)

  • Gestational age at first contact/ANC

    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)

  • Iron supplementation during pregnancy

    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)

  • HIV screening HIV Screening

    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)

  • De-worming treatment during pregnancy

    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)

  • Bednet use

    Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)

  • +10 more secondary outcomes

Study Arms (2)

Control (paper based)

ACTIVE COMPARATOR

Women received prenatal household visits from CHWs who were trained on the Tanzania Ministry of Health and Social Welfare's National integrated Maternal, Newborn and Child Health (i-MNCH) paper-based protocols, i.e. received intervention "SUSTAIN Paperbased training of CHW (SOC)"

Behavioral: SUSTAIN Paperbased training of CHW (SOC)

Intervention (Smart phone assisted)

EXPERIMENTAL

Women received prenatal household visits from CHWs trained on the following: A) National i-MNCH programme; and B) Smartphone-assisted counseling protocol: a smartphone application designed to assist with identification of danger signs during pregnancy, referral to health facilities, and MNCH counseling , i.e. received intervention "SUSTAIN Smartphone training of CHW (SP+)"

Behavioral: SUSTAIN Smartphone training of CHW (SP+)Behavioral: SUSTAIN Paperbased training of CHW (SOC)

Interventions

Intervention (Smart phone assisted): During prenatal household visits, the smart phone based application guides CHW through electronic "decision tree" protocols, directing them to specific health/nutrition counseling topics and messages based on each woman's gestational age, and her answers to a specific series of diagnostic questions. Based on the client's gestational age, the tool directs CHW to lessons in an accompanying photo book, and reminds them to counsel on the importance of accessing timed and targeted maternal health services at health facilities. The application also assists CHW to identify danger signs during pregnancy, flags clients who require immediate referral to health facilities, and reminds CHW to follow-up with clients who were previously referred to clinics.

Intervention (Smart phone assisted)

SUSTAIN Paperbased training of CHW (SOC): During prenatal household visits, the CHW asks a specific series of diagnostic questions based on the client's gestational age, offers counsel on the importance of accessing appropriate maternal health services at health facilities and uses lessons in an accompanying photo book to deliver messages on a variety of maternal and newborn health and nutrition topics. CHW are trained to identify danger signs during pregnancy, flag clients who require immediate referral to health facilities, and follow-up with clients who were previously referred to clinics.

Control (paper based)Intervention (Smart phone assisted)

Eligibility Criteria

Age16 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipant eligibility is based on self-representation of gender identity
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • client of one of the CHWs enrolled in the mHealth study
  • visited at least once by a CHW following intervention (baseline training for CHWs) and during their most recent pregnancy
  • most recent delivery was a live birth and the child is still living

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hackett K, Lafleur C, Nyella P, Ginsburg O, Lou W, Sellen D. Impact of smartphone-assisted prenatal home visits on women's use of facility delivery: Results from a cluster-randomized trial in rural Tanzania. PLoS One. 2018 Jun 18;13(6):e0199400. doi: 10.1371/journal.pone.0199400. eCollection 2018.

MeSH Terms

Conditions

Birth InjuriesWounds and Injuries

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Daniel W Sellen, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants assigned to one of two groups in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 1, 2017

First Posted

May 19, 2017

Study Start

July 23, 2013

Primary Completion

June 25, 2014

Study Completion

June 25, 2014

Last Updated

May 19, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Sharing raw data is inconsistent with what was stated in the ethics application form and participant informed consent materials.