Impact of a Smartphone Intervention on Tanzanian Women's Childbirth Location (SUSTAIN1)

Evaluation of an mHealth Intervention to Improve Women's Access to Maternal Health Services in Rural Tanzania

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.

Study Overview

• Status: Completed
• Conditions: Obstetric Complication; Delivery Complication; Delivery; Injury, Maternal; Birth Injuries; Delivery Problem for Fetus; Maternal Death Affecting Fetus or Newborn
• Intervention / Treatment: Behavioral: SUSTAIN Paperbased training of CHW (SOC); Behavioral: SUSTAIN Smartphone training of CHW (SP+)

Detailed Description

In low-income countries, frontline community health workers (CHWs) have potential to improve women's access to maternal health services through prenatal counseling and referral. However, CHW performance can often be enhanced with sufficient training, incentives, supportive supervision and job aids. Smartphone-based applications designed to assist CHWs with referrals, health education and client counseling may improve the quality of care delivered during household visits. There is a need for rigorous scientific studies on the impact of such interventions.

This study investigates whether CHWs' use of a smartphone-based application increases women's use of maternal health services in Singida region, Tanzania. It is hypothesized that smartphone-assisted counselling by CHWs can increase use of health facility-based delivery services compared to a control group of CHWs using standard paper-based protocols. This study is conducted within the context of larger project - SUSTAIN-MNCH Project (Supporting Systems to Improve Nutrition, Maternal, Newborn and Child Health), implemented by World Vision through multiple partners.

• Study Type: Interventional
• Enrollment (Actual): 572
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control (paper based); 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); 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.
Experimental: Intervention (Smart phone assisted); 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 Paperbased training of CHW (SOC); 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.; Behavioral: SUSTAIN Smartphone training of CHW (SP+); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age at first contact/ANC	Number of months into pregnancy the participant had first ANC visit	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	Whether participant received 100 IFA tablets 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	Whether the participant was screened for HIV 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)
De-worming treatment during pregnancy	Whether the participant reported during interview taking any listed de-worming medication 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	Whether the participant slept under an insecticide treated bed net 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)
Malaria prophylaxis during pregnancy	Whether the participant reported during interview receiving two doses of IPTp 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)
Tetanus Toxoid Vaccination	Whether the participant received two TT vaccinations 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)
Referrals	Whether the participant was referred to a clinic during pregnancy by a CHW	Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Referral uptake	Whether a referred participant went to the facility 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)
Presence of partner at ANC	Whether the participant's husband/spouse accompanied her to at least one ANC visit	Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Birth plan	Whether the participant developed a birth plan 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)
Early initiation of breastfeeding	Whether the participant initiated breastfeeding within 1 hour after birth	Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Exclusive breastfeeding at 7 days	Whether the participant breastfed exclusively for the first week after birth	Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
BCG vaccination	Whether the participant's child received BCG vaccination within the first week of life	Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Maternal knowledge of danger signs during pregnancy	Number of pregnancy danger signs listed by participant	Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: World Vision; Muhimbili University of Health and Allied Sciences
• Investigators: Principal Investigator: Daniel W Sellen, PhD, University of Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2013
• Primary Completion (Actual): June 25, 2014
• Study Completion (Actual): June 25, 2014

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Tanzania; evaluation; maternal health; community health; health services; cluster randomized trial
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Death; Parental Death; Wounds and Injuries; Dystocia; Maternal Death; Birth Injuries; Anti-Infective Agents; Sulfamethazine
• Other Study ID Numbers: 28832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing raw data is inconsistent with what was stated in the ethics application form and participant informed consent materials.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No