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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03161184
Other study ID # 28832
Secondary ID
Status Completed
Phase N/A
First received May 1, 2017
Last updated May 18, 2017
Start date July 23, 2013
Est. completion date June 25, 2014

Study information

Verified date May 2017
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 572
Est. completion date June 25, 2014
Est. primary completion date June 25, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years to 49 Years
Eligibility 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:

Study Design


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of Toronto Muhimbili University of Health and Allied Sciences, World Vision

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
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