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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Maternal Death Affecting Fetus or Newborn, Delivery Complication, Obstetric Complication, Birth Injuries, Delivery; Injury, Maternal, Delivery Problem for Fetus

Intervention / Treatment
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* Behavioral: SUSTAIN Smartphone training of CHW (SP+)
* Behavioral: SUSTAIN Paperbased training of CHW (SOC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants assigned to one of two groups in parallel for the duration of the study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control (paper based)<br>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)<br>* 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.<br>|
| Experimental: Intervention (Smart phone assisted)<br>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+)<br>* 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.<br>Behavioral: SUSTAIN Paperbased training of CHW (SOC)<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maternal health, community health, health services, Tanzania, evaluation, cluster randomized trial