Clinical trial NCT03161184: Impact of a Smartphone Intervention on Tanzanian Women's Childbirth Location
Official title: Evaluation of an mHealth Intervention to Improve Women's Access to Maternal Health Services in Rural Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Death Affecting Fetus or Newborn
Delivery Complication
Obstetric Complication
Birth Injuries
Delivery; Injury, Maternal
Delivery Problem for Fetus
Keywords: maternal health
community health
health services
Tanzania
evaluation
cluster randomized trial
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: World Vision
name: Muhimbili University of Health and Allied Sciences
First posted: 2017-05-19
Enrollment: 572
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants assigned to one of two groups in parallel for the duration of the study
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delivery in a facility
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
measure: Antenatal care attendance
timeFrame: 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:
measure: Gestational age at first contact/ANC
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
measure: Iron supplementation during pregnancy
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
measure: HIV screening HIV Screening
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
measure: De-worming treatment during pregnancy
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
measure: Bednet use
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
measure: Malaria prophylaxis during pregnancy
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
measure: Tetanus Toxoid Vaccination
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
measure: Referrals
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
measure: Referral uptake
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
measure: Presence of partner at ANC
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
measure: Birth plan
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
measure: Early initiation of breastfeeding
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
measure: Exclusive breastfeeding at 7 days
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
measure: BCG vaccination
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
measure: Maternal knowledge of danger signs during pregnancy
timeFrame: Time between the participant's first prenatal visit by a trained CHW and the date of the postnatal household interview (up to 10 months)
Other outcomes:
Locations:
Study officials:
affiliation: University of Toronto
name: Daniel W Sellen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.