Faith Leaders Advocating for Maternal Empowerment (FLAME)

NCT04039932 | Completed

• 1 other identifier: STUDY00001662
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

In 2015, the average Ethiopian woman had a 1 in 64 lifetime risk of death due to complications of childbirth and 87,414 newborns died before their 28th day of life. Demand for MNCH services, however, remains low in Ethiopia's rural communities most at risk with only 16% of women delivering in a health facility. The investigator's project responds to the challenge of creating demand for existing MNCH services in rural Ethiopia, which fell short of reaching Millennium Development Goal targets for reducing preventable maternal and neonatal deaths. This study addresses two strategic drivers to prevent maternal mortality identified by USAID including improving individual, household, and community behaviors and norms and increasing equity of access and use of services by the most vulnerable. The primary objective of the study is to determine the impact of a behavior change intervention that partners Ethiopian Orthodox priests with members of the Health Development Army (HDA) and trains them to conduct maternal health outreach to increase births attended by skilled health personnel among women who attend ≥1 ANC visits.

Conditions

Prenatal Care; Maternal Health Services; Perinatal Care

Outcome Measures

Primary Outcomes (1)

• Facility delivery

  The proportion of births attended by skilled health personnel among the women who attended ≥1 ANC visits

  Through study completion, an average of 18 months

Secondary Outcomes (2)

• Any ANC

  Through study completion, an average of 18 months

• Complete ANC

  Through study completion, an average of 18 months

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: FLAME

Standard of Care

NO INTERVENTION

Interventions

FLAME BEHAVIORAL

The FLAME intervention trains pairs of faith leaders and community health workers and deploys them to conduct behavior change outreach in their communities.

Intervention

Eligibility Criteria

• Gender Eligibility Details: Limited to pregnant women with female sex assigned at birth
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women
• Willing to receive intervention counseling

You may not qualify if:

• None

Sponsors & Collaborators

• University of Washington: lead
• University of Gondar: collaborator

Study Sites (1)

University of Gondar

Gonder, Amhara, P.O. Box 126, Ethiopia

Location

Related Publications (1)

• Guthrie BL, Tsegaye AT, Rankin KC, Walson JL, Alemie GA. Partnering faith leaders with community health workers increases utilization of antenatal care and facility delivery services in Ethiopia: A cluster randomized trial. J Glob Health. 2021 Oct 30;11:04063. doi: 10.7189/jogh.11.04063. eCollection 2021.

  PMID: 34737863 DERIVED

Study Officials

• Brandon Guthrie, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Public Health, Global Health

Model Details: Cluster randomized trial assigning facility catchment areas to intervention vs. standard of care

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 31, 2019
• Study Start: June 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)