CClinicalTrials.gg
CompletedNCT04039932Updated Oct 27, 2021

Faith Leaders Advocating for Maternal Empowerment (FLAME)

An interventional study of FLAME in Prenatal Care, Maternal Health Services and Perinatal Care, sponsored by University of Washington. Completed at 1 site in Ethiopia. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-27.

Sponsored by University of Washington · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jun 2018, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Sex
Female
01

Study 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.

02

Conditions studied

  • Prenatal Care
  • Maternal Health Services
  • Perinatal Care
03

In context

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Pregnant women
  • Willing to receive intervention counseling

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Intervention

    Behavioral: FLAME

  • No intervention
    Standard of Care

Interventions

  • BehavioralFLAME

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

06

What researchers measure

Primary outcomes

  1. Facility delivery

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

    Time frame: Through study completion, an average of 18 months

Secondary outcomes

  1. Any ANC

    Number of women who attended ≥1 ANC visits

    Time frame: Through study completion, an average of 18 months

  2. Complete ANC

    Number of women who attended ANC 4

    Time frame: Through study completion, an average of 18 months

07

Study locations

1 site
  • University of Gondar
    Gondar, Amhara P.O. Box 126, Ethiopia
08

References and documents

Publications

  • 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. PubMed 34737863 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04039932
Lead sponsor
University of Washington
Collaborators
University of Gondar
Responsible party
Brandon Guthrie (Assistant Professor, School of Public Health, Global Health, University of Washington) — Principal investigator
First posted
Jul 31, 2019
Start date
Jun 1, 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Oct 27, 2021

Study contacts

Brandon Guthrie, PhD
principal investigator · University of Washington

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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