Faith Leaders Advocating for Maternal Empowerment (FLAME)

NCT ID: NCT04039932

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prenatal Care Maternal Health Services Perinatal Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized trial assigning facility catchment areas to intervention vs. standard of care
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

FLAME

Intervention Type BEHAVIORAL

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

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FLAME

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Pregnant women
* Willing to receive intervention counseling

Exclusion Criteria

* None
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Gondar

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Brandon Guthrie

Assistant Professor, School of Public Health, Global Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brandon Guthrie, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Gondar

Gonder, Amhara, Ethiopia

Site Status

Countries

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Ethiopia

References

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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.

Reference Type DERIVED
PMID: 34737863 (View on PubMed)

Other Identifiers

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STUDY00001662

Identifier Type: -

Identifier Source: org_study_id