Faith Leaders Advocating for Maternal Empowerment (FLAME)

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT04039932

Collaborator

University of Gondar (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prenatal Care Maternal Health Services Perinatal Care	Behavioral: FLAME	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cluster randomized trial assigning facility catchment areas to intervention vs. standard of careCluster randomized trial assigning facility catchment areas to intervention vs. standard of care

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Faith Leaders Advocating for Maternal Empowerment (FLAME)

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention	Behavioral: FLAME The FLAME intervention trains pairs of faith leaders and community health workers and deploys them to conduct behavior change outreach in their communities.
No Intervention: Standard of Care

Arm

Intervention/Treatment

Experimental: Intervention

Behavioral: FLAME

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

No Intervention: Standard of Care

Outcome Measures

Primary Outcome Measures

Facility delivery [Through study completion, an average of 18 months]
The proportion of births attended by skilled health personnel among the women who attended ≥1 ANC visits

Secondary Outcome Measures

Any ANC [Through study completion, an average of 18 months]
Number of women who attended ≥1 ANC visits
Complete ANC [Through study completion, an average of 18 months]
Number of women who attended ANC 4

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Pregnant women
Willing to receive intervention counseling

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Gondar	Gondar	Amhara	Ethiopia	P.O. Box 126

Sponsors and Collaborators

University of Washington
University of Gondar

Investigators

Principal Investigator: Brandon Guthrie, PhD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brandon Guthrie, Assistant Professor, School of Public Health, Global Health, University of Washington

ClinicalTrials.gov Identifier:

NCT04039932

Other Study ID Numbers:

STUDY00001662

First Posted:

Jul 31, 2019

Last Update Posted:

Oct 27, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 27, 2021