NCT04115124

Brief Summary

Female Genital Mutilation(FGM) is a harmful practice on girls and women which causes irreparable sexual, reproductive and psychological harm. It is an act of violence, extreme discrimination and fundamental human rights violation against women and girls. This practice leaves victims feeling scared, psychologically scarred and distressed. FGM sustains deep rooted inequality between the sexes, constitutes a barrier to female civic participation and social inclusion and therefore, leads to inequitable socio- economic growth and prosperity. The World Health Organization(WHO) estimates that an alarming 200 million girls alive today have undergone FGM, while an estimated 3 million girls are at risk annually. A common factor influencing the continuation of FGM is the need to conform to social norms. Social norms among other roles, influence behaviors that shape people's ability to protect their health and achieve their life potential. Methods: The investigators have designed a quasi-experimental comparison group pre-post test study involving members of Oduma, Okigwe, Nkerefi, Edda communities in Eastern Nigeria. Our study will run for a period of 12 months. The investigators expect that the outcome of this study will lead to policy changes placing emphasis on using participatory action research in addressing FGM in Nigeria.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

October 2, 2019

Last Update Submit

October 3, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of Female Genital mutilation Secondary to Ethnographic Participatory Action Research(PAR) Intervention.

    Number of Cut Girls secondary to PAR Intervention.

    12 months

Study Arms (1)

E-PAR Arm

EXPERIMENTAL

Exposed to media, information and communication technology through ethnographic participatory action research.

Behavioral: Participatory Action Research

Interventions

The research will employ a Participatory Action research quasi-experimental pre-post test study design .

E-PAR Arm

Eligibility Criteria

Age1 Year - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Consenting Participants living in the intervention communities.
  • Consenting community health workers working in the intervention communities.
  • Consenting patent medicine sellers working in the intervention communities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oduma

Oduma, Ebonyi State, Nigeria

RECRUITING

MeSH Terms

Conditions

Social Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Emmanuel Ihedioha, MD

    Lifespan Heathcare Resource

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 3, 2019

Study Start

June 30, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

October 7, 2019

Record last verified: 2019-10

Locations