Using Ethnographic Participatory Action Research to Decrease the Incidence of Female Genital Mutilation in Nigeria

October 3, 2019 updated by: Dr.Ihedioha Emmanuel Chukwunwike, Lifespan Healthcare Resource Limited

The Efficacy of Ethnographic Participatory Action Research In Decreasing the Incidence of Female Genital Mutilation in Nigeria

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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 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 community in Ebonyi state. This research 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

Rationale There is a considerable lack of information on the efficacy of interventions to reduce the prevalence of FGM in Nigeria. In addition, this research study is needed to provide critical updated information on the efficacy of participatory action research in improving communities knowledge and attitude towards SHRH and how this affects the prevalence of FGM.

Objectives:

To determine the efficacy of e- PAR in reducing the incidence of FGM in Nigeria.

To determine the efficacy of e-PAR in improving Sexual Reproductive Health and Rights(SRHR) knowledge.

To determine the efficacy of e-PAR in improving Sexual Reproductive Health and Rights (SRHR) attitudes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Nigeria
    • Ebonyi
      • Oduma, Ebonyi, Nigeria
        • Recruiting
        • Oduma
        • Contact:
          • Joy Amanze

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 59 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: E-PAR Arm
Exposed to media, information and communication technology through ethnographic participatory action research.
Behavioral: Participatory Action Research
The research will employ a Participatory Action research quasi-experimental pre-post test study design .

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Female Genital mutilation Secondary to Ethnographic Participatory Action Research(PAR) Intervention.
Time Frame: 12 months
Number of Cut Girls secondary to PAR Intervention.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lifespan Healthcare Resource Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emmanuel Ihedioha, MD, Lifespan Heathcare Resource

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ST-POC-1908-25739

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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