Behavior, SocialNCT04115124
Using Ethnographic Participatory Action Research to Decrease the Incidence of Female Genital Mutilation in Nigeria
A study testing Participatory Action Research in people with Behavior, Social, run by Lifespan Healthcare Resource Limited at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Social
- What is being tested?
- Participatory Action Research
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteNigeria
- Study dates
- 30 Jun 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Behavior, Social
- Being tested
- Participatory Action Research
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participatory Action ResearchBehavioural
The research will employ a Participatory Action research quasi-experimental pre-post test study design .
| Study group | Role | What they receive |
|---|---|---|
| E-PAR Arm | Experimental | Exposed to media, information and communication technology through ethnographic participatory action research. Receives: Behavioral: Participatory Action Research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Female Genital mutilation Secondary to Ethnographic Participatory Action Research(PAR) Intervention.
Number of Cut Girls secondary to PAR Intervention.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start30 Jun 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifespan Healthcare Resource Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Ihedioha Emmanuel Chukwunwike, Lifespan Healthcare Resource Limited
- Investigators
- Emmanuel Ihedioha, MD, Principal investigator, Lifespan Heathcare Resource
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115124
- Sponsor's protocol ID
- ST-POC-1908-25739
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 7 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ethnographic Participatory Action Research In Decreasing the Incidence of Female Genital Mutilation in Nigeria
- ClinicalTrials.gov ID
- NCT04115124
- Acronym / sponsor ID
- ST-POC-1908-25739
- Conditions
- Behavior, Social
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Lifespan Healthcare Resource LimitedUniversity, hospital or other
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-PAR Arm | Experimental | Behavioral: Participatory Action ResearchExposed to media, information and communication technology through ethnographic participatory action research. |
Who may qualify
- Ages
- 1 year to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participatory Action ResearchThe research will employ a Participatory Action research quasi-experimental pre-post test study design . | Behavioural | E-PAR Arm |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Ihedioha, MD principal investigator
Lifespan Heathcare Resource
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participatory Action Research in people with Behavior, Social, run by Lifespan Healthcare Resource Limited at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel Ihedioha, MD (23407038861841 ext. 23407038861841, emmanuel.ihedioha@lifespanhcr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Female Genital mutilation Secondary to Ethnographic Participatory Action Research(PAR) Intervention. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.