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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04115124
Other study ID # ST-POC-1908-25739
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 30, 2019
Est. completion date June 30, 2020

Study information

Verified date October 2019
Source Lifespan Healthcare Resource Limited
Contact Emmanuel Ihedioha, MD
Phone 23407038861841
Email emmanuel.ihedioha@lifespanhcr.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 59 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Nigeria Oduma Oduma Ebonyi

Sponsors (1)

Lead Sponsor Collaborator
Lifespan Healthcare Resource Limited

Country where clinical trial is conducted

Nigeria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Female Genital mutilation Secondary to Ethnographic Participatory Action Research(PAR) Intervention. Number of Cut Girls secondary to PAR Intervention. 12 months
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