NCT06119984

Brief Summary

Background: Intimate partner violence is arguably the most prevalent, persistent and pernicious type of violence against women, all around the world. It also has significant repercussions for women's health, yet, in some parts of the world, considered an acceptable practice within intimate partner relationships. Community-based interventions, on the other hand, offer promises as a strategy that can get community members involved in working to prevent IPV. This study evaluated a community mobilisation intervention to challenge attitudes toward IPV and prevent violence within intimate relationships. Methods: This mixed-method randomised community trial was conducted in selected rural communities in Oyo State, Nigeria, between January 2018 and April 2021. It employed a six-month community mobilisation intervention focused on creating awareness and challenging harmful social norms relating to IPV. In-depth interviews, focus group discussions and two cross-sectional surveys were conducted among men and women of reproductive age who were married at baseline and end line to estimate changes in key outcomes. Difference-in-difference regression models were estimated to compare changes in IPV levels in the intervention and control arms. Conclusion: This trial should demonstrate the effectiveness of community mobilisation interventions to change attitudes supportive of IPV and prevent women's experience of IPV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,650

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 12, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 7, 2023

Last Update Submit

October 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Attitudes towards social norms around intimate partner violence

    Respondent agreed that a man is justified to beat his wife in seven scenarios provided. A score of 0 showed not supportive of physical IPV, while a score of 1 -7 showed attitude supportive of IPV

    One year before the survey

Secondary Outcomes (3)

  • Experience of intimate partner violence

    One year before the survey

  • Perpetration of intimate partner violence

    One year before the survey

  • Community response to women's experience of of intimate partner violence

    One year

Study Arms (2)

Community mobilization

EXPERIMENTAL

a six-month community mobilization intervention that consisted of advocacy to stakeholders, community workshops and small group discussions in intervention communities

Behavioral: Community mobilization

No intervention

NO INTERVENTION

Interventions

The intervention focused on creating awareness, challenging social norms, and promoting actions against violence. To achieve these, the following activities were undertaken: introductory meetings, selection and training of model couples, structured workshops and small group meetings.

Community mobilization

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged 18 to 59 years
  • Women aged 18 to 49 years
  • Currently married or cohabiting with a partner
  • had lived in the community for a minimum of one year.

You may not qualify if:

  • Married/ cohabiting males or females
  • does not speak either Yoruba or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oriire LGA

Ibadan, Oyo State, Nigeria

Location

MeSH Terms

Conditions

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

October 7, 2023

First Posted

November 7, 2023

Study Start

January 12, 2021

Primary Completion

August 1, 2021

Study Completion

December 1, 2022

Last Updated

November 7, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations