NCT03888495

Brief Summary

Sub-Saharan African women continue to face socio-economic challenges and limited reproductive freedoms, which diminishes their ability to exercise agency and choice in their lives and their environment. The goal of this study is to generate rigorous scientific evidence on empowering women individually and in households through a cluster randomized control trial. The trial will test the efficacy of a multi-sectoral program targeting three critical domains of female empowerment through gender socialization education, counseling and improved access to family planning, financial literacy among couples in Ibadan, Nigeria. The innovation in this approach is the focus on creating a supportive intra-familial environment to accelerate progress towards female empowerment, not just with the multi-sectoral intervention, but also by targeting both partners of couples, individually and together. It is hoped that there will be a shift of broader community norms by building the capacity of study couples to transfer their newly acquired knowledge and skills to other couples in their community, thereby creating a ripple of change.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,472

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2019

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

March 6, 2019

Last Update Submit

March 27, 2020

Conditions

Outcome Measures

Primary Outcomes (8)

  • Change in proportion of couples that agree on spousal right to refuse sex

    A difference between the proportion of couples at endline and baseline that agree on spousal right to refuse sex

    6 months post-intervention

  • Change in proportion of couples that agree on time spouse spends on managing or performing child-care and other household chores

    A difference between the proportion of couples at endline and baseline that agree on their report of time spouse spends on managing or performing child-care and other household chores

    6 months post-intervention

  • Reduced risk of intimate partner violence

    A reduction in report of risk of intimate partner violence between baseline and endline

    6 months post-intervention

  • Change in proportion of women reporting involvement in financial decision-making

    Difference in proportion of women reporting involvement in financial decision-making between baseline and endline

    6 months post-intervention

  • Change in proportion of men with positive attitudes toward their wife/partner's involvement in financial decision-making

    Difference in proportion of men reporting positive attitudes toward their wife/partner's involvement in financial decision-making between baseline and endline

    6 months post-intervention

  • Change in the proportion of couples who agree on responses to questions on financial decision-making, ownership and investments

    A difference in the proportion of couples that agree on involvement in financial decision-making, ownership of property and individual or joint investments between baseline and endline

    6 months post-intervention

  • Change in proportion of couples that agree on modern family planning method use & type of method used

    A difference in the agreement of couples on reported modern family planning method use \& type of method used between baseline and endline

    6 months post-intervention

  • Improved quality of family planning use (consistent method use, commitment to method choice)

    Report of consistent family planning method use and commitment to use, comparing baseline and endline

    6 months post-intervention

Study Arms (4)

Gender socialization (GS)

EXPERIMENTAL

Gender socialization workshops raised awareness on gender, its social construction and inequality, notions of masculinity and femininity, division of labor, access and control over resources. The workshop also included skill-building sessions on effective communication and negotiation and relationship building.

Behavioral: Gender Socialization Training workshop

GS + Financial literacy (FL)

EXPERIMENTAL

Financial literacy workshops promoted knowledge and skills in budgeting, financial planning and accessing and using financial services and income generating activities.

Behavioral: Gender Socialization Training workshopBehavioral: Financial Literacy Training Intervention

GS + FL + Family planning

EXPERIMENTAL

Family planning counseling was provided to couples by family planning providers from nearby facilities. Couples were encouraged to seek services in facilities of their choice. A voucher system provided financial support for the poorest couples.

Behavioral: Gender Socialization Training workshopBehavioral: Financial Literacy Training InterventionBehavioral: Family Planning Counseling and Services

Control

NO INTERVENTION

Couples were interviewed at baseline, and will be interviewed at endline.

Interventions

Hands-on training workshops including lectures, group activities, role play and group discussions focused on gender socialization.

GS + FL + Family planningGS + Financial literacy (FL)Gender socialization (GS)

Hands-on training workshops including lectures, group activities, role play and group discussions focused on financial literacy.

GS + FL + Family planningGS + Financial literacy (FL)

Family planning counseling sessions and linkage to services.

GS + FL + Family planning

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women ages 18-35 years who live with their husbands or partners within the pre-selected study clusters
  • Consent from husband/partner as well as eligible woman
  • Women in polygynous unions, if the wife co-resides with her husband

You may not qualify if:

  • Either woman or partner does not give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

48 Communities in Ibadan North, Ibadan Southwest, Oluyole & Akinyele LGA

Ibadan, Oyo State, Nigeria

Location

Related Publications (3)

  • Campbell MJ, Walters SJ. How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research (Statistics in Practice). Wiley Publishers, 253 pp. ISBN-13: 978-1119992028

    BACKGROUND
  • Choi SY, Ting KF. Wife beating in South Africa: an imbalance theory of resources and power. J Interpers Violence. 2008 Jun;23(6):834-52. doi: 10.1177/0886260507313951. Epub 2008 Feb 21.

  • John NA, Adebayo A, Boychuk NA, OlaOlorun F. Intimate partner violence (IPV) prevention using a cross-sectoral couple-based intervention: results from a cluster randomised control trial in Ibadan, Nigeria. BMJ Glob Health. 2022 Feb;7(2):e007192. doi: 10.1136/bmjgh-2021-007192.

MeSH Terms

Conditions

Literacy

Interventions

Family Planning Services

Condition Hierarchy (Ancestors)

CommunicationBehavior

Intervention Hierarchy (Ancestors)

Community Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesReproductive Health Services

Study Officials

  • Funmilola OlaOlorun, PhD

    College of Medicine University of Ibadan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The intervention involved attendance at training workshops, so once randomization was completed by the biostatistician, random assignments had to be revealed.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 25, 2019

Study Start

September 15, 2017

Primary Completion

July 10, 2018

Study Completion

May 28, 2019

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

The funders require that data be made publicly available, and we will do this. However, we are yet to discuss detailed preparations for public release with the funders.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will become available six months following completion of analysis of baseline data. Duration of availability will depend on the host server from the funders. The current funding stream does not elaborate on this.
Access Criteria
Completion of a form indicating demographic data and affiliation of the person making the request, as well as the intended use of the data, and variables of interest.

Locations