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Promoting Female Empowerment at the Household Level Among Couples in Ibadan, Nigeria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03888495
Recruitment Status : Completed
First Posted : March 25, 2019
Last Update Posted : March 31, 2020
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
International Center for Research on Women
Information provided by (Responsible Party):
Funmilola OlaOlorun, University of Ibadan

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.

Condition or disease Intervention/treatment Phase
Gender Role Woman's Role Couples Literacy Family Size Behavioral: Gender Socialization Training workshop Behavioral: Financial Literacy Training Intervention Behavioral: Family Planning Counseling and Services Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: The intervention involved attendance at training workshops, so once randomization was completed by the biostatistician, random assignments had to be revealed.
Primary Purpose: Other
Official Title: Promoting Female Empowerment at the Household Level With Family Planning Use, Financial Literacy and Gender Socialization Education Among Couples in Ibadan, Nigeria
Actual Study Start Date : September 15, 2017
Actual Primary Completion Date : July 10, 2018
Actual Study Completion Date : May 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gender socialization (GS)
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
Hands-on training workshops including lectures, group activities, role play and group discussions focused on gender socialization.

Experimental: GS + Financial literacy (FL)
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 workshop
Hands-on training workshops including lectures, group activities, role play and group discussions focused on gender socialization.

Behavioral: Financial Literacy Training Intervention
Hands-on training workshops including lectures, group activities, role play and group discussions focused on financial literacy.

Experimental: GS + FL + Family planning
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 workshop
Hands-on training workshops including lectures, group activities, role play and group discussions focused on gender socialization.

Behavioral: Financial Literacy Training Intervention
Hands-on training workshops including lectures, group activities, role play and group discussions focused on financial literacy.

Behavioral: Family Planning Counseling and Services
Family planning counseling sessions and linkage to services.

No Intervention: Control
Couples were interviewed at baseline, and will be interviewed at endline.



Primary Outcome Measures :
  1. Change in proportion of couples that agree on spousal right to refuse sex [ Time Frame: 6 months post-intervention ]
    A difference between the proportion of couples at endline and baseline that agree on spousal right to refuse sex

  2. Change in proportion of couples that agree on time spouse spends on managing or performing child-care and other household chores [ Time Frame: 6 months post-intervention ]
    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

  3. Reduced risk of intimate partner violence [ Time Frame: 6 months post-intervention ]
    A reduction in report of risk of intimate partner violence between baseline and endline

  4. Change in proportion of women reporting involvement in financial decision-making [ Time Frame: 6 months post-intervention ]
    Difference in proportion of women reporting involvement in financial decision-making between baseline and endline

  5. Change in proportion of men with positive attitudes toward their wife/partner's involvement in financial decision-making [ Time Frame: 6 months post-intervention ]
    Difference in proportion of men reporting positive attitudes toward their wife/partner's involvement in financial decision-making between baseline and endline

  6. Change in the proportion of couples who agree on responses to questions on financial decision-making, ownership and investments [ Time Frame: 6 months post-intervention ]
    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

  7. Change in proportion of couples that agree on modern family planning method use & type of method used [ Time Frame: 6 months post-intervention ]
    A difference in the agreement of couples on reported modern family planning method use & type of method used between baseline and endline

  8. Improved quality of family planning use (consistent method use, commitment to method choice) [ Time Frame: 6 months post-intervention ]
    Report of consistent family planning method use and commitment to use, comparing baseline and endline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Either woman or partner does not give consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888495


Locations
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Nigeria
48 Communities in Ibadan North, Ibadan Southwest, Oluyole & Akinyele LGA
Ibadan, Oyo, Nigeria
Sponsors and Collaborators
University of Ibadan
Bill and Melinda Gates Foundation
International Center for Research on Women
Investigators
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Principal Investigator: Funmilola OlaOlorun, PhD College of Medicine, University of Ibadan
Publications of Results:
Other Publications:
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Funmilola OlaOlorun, Senior Lecturer, University of Ibadan
ClinicalTrials.gov Identifier: NCT03888495    
Other Study ID Numbers: OPP1141628
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No