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Gender RoleNCT03888495

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

A study testing Gender Socialization Training workshop, Financial Literacy Training Intervention and Family Planning Counseling and Services in people with Gender Role and Woman's Role, run by University of Ibadan at 1 site in Nigeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Gender Role, Woman's Role, Couples
What is being tested?
Gender Socialization Training workshop, Financial Literacy Training Intervention and Family Planning Counseling and Services
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,472 participants
Where
1 siteNigeria
Study dates
15 Sep 2017to 28 May 2019
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 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Either woman or partner does not give consent

Trial locations and contacts

1 site in 1 country.

Nigeria1 site
  • 48 Communities in Ibadan North, Ibadan Southwest, Oluyole & Akinyele LGA

    Ibadan, Oyo State

Other trials in Nigeria

About this study

Official title: Promoting Female Empowerment at the Household Level With Family Planning Use, Financial Literacy and Gender Socialization Education Among Couples in Ibadan, Nigeria

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.

Read the detailed description

Background: Despite the growing influences of modernization and westernization, most Nigerian subcultures remain largely traditional. Household division of labor continues to follow traditional gendered roles with the male partner being the breadwinner and decision-maker, while women are ascribed tasks such as childcare and homemaking. These traditional roles often disempower the woman such that she has no say regarding how household funds will be spent and inhibit her from making important household decisions such as whether or when she or her children will receive preventive, curative or rehabilitative healthcare. Moreover, in Nigeria, both the customary law and the major religions stipulate that a woman should be submissive to her husband. The sociocultural and religious contexts appear to be in a conspiracy against women, and favor men who are encouraged to "be in control" of their homes. In some cases, this translates to the controlling husband preventing his wife from working outside the home, making it difficult for her to become economically independent and own assets. Such women, and those who lack the education and/or skills to join the labor force are further disempowered in the sense that they are unable to contribute to the family income, a quality known to improve women's status and decision-making autonomy. Women who do not work for cash or kind often find themselves fully dependent on their husbands for both economic and social identity, predisposing them to intimate partner violence, IPV. This lack of decision-making autonomy penetrates all spheres of women's lives, including reproduction, such that many women are unable, on their own, to choose to use modern contraception to space or limit births, without their husbands' permission.

Study goal and design: The goal of this study is to generate rigorous evidence on how to empower women individually and in households, by targeting both partners in a couple, with a multi-sectoral approach that affects three critical domains of female empowerment - creating more equitable spousal relationships, expanding reproductive choice, and increasing economic empowerment, and is potentially sustainable and can be scaled-up. By influencing these three domains of female empowerment, while simultaneously involving male partners, the intervention aims to set into motion a set of processes that will generate equitable and supportive gender relationships at the household level.

To rigorously evaluate the intervention, a cluster randomized control design was chosen. The primary goal of the evaluation is to test the impact of the gender socialization arm, the key intervention, and the added improvements in female empowerment and spousal supportiveness measures that may be seen with the incorporation of financial literacy and family planning interventions. The trial consists of 4 arms: Arm 1 - couples participate in a structured group education program on gender socialization; Arm 2 - couples participate in a structured financial literacy education program, in addition; Arm 3 - couples receive the complete package of interventions (gender socialization education, financial literacy and family planning counseling and services, with vouchers for the poorest women); Arm 4 - control group.

Study hypotheses: Couples receiving the complete package of interventions will have stronger female empowerment outcomes as reflected through measures of spousal supportiveness and equitable gender relationships in households as compared to couples receiving fewer components of the intervention, or no intervention. In addition, couples that receive only the gender socialization intervention or a combination of interventions will have stronger female empowerment outcomes as compared to couples in the control group.

Study area: The study is taking place in Ibadan, the capital of Oyo State, Nigeria. As part of the 2006 population census, the Nigerian National Population Commission prepared a list of 665,000 EAs that has served as a sampling frame for many national and subnational surveys, where a census enumeration area is defined as a cluster and is the primary sampling unit. Enumeration areas consist of approximately 211 inhabitants or 48 households. Enumeration areas form localities, localities form Local Government Areas (LGAs), and LGAs form states. The LGA is a large enough area, where multiple intervention arms can be implemented while avoiding contamination, but at the same time couples residing in an LGA are more likely to be similar as compared to couples living elsewhere. The research team worked in two urban (Ibadan North and Ibadan Southwest) and two peri-urban (Akinyele and Oluyole) LGAs.

Sample size calculations: These were based on the use of selective empowerment measures for Oyo state from raw data available from the 2013 Nigeria Demographic and Health Survey dataset (www.measuredhs.com). Assuming the intervention would improve each of the three main outcome measures by 15%, 80% power, a 2-sided type 1 error of 5%, and the proportion of married/cohabiting women ages 18-35 years who were involved in decisions regarding large household purchases to be 0.275, 225 participants in each arm would be required. An intra-class correlation coefficient of 0.015 was assumed in the calculations, as well as a fixed number of clusters of 12 per arm (48 in all). Adjustments for 20% loss to follow up rates gave a total of 282 couples per study arm. Calculations based on the above assumptions produced a minimum sample size of 1125 couples. Sample size calculations for other outcomes were smaller.

Sampling strategy: Study participants were selected through a 3-stage randomization process. First, geographical landmarks/boundaries were used to split the 11 LGAs (5 urban, 6 peri-urban) in Ibadan into two roughly equal halves. Then one urban and one periurban LGA was selected randomly from each half, using the random number generator application, after assigning numbers to LGAs in each half. Second, using a map of each of the four selected LGAs displaying localities, alternate distinct localities were selected in a serpentine fashion, following a random start. This was done to ensure that 12 geographically distinct clusters were selected from each LGA. Using a sampling frame of enumeration areas by locality in each of the 4 LGAs, one index enumeration area, and its adjoining enumeration area with a higher code was randomly selected to form study clusters. Thereafter, household-listing surveys were conducted in the selected EA clusters to enable identification and recruitment of 282 eligible couples, ages 18-35 years, per study arm to participate in the study. Where there were not enough listed couples, additional adjacent EAs were listed. Couple selection only took place once, at the beginning of the study.

Training: Training was conducted in multiple phases. Initially, a 3-day training was conducted to introduce team members to human subjects' research, the study protocol, interviewing techniques and the study instruments. Thereafter, once the team was ready to start, a refresher training was held to describe and practice the protocol for the listing and recruitment exercise. Another refresher training was held, and pre-testing done once the final instruments were field-ready. A subset of the field workers, all with at least high school education, were retained to serve as facilitators for the intervention. A 3-day training of trainers' workshop was organized to prepare the facilitators to train the couples that had been recruited into the study. Thereafter, weekly refresher trainings were held to ensure facilitators were fully ready for the roll out of the weekly intervention sessions.

Data Collection: Formative research was conducted to assess the feasibility of the proposed program design. In all, five focus group discussions were held among men, women and couples. Co-investigators facilitated the FGDs which held in neutral places that were acceptable to the respective groups. All sessions were audio-recorded and later transcribed. Where the session took place in Yoruba, the local language, both transcription and translation were done. A quick analysis was performed so that the information obtained could be used to refine the implementation of the intervention.

Randomization: Following selection of clusters, recruitment of couples, and baseline interviews, a statistician conducted block randomization with stratification (block size of 4) whereby each LGA had all 4 study arms represented. Clusters were randomly allocated into one of four study arms (Arm 1: gender socialization training; Arm 2: gender socialization + financial literacy training; Arm 3: gender socialization + financial literacy training + FP counseling/service; Arm 4: control).

Intervention: A total of 3 gender socialization (GS) and 2 financial literacy (FL) workshops were held weekly by cluster, separately for male and female participants to avoid any potential gender conflicts. To minimize loss to follow up, those who received both of these interventions had the sessions back to back, on the same day. Such sessions lasted a total of 3 hours, at most. Additionally, one couple session was conducted for both the husband and wife together for each of these interventions, as well as one joint workshop of family planning counseling for the arm that was randomized to the full intervention. The workshops were interactive and organized around lectures, exercises, role-play and group activities. Peer learning formed an important part of the skill acquisition process. 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. Financial literacy workshops promoted knowledge and skills in budgeting, financial planning and accessing and using financial services and income generating activities. Couples were provided with study materials for their own review and to facilitate their subsequent teaching activities. Immediate post-intervention surveys were conducted immediately after the final intervention session for each group, or within a week for couples who did not attend the last session.

The FP component of the intervention package was delivered by FP providers in NURHI-supported health facilities. These facilities were well stocked and had training and re-training activities for the providers. Couples were referred to these facilities, but had the option of choosing any facility they would like to attend.

In the FP arm, the poorest participants were invited to be part of a voucher system to secure a contraceptive method of their choice from a health facility. Most contraceptive methods are available free of cost in public sector health facilities in Nigeria. However, users have to pay a registration fee, pay for a pregnancy test, and in some facilities, there is an additional fee associated with consumables, and the insertion of IUDs and implants, as well as sterilization. A team member, the voucher officer, was responsible for accompanying women to the health facility of their choice to obtain FP counseling and their method of choice. The voucher officer paid all the bills at the health facility and refunded the woman her transportation expenses. She was also responsible for reminding the woman of an upcoming appointment prior to the date, usually 3-5 days in advance.

Post-intervention assessments: Surveys were conducted immediately following the last intervention session (Immediate post-intervention) for all three intervention arms, and 6 months post-intervention for all 4 study arms (Endline). At endline, six focus group discussions were also conducted in order to better understand the impact the intervention had on participants.

Being tested
Gender Socialization Training workshop, Financial Literacy Training Intervention, Family Planning Counseling and Services
Medical subject headings
Literacy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gender Socialization Training workshopBehavioural

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

  • Financial Literacy Training InterventionBehavioural

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

  • Family Planning Counseling and ServicesBehavioural

    Family planning counseling sessions and linkage to services.

Study groups in NCT03888495
Study groupRoleWhat they receive
Gender socialization (GS)ExperimentalGender 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.
Receives: Behavioral: Gender Socialization Training workshop
GS + Financial literacy (FL)ExperimentalFinancial literacy workshops promoted knowledge and skills in budgeting, financial planning and accessing and using financial services and income generating activities.
Receives: Behavioral: Gender Socialization Training workshop; Behavioral: Financial Literacy Training Intervention
GS + FL + Family planningExperimentalFamily 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.
Receives: Behavioral: Gender Socialization Training workshop; Behavioral: Financial Literacy Training Intervention; Behavioral: Family Planning Counseling and Services
ControlNo interventionCouples were interviewed at baseline, and will be interviewed at endline.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months post-intervention

  2. 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

    Measured: 6 months post-intervention

  3. Reduced risk of intimate partner violence

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

    Measured: 6 months post-intervention

  4. 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

    Measured: 6 months post-intervention

  5. 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

    Measured: 6 months post-intervention

  6. 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

    Measured: 6 months post-intervention

  7. 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

    Measured: 6 months post-intervention

  8. 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

    Measured: 6 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2019
  2. Study start15 Sep 2017
  3. Primary completion10 Jul 2018
  4. Study completion28 May 2019

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,472 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03888495
Sponsor's protocol ID
OPP1141628
Status last verified
Mar 2020
First submitted
6 Mar 2019
Last updated
31 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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

  • 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.

    PubMed 18292404
  • 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.

    PubMed 35140139

Questions about this trial

What is this clinical trial studying?

A study testing Gender Socialization Training workshop, Financial Literacy Training Intervention and Family Planning Counseling and Services in people with Gender Role and Woman's Role, run by University of Ibadan 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: finished, as of the sponsor's last update on 31 Mar 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in proportion of couples that agree on spousal right to refuse sex (time frame: 6 months post-intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03888495, which also lists 3 linked publications.

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 31 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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