- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06942481
Evaluating Girls Invest: A Mobile-Enabled Economic Empowerment Intervention for Girls to Reduce Risk for Partner Violence
Girls Invest: A Mobile-Enabled Economic Empowerment Intervention for Girls to Reduce Risk for Partner Violence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adolescent girls residing in low-income communities in Nigeria experience high rates of IPV. Economic vulnerability contributes to these high rates of IPV in two major ways: 1) Economic vulnerability increases financial reliance on male partners; IPV is common in these partnerships with males and financial reliance on males decreases girls' ability to leave abusive partnerships. 2) Economic vulnerability can intersect with gender-based constraints (e.g. low prioritization of limited household resources for girls' education) and create low expectations of educational/career opportunities, which can shift girls' priorities away from the participants future training/education and increase intentions to find a male partner and start a family - thereby, increasing girls' risk for relying financially on male partners and risk for IPV. By promoting young females' financial knowledge as well as social/economic expectations and opportunities, Girls Invest seeks to decrease economic vulnerability, reduce girls' financial reliance on male partnerships, and reduce girls' risk for IPV.
First, the investigators aim to pilot Girls Invest with 20 adolescent females ages 15-19; assessments will include quantitative app-based surveys and focus group discussions to assess initial feasibility, acceptability and fidelity of implementation. The investigators will refine Girls Invest with consultation from a community advisory board. Second, to determine preliminary efficacy, the investigators will implement a 2-armed randomized-controlled trial, randomizing 240 adolescent girls ages 15-19 to the Girls Invest intervention or a wait-list control condition.
Girls Invest expands previous work on economic interventions for reducing IPV, and also employs innovative mobile technology methodologies. The proposed research has potential for high impact, particularly given the increase in economic vulnerability as a result of COVID-19, especially among girls who were already living in poverty prior to the pandemic, as well as the coinciding reports of increased IPV.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Ibadan, Nigeria
- University of Ibadan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Girls ages 15-19 in selected secondary classes of 16 schools in Ibadan
Exclusion Criteria:
- Girls under 15 and over 19 years of age
- Do not attend one of the selected secondary classes of 16 schools in Ibadan
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Girls Invest
Girls Invest is an app-based economic empowerment intervention to address social and economic factors associated with IPV among girls ages 15-19 in low-income communities in Ibadan, Nigeria.
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The Girls Invest intervention involved: 1) app-based trainings on topics related to financial literacy, gender equity, and health and 2) financial resources/incentives supporting girls' education/career.
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Placebo Comparator: Waitlist Control group
Participants receive the intervention after they complete the 6 month follow-up survey
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Participants receive Girls Invest after they complete the 6 month follow-up survey.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Attitudes supportive of IPV: Items adapted from Demographic Health Surveys
Time Frame: baseline to 6 months follow up
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7 validated items adapted from Demographic Health Surveys asking whether any of the following scenarios a husband has good reason to hit his wife: (1) She does not complete housework to his satisfaction, (2) She disobeys him, (3) She refuses to have sexual relations with him, (4) She asks him whether he has other girlfriends, (5) He finds out she has been unfaithful, (6) She goes out without telling him, or (7) She does not prepare a meal to his satisfaction.
Responses involved 5-point Likert scales ranging from strongly agree to strongly disagree.
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baseline to 6 months follow up
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Coping with experiences of gender-based discrimination
Time Frame: baseline to 6 months follow up
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three items assessing perceived ability to identify instances of "gender-based discrimination against me" and coping with such experiences as being able to "take care of myself," and recognizing that such experiences are not "about anything I did as an individual; items developed based on previous literature on the topic and investigator's previous research, given the absence of a validated scale.
Measure was piloted with 5 participants and refined prior to implementation.
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baseline to 6 months follow up
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Perceptions of economic vulnerability
Time Frame: baseline to 6 months follow up
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eight items asking about perceived household economic situation, including having enough money to purchase basic necessities (e.g., food, clothes, other needs) and money to pay for education/training of the participant.
Items also assessed perceived financial stress of the household.
Responses involved 5-point Likert scales ranging from strongly agree to strongly disagree.
Scale was developed based on investigator's research and existing literature on this topic, given the lack of a validated scale.
It was piloted among 5 participants prior to implementation.
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baseline to 6 months follow up
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Attitudes supportive of traditional gender roles: Gender Equitable Men (GEM) Scale
Time Frame: baseline to 6 months follow up
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seven items adapted from Gender Equitable Men (GEM) Scale assessing male and female roles in the following: decision-making (e.g., when to have sex, household purchases), household chores, childcare, reproductive decisions (including pregnancy prevention), and in receiving education/training.
Responses involved 5-point Likert scales ranging from strongly agree to strongly disagree.
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baseline to 6 months follow up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth Reed, San Diego State University
- Principal Investigator: Olufunmilayo Fawole, University of Ibadan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HS-2018-0195
- D-0000009194-01 (Other Grant/Funding Number: Wellspring Philanthropic Fund)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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