Risk Factors for Intimate Partner ViolenceEarly Phase 1NCT06942481
Evaluating Girls Invest: A Mobile-Enabled Economic Empowerment Intervention for Girls to Reduce Risk for Partner Violence
A Early Phase 1 study testing Girls Invest in people with Risk Factors for Intimate Partner Violence, run by San Diego State University at 1 site in Nigeria.
Trial summary
The research aims to refine and evaluate Girls Invest, a newly developed economic empowerment intervention, to reduce economic and social risks associated with high rates of intimate partner violence (IPV) among adolescent girls in Ibadan, Nigeria. Read more about this study
- Who is it for?
- Ages 15 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Risk Factors for Intimate Partner Violence
- What is being tested?
- Girls Invest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteNigeria
- Study dates
- 7 Sep 2022to 15 Sep 2023
- Phase
- Early Phase 1
- 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 15 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Girls ages 15-19 in selected secondary classes of 16 schools in Ibadan
Who cannot join
- Girls under 15 and over 19 years of age
- Do not attend one of the selected secondary classes of 16 schools in Ibadan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Girls Invest: A Mobile-Enabled Economic Empowerment Intervention for Girls to Reduce Risk for Partner Violence
The research aims to refine and evaluate Girls Invest, a newly developed economic empowerment intervention, to reduce economic and social risks associated with high rates of intimate partner violence (IPV) among adolescent girls in Ibadan, Nigeria. Girls Invest, initially developed and tested in the US, has been adapted for use in Nigeria via Phase I Wellspring support. Girls Invest participants complete gender equity and financial skills training modules via a mobile "app." Upon completion, each participant receives a financial resource of supporting girls' education/vocation (e.g., sewing machine, baking oven and pans, or funds to cover educational exams).
Read the 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.
- Being tested
- Girls Invest, Waitlist control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Girls InvestBehavioural
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.
Waitlist controlBehavioural
Participants receive Girls Invest after they complete the 6 month follow-up survey.
| Study group | Role | What they receive |
|---|---|---|
| Girls Invest | Experimental | 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. Receives: Behavioral: Girls Invest |
| Waitlist Control group | Placebo comparator | Participants receive the intervention after they complete the 6 month follow-up survey Receives: Behavioral: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitudes supportive of traditional gender roles: Gender Equitable Men (GEM) Scale
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.
Measured: baseline to 6 months follow up
Attitudes supportive of IPV: Items adapted from Demographic Health Surveys
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.
Measured: baseline to 6 months follow up
Coping with experiences of gender-based discrimination
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.
Measured: baseline to 6 months follow up
Perceptions of economic vulnerability
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.
Measured: baseline to 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start7 Sep 2022
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Factors for Intimate Partner ViolenceStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ibadan
- Responsible party
- Sponsor
- Investigators
- Elizabeth Reed, Principal investigator, San Diego State UniversityOlufunmilayo Fawole, Principal investigator, University of Ibadan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942481
- Sponsor's protocol ID
- HS-2018-0195
- Other IDs
- D-0000009194-01
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Girls Invest: A Mobile-Enabled Economic Empowerment Intervention for Girls to Reduce Risk for Partner Violence
- ClinicalTrials.gov ID
- NCT06942481
- Acronym / sponsor ID
- HS-2018-0195
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- University of Ibadan
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research aims to refine and evaluate Girls Invest, a newly developed economic empowerment intervention, to reduce economic and social risks associated with high rates of intimate partner violence (IPV) among adolescent girls in Ibadan, Nigeria. Girls Invest, initially developed and tested in the US, has been adapted for use in Nigeria via Phase I Wellspring support. Girls Invest participants complete gender equity and financial skills training modules via a mobile "app." Upon completion, each participant receives a financial resource of supporting girls' education/vocation (e.g., sewing machine, baking oven and pans, or funds to cover educational exams).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Girls Invest | Experimental | Behavioral: Girls InvestGirls 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. |
| Waitlist Control group | Placebo comparator | Behavioral: Waitlist controlParticipants receive the intervention after they complete the 6 month follow-up survey |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Girls ages 15-19 in selected secondary classes of 16 schools in Ibadan
Key exclusion criteria (2 listed)
- Girls under 15 and over 19 years of age
- Do not attend one of the selected secondary classes of 16 schools in Ibadan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Girls InvestThe 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. | Behavioural | Girls Invest |
| Waitlist controlParticipants receive Girls Invest after they complete the 6 month follow-up survey. | Behavioural | Waitlist Control group |
Primary outcome
Attitudes supportive of traditional gender roles: Gender Equitable Men (GEM) Scale
Time frame: baseline to 6 months follow up
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.
Attitudes supportive of IPV: Items adapted from Demographic Health Surveys
Time frame: baseline to 6 months follow up
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.
Coping with experiences of gender-based discrimination
Time frame: baseline to 6 months follow up
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.
Perceptions of economic vulnerability
Time frame: baseline to 6 months follow up
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Reed principal investigator
San Diego State University
Olufunmilayo Fawole principal investigator
University of Ibadan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Girls Invest in people with Risk Factors for Intimate Partner Violence, run by San Diego State University 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 1 inclusion and 2 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 27 Apr 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Attitudes supportive of traditional gender roles: Gender Equitable Men (GEM) Scale (time frame: baseline to 6 months follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2025.