Dissemination and Implementation of a Web-based Relationship Safety App, myPlanKenya, for Women a… (NCT05609786) | Clinical Trial Compass
CompletedNot Applicable
Dissemination and Implementation of a Web-based Relationship Safety App, myPlanKenya, for Women at Risk for Intimate Partner Violence in Nairobi, Kenya
Kenya440 participantsStarted 2022-06-22
Plain-language summary
This effectiveness-implementation hybrid-3 study evaluates dissemination, implementation, and effectiveness of myPlanKenya. myPlanKenya will be disseminated through formal and informal sectors. This clinical trial portion of the study enrolls women at risk for intimate partner violence (IPV) who are referred to myPlanKenya by disseminators (i.e. "end-users").
This trial aims to evaluate the effectiveness of myPlanKenya referral on resilience, health and safety among a cohort of women referred to myPlanKenya based on disclosure of IPV or assessed to have IPV related risks.
Who can participate
Age range
16 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female
* Age 16 or older
* Physical or sexual partner violence or relationship-based fears within the past six months; behaviorally assessed
* Living in Nairobi, Kenya with no plans to move in the next 12 months
* Access to a safe smart phone or computer (personal or shared), and comfort using it to access the myPlan Kenya app
* Literate in English or Swahili languages; confirmed by reading and completing a short passage by filling in several blanks with the appropriate words, selected from a drop-down menu.
Exclusion Criteria:
* Male
* Under age 16
* Have not experienced physical or sexual partner violence or relationship-based fears in past 6 months
* Lives outside of the study area or plans to move within the next 12 months
* Does not have access to a safe smart phone or computer, or is uncomfortable using it to access the myPlan Kenya app
* Illiterate in English or Swahili languages
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in decisional conflict
Timeframe: Baseline, 6-month, 12-month
2
Change in resilience as assessed by Connor-Davidson Resilience Scale
Timeframe: Baseline, 6-month, 12-month
3
Change in safety/IPV experience(s) as assessed by the Conflict Tactics Scale-2
Timeframe: Baseline, 6-month, 12-month
4
Change in help-seeking
Timeframe: Baseline, 6-month, 12-month
Trial details
NCT IDNCT05609786
SponsorJohns Hopkins Bloomberg School of Public Health