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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05609786
Other study ID # IRB00017456
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 22, 2022
Est. completion date October 31, 2025

Study information

Verified date April 2024
Source Johns Hopkins Bloomberg School of Public Health
Contact Michele Decker
Phone 410-502-2747
Email mdecker@jhu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date October 31, 2025
Est. primary completion date October 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Personalized safety planning tool
The myPlan Kenya app is a web-based safety planning tool that is secure, private, free and personalized to the user. The app includes multiple, evidence-based modules: Strategies (safety strategies tailored to the user's needs and violence experience); Resources (referrals to local health, safety and justice resources and services); About You (questionnaires that help the user assess their relationship safety and tailor their Strategies, including My Relationship, Red Flags, My Safety, My Priorities); Understanding (knowledge sections that share information on relationships and violence, including Healthy Relationships, Harmful Beliefs About Abuse, About Violence).

Locations

Country Name City State
Kenya Ujamaa Africa Nairobi

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health Ujamaa Africa

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in decisional conflict 12-item pre-intervention and 10-item post-intervention decisional conflict measures (specific to safety), assessed using a 5-point Likert scale (0-4). Items are scored from 0-60 pre-intervention and 0-50 post-intervention, with higher scores indicating higher lower decisional conflict and lower scores indicating higher decisional conflict. Baseline, 6-month, 12-month
Primary Change in resilience as assessed by Connor-Davidson Resilience Scale 10-item Connor-Davidson Resilience Scale, which assesses resilience using a 5-point Likert scale (0-4). Items are scored from 0-40, with higher scores indicating greater resilience and lower scores indicating lower resilience. Baseline, 6-month, 12-month
Primary Change in safety/IPV experience(s) as assessed by the Conflict Tactics Scale-2 10-item adapted Conflict Tactics Scale-2 (CTS2), which assesses IPV experiences using a 3-point scale on the frequency of these experiences. Baseline, 6-month, 12-month
Primary Change in help-seeking 6-item index on help-seeking, which assesses abuse disclosure and services/information received on a 2-point scale (yes/no), and the helpfulness of these disclosures and services on a 5-point Likert scale. Scale examined for fit and will be handled as individual items as needed. Baseline, 6-month, 12-month
Secondary Change in safety strategies 5-item index on safety strategies, which assesses the use of strategies on a 2-point scale (yes/no), and the helpfulness of these strategies on a 5-point Likert scale. Baseline, 6-month, 12-month
Secondary Change in IPV recognition as assessed by the Abusive Behaviors Scale 7-item adapted Abusive Behaviors Scale, which assesses IPV recognition using a 5-point Likert scale (0-4). Items are scored from 0-35, with higher scores indicating greater IPV recognition and lower scores indicating lower IPV recognition. Baseline, 6-month, 12-month
Secondary Change in relationship intention Single item which assesses intention for current relationship on a 4-point scale. Baseline, 6-month, 12-month
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