NCT05609786

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2025

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 31, 2026

Completed
Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

2.5 years

First QC Date

November 2, 2022

Results QC Date

May 6, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

Intimate Partner ViolenceRelationshipsSafety Planningtechnologyimplementation

Outcome Measures

Primary Outcomes (5)

  • Resilience as Assessed by Connor-Davidson Resilience Scale

    10-item Connor-Davidson Resilience Scale assesses resilience using a 5-point Likert scale (0-4). Scored from 0-40, with higher scores indicating greater resilience and lower scores indicating lower resilience.

    Baseline, 6-month, 12-month

  • Decisional Conflict Score

    12-item decisional conflict measures (specific to safety), assessed using a 5-point Likert scale (0-4). The mean Decisional Conflict score is multiplied by 25 to create an overall score, ranging from 0-100; 0 (no decisional conflict) to 100 (extremely high decisional conflict).

    Baseline, 6-month, 12-month

  • 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. Score range 0-20; higher score indicates more IPV.

    Baseline, 6-month, 12-month

  • Percentage of Participants Who Sought Services (Help-seeking)

    6-item index on help-seeking, which assesses abuse disclosure and services/information received on a 2-point scale (yes/no); operationally defined as percentage of participants who sought help from any of the services.

    Baseline, 6-month, 12-month

  • Helpfulness of Services Assessed by Help-Seeking Index

    6-item index on help-seeking which assesses abuse disclosure and services/information. Helpfulness of services rated on a 5-point Likert scale (Score range 0-4; with higher score more helpful). Mean helpfulness score of services sought is reported.

    Baseline, 6-month, 12-month

Secondary Outcomes (2)

  • Safety Strategy Score

    Baseline, 6-month, 12-month

  • IPV Recognition as Assessed by the Abusive Behaviors Scale

    Baseline, 6-month, 12-month

Study Arms (1)

myPlan Kenya

EXPERIMENTAL

myPlan Kenya web-based application

Behavioral: Personalized safety planning tool

Interventions

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).

myPlan Kenya

Eligibility Criteria

Age16 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ujamaa Africa

Nairobi, Kenya

Location

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Limitations and Caveats

Technical problems emerged with measurements of relationship intention. Results were un-interpretable, thus the effect of the intervention on this outcome cannot be determined.

Results Point of Contact

Title
Michele Decker
Organization
Johns Hopkins Bloomberg School of Public Health

Study Officials

  • Michele Decker

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 8, 2022

Study Start

June 22, 2022

Primary Completion

December 31, 2024

Study Completion

April 19, 2025

Last Updated

July 31, 2026

Results First Posted

July 31, 2026

Record last verified: 2026-07

Locations