CClinicalTrials.gg
CompletedNCT05609786myPlanKenyaUpdated Jul 31, 2026Results posted

Dissemination and Implementation of a Web-based Relationship Safety App, myPlanKenya, for Women at Risk for Intimate Partner Violence in Nairobi, Kenya

An interventional study of Personalized safety planning tool in Violence, Domestic, Violence, Sexual and Violence, Gender-Based, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Kenya. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2022, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
440
Allocation
Not applicable
Ages
16 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Violence, Domestic
  • Violence, Sexual
  • Violence, Gender-Based

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Keywords

  • Intimate Partner Violence
  • Relationships
  • Safety Planning
  • technology
  • implementation
03

In context

Coitus

108 studies on the registry are indexed under Coitus; 49 are open to participants now.

This study's enrollment of 440 is above the median of 148 across 80 interventional studies indexed under Coitus.

Browse Coitus studies →

Lead sponsor

Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
440 participants (actual)

Study arms

  • Experimental
    myPlan Kenya

    myPlan Kenya web-based application

    Behavioral: Personalized safety planning tool

Interventions

  • BehavioralPersonalized 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 6-month, 12-month

  2. 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).

    Time frame: Baseline, 6-month, 12-month

  3. 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.

    Time frame: Baseline, 6-month, 12-month

  4. 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.

    Time frame: Baseline, 6-month, 12-month

  5. 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.

    Time frame: Baseline, 6-month, 12-month

Secondary outcomes

  1. Safety Strategy Score

    5-item index on safety strategies used (yes/no), summed for a range of 0-5 with higher scores indicating more safety strategies used. For each strategy used, helpfulness is assessed on a 5-point Likert scale (1-5), with higher scores indicating more helpfulness; mean scores are presented (range 1-5).

    Time frame: Baseline, 6-month, 12-month

  2. 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 0-28, with higher scores indicating greater IPV recognition and lower scores indicating lower IPV recognition.

    Time frame: Baseline, 6-month, 12-month

07

Results

Posted Jul 31, 2026
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.

Participant flow

This single arm implementation trial enrolled 440 women referred to the myPlanKenya safety decision aid. Individuals were eligible for 12-month follow-up irrespective of 6-month completion.

Participant flow — Overall Study
MilestonemyPlanKenya: Web-based Personalized Safety Decision Aid
Started440
6 month follow-up331
12 month follow-up365
Completed440
Not completed0

Outcome measures

PrimaryResilience 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.

Time frame:
Baseline, 6-month, 12-month
Reported as:
Mean · score on a scale
Resilience as Assessed by Connor-Davidson Resilience Scale
score on a scalemyPlanKenya: Web-based Personalized Safety Decision Aid
Baseline19.92 ± .40
6-Month Follow-up20.75 ± .45
12-Month Follow-up21.17 ± .43
Statistical analysis
  • myPlanKenya: Web-based Personalized Safety Decision Aid · Linear GEE models · p = 0.036 (p-value from Wald Chi2 embedded in GEE, to test for changes over time.)
PrimaryDecisional 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).

Time frame:
Baseline, 6-month, 12-month
Reported as:
Mean · score on a scale
Decisional Conflict Score
score on a scalemyPlanKenya: Web-based Personalized Safety Decision Aid
Baseline42.67 ± 1.06
6-month Follow-up36.10 ± 1.19
12-month Follow-up31.55 ± 1.14
Statistical analysis
  • myPlanKenya: Web-based Personalized Safety Decision Aid · Chi-squared · p = <0.001 (p-value from Wald Chi2 embedded in GEE, to test for changes over time.)
PrimarySafety/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.

Time frame:
Baseline, 6-month, 12-month
Reported as:
Mean · score on a scale
Safety/IPV Experience(s) as Assessed by the Conflict Tactics Scale-2
score on a scalemyPlanKenya: Web-based Personalized Safety Decision Aid
Baseline9.72 ± 0.28
6-month Follow-up7.69 ± 0.31
12-month Follow-up7.17 ± 0.30
Statistical analysis
  • myPlanKenya: Web-based Personalized Safety Decision Aid · Chi-squared · p = <0.001 (p-value from Wald Chi2 embedded in GEE, to test for changes over time.)
PrimaryPercentage 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.

Time frame:
Baseline, 6-month, 12-month
Reported as:
Number · Percentage of participants
Percentage of Participants Who Sought Services (Help-seeking)
Percentage of participantsmyPlanKenya: Web-based Personalized Safety Decision Aid
Baseline Percentage who sought IPV services94.32
6-month Follow-up (% who sought services)96.68
12-month Follow-up (% who sought services)96.44
Statistical analysis
  • myPlanKenya: Web-based Personalized Safety Decision Aid · Chi-squared · p = 0.160 (p-value from Wald Chi2 embedded in GEE, to test for changes over time. pertains to use of services.)
PrimaryHelpfulness 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.

Time frame:
Baseline, 6-month, 12-month
Reported as:
Mean · score on a scale
Helpfulness of Services Assessed by Help-Seeking Index
score on a scalemyPlanKenya: Web-based Personalized Safety Decision Aid
Baseline- mean helpfulness of services sought3.32 ± 0.06
6-month Follow-up (mean helpfulness of services sought)3.56 ± 0.07
12-month Follow-up (mean helpfulness of services sought)3.60 ± 0.07
Statistical analysis
  • myPlanKenya: Web-based Personalized Safety Decision Aid · Chi-squared · p = 0.001p-value from Wald Chi2 embedded in GEE, to test for changes over time
SecondarySafety Strategy Score

5-item index on safety strategies used (yes/no), summed for a range of 0-5 with higher scores indicating more safety strategies used. For each strategy used, helpfulness is assessed on a 5-point Likert scale (1-5), with higher scores indicating more helpfulness; mean scores are presented (range 1-5).

Time frame:
Baseline, 6-month, 12-month
Reported as:
Mean · score on a scale
Safety Strategy Score
score on a scalemyPlan Kenya Web-based Decision Aid
Baseline (helpfulness)2.90 ± 0.07
6-month Follow-up (helpfulness)3.02 ± 0.08
12-month Follow-up (helpfulness)3.26 ± 0.07
Baseline (use)3.03 ± 0.07
6-month Follow-up (use)2.97 ± 0.08
12-month Follow-up (use)3.11 ± 0.08
Statistical analysis
  • myPlan Kenya Web-based Decision Aid · Chi-squared · p = <0.001 (p-value from Wald Chi2 embedded in GEE, to test for changes over time.)
  • myPlan Kenya Web-based Decision Aid · Chi-squared · p = 0.369 (Safety strategies used.)p-value from Wald Chi2 embedded in GEE, to test for changes over time.
SecondaryIPV 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 0-28, with higher scores indicating greater IPV recognition and lower scores indicating lower IPV recognition.

Time frame:
Baseline, 6-month, 12-month
Reported as:
Mean · score on a scale
IPV Recognition as Assessed by the Abusive Behaviors Scale
score on a scalemyPlanKenya: Web-based Personalized Safety Decision Aid
Baseline23.47 ± 0.26
6-month Follow-up23.40 ± 0.30
12-month Follow-up23.68 ± 0.28
Statistical analysis
  • myPlanKenya: Web-based Personalized Safety Decision Aid · Chi-squared · p = 0.656 (p-value from Wald Chi2 embedded in GEE, to test for changes over time)

Adverse events

Collected over From enrollment until the end of trial follow-up, up to 12 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
myPlanKenya: Web-based Personalized Safety Decision Aid0/440 (0%)0/440 (0%)0/440 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)myPlanKenya: Web-based Personalized Safety Decision Aid
<18 years4
18-24 years186
25-34 years159
35-44 years76
>=45 years14
Sex: Female, Male
Sex: Female, Male(Participants)myPlanKenya: Web-based Personalized Safety Decision Aid
Female440
Male0
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)myPlanKenya: Web-based Personalized Safety Decision Aid
Luo147
Kikuyu103
Luhya62
Kamba60
Other66
Educational Attainment
Educational Attainment(Participants)myPlanKenya: Web-based Personalized Safety Decision Aid
Primary39
Some secondary37
Secondary204
Vocational training107
University or beyond47
08

Study locations

1 site
  • Ujamaa Africa
    Nairobi, Kenya
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 18, 2024
  • Informed consent form · Jul 15, 2022

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05609786
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Ujamaa Africa, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Nov 8, 2022
Start date
Jun 22, 2022
Primary completion
Dec 31, 2024
Completion
Apr 19, 2025
Results posted
Jul 31, 2026
Last update
Jul 31, 2026

Study contacts

Michele Decker
principal investigator · Johns Hopkins Bloomberg School of Public Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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