NCT07492368

Brief Summary

This study is testing a smartphone-delivered program to help women living in informal settlements in Kenya manage intimate partner violence (IPV) and stress related to extreme weather events. Women in these communities often face high levels of violence from partners, challenges caused by climate-related events, and limited access to support services. Participants will be randomly assigned to either a mobile intervention or a comparison condition. The mobile program provides short, tailored sessions that help women learn safety planning, coping skills, and strategies for adapting to climate-related stress. The program also offers tools to improve communication and strengthen social support. The main goal of the study is to see whether this smartphone-based approach can reduce the frequency and severity of IPV over 12 months. The study will also examine changes in stress levels, self-confidence in handling problems, social support, and safety behaviors. Results from this study may help create accessible, scalable support for women experiencing IPV and climate-related stress in similar settings.

Trial Health

65
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Trial Health Score

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

Enrollment
272

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Mar 2026

Status
not yet recruiting

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 Progress22%
Mar 2026Jul 2027

First Submitted

Initial submission to the registry

February 13, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

February 13, 2026

Last Update Submit

March 19, 2026

Conditions

Keywords

Intimate partner violenceClimateStressEcological momentary assessmentEcological momentary intervention

Outcome Measures

Primary Outcomes (1)

  • Incidence and Severity of Intimate Partner Violence (VAR CORR-5)

    Measured using the WHO IPV diagnostic (VAW CORR-5) instrument, which includes subscales for controlling behaviors and sexual, physical, and emotional IPV.

    Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months; daily during two-week EMA periods

Secondary Outcomes (13)

  • Safety Behaviors (Safety Behavior Checklist)

    Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months

  • Receipt of IPV-Related Services (SRI)

    Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months; daily during two-week EMA periods

  • Social Support (ESSI)

    Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months

  • Perceived Stress (PSS)

    Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months

  • Depression Symptoms (PHQ-9)

    Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months

  • +8 more secondary outcomes

Study Arms (2)

Event-triggered WINGS-based EMI

EXPERIMENTAL

Participants receive the single-session WINGS plus ongoing, event-triggered Ecological Momentary Intervention (EMI) following extreme weather events (EWE)(heatwaves, cold spells, heavy rainfall). EMIs include daily prompts with personalized safety plans, SOS contacts, and service lists for two weeks post-EWE.

Behavioral: Event-Triggered WINGS-Based EMIBehavioral: Single-Session Mobile WINGS

Single-session WINGS (mobile version)

ACTIVE COMPARATOR

Participants receive a one-time, self-administered mobile version of the WINGS intervention, including safety planning, psychoeducation, goal setting, and service referrals.

Behavioral: Single-Session Mobile WINGS

Interventions

Participants receive a single-session mobile WINGS intervention with self-administered activities on psychoeducation about IPV types/mechanisms, motivation building, safety planning/revision, goal setting, social support enhancement, service needs identification, referral linkage, and self-care planning. Content adapted to address climate change-IPV linkages. Over 9 months following extreme weather events (heatwaves, cold spells, heavy rainfall), participants receive 2 weeks of daily EMI morning prompts with personalized, revisable safety plans, SOS contact lists, and updated IPV service referrals. Daily questions assess IPV self-efficacy, safety plan implementation, social support, and service utilization. Kenya Meteorological Department provides localized 24-hour forecasts. Delivered via decoy wellness app with PIN protection and untraceable SOS button. Study smartphone, monthly data package, and on-call counselor provided.

Event-triggered WINGS-based EMI

Participants receive a single-session mobile WINGS intervention with self-administered activities on psychoeducation about IPV type, motivation building, safety planning/revision, goal setting, social support enhancement, service needs identification, referral linkage, and self-care planning. Content adapted to address climate change-IPV linkages. Delivered via decoy wellness app with personalized PIN protection and untraceable SOS button that sends pre-written texts to emergency contacts. Participants complete intervention once following enrollment. No event-triggered EMI prompts following extreme weather events. Continuous access to SOS emergency protocols, emergency contact setup, and regularly updated lists of local IPV-related services. Study smartphone, monthly data package, and on-call counselor provided

Event-triggered WINGS-based EMISingle-session WINGS (mobile version)

Eligibility Criteria

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

You may qualify if:

  • Female
  • Age 18 years or older
  • Resident of Kibera or Mathare informal settlement in Nairobi, Kenya
  • Speaks Swahili or English
  • Participated in the parent study (1R21MH127356)
  • Reported at least one form of intimate partner violence (psychological, -physical, or sexual) in the past 12 months
  • Willing to provide informed consent
  • Willing to use a smartphone for daily assessments and intervention activities

You may not qualify if:

  • No past-year intimate partner violence reported in parent study
  • Did not participate in the parent study (1R21MH127356)
  • Under 18 years of age
  • Unable to provide informed consent
  • Does not speak Swahili or English
  • Not a resident of Kibera or Mathare informal settlements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2026

First Posted

March 25, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

March 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

IPD and supporting information will become available beginning 6 months after publication of the primary study results. Data will remain available for a minimum of 5 years following study completion. No end date is specified; requests will be considered as long as data are maintained in secure repositories.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
IPD and supporting information will become available beginning 6 months after publication of the primary study results. Data will remain available for a minimum of 5 years following study completion, consistent with NIH data sharing policies. No end date is specified; requests will be considered as long as data are maintained in secure repositories.
Access Criteria
IPD and supporting information will be available to qualified academic and non-commercial researchers conducting methodologically rigorous research related to intimate partner violence, climate change, women's health, or mobile health interventions. Requestors must submit a written proposal describing the intended analyses, provide evidence of institutional ethics approval, and sign a data use agreement that prohibits re-identification of participants, restricts data to approved analyses, and requires destruction of data after analysis completion. Requests should be directed to the Principal Investigators.