- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07492368
Smartphone Climate Adaptation and IPV Intervention for Women in Informal Settlements in Kenya
Development and Testing of a Smartphone-Delivered Climate Adaptation and IPV-Related Stress Intervention for Residents of Informal Settlements in Kenya Using Ecological Momentary Approaches
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study is a randomized controlled trial designed to test the effectiveness of a smartphone-delivered intervention that integrates climate adaptation strategies with an evidence-based approach to reducing intimate partner violence (IPV) and related stress among women living in informal settlements in Kenya.
Women living in informal settlements face high levels of poverty, climate-related stressors, and intimate partner violence. Climate-related shocks can increase household stress and economic strain, which may in turn increase the risk of IPV. Despite growing evidence linking climate stress and violence, there are few scalable, low-cost interventions that address both climate-related stress and IPV risk simultaneously.
The intervention builds on prior formative and pilot work conducted in the R21 phase of this project. It combines climate adaptation and problem-solving strategies with core elements of the Women Initiating New Goals of Safety (WINGS) intervention. The program is delivered via smartphone and uses brief, event-triggered sessions to provide support when participants report elevated stress or conflict risk. Participants receive tailored content focused on safety planning, coping skills, communication strategies, and climate-related adaptation planning.
In the R33 phase, 272 women who previously participated in the R21 phase and meet eligibility criteria will be enrolled and randomized to either the smartphone intervention or a comparison condition. Participants will be followed for 12 months.
The primary outcome is the incidence and severity of intimate partner violence over the 12-month follow-up period. Secondary outcomes include stress, self-efficacy, social support, safety behaviors, and related mental health indicators. Assessments will occur at baseline and at multiple follow-up time points, including 3, 6, and 12 months.
The results of this trial will provide evidence on whether a scalable, smartphone-delivered intervention that integrates climate adaptation and violence prevention strategies can reduce IPV and related stress among women living in high-risk urban settings in Kenya.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Principal Investigator
- Phone Number: +254 20 265 1360.
- Email: christine.musyimi@amhf.or.ke
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Event-triggered WINGS-based EMI
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.
|
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.
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
|
|
Active Comparator: Single-session WINGS (mobile version)
Participants receive a one-time, self-administered mobile version of the WINGS intervention, including safety planning, psychoeducation, goal setting, and service referrals.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence and Severity of Intimate Partner Violence (VAR CORR-5)
Time Frame: Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months; daily during two-week EMA periods
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety Behaviors (Safety Behavior Checklist)
Time Frame: Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months
|
Measured using an adapted 7-item Safety Behavior Checklist.
Assesses use of safety behaviors including hiding money, hiding an extra set of house keys, establishing a safety code/protocol with family or friends, asking neighbors to call police if violence begins, removing weapons from the house, preparing a safety packet with important documents (national IDs, birth certificates), preparing a list of important phone numbers for emergencies, hiding a bag with extra clothing, and setting aside money or other valuables for safety purposes.
|
Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months
|
|
Receipt of IPV-Related Services (SRI)
Time Frame: Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months; daily during two-week EMA periods
|
Measured using the Services Receipt Inventory (SRI).
Assesses whether participants have received services, counseling, or support for partner abuse.
|
Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months; daily during two-week EMA periods
|
|
Social Support (ESSI)
Time Frame: Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months
|
Measured with the 6-item Enriched Social Support Inventory (ESSI), which assesses the availability of emotional and instrumental support and advice for relationship conflict or problems with intimate partners and other issues
|
Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months
|
|
Perceived Stress (PSS)
Time Frame: Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months
|
Measured using the 10-item Perceived Stress Scale.
Assesses degree to which situations are felt as stressful over the past month
|
Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months
|
|
Depression Symptoms (PHQ-9)
Time Frame: Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months
|
Measured using the Patient Health Questionnaire (PHQ-9).
Assesses frequency of depressive symptoms over the past two weeks including little interest or pleasure in doing things; feeling down, depressed, or hopeless; trouble sleeping; feeling tired; poor appetite or overeating; feeling bad about yourself; trouble concentrating; moving or speaking slowly or being restless; and thoughts of being better off dead or hurting yourself
|
Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months
|
|
Anxiety Symptoms (GAD-7)
Time Frame: Baseline, immediately post-single session of WINGS, and at 3, 6, and 12 months
|
Measured using the Generalized Anxiety Disorder scale (GAD-7).
Assesses frequency of anxiety symptoms over the past two weeks including feeling nervous, unable to stop worrying, worrying too much, trouble relaxing, restlessness, irritability, and feeling afraid.
Also assesses how difficult these problems have made it to do work, take care of things at home, or get along with others.
|
Baseline, immediately post-single session of WINGS, and at 3, 6, and 12 months
|
|
Emotional Stress (Momentary)
Time Frame: Daily during two-week EMA periods
|
Measured using a single-item scale.
Assesses current feelings of stress, tension, restlessness, nervousness, or anxiety where 0=Not at all to 5=Very much.
|
Daily during two-week EMA periods
|
|
Climate Related Comfort
Time Frame: Daily during two-week EMA periods
|
Measured using EMA questions.
Assesses perceived comfort with temperature (Very comfortable to Very uncomfortable); feeling unsafe/unwell due to temperature; perception of extreme temperatures or rainfall; and approximate temperature where participant is located.
|
Daily during two-week EMA periods
|
|
Social and Environmental Context
Time Frame: Daily during two-week EMA periods
|
Measured using EMA questions.
Assesses current location (indoors/outdoors); specific location type (home, work, visiting, vehicle, shop, kitchen, toilet, bar/restaurant); who participant is with (alone, children, partner, friends, strangers, colleagues); and current activities.
|
Daily during two-week EMA periods
|
|
Current Safety
Time Frame: Daily during two-week EMA periods
|
Measured using EMA questions.
Assesses perceived safety at the moment (Very unsafe to Very safe) and reasons for feeling unsafe or unsure.
|
Daily during two-week EMA periods
|
|
Coping Strategies
Time Frame: Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months
|
Measured using coping and support questions.
Assesses behaviors used to cope with stress over the past month including getting a good night's sleep; meditation/mindfulness practices; talking with friends; talking with family; engaging in more family activities (farming, washing, games, sports); talking to people who are pregnant or parenting; increased television time; increased time on social media; decreased time on social media; increased time following news coverage; decreased time following news coverage; increased food intake; decreased food intake; increased self-care (baths, facial make up); increased time reading books or doing puzzles; using alcohol; using drugs; talking to health providers more frequently; talking with a mental health care provider (therapist, psychologist, counselor); helping others; and other strategies.
|
Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months
|
|
Disability and Functioning (WHODAS)
Time Frame: Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months
|
Measured using the WHO Disability Assessment Schedule (WHODAS).
Assesses difficulty over the past 30 days with standing for long periods, household responsibilities, learning new tasks, community participation, concentration, walking long distances, washing whole body, getting dressed, dealing with strangers, maintaining friendships, and day-to-day work due to health problems.
|
Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months
|
|
IPV Self-Efficacy (DVSE)
Time Frame: Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months; daily during two-week EMI periods
|
Measured using the Domestic Violence Self-efficacy Scale (DVSE)-an 8-item scale that measures perceived competency in managing abuse and conflict with partners.
|
Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months; daily during two-week EMI periods
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R21_R33
- 4R33MH134257-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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