Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:38 AM
Study NCT ID:
NCT07492368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smartphone Climate Adaptation and IPV Intervention for Women in Informal Settlements in Kenya
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 272}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and Severity of Intimate Partner Violence (VAR CORR-5)', 'timeFrame': 'Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months; daily during two-week EMA periods', 'description': 'Measured using the WHO IPV diagnostic (VAW CORR-5) instrument, which includes subscales for controlling behaviors and sexual, physical, and emotional IPV.'}], 'secondaryOutcomes': [{'measure': 'Safety Behaviors (Safety Behavior Checklist)', 'timeFrame': 'Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months', 'description': '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.'}, {'measure': 'Receipt of IPV-Related Services (SRI)', 'timeFrame': 'Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months; daily during two-week EMA periods', 'description': 'Measured using the Services Receipt Inventory (SRI). Assesses whether participants have received services, counseling, or support for partner abuse.'}, {'measure': 'Social Support (ESSI)', 'timeFrame': 'Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months', 'description': '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'}, {'measure': 'Perceived Stress (PSS)', 'timeFrame': 'Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months', 'description': 'Measured using the 10-item Perceived Stress Scale. Assesses degree to which situations are felt as stressful over the past month'}, {'measure': 'Depression Symptoms (PHQ-9)', 'timeFrame': 'Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months', 'description': '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'}, {'measure': 'Anxiety Symptoms (GAD-7)', 'timeFrame': 'Baseline, immediately post-single session of WINGS, and at 3, 6, and 12 months', 'description': '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.'}, {'measure': 'Emotional Stress (Momentary)', 'timeFrame': 'Daily during two-week EMA periods', 'description': '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.'}, {'measure': 'Climate Related Comfort', 'timeFrame': 'Daily during two-week EMA periods', 'description': '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.'}, {'measure': 'Social and Environmental Context', 'timeFrame': 'Daily during two-week EMA periods', 'description': '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.'}, {'measure': 'Current Safety', 'timeFrame': 'Daily during two-week EMA periods', 'description': 'Measured using EMA questions. Assesses perceived safety at the moment (Very unsafe to Very safe) and reasons for feeling unsafe or unsure.'}, {'measure': 'Coping Strategies', 'timeFrame': 'Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months', 'description': "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."}, {'measure': 'Disability and Functioning (WHODAS)', 'timeFrame': 'Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months', 'description': '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.'}, {'measure': 'IPV Self-Efficacy (DVSE)', 'timeFrame': 'Baseline, immediately post single session of WINGS, and at 3, 6, and 12 months; daily during two-week EMI periods', 'description': 'Measured using the Domestic Violence Self-efficacy Scale (DVSE)-an 8-item scale that measures perceived competency in managing abuse and conflict with partners.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intimate partner violence', 'Climate', 'Stress', 'Ecological momentary assessment', 'Ecological momentary intervention'], 'conditions': ['Intimate Partner Violence (IPV)', 'Climate Change', 'Stress (Psychology)']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants 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.\n\nThe 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.\n\nResults from this study may help create accessible, scalable support for women experiencing IPV and climate-related stress in similar settings.', 'detailedDescription': '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.\n\nWomen 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.\n\nThe 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.\n\nIn 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Age 18 years or older\n* Resident of Kibera or Mathare informal settlement in Nairobi, Kenya\n* Speaks Swahili or English\n* Participated in the parent study (1R21MH127356)\n* Reported at least one form of intimate partner violence (psychological, -physical, or sexual) in the past 12 months\n* Willing to provide informed consent\n* Willing to use a smartphone for daily assessments and intervention activities\n\nExclusion Criteria:\n\n* No past-year intimate partner violence reported in parent study\n* Did not participate in the parent study (1R21MH127356)\n* Under 18 years of age\n* Unable to provide informed consent\n* Does not speak Swahili or English\n* Not a resident of Kibera or Mathare informal settlements'}, 'identificationModule': {'nctId': 'NCT07492368', 'briefTitle': 'Smartphone Climate Adaptation and IPV Intervention for Women in Informal Settlements in Kenya', 'organization': {'class': 'OTHER', 'fullName': 'Africa Institute of Mental and Brain Health (AFRIMEB)'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'R21_R33'}, 'secondaryIdInfos': [{'id': '4R33MH134257-03', 'link': 'https://reporter.nih.gov/quickSearch/4R33MH134257-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Event-triggered WINGS-based EMI', 'description': '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.', 'interventionNames': ['Behavioral: Event-Triggered WINGS-Based EMI', 'Behavioral: Single-Session Mobile WINGS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single-session WINGS (mobile version)', 'description': 'Participants receive a one-time, self-administered mobile version of the WINGS intervention, including safety planning, psychoeducation, goal setting, and service referrals.', 'interventionNames': ['Behavioral: Single-Session Mobile WINGS']}], 'interventions': [{'name': 'Event-Triggered WINGS-Based EMI', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Event-triggered WINGS-based EMI']}, {'name': 'Single-Session Mobile WINGS', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Event-triggered WINGS-based EMI', 'Single-session WINGS (mobile version)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'christine.musyimi@amhf.or.ke', 'phone': '+254 20 265 1360.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '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.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Africa Institute of Mental and Brain Health (AFRIMEB)', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}