protocolSection identificationModule nctId: NCT06350383, orgStudyIdInfo id: K01TW011775, type: NIH, link: https://reporter.nih.gov/quickSearch/K01TW011775, briefTitle: Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-01-06, completionDateStruct date: 2025-01-06, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Columbia University, class: OTHER, collaborators name: Drexel University, collaborators name: Africa Mental Health Research and Training Foundation, descriptionModule briefSummary: The goal of this feasibility study (clinical trial) is to test a low-cost, combined, adapted intimate partner violence (IPV) and mental health intervention (Wings of Hope: WINGS + Problem Management Plus: PM+) that can be carried out by lay community health workers as a foundation for a potential low-cost essential services package for women experiencing IPV and related mental health challenges in informal settlements in Kenya. The main aims of the study are to (1) assess the safety, feasibility, and acceptability of WINGS+PM+ among women experiencing IPV in informal settlements in Kenya; (2) to test preliminary efficacy of program mediating outcomes in addition to the distal outcome (incidence/severity of IPV), while closely monitoring fidelity or process measures, including attendance/retention, adherence, quality of delivery, participant satisfaction, safety and quality improvement and adaptation modifications; and (3) generate data on distributions of study outcomes to calculate the power to detect a meaningful effect size in a future efficacy trial. Women experiencing IPV (n=260) will be recruited from the outpatient walk-in departments at the Kianda 42 Hospital in Kibera informal settlement (n=130) and Upendo Clinic in Mathare informal settlement (n=130). Consenting women will be screened for experiences of recent IPV (last 3 months). Subsequently 130 eligible IPV survivors from the Kianda 42 Hospital and 130 from the Upendo Clinic will be randomized to either receive the combined WINGS+PM+ intervention (n=65) or the PM+-only intervention (control/comparison arm) (n=65) at each clinic., conditionsModule conditions: Violence, Domestic, conditions: Psychological Distress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two-arm, parallel-group design, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Participants will not be told which arm they have been randomized to. Additionally, to reduce contamination, community health volunteers (CHVs) will either carry out assessment or intervention, not both. Assessors will not be told to which arm participants they are assessing have been assigned., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: WINGS+PM+, interventions name: PM+-only, outcomesModule primaryOutcomes measure: World Health Organization (WHO) Violence Against Women (VAW) diagnostic instrument, secondaryOutcomes measure: Receipt of violence services, secondaryOutcomes measure: Domestic Violence Coping Self-efficacy Scale (DVCSE), secondaryOutcomes measure: Multidimensional Scale of Perceived Social Support (MSPSS), secondaryOutcomes measure: Safety Behavior Checklist, secondaryOutcomes measure: Psychological distress (GHQ-12), secondaryOutcomes measure: Functioning (WHODAS 2.0), secondaryOutcomes measure: Short form of the Posttraumatic Stress Disorder Checklist (PCL-5), secondaryOutcomes measure: Personalized outcomes (PSYCHLOPS), otherOutcomes measure: Quality control/intervention fidelity, otherOutcomes measure: Facilitator Satisfaction and ease of intervention delivery (EBPAS-36), otherOutcomes measure: Adverse events, otherOutcomes measure: Participant satisfaction with intervention, otherOutcomes measure: Number of participants in attendance at sessions, otherOutcomes measure: Retention Rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False