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NCT06350383
Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention
NA trial testing WINGS+PM+ in Violence, Domestic in 260 participants. Completed in 30 April 2025.
30 April 2025
Quick facts
| Lead sponsor | Columbia University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 260 |
| Start date | 21 May 2024 |
| Primary completion | 30 April 2025 |
| Estimated completion | 30 April 2025 |
| Sites | 2 locations across Kenya |
Drugs / interventions tested
- WINGS+PM+
- PM+-only
Conditions studied
- Violence, Domestic — all drugs for Violence, Domestic →
- Psychological Distress — all drugs for Psychological Distress →
Sponsor
Columbia University
Who can join
18 and older, female only, with Violence, Domestic or Psychological Distress. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06350383
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Columbia University trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06350383 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Columbia University
- Last refreshed: 14 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06350383.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing