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NCT05123144 · ClinicalTrials.gov registry record · Phase 2
A Hybrid Type II Trial of the Optimizing Resilience and Coping With HIV Through Internet Delivery in Ryan White Clinics in Chicago
A Phase 2 study of People Living With HIV, sponsored by Northwestern University.
- Active
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 3
- Study locations
NCT05123144 is a Phase 2 study of People Living With HIV that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 300 participants. The trial reports 3 study locations across 1 state.
The verdict
NCT05123144, a Phase 2 study of People Living With HIV, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 3
- Study locations
Study Summary
Among people living with HIV (PLWH), positive affect is uniquely associated with lower levels of depression, slower disease progression, better adherence to medication, and higher likelihood of achieving suppressed viral load, independent of negative affect. In two randomized controlled trials with PLWH (R01 MH084723; R01 DA033854), the investigators have shown significant beneficial effects of an intervention that aims to increase positive affect on viral suppression and psychological well being. The investigators also have demonstrated feasibility, acceptability, and early efficacy of a self-guided, online-delivered, positive affect skills intervention for PLWH (R34 MH101265). Now, in collaboration with the AIDS Foundation of Chicago (AFC), the investigators propose to conduct a Hybrid Type II effectiveness-implementations study of a stepped wedge cluster randomized trial (SW-CRT) of mental health screening and referral to ORCHID (Optimizing Resilience and Coping with HIV through Internet Delivery). The proposed study was initiated by AFC, which developed the mental health screening and selected the SW-CRT design as an ethical way to study implementation while ensuring that all clients with elevated depression receive the intervention. Mental health screening + ORCHID will be implemented through all medical case managers (MCMs) at 17 Ryan White-funded clinics in Chicago. The investigators will use the RE-AIM framework to structure the effectiveness and implementation outcomes and the Consolidated Framework for Implementation Research (CFIR) to understand the implementation outcomes at the patient and clinic levels. The specific aims are to: (1) Operationalize an implementation facilitation strategy to link mental health screening with referral to ORCHID through MCMs at Ryan White-funded clinics in Chicago; (2) Determine the effectiveness of screening + ORCHID for improving depression, retention in care, and viral suppression, among 300 PLWH receiving care at 17 Ry
Conditions Studied
Interventions
- BEHAVIORAL BHS+ORCHID
Study Locations (3)
Illinois
- AIDS Foundation of Chicago - Chicago
- Northwestern University - Chicago
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2021-10-15 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05123144
The ClinicalTrials.gov registry entry for NCT05123144 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with People Living With HIV appearing as the primary indexed condition, and to 1 intervention - of which BHS+ORCHID is the first listed.
NCT05123144 reports 3 study locations spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT05123144 about?
NCT05123144 is a clinical study titled "A Hybrid Type II Trial of the Optimizing Resilience and Coping With HIV Through Internet Delivery in Ryan White Clinics in Chicago". Among people living with HIV (PLWH), positive affect is uniquely associated with lower levels of depression, slower disease progression, better adherence to medication, and higher likelihood of achieving suppressed viral load, independent of negative affect. In two randomized controlled trials with ...
What is the current status of trial NCT05123144?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2021-10-15. Estimated completion is 2025-12-31.
What conditions does trial NCT05123144 study?
This clinical trial studies the following conditions: People Living With HIV.
What interventions are being tested in trial NCT05123144?
The interventions under investigation include: BHS+ORCHID (BEHAVIORAL).
Who is sponsoring clinical trial NCT05123144?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05123144 being conducted?
This trial has 3 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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