A Hybrid Type II Trial of the Optimizing Resilience and Coping With HIV Through Internet Delivery in Ryan White Clinics in Chicago

NCT05123144 | Completed

• 1 other identifier: R01MH124632-01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

Brief 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 Ryan White clinical sites, using a stepped wedge cluster randomized design. Depression is the primary outcome and retention in care and viral suppression at both the individual and clinic level are the secondary outcomes; and (3) Evaluate the implementation of screening + ORCHID and iteratively refine the strategy for subsequent steps. The proposed research holds significant promise for advancing current knowledge on how best to integrate and respond to mental health screening in Ryan White clinics. Data from the hybrid trial will result in a sustainable, scalable program that can be disseminated in Ryan White clinics nationwide, thus holding significant promise for advancing Chicago toward goals in the National Ending the HIV Epidemic Plan.

Conditions

People Living With HIV

Outcome Measures

Primary Outcomes (1)

• Depression

  Primary outcome is change on depression (PROMIS-depression) from baseline to the 3 follow up points out to 12 months post intervention

  12 months

Study Arms (2)

Behavioral Health Screener + ORCHID Intervention (BHS+ORCHID)

EXPERIMENTAL

At the clinic level, sites randomized to implement BHS+ORCHID will receive training, materials, and other support to administer behavioral health screening and refer their clients with elevated depression symptoms to ORCHID. At the individual level, those clients who are eligible and choose to enroll in ORCHID will receive self-guided training on 8 positive affect skills through weekly online sessions and daily practice exercises.

Behavioral: BHS+ORCHID

Standard of Care

NO INTERVENTION

usual care

Interventions

BHS+ORCHID BEHAVIORAL

At the clinic level, sites randomized to implement BHS+ORCHID will receive training, materials, and other support to administer behavioral health screening and refer their clients with elevated depression symptoms to ORCHID. At the individual level, those clients who are eligible and choose to enroll in ORCHID will receive self-guided training on 8 positive affect skills through weekly online sessions and daily practice exercises.

Behavioral Health Screener + ORCHID Intervention (BHS+ORCHID)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinic-Level:
• Ryan White clinic in the Chicagoland area
• On-site medical services
• Individual-Level:
• Age 18 and over
• Speaks and reads English
• Receives medical case management through one of the eligible Ryan White clinics
• Referral from medical case manager (on basis of screening positive for elevated depression through a clinic-based screener; PHQ-9 score \> 5)
• Daily access to a device connected to the internet
• Willingness to provide access to health and medical care from the Chicago Department of Health, primary care provider, and/or from the AIDS Foundation Chicago, confirmed by signature on two Release of Information forms.

You may not qualify if:

• None

Sponsors & Collaborators

• Northwestern University: lead
• University of Chicago: collaborator
• AIDS Foundation Chicago: collaborator

Study Sites (3)

AIDS Foundation of Chicago

Chicago, Illinois, 60606, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

• Garner BR, Bouris A, Charlebois ED, Li DH, Dakin A, Moskowitz J, Benbow N, Christopoulos K, Hickey MD, Imbert E. The Strategies Timeline and Activities Reporting Tables: Improving HIV Care by Improving the Reporting of Implementation Strategies. J Acquir Immune Defic Syndr. 2025 Apr 15;98(5S):e205-e215. doi: 10.1097/QAI.0000000000003613.

  PMID: 40163072 DERIVED

• Xavier Hall CD, Ethier K, Cummings P, Freeman A, Bovbjerg K, Bannon J, Dakin A, Abujado F, Bouacha N, Derricotte D, Patterson L, Hirschhorn LR, Bouris A, Moskowitz JT. A hybrid type II effectiveness-implementation trial of a positive emotion regulation intervention among people living with HIV engaged in Ryan White Medical Case Management: protocol and design for the ORCHID study. Trials. 2024 Sep 27;25(1):631. doi: 10.1186/s13063-024-08475-1.

  PMID: 39334472 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: November 17, 2021
• Study Start: October 15, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)