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

March 11, 2024 updated by: Judith Moskowitz, Northwestern University

A Stepped Wedge Hybrid Type II Trial of an Online Positive Affect Intervention: Blending Implementation and Effectiveness to Improve HIV Continuum Outcomes 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 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.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

Current HIV prevention strategies for PLWH emphasize engagement across the HIV Continuum of Care: linkage to and retention in care, adherence to antiretroviral therapy, and maintenance of suppressed viral load. The National HIV/AIDS Strategy goals for engagement in each phase of the continuum include: 85% of those diagnosed with HIV linked to care within 1 month, 90% of those living with HIV retained in care, and 80% achieving suppressed viral load.23 As with many other cities, Chicago falls far below these targets: in 2018, only 41.1% of PLWH were retained in care, as measured by having at least 2 visits during which CD4 or viral load count were obtained 3 months apart, and 52% were virally suppressed (i.e., <200 copies/mL at their last viral load test).

Depression, highly prevalent in PLWH, predicts HIV progression and is associated with lack of engagement in Continuum of Care. Screening for depression is a first step to addressing the significant barrier to engaging in care and improving the health and well-being of PLWH. However, even if clients are routinely screened, there are few models of effective, sustainable, and cost-effective mental health care that are easily integrated into clinic workflow. In many places, there is a dearth of mental health providers and services able to address the needs of PLWH and depression. The investigators propose to address this gap with ORCHID (Optimizing Resilience and Coping with HIV through Internet Delivery), a self-guided online-delivered intervention that specifically targets positive affect. The theory and empirically-based program includes eight skills (noticing and capitalizing on positive events, gratitude, mindfulness, positive reappraisal, personal strengths, attainable goals, and self-compassion), delivered in a self-guided online format. Across delivery modes and type of participant stress, the intervention has shown good feasibility, acceptability, and efficacy.

The intervention is based on revised Stress and Coping Theory and the Broaden-and-Build Theory of positive emotion. The preliminary data for the proposed study consists of 1) two randomized trials of an in-person positive affect intervention for PLWH who are newly diagnosed (n=159) or are sexual minority men who use methamphetamines (n=110); 2) an online adaptation of the positive affect intervention for people with elevated depression demonstrates feasibility, acceptability and efficacy (n=539); and 3) a pilot RCT of the online version of this intervention conducted with 21 PLWH.

The goal of the proposed study is to examine whether those who complete ORCHID, as implemented through Ryan White clinics, will experience improvements to depression and engagement in care. At the clinic level, we will examine whether clinics that are implementing the screening and referral to ORCHID have overall lower depression and higher engagement in care, compared to those clinics not yet implementing the screening and ORCHID referral. If effective, the ORCHID program can be disseminated to other geographical locations facing a high burden of HIV.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60637
        • Active, not recruiting
        • University of Chicago
      • Chicago, Illinois, United States, 60606
        • Active, not recruiting
        • AIDS Foundation of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral Health Screener + ORCHID Intervention (BHS+ORCHID)

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.

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.

No Intervention: Standard of Care
usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: 12 months
Primary outcome is change on depression (PROMIS-depression) from baseline to the 3 follow up points out to 12 months post intervention
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2021

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

November 4, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • R01MH124632-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Based on the updated NIH Policy as of January 2018, we aim to make the data available as early as 12 months after primary data collection has been completed depending on the study timeline and research team's progress on data collection, rigorous data analysis, consultation with field experts/collaborators, manuscript writing, and timing of publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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