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

  • End date
    Mar 1, 2025
  • participants needed
  • sponsor
    Northwestern University
Updated on 25 April 2022


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.


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.

Condition People Living With HIV
Treatment BHS+ORCHID
Clinical Study IdentifierNCT05123144
SponsorNorthwestern University
Last Modified on25 April 2022


Yes No Not Sure

Inclusion Criteria

Ryan White clinic in the Chicagoland area
On-site medical services
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

Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note