People Living With HIVORCHIDNCT05123144
A Hybrid Type II Trial of the Optimizing Resilience and Coping With HIV Through Internet Delivery in Ryan White Clinics in Chicago
A study testing BHS+ORCHID in people with People Living With HIV, run by Northwestern University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- People Living With HIV
- What is being tested?
- BHS+ORCHID
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Oct 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinic-Level:
- Ryan White clinic in the Chicagoland area
- On-site medical services
- Individual-Level:
- Age 18 and over
- Speaks and reads English
Show all 10Show fewer
- 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.
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
AIDS Foundation of Chicago
Chicago, Illinois, 60606
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
About this study
Official title: 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.
Read the 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.
- Conditions
- People Living With HIV
- Being tested
- BHS+ORCHID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHS+ORCHIDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: BHS+ORCHID |
| Standard of Care | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Primary outcome is change on depression (PROMIS-depression) from baseline to the 3 follow up points out to 12 months post intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start15 Oct 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for People Living With HIVStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, AIDS Foundation Chicago
- Responsible party
- Principal investigator, Judith Moskowitz, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123144
- Sponsor's protocol ID
- R01MH124632-01
- Acronym
- ORCHID
- Status last verified
- Apr 2026
- First submitted
- 24 Jun 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40163072Xavier 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.
PubMed 39334472
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05123144
- Acronym / sponsor ID
- ORCHID / R01MH124632-01
- Conditions
- People Living With HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Chicago, AIDS Foundation Chicago
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Health Screener + ORCHID Intervention (BHS+ORCHID) | Experimental | Behavioral: BHS+ORCHIDAt 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. |
| Standard of Care | No intervention | –usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BHS+ORCHIDAt 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. | Behavioural | Behavioral Health Screener + ORCHID Intervention (BHS+ORCHID) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 40163072Garner 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.
- Derived from this study: PubMed 39334472Xavier 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BHS+ORCHID in people with People Living With HIV, run by Northwestern University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05123144, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.