- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05123144
A Hybrid Type II Trial of the Optimizing Resilience and Coping With HIV Through Internet Delivery in Ryan White Clinics in Chicago (ORCHID)
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
Study Overview
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
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Katrin Bovbjerg
- Phone Number: (312) 503-5915
- Email: katrin.bovbjerg@northwestern.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
-
Contact:
- Amanda Summers, MA
- Phone Number: 312-771-0373
- Email: amanda.summers@northwestern.edu
-
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
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on People Living With HIV
-
ANRS, Emerging Infectious DiseasesInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedPeople Living With HIV | Men Who Have Sex With MenFrance
-
Gérond'ifRecruitingElderly People Living at Home | With an Internet Connection at HomeFrance
-
Jean-Pierre RoutyRecruiting
-
National Center for Geriatrics and Gerontology,...GE HealthcareCompleted
-
University Medical Center GoettingenWithdrawnUtilization of Nursing, Medical and Therapeutical Care of People Living at Home With Care Needs
-
University of Erlangen-Nürnberg Medical SchoolGerman Federal Ministry of Education and Research; University of Erlangen-NürnbergCompletedIndependent Living | Old and Very Old People | FunctioningGermany
-
Centre Hospitalier le MansCompletedPatients Living With HIVFrance
-
Foundation for Innovative New Diagnostics, SwitzerlandSwiss Tropical & Public Health Institute; University of Cape Town; The HIV Netherlands... and other collaboratorsCompletedDiagnosis of Tuberculosis in People Living With HIVMalawi, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia
-
Beijing 302 HospitalRecruitingCOVID-19 | Vaccine | People Living With HIVChina
-
Hospital Comarcal de IncaCompletedElderly (People Aged 65 or More) | Polypharmacy (People Under Treatment With 5 or More Drugs)Spain
Clinical Trials on BHS+ORCHID
-
PharmatrophiX Inc.National Institute on Aging (NIA)CompletedMild to Moderate Alzheimer's DiseaseSpain, Germany, Austria, Czechia, Sweden
-
Shanghai Ninth People's Hospital Affiliated to...RecruitingPeripheral Artery DiseaseChina
-
University of MiamiNorthwestern UniversityNot yet recruitingHIV/AIDS | HPV InfectionUnited States
-
Thammasat UniversityCompletedAllergic RhinitisThailand
-
Acotec Scientific Co., LtdCompletedPeripheral Artery DiseaseChina
-
Acotec Scientific Co., LtdCompleted
-
Xuanwu Hospital, BeijingUnknownDiabetes | Popliteal Artery Occlusion | Popliteal StenosisChina
-
Acotec Scientific Co., LtdActive, not recruitingIschemic Stroke | Transient Ischemic AttackChina
-
Karolinska University HospitalCompleted