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Mental Health Program for People Living With HIV (ORCHID Trial)

Phase 2
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 and over
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

ORCHID Trial Summary

This trial aims to study the effectiveness of a mental health screening and referral program for people living with HIV (PLWH) in Chicago. The study will use a stepped wedge cluster randomized design, which will allow all clients with elevated depression to receive the intervention. The study 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.

Who is the study for?
This trial is for adults over 18 living with HIV in Chicago, who are clients at Ryan White clinics and show signs of depression. Participants must speak English, have daily internet access, and agree to share their health information.Check my eligibility
What is being tested?
The study tests a mental health intervention called ORCHID delivered online to improve mood and health outcomes in HIV patients. It involves screening for depression and providing resources through case managers using a stepped wedge design.See study design
What are the potential side effects?
Since ORCHID is a psychological support program delivered online, it may not have direct medical side effects but could include emotional discomfort or distress as participants engage with the content.

ORCHID Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

ORCHID Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Depression

ORCHID Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral Health Screener + ORCHID Intervention (BHS+ORCHID)Experimental Treatment1 Intervention
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.
Group II: Standard of CareActive Control1 Intervention
usual care

Find a Location

Who is running the clinical trial?

AIDS Foundation of ChicagoUNKNOWN
AIDS Foundation ChicagoUNKNOWN
University of ChicagoOTHER
1,004 Previous Clinical Trials
819,477 Total Patients Enrolled

Media Library

BHS+ORCHID Clinical Trial Eligibility Overview. Trial Name: NCT05123144 — Phase 2
People Living With HIV Research Study Groups: Behavioral Health Screener + ORCHID Intervention (BHS+ORCHID), Standard of Care
People Living With HIV Clinical Trial 2023: BHS+ORCHID Highlights & Side Effects. Trial Name: NCT05123144 — Phase 2
BHS+ORCHID 2023 Treatment Timeline for Medical Study. Trial Name: NCT05123144 — Phase 2
People Living With HIV Patient Testimony for trial: Trial Name: NCT05123144 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the most severe side effects associated with BHS+ORCHID?

"BHS+ORCHID was given a safety rating of 2. Although there is some evidence supporting its safety, Phase 2 trials have not looked at efficacy yet."

Answered by AI

How many people are being enrolled to this medical study?

"That is correct. The online clinicaltrials.gov registry shows that this trial, which was first advertised on October 15th 2021, is still looking for participants. They are currently recruiting for 300 individuals at 1 medical site."

Answered by AI

Are we still recruiting for participants in this research?

"Indeed, the most recent information on clinicaltrials.gov reveals that this study is still recruiting patients. This particular trial was first posted on October 15th 2021 and last updated less than two months ago on March 30th, 2022. They are looking for 300 individuals at a single site."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
Northwestern University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
2

Why did patients apply to this trial?

I've tried many antidepressants and am still living with depression.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long is the study? How long does the screening take?
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Email
Most responsive sites:
  1. Northwestern University: < 24 hours
~75 spots leftby Mar 2025