What side effects are associated with this type of intervention?

The ORCHID trial focuses on increasing positive affect through internet-delivered interventions, which are generally non-pharmacologic and aim to improve psychological well-being. Common treatments for people living with HIV, particularly antiretroviral therapy (ART), can have side effects such as gastrointestinal issues, fatigue, and potential long-term effects like lipodystrophy and cardiovascular problems. However, the ORCHID intervention itself, being a psychological and behavioral approach, is less likely to have physical side effects and more likely to improve mental health outcomes, such as reducing depression and anxiety.

What prior FDA approvals exist?

FDA-approved treatments for People Living With HIV (PLWH) primarily include antiretroviral therapies (ART) such as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. These treatments focus on viral suppression and improving immune function. The ORCHID trial, which combines mental health screening with an online-delivered intervention to enhance positive affect, represents a novel approach that complements traditional ART by addressing psychological well-being and mental health outcomes in PLWH.

What other types of research exist?

Promising alternatives to ORCHID for PLWH include: 1) Mindfulness-Based Stress Reduction (MBSR) programs, which have shown benefits in reducing stress and improving psychological well-being; 2) Cognitive Behavioral Therapy (CBT) tailored for PLWH, focusing on coping strategies and positive thinking; 3) Mobile health (mHealth) interventions that provide real-time support and resources through smartphone apps; and 4) Peer support groups facilitated through online platforms, which can enhance social support and positive affect.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The ORCHID trial aims to improve mental health and viral suppression in People Living With HIV (PLWH) by increasing positive affect through an online-delivered intervention. Common treatments for PLWH include antiretroviral therapy (ART), which works by inhibiting the replication of the HIV virus, thereby reducing viral load and improving immune function. Increasing positive affect is crucial as it is associated with better adherence to ART, lower levels of depression, and slower disease progression. This holistic approach not only targets the virus but also enhances psychological well-being, leading to better overall health outcomes for PLWH.

A Qualitative Study to Identify Perceptual Barriers to Antiretroviral Therapy (ART) Uptake and Adherence in HIV Positive People from UK Black African and Caribbean Communities.