ORCHID: An Online Intervention for Persons With HIV (Miami) (ORCHID-Miami)

May 20, 2026 updated by: Lunthita M. Duthely, University of Miami

ORCHID: A Novel Positive Affect Intervention for Aging, Racial/Ethnic Minoritized Women With HIV (Miami)

The purpose of this research is to test ORCHID (Optimizing Resilience & Coping with HIV through Internet Delivery), a skills-building intervention that improves mental health status for persons with HIV, who are at-risk for falling out of care.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami School Of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Cis-gender women,
  2. Receiving human immunodeficiency virus (HIV) care at the University of Miami Women's HIV Service,
  3. Recent history (12-month) of cervical or anal dysplasia or human papilloma virus (HPV) positivity; AND a recent (12-month) history of one or more of the following:

i) drug use (alcohol, tobacco products, marijuana, illicit drugs) or ii) depression or iii) psychiatric condition (anxiety, post-traumatic stress disorder (PTSD)) or iv) unsuppressed HIV viral load d. All life stages - pregnant, non-pregnant, pre/post-menopausal

Exclusion Criteria:

  1. Under 18
  2. Not able to read/write English at the 6th grade level
  3. Cognitively impaired adults (as documented in medical records)
  4. Debilitating psychiatric condition (e.g. schizophrenia/bi-polar/psychotic disorders)
  5. Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ORCHID Group
Participants in the ORCHID group will receive an online intervention that improves depressive symptoms and positive affect (emotions) for clinic-based persons living with HIV, for up to 6 months.
Behavioral: ORCHID
The intervention includes 8 modules, which are delivered online, approximately 30 minutes per session, and participants will engage a minimum of once per week. Participants may also meet online or in-person with a navigator, up to 4 times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants who Complete ORCHID
Time Frame: Up to 6 months
Average across all participants of the proportion of participants who login to all 8 ORCHID intervention sessions, calculated as total number of sessions opened (0-8) divided by 8.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression as measured by Patient Health Questionnaire (PHQ-9)
Time Frame: Up to 6 months
Depression will be measured using the PHQ-9 (range 0 to 27), higher scores indicate higher levels of depressive symptoms
Up to 6 months
Positive Affect as measured by Positive and Negative Affect Schedule (PANAS)
Time Frame: Up to 6 months
Positive affect will be measured using the PANAS, range is 10 to 50, higher scores indicate higher levels of positive emotions.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Northwestern University

Investigators

  • Principal Investigator: Lunthita M Duthely, Ed.D., University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

October 27, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

June 29, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20221247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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