The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05935644
Recruitment Status : Not yet recruiting
First Posted : July 7, 2023
Last Update Posted : February 21, 2024
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
Lunthita M. Duthely, University of Miami

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV/AIDS HPV Infection Behavioral: ORCHID Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ORCHID: A Novel Positive Affect Intervention for Aging, Racial/Ethnic Minoritized Women With HIV (Miami)
Estimated Study Start Date : April 13, 2024
Estimated Primary Completion Date : December 13, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05935644


Contacts
Layout table for location contacts
Contact: Lunthita M Duthely, Ed.D. 305.243.5800 lduthely@med.miami.edu
Contact: Latoya D Johnson, MBA 305.243.2170 ldj32@med.miami.edu

Locations
Layout table for location information
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Contact: Latoya D Johnson, MBA    305-243-2170    ldj32@med.miami.edu   
Principal Investigator: Lunthita M Duthely, Ed.D.         
Sponsors and Collaborators
University of Miami
Northwestern University
Investigators
Layout table for investigator information
Principal Investigator: Lunthita M Duthely, Ed.D. University of Miami
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Lunthita M. Duthely, Research Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT05935644    
Other Study ID Numbers: 20221247
First Posted: July 7, 2023    Key Record Dates
Last Update Posted: February 21, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lunthita M. Duthely, University of Miami:
depression
mobile applications
cortisol levels
Additional relevant MeSH terms:
Layout table for MeSH terms
Papillomavirus Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Virus Diseases
 Genital Diseases
Urogenital Diseases
DNA Virus Infections
Tumor Virus Infections
Disease Attributes
Pathologic Processes