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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

Tracking Information
First Submitted Date  ICMJE June 29, 2023
First Posted Date  ICMJE July 7, 2023
Last Update Posted Date February 21, 2024
Estimated Study Start Date  ICMJE April 13, 2024
Estimated Primary Completion Date December 13, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2023)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2023)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ORCHID: An Online Intervention for Persons With HIV (Miami)
Official Title  ICMJE ORCHID: A Novel Positive Affect Intervention for Aging, Racial/Ethnic Minoritized Women With HIV (Miami)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV/AIDS
  • HPV Infection
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: ORCHID
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2023)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 13, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05935644
Other Study ID Numbers  ICMJE 20221247
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Lunthita M. Duthely, University of Miami
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Miami
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Northwestern University
Investigators  ICMJE
Principal Investigator: Lunthita M Duthely, Ed.D. University of Miami
PRS Account University of Miami
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP