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Trial Title:
ORCHID: An Online Intervention for Persons With HIV (Miami)
NCT ID:
NCT05935644
Condition:
HIV/AIDS
HPV Infection
Conditions: Official terms:
Papillomavirus Infections
Conditions: Keywords:
depression
mobile applications
cortisol levels
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
ORCHID
Description:
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.
Arm group label:
ORCHID Group
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.
Criteria for eligibility:
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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami School of Medicine
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Caroline Torres
Phone:
305-243-5800
Email:
wxb257@med.miami.edu
Investigator:
Last name:
Lunthita M Duthely, Ed.D.
Email:
Principal Investigator
Start date:
October 1, 2024
Completion date:
March 27, 2025
Lead sponsor:
Agency:
University of Miami
Agency class:
Other
Collaborator:
Agency:
Northwestern University
Agency class:
Other
Source:
University of Miami
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05935644
