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

Primary Purpose

HIV/AIDS, HPV Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ORCHID
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS focused on measuring depression, mobile applications, cortisol levels

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Cis-gender women, Receiving human immunodeficiency virus (HIV) care at the University of Miami Women's HIV Service, 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: Under 18 Not able to read/write English at the 6th grade level Cognitively impaired adults (as documented in medical records) Debilitating psychiatric condition (e.g. schizophrenia/bi-polar/psychotic disorders) Prisoners

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ORCHID Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of Participants who Complete ORCHID
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

Depression as measured by Patient Health Questionnaire (PHQ-9)
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)
Positive affect will be measured using the PANAS, range is 10 to 50, higher scores indicate higher levels of positive emotions.

Full Information

First Posted
June 29, 2023
Last Updated
September 30, 2023
Sponsor
University of Miami
Collaborators
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05935644
Brief Title
ORCHID: An Online Intervention for Persons With HIV (Miami)
Acronym
ORCHID-Miami
Official Title
ORCHID: A Novel Positive Affect Intervention for Aging, Racial/Ethnic Minoritized Women With HIV (Miami)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 13, 2023 (Anticipated)
Primary Completion Date
October 13, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, HPV Infection
Keywords
depression, mobile applications, cortisol levels

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ORCHID Group
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
ORCHID
Intervention 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.
Primary Outcome Measure Information:
Title
Proportion of Participants who Complete ORCHID
Description
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.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Depression as measured by Patient Health Questionnaire (PHQ-9)
Description
Depression will be measured using the PHQ-9 (range 0 to 27), higher scores indicate higher levels of depressive symptoms
Time Frame
Up to 6 months
Title
Positive Affect as measured by Positive and Negative Affect Schedule (PANAS)
Description
Positive affect will be measured using the PANAS, range is 10 to 50, higher scores indicate higher levels of positive emotions.
Time Frame
Up to 6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cis-gender women, Receiving human immunodeficiency virus (HIV) care at the University of Miami Women's HIV Service, 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: Under 18 Not able to read/write English at the 6th grade level Cognitively impaired adults (as documented in medical records) Debilitating psychiatric condition (e.g. schizophrenia/bi-polar/psychotic disorders) Prisoners
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lunthita M Duthely, Ed.D.
Phone
305.243.5800
Email
lduthely@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Latoya D Johnson, MBA
Phone
305.243.2170
Email
ldj32@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lunthita M Duthely, Ed.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Latoya D Johnson, MBA
Phone
305-243-2170
Email
ldj32@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Lunthita M Duthely, Ed.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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