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

HIV/AIDS Clinical Trial

— ORCHID-Miami  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05935644
• Other study ID #: 20221247
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 13, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: University of Miami
• Contact: Lunthita M Duthely, Ed.D.
• Phone: 305.243.5800
• Email: lduthely[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 13, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS
• HPV Infection
• Papillomavirus Infections

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 6 months
Secondary	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	Up to 6 months
Secondary	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.	Up to 6 months