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

Not Applicable

Recruiting

• Conditions: HIV/AIDS; HPV Infection
• Interventions: Behavioral: ORCHID

• Registration Number: NCT05935644
• Lead Sponsor: University of 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 available

Study Timeline

• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-06-29
• Study First Posted: 2023-07-07
• Study Start: 2024-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-10-27
• Study Completion: 2025-10-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ORCHID Group	ORCHID	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants who Complete ORCHID	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

Name	Time	Method
Positive Affect as measured by Positive and Negative Affect Schedule (PANAS)	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.
Depression as measured by Patient Health Questionnaire (PHQ-9)	Up to 6 months	Depression will be measured using the PHQ-9 (range 0 to 27), higher scores indicate higher levels of depressive symptoms

Trial Locations

Locations (1)

University of Miami School of Medicine; 🇺🇸 Miami, Florida, United States