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

NCT05935644 | Suspended

• 1 other identifier: 20221247
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS; HPV Infection

Keywords

depression; mobile applications; cortisol levels

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Depression as measured by Patient Health Questionnaire (PHQ-9)

  Up to 6 months

• Positive Affect as measured by Positive and Negative Affect Schedule (PANAS)

  Up to 6 months

Study Arms (1)

ORCHID Group

EXPERIMENTAL

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.

Behavioral: ORCHID

Interventions

ORCHID BEHAVIORAL

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.

ORCHID Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• Northwestern University: collaborator

Study Sites (1)

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Papillomavirus Infections; Depression

Interventions

Benzethonium

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; DNA Virus Infections; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Lunthita M Duthely, Ed.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 7, 2023
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 27, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)