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Clinical Trials/NCT05935644
NCT05935644
Enrolling By Invitation
Not Applicable

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

University of Miami1 site in 1 country30 target enrollmentOctober 1, 2024
InterventionsORCHID

Overview

Phase
Not Applicable
Intervention
ORCHID
Conditions
HIV/AIDS
Sponsor
University of Miami
Enrollment
30
Locations
1
Primary Endpoint
Proportion of Participants who Complete ORCHID
Status
Enrolling By Invitation
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2024
End Date
October 31, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lunthita M. Duthely

Research Associate Professor

University of Miami

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

  • 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)

Arms & Interventions

ORCHID Group

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: ORCHID

Outcomes

Primary Outcomes

Proportion of Participants who Complete ORCHID

Time Frame: 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 Outcomes

  • Positive Affect as measured by Positive and Negative Affect Schedule (PANAS)(Up to 6 months)
  • Depression as measured by Patient Health Questionnaire (PHQ-9)(Up to 6 months)

Study Sites (1)

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