ORCHID: A Novel Positive Affect Intervention for Aging, Racial/Ethnic Minoritized Women With HIV (Miami)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- University of Miami
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Proportion of Participants who Complete ORCHID
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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 (Behavioral)
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)
Investigators
Lunthita M. Duthely
Research Associate Professor
University of Miami