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

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

Status
Suspended
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05935644
Acronym
ORCHID-Miami
Enrollment
30
Registered
2023-07-07
Start date
2024-10-01
Completion date
2026-10-31
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS, HPV Infection

Keywords

depression, mobile applications, cortisol levels

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.

Interventions

BEHAVIORALORCHID

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.

Sponsors

University of Miami
Lead SponsorOTHER
Northwestern University
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Participants who Complete ORCHIDUp to 6 monthsAverage 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

MeasureTime frameDescription
Depression as measured by Patient Health Questionnaire (PHQ-9)Up to 6 monthsDepression will be measured using the PHQ-9 (range 0 to 27), higher scores indicate higher levels of depressive symptoms
Positive Affect as measured by Positive and Negative Affect Schedule (PANAS)Up to 6 monthsPositive affect will be measured using the PANAS, range is 10 to 50, higher scores indicate higher levels of positive emotions.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLunthita M Duthely, Ed.D.

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026