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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV/AIDS, HPV Infection

Intervention / Treatment
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* Behavioral: ORCHID


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ORCHID Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression as measured by Patient Health Questionnaire (PHQ-9) | Depression will be measured using the PHQ-9 (range 0 to 27), higher scores indicate higher levels of depressive symptoms | Up to 6 months | 
| Positive Affect as measured by Positive and Negative Affect Schedule (PANAS) | Positive affect will be measured using the PANAS, range is 10 to 50, higher scores indicate higher levels of positive emotions. | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, mobile applications, cortisol levels