Online intervention to support mental health for people with HIV
ORCHID: A Novel Positive Affect Intervention for Aging, Racial/Ethnic Minoritized Women With HIV (Miami)
NA · University of Miami · NCT05935644
This study is testing an online program to help improve mental health for women living with HIV by teaching them skills to cope with challenges like depression and substance use.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | University of Miami (other) |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05935644 on ClinicalTrials.gov |
What this trial studies
This research tests ORCHID, an online skills-building intervention designed to enhance mental health for individuals living with HIV who are at risk of losing access to care. The program focuses on improving resilience and coping strategies, particularly for cis-gender women receiving HIV care at the University of Miami Women's HIV Service. Participants will engage with the intervention to address issues such as depression and substance use, while also managing HPV-related health concerns. The study aims to evaluate the effectiveness of this digital approach in improving overall mental health outcomes.
Who should consider this trial
Good fit: Ideal candidates include cis-gender women receiving HIV care with a recent history of HPV positivity or cervical/anal dysplasia and associated mental health challenges.
Not a fit: Patients under 18, those unable to read/write English at a 6th grade level, or individuals with severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mental health and care retention for women living with HIV.
How similar studies have performed: Other studies have shown promise in using online interventions for mental health support in similar populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Miami, Florida
- University of Miami School of Medicine — Miami, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Lunthita M Duthely, Ed.D. — University of Miami
- Study coordinator: Lunthita M Duthely, Ed.D.
- Email: lduthely@med.miami.edu
- Phone: 305.243.5800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV/AIDS, HPV Infection, depression, mobile applications, cortisol levels