This clinical trial evaluates the effect of Optimizing Resilience and Coping with HIV through Internet Delivery (ORCHID), a skills-building intervention on improving mental health in women with HIV and cervical or anal cells that look abnormal under a microscope but are not cancer (dysplasia). ORCHID may be an effective method to reduce stress and improve the overall well-being and quality of life in women with HIV and cervical or anal dysplasia.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05935644.
Locations matching your search criteria
United States
Florida
Miami
Jackson Memorial Hospital-Holtz Children's HospitalStatus: Temporarily closed to accrual
Contact: Lunthita Duthely
Phone: 305-243-5800
University of Miami Miller School of Medicine-Sylvester Cancer CenterStatus: Temporarily closed to accrual
Contact: Lunthita Duthely
Phone: 305-243-5800
PRIMARY OBJECTIVE:
I. Assess feasibility of the ORCHID online intervention for aging, racial/ethnic minoritized women with HIV.
SECONDARY OBJECTIVES:
I. Assess preliminary efficacy of the ORCHID online intervention on psychological, mental health and behavioral factors.
II. Assess retention rate and referral uptake rate.
III. Characterize participants with cervical or anal dysplasia, or high-risk human papillomavirus (HPV) positivity by age group (≥ 50 versus [vs] < 50).
IV. Report participant interview at study end.
OUTLINE:
Patients complete ORCHID self-paced modules over 15-30 minutes once weekly (QW) for 8 weeks. Patients also undergo blood sample collection as well as self-collection of saliva and anal and vaginal canal swabs.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorLunthita Duthely
