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NCT05287230 Clinical Trial

Developing a Trauma-focused Intervention for Older Adults Living With HIV

Hiv Clinical Trial

Official title:
Developing a Trauma-focused Intervention for Older Adults Living With HIV

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05287230
Other study ID # Pro00114522
Secondary ID K01MH115794
Status Recruiting
Phase N/A
First received
Last updated
Start date January 18, 2022
Est. completion date June 1, 2024

Study information
Verified date December 2023
Source University of South Carolina
Contact Monique J Brown, PhD, MPH
Phone 803-777-5057
Email brownm68@mailbox.sc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators are adapting the LIFT and REFLECT interventions for older adults living with HIV who have been exposed to childhood sexual abuse.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date June 1, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria: - Living with HIV - 50 years old or older - <100 % ART adherence - depressive symptoms Exclusion Criteria: - Not living with HIV - <50 years - 100% ART Adherence

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging)
Investigators will use concepts from the LIFT and REFLECT interventions.
• Control
Participants will watch HIV and health related videos and discuss how it is related to aging with HIV.

Locations
Country Name City State
United States University of South Carolina Columbia South Carolina

Sponsors (2)
Lead Sponsor Collaborator
University of South Carolina National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Depressive symptoms Investigators will measure depressive symptoms as measured by the Patient Health Questionnaire-9 which ranges from 0 to 24 with higher values representing greater depressive symptoms. Baseline
Other Depressive symptoms Investigators will measure depressive symptoms as measured by the Patient Health Questionnaire-9 which ranges from 0 to 24 with higher values representing greater depressive symptoms. 6 weeks
Other Depressive symptoms Investigators will measure depressive symptoms as measured by the Patient Health Questionnaire-9 which ranges from 0 to 24 with higher values representing greater depressive symptoms. 3 months
Other Depressive symptoms Investigators will measure depressive symptoms as measured by the Patient Health Questionnaire-9 which ranges from 0 to 24 with higher values representing greater depressive symptoms. 6 months
Primary ART adherence Investigators will measure number of participants who report improved adherence to antiretroviral therapy in the past month using the 30-day visual analogue scale (VAS) Baseline
Primary ART adherence Investigators will measure number of participants who report improved adherence to antiretroviral therapy in the past month using the 30-day visual analogue scale (VAS) 6 weeks
Primary ART adherence Investigators will measure number of participants who report improved adherence to antiretroviral therapy in the past month using the 30-day visual analogue scale (VAS) 3 months
Primary ART adherence Investigators will measure number of participants who report improved adherence to antiretroviral therapy in the past month using the 30-day visual analogue scale (VAS) 6 months
Secondary Health-related quality of life Investigators will measure health-related quality of life of participants using the Centers for Disease Control and Prevention Health Days Core Module (CDC HRQOL-4). Baseline
Secondary Health-related quality of life Investigators will measure health-related quality of life of participants using the Centers for Disease Control and Prevention Health Days Core Module (CDC HRQOL-4). 6 weeks
Secondary Health-related quality of life Investigators will measure health-related quality of life of participants using the Centers for Disease Control and Prevention Health Days Core Module (CDC HRQOL-4). 3 months
Secondary Health-related quality of life Investigators will measure health-related quality of life of participants using the Centers for Disease Control and Prevention Health Days Core Module (CDC HRQOL-4). 6 months
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