Developing a Trauma-focused Intervention for Older Adults Living With HIV
Primary Purpose
Trauma, Hiv, Aging
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging)
Control
Sponsored by
About this trial
This is an interventional treatment trial for Trauma
Eligibility Criteria
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
Sites / Locations
- University of South CarolinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
Secondary Outcome Measures
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).
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).
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).
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).
Full Information
NCT ID
NCT05287230
First Posted
February 18, 2022
Last Updated
March 10, 2022
Sponsor
University of South Carolina
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05287230
Brief Title
Developing a Trauma-focused Intervention for Older Adults Living With HIV
Official Title
Developing a Trauma-focused Intervention for Older Adults Living With HIV
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigators are adapting the LIFT and REFLECT interventions for older adults living with HIV who have been exposed to childhood sexual abuse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Hiv, Aging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging)
Intervention Description
Investigators will use concepts from the LIFT and REFLECT interventions.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Participants will watch HIV and health related videos and discuss how it is related to aging with HIV.
Primary Outcome Measure Information:
Title
ART adherence
Description
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)
Time Frame
Baseline
Title
ART adherence
Description
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)
Time Frame
6 weeks
Title
ART adherence
Description
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)
Time Frame
3 months
Title
ART adherence
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
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).
Time Frame
Baseline
Title
Health-related quality of life
Description
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).
Time Frame
6 weeks
Title
Health-related quality of life
Description
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).
Time Frame
3 months
Title
Health-related quality of life
Description
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).
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Depressive symptoms
Description
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.
Time Frame
Baseline
Title
Depressive symptoms
Description
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.
Time Frame
6 weeks
Title
Depressive symptoms
Description
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.
Time Frame
3 months
Title
Depressive symptoms
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monique J Brown, PhD, MPH
Phone
803-777-5057
Email
brownm68@mailbox.sc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amandeep Kaur, MPH
Email
akaur@email.sc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monique J Brown, PhD, MPH
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monique J Brown, PhD, MPH
Phone
803-777-5057
Email
brownm68@mailbox.sc.edu
First Name & Middle Initial & Last Name & Degree
Monique J Brown, PhD, MPH
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available to other researchers.
IPD Sharing Time Frame
Data will be made available to other researchers after investigators have submitted the related primary paper.
Learn more about this trial
Developing a Trauma-focused Intervention for Older Adults Living With HIV
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