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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
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 18, 2022
Last Updated
March 10, 2022
Sponsor
University of South Carolina
Collaborators
National Institute of Mental Health (NIMH)
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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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