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

July 11, 2025 updated by: Monique J. Brown, University of South Carolina
Investigators are adapting the LIFT and REFLECT interventions for older adults living with HIV who have been exposed to childhood sexual abuse.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ART Adherence
Time Frame: Baseline
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). Minimum is 0, Maximum is 100%. Higher scores mean better ART adherence.
Baseline
ART Adherence
Time Frame: 6 weeks
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). Minimum is 0, Maximum is 100%. Higher scores mean better ART adherence.
6 weeks
ART Adherence
Time Frame: 3 months
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
ART Adherence
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of Life - General Health
Time Frame: Baseline
Investigators will measure health-related quality of life of participants, specifically, general health, using the Centers for Disease Control and Prevention Health Days Core Module (CDC HRQOL-4). Minimum value is 1. Maximum value is 5. Values were recoded so that higher scores mean better outcome.
Baseline
Health-related Quality of Life - General Health
Time Frame: 6 weeks
Investigators will measure health-related quality of life of participants, specifically, general health, using the Centers for Disease Control and Prevention Health Days Core Module (CDC HRQOL-4). Minimum value is 1. Maximum value is 5. Values were recoded so that higher scores mean better outcome.
6 weeks
Health-related Quality of Life - General Health
Time Frame: 3 months
Investigators will measure health-related quality of life of participants, specifically, general health, using the Centers for Disease Control and Prevention Health Days Core Module (CDC HRQOL-4). Minimum value is 1. Maximum value is 5. Values were recoded so that higher scores mean better outcome.
3 months
Health-related Quality of Life - General Health
Time Frame: 6 months
Investigators will measure health-related quality of life of participants, specifically, general health, using the Centers for Disease Control and Prevention Health Days Core Module (CDC HRQOL-4). Minimum value is 1. Maximum value is 5. Values were recoded so that higher scores mean better outcome.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive Symptoms
Time Frame: Baseline
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
Depressive Symptoms
Time Frame: 6 weeks
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
Depressive Symptoms
Time Frame: 3 months
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
Depressive Symptoms
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Carolina

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Monique J Brown, PhD, MPH, University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2022

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

March 10, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 11, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00114522
  • K01MH115794 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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