TraumaNCT05287230

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

A study testing CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging) in people with Trauma and Hiv, run by University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 50 to 85 years
Conditions the study is for: Trauma, Hiv, Aging
What is being tested?: CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 18 Jan 2022to 30 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Living with HIV
50 years old or older
<100 % ART adherence
depressive symptoms

Who cannot join

Not living with HIV
<50 years
100% ART Adherence

Trial locations and contacts

1 site in 1 country.

United States1 site

University of South Carolina
Columbia, South Carolina, 29208

Other trials in United States

About this study

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

Conditions: Trauma, Hiv, Aging
Being tested: CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging), Control
Medical subject headings: Wounds and Injuries, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05287230
Study group	Role	What they receive
Intervention	Experimental	Not described Receives: Behavioral: CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging)
Control	Other	Not described Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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). Minimum is 0, Maximum is 100%. Higher scores mean better ART adherence.
Measured: Baseline
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). Minimum is 0, Maximum is 100%. Higher scores mean better ART adherence.
Measured: 6 weeks
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)
Measured: 3 months
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)
Measured: 6 months

Secondary outcomes (4)

Health-related Quality of Life - General Health
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.
Measured: Baseline
Health-related Quality of Life - General Health
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.
Measured: 6 weeks
Health-related Quality of Life - General Health
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.
Measured: 3 months
Health-related Quality of Life - General Health
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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jan 202230 Nov 2024

First posted18 Mar 2022
Study start18 Jan 2022
Primary completion30 Nov 2024
Study completion30 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for TraumaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05287230
Sponsor's protocol ID: Pro00114522
Other IDs: K01MH115794
Status last verified: Jul 2025
First submitted: 18 Feb 2022
Last updated: 31 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data will be made available to other researchers.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Trauma trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Developing a Trauma-focused Intervention for Older Adults Living With HIV
ClinicalTrials.gov ID: NCT05287230
Acronym / sponsor ID: Pro00114522
Conditions: Trauma, Hiv, Aging
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: University of South CarolinaUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 18 Jan 2022 (actual)
Primary completion: 30 Nov 2024 (actual)
Study completion: 30 Nov 2024 (actual)
First posted: 18 Mar 2022 (actual)
Results: Posted 31 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging)
Control	Other	Behavioral: Control

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Living with HIV
50 years old or older
<100 % ART adherence
depressive symptoms

Key exclusion criteria (3 listed)

Not living with HIV
<50 years
100% ART Adherence

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging)Investigators will use concepts from the LIFT and REFLECT interventions.	Behavioural	Intervention
ControlParticipants will watch HIV and health related videos and discuss how it is related to aging with HIV.	Behavioural	Control

Primary outcome

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.
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.
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)
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)

4 secondary outcomes

Health-related Quality of Life - General Health
Time frame: Baseline
Health-related Quality of Life - General Health
Time frame: 6 weeks
Health-related Quality of Life - General Health
Time frame: 3 months
Health-related Quality of Life - General Health
Time frame: 6 months

Results and safety

Results posted to the registry on 31 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	17	13
Control	11	6

Primary outcome: ART Adherence

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention n = 17	Control n = 11
Value	79.0 (25.9)	92.7 (2.5)

Intervention vs Control: p = 0.061, ANOVA

Primary outcome: ART Adherence

Time frame: 6 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention n = 10	Control n = 7
Value	92.4 (11.3)	96.4 (4.8)

Primary outcome: ART Adherence

Time frame: 3 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention n = 12	Control n = 6
Value	79.1 (29.1)	96.3 (4.3)

Primary outcome: ART Adherence

Time frame: 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention n = 12	Control n = 7
Value	83.7 (22.0)	91.1 (22.6)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Control	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Limitations and caveats (from the sponsor): Small sample size as this is a pilot trial. Therefore, results should be interpreted with caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Data will be made available to other researchers.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Monique J Brown, PhD, MPH principal investigator

University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CoSHA (Coping with childhood Sexual Abuse, HIV, and Aging) in people with Trauma and Hiv, run by University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ART Adherence (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05287230.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.