HIV/AIDSTRACENCT04163341
Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States
A study testing Adapted Common Elements Treatment Approach in people with HIV/AIDS and Depression, run by Michael J Mugavero, MD at 1 site in United States.
Trial summary
This pilot randomized clinical trial will randomize 60 participants 1:1 to either enhanced usual care or to adapted Common Elements Treatment Approach (CETA), a counseling intervention for HIV care engagement plus depression, anxiety, PTSD, and/or substance use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Depression, Anxiety
- What is being tested?
- Adapted Common Elements Treatment Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2020to 13 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years.
- Patient receiving HIV care at University of Alabama at Birmingham (UAB) 1917 Clinic.
- Elevated symptoms of depression, anxiety, post-traumatic stress, or substance use disorder: At least one of the following:
- Patient Health Questionnaire-9 score >= 10;
- Generalized Anxiety Disorder 7-Item Scale score >= 10;
- Post-Traumatic Stress Symptoms Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) score >= 33;
Show all 13Show fewer
- ASSIST score >=11 for alcohol or >=4 for any other substance
- At risk for suboptimal HIV care engagement: At least one of the following:
- Engaged in HIV care for the first time within the past 6 months;
- Have an HIV RNA viral load >1,000 copies/mL within the past 6 months;
- Antiretroviral regimen was changed due to treatment failure within the past 6 months;
- No-showed to an HIV primary care appointment within the past year.
- Willing to provide written informed consent.
Who cannot join
- 1. Non-English speaking 2. Unable to attend counseling sessions 3. Unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35222
About this study
This pilot randomized clinical trial will randomize 60 participants 1:1 to either enhanced usual care or to adapted Common Elements Treatment Approach (CETA), a counseling intervention for HIV care engagement plus depression, anxiety, PTSD, and/or substance use.
Read the detailed description
Patient participants in this study will be randomized 1:1 to either enhanced usual care or the adapted CETA intervention. Enhanced usual care will include provision of feedback about psychiatric diagnoses to the HIV provider and the clinic's behavioral health team for follow-up according to the clinic's standard care. Participants randomized to the adapted CETA arm will initiate CETA with the trained counselor. The number of CETA sessions will depend on the patient's presentation but will range from 7-13 weekly in-person 1-hour sessions.Before randomization, enrolled participants will complete a baseline assessment including sociodemographic information; self-reported health; standardized assessments of depressive, anxiety, and post-traumatic stress symptoms and substance use; and key related structural and psychosocial factors including housing stability,intimate partner violence (IPV), other violence in the home, coping, social support, and experiences of stigma related to mental health.
Participants in the Enhanced Contact arm will complete a follow-up research assessment at 3 months post baseline.Participants in the adapted CETA arm will complete this assessment after the final CETA session,also expected to be at approximately 3 months post-baseline. All participants will complete a final research assessment at 9 months post-baseline (approximately 6 months post-treatment exit for those in the adapted CETA arm). These follow-up assessments will assess the same domains as the baseline assessment.
- Being tested
- Adapted Common Elements Treatment Approach
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Common Elements Treatment ApproachBehavioural
The intervention is a transdiagnostic cognitive behavioral therapy approach to treating any combination of depression, anxiety, post-traumatic stress, or substance use disorder that has been adapted the needs of adults with HIV and to additionally address HIV care engagement.
| Study group | Role | What they receive |
|---|---|---|
| Common Elements Treatment Approach (CETA) protocol | Experimental | Adapted Common Elements Treatment Approach (CETA): The intervention is a transdiagnostic cognitive behavioral therapy approach to treating any combination of depression, anxiety, post-traumatic stress, or substance use disorder that has been adapted the needs of adults with HIV and to additionally address HIV care engagement. Receives: Behavioral: Adapted Common Elements Treatment Approach |
| Enhanced Usual Care (EUC) | No intervention | Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment
We defined feasibility as the total number of patients approached in order to accrue the final study sample size of n=60.
Measured: Duration of recruitment phase (9 months)
Client Acceptability
Client acceptability will be assessed via the Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is an 8-item questionnaire, with a minimum value of 8 and a maximum score of 32. A higher score indicates greater client acceptability.
Measured: At treatment exit (approximately 9 months post-baseline)
Fidelity
Counselor fidelity to CETA will be rated by the trainer based on the trainer's supervisory experience working with CETA counselors. After all CETA patients complete the study, the trainer will rate up to 5 cross-cutting aspects of CETA delivery and 13 CETA components targeting specific symptoms for fidelity. The trainer will rate the degree of confidence on a scale of 0 ("Not at all") to 4 ("Completely") that the counselor was routinely delivering each cross-cutting aspect or component of CETA with fidelity, for those aspects and components that the trainer had experience supervising the counselor in. The fidelity rating will be calculated separately for the 2 CETA counselors and reported as the mean score across the number of CETA aspects and components rated by the trainer. Higher scores indicate greater fidelity to CETA.
Measured: At the end of CETA completion or withdrawal, across all CETA participants
Secondary outcomes (8)
Number of Participants Suppressed HIV RNA Viral Load
HIV RNA viral load <200 copies/mL
Measured: 4 months post-baseline
Number of Participants With Suppressed HIV RNA Viral Load
HIV RNA viral load <200 copies/mL
Measured: 9 months post-baseline
HIV Appointment Attendance
Health Resources and Services Administration (HRSA) attendance measure: Engaged in care if attended >=2 HIV primary care visits >= 90 days apart in the 12 months after baseline.
Measured: From baseline to 12 months post-baseline
Depressive Symptoms
Patient Health Questionnaire-9 (PHQ-9) score; minimum score is 0, maximum score is 27, with higher scores meaning a worse outcome.
Measured: 4 months post-baseline
Anxiety Symptoms
Generalized Anxiety Disorder-7 (GAD-7) anxiety subscale score; minimum score is 0, maximum score is 21, with higher scores meaning a worse outcome.
Measured: 4 months post-baseline
Post-traumatic Stress Symptoms
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5); minimum score is 0, maximum score is 80, with higher scores meaning a worse outcome.
Measured: 4 months post-baseline
Substance Use Symptoms
The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST); each substance is scored separately. The minimum score is 0, maximum score is 39, with higher scores meaning a worse outcome. For this outcome, we will report substance use symptoms at 4 months post-baseline for the substance with the highest score at baseline only.
Measured: 4 months post-baseline
HIV Kept Visit Attendance
Mean kept visit proportion: Total number of kept visits HIV clinical care visits divided by total number of missed plus kept HIV clinical care visits.
For one individual: The numerator in this proportion is all the scheduled HIV clinical care visits a participant attended from baseline to 12-months post-baseline.The denominator in this proportion is all the scheduled HIV clinical care visits a participant attended plus all the scheduled HIV clinical care visits a participant did not attend or 'missed' from baseline to 12-months post-baseline.
For each arm: We calculated the mean kept visit proportion per study arm by adding each individual kept visit proportion and dividing by the total number of participants in each arm.
Measured: From baseline to 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start23 Oct 2020
- Primary completion1 Sep 2022
- Study completion13 Dec 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael J Mugavero, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor-investigator, Michael J Mugavero, MD, University of Alabama at Birmingham
- Investigators
- Brian Pence, PhD, Principal investigator, UNC-Chapel HillBradley Gaynes, MD, Principal investigator, UNC-Chapel HillDoyane Darnell, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163341
- Sponsor's protocol ID
- IRB-300004217
- Acronym
- TRACE
- Status last verified
- Sep 2024
- First submitted
- 12 Nov 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pence BW, Darnell D, Ranna-Stewart M, Psaros C, Gaynes BN, Grimes L, Henderson S, Parman M, Filipowicz TR, Gaddis K, Dorsey S, Mugavero MJ. Provocative Findings From a Transdiagnostic Counseling Intervention to Improve Psychiatric Comorbidity and HIV Care Engagement Among People With HIV: A Pilot Randomized Clinical Trial. J Acquir Immune Defic Syndr. 2024 Sep 1;97(1):68-77. doi: 10.1097/QAI.0000000000003457.
PubMed 39116333
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States
- ClinicalTrials.gov ID
- NCT04163341
- Acronym / sponsor ID
- TRACE / IRB-300004217
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Michael J Mugavero, MDUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot randomized clinical trial will randomize 60 participants 1:1 to either enhanced usual care or to adapted Common Elements Treatment Approach (CETA), a counseling intervention for HIV care engagement plus depression, anxiety, PTSD, and/or substance use.
Detailed description
Patient participants in this study will be randomized 1:1 to either enhanced usual care or the adapted CETA intervention. Enhanced usual care will include provision of feedback about psychiatric diagnoses to the HIV provider and the clinic's behavioral health team for follow-up according to the clinic's standard care. Participants randomized to the adapted CETA arm will initiate CETA with the trained counselor. The number of CETA sessions will depend on the patient's presentation but will range from 7-13 weekly in-person 1-hour sessions.Before randomization, enrolled participants will complete a baseline assessment including sociodemographic information; self-reported health; standardized assessments of depressive, anxiety, and post-traumatic stress symptoms and substance use; and key related structural and psychosocial factors including housing stability,intimate partner violence (IPV), other violence in the home, coping, social support, and experiences of stigma related to mental health.
Participants in the Enhanced Contact arm will complete a follow-up research assessment at 3 months post baseline.Participants in the adapted CETA arm will complete this assessment after the final CETA session,also expected to be at approximately 3 months post-baseline. All participants will complete a final research assessment at 9 months post-baseline (approximately 6 months post-treatment exit for those in the adapted CETA arm). These follow-up assessments will assess the same domains as the baseline assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common Elements Treatment Approach (CETA) protocol | Experimental | Behavioral: Adapted Common Elements Treatment ApproachAdapted Common Elements Treatment Approach (CETA): The intervention is a transdiagnostic cognitive behavioral therapy approach to treating any combination of depression, anxiety, post-traumatic stress, or substance use disorder that has been adapted the needs of adults with HIV and to additionally address HIV care engagement. |
| Enhanced Usual Care (EUC) | No intervention | –Enhanced Usual Care (EUC): Usual care at the 1917 Clinic for patients with mental health concerns includes referral to a clinic social worker or counselor or to an external mental health clinic as needed. Usual care was enhanced by providing the participant's medical provider with information about the participant's elevated mental health symptoms at enrollment and recommendations for treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age >= 18 years.
- Patient receiving HIV care at University of Alabama at Birmingham (UAB) 1917 Clinic.
- Elevated symptoms of depression, anxiety, post-traumatic stress, or substance use disorder: At least one of the following:
- At risk for suboptimal HIV care engagement: At least one of the following:
- Willing to provide written informed consent.
Key exclusion criteria (1 listed)
- 1. Non-English speaking 2. Unable to attend counseling sessions 3. Unwilling to provide informed consent
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 |
|---|---|---|
| Adapted Common Elements Treatment ApproachThe intervention is a transdiagnostic cognitive behavioral therapy approach to treating any combination of depression, anxiety, post-traumatic stress, or substance use disorder that has been adapted the needs of adults with HIV and to additionally address HIV care engagement. | Behavioural | Common Elements Treatment Approach (CETA) protocol |
Primary outcome
Feasibility of Recruitment
Time frame: Duration of recruitment phase (9 months)
We defined feasibility as the total number of patients approached in order to accrue the final study sample size of n=60.
Client Acceptability
Time frame: At treatment exit (approximately 9 months post-baseline)
Client acceptability will be assessed via the Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is an 8-item questionnaire, with a minimum value of 8 and a maximum score of 32. A higher score indicates greater client acceptability.
Fidelity
Time frame: At the end of CETA completion or withdrawal, across all CETA participants
Counselor fidelity to CETA will be rated by the trainer based on the trainer's supervisory experience working with CETA counselors. After all CETA patients complete the study, the trainer will rate up to 5 cross-cutting aspects of CETA delivery and 13 CETA components targeting specific symptoms for fidelity. The trainer will rate the degree of confidence on a scale of 0 ("Not at all") to 4 ("Completely") that the counselor was routinely delivering each cross-cutting aspect or component of CETA with fidelity, for those aspects and components that the trainer had experience supervising the counselor in. The fidelity rating will be calculated separately for the 2 CETA counselors and reported as the mean score across the number of CETA aspects and components rated by the trainer. Higher scores indicate greater fidelity to CETA.
8 secondary outcomes
Number of Participants Suppressed HIV RNA Viral Load
Time frame: 4 months post-baseline
Number of Participants With Suppressed HIV RNA Viral Load
Time frame: 9 months post-baseline
HIV Appointment Attendance
Time frame: From baseline to 12 months post-baseline
Depressive Symptoms
Time frame: 4 months post-baseline
Anxiety Symptoms
Time frame: 4 months post-baseline
Post-traumatic Stress Symptoms
Time frame: 4 months post-baseline
Substance Use Symptoms
Time frame: 4 months post-baseline
HIV Kept Visit Attendance
Time frame: From baseline to 12 months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39116333Pence BW, Darnell D, Ranna-Stewart M, Psaros C, Gaynes BN, Grimes L, Henderson S, Parman M, Filipowicz TR, Gaddis K, Dorsey S, Mugavero MJ. Provocative Findings From a Transdiagnostic Counseling Intervention to Improve Psychiatric Comorbidity and HIV Care Engagement Among People With HIV: A Pilot Randomized Clinical Trial. J Acquir Immune Defic Syndr. 2024 Sep 1;97(1):68-77. doi: 10.1097/QAI.0000000000003457.
- Individual participant dataSharing planned: No
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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.
Brian Pence, PhD principal investigator
UNC-Chapel Hill
Bradley Gaynes, MD principal investigator
UNC-Chapel Hill
Doyane Darnell, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Common Elements Treatment Approach in people with HIV/AIDS and Depression, run by Michael J Mugavero, MD 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 13 inclusion and 1 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 19 Sep 2024. 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 19 Sep 2024). 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?
Feasibility of Recruitment (time frame: Duration of recruitment phase (9 months)). The study lists 3 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 NCT04163341, which also lists 1 linked publication.
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 19 Sep 2024.