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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted Common Elements Treatment Approach | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | At the end of CETA completion or withdrawal, across all CETA participants |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Suppressed HIV RNA Viral Load | HIV RNA viral load <200 copies/mL | 4 months post-baseline |
| Number of Participants With Suppressed HIV RNA Viral Load | HIV RNA viral load <200 copies/mL |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Pence, PhD | UNC-Chapel Hill | Principal Investigator |
| Bradley Gaynes, MD | UNC-Chapel Hill | Principal Investigator |
| Doyane Darnell, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35222 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39116333 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CETA Protocol | Adapted Common Elements Treatment Approach: 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. |
| FG001 | Enhanced Usual Care | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CETA Protocol | Adapted Common Elements Treatment Approach: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis population for this outcome measure (feasibility of recruitment) is larger than the study population as we included all patients approached for screening (n=92) to reach our study sample (n=60). | Posted | Number | participants | Duration of recruitment phase (9 months) |
|
Adverse event data were collected from the time a participant provided informed consent and was randomized in the study through ~ 12 months post-randomization.
We collected systematic information on serious adverse events via a study collection form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CETA Protocol | Adapted Common Elements Treatment Approach: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Mugavero | University of Alabama at Birmingham | 202-966-5822 | mmugavero@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2023 | Jun 22, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 17, 2022 | Mar 11, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| 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. | 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. | 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. | 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. | 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. | 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. | From baseline to 12 months post-baseline |
| BG001 |
| Enhanced Usual Care |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 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. | Client acceptability was only measured for participants in the CETA arm since this outcome reflects their overall satisfaction with the intervention. This population includes the 25 participants who completed the exit interview ~9 months post-baseline | Posted | Mean | Standard Deviation | units on a scale | At treatment exit (approximately 9 months post-baseline) |
|
|
|
| Primary | 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. | The analysis population includes the total number of clients assigned to each counselor. | Posted | Mean | Standard Deviation | units on a scale | At the end of CETA completion or withdrawal, across all CETA participants |
|
|
|
| Secondary | Number of Participants Suppressed HIV RNA Viral Load | HIV RNA viral load <200 copies/mL | The analysis population includes all participants with a collected 4-month viral load. | Posted | Count of Participants | Participants | 4 months post-baseline |
|
|
|
| Secondary | Number of Participants With Suppressed HIV RNA Viral Load | HIV RNA viral load <200 copies/mL | This analysis population includes all participants with a completed viral load at 9 months post-baseline. | Posted | Count of Participants | Participants | 9 months post-baseline |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | From baseline to 12 months post-baseline |
|
|
|
| Secondary | Depressive Symptoms | Patient Health Questionnaire-9 (PHQ-9) score; minimum score is 0, maximum score is 27, with higher scores meaning a worse outcome. | The analysis population includes all participants with a completed interview at 4 months post-baseline | Posted | Mean | Standard Deviation | score on a scale | 4 months post-baseline |
|
|
|
| Secondary | 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. | The analysis population includes all participants with a completed interview at 4 months post-baseline | Posted | Mean | Standard Deviation | score on a scale | 4 months post-baseline |
|
|
|
| Secondary | 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. | The analysis population includes all participants with a completed interview at 4 months post-baseline. | Posted | Mean | Standard Deviation | score on a scale | 4 months post-baseline |
|
|
|
| Secondary | 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. | The analysis population includes all participants with a completed interview at 4 months post-baseline. | Posted | Mean | Standard Deviation | score on a scale | 4 months post-baseline |
|
|
|
| Secondary | 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. | Analysis population includes all participants with data on their total number of HIV care visits collected from baseline to 12 months post-baseline. | Posted | Mean | Standard Deviation | Proportion of HIV care visits | From baseline to 12 months post-baseline |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Enhanced Usual Care | 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. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D064419 | Chemically-Induced Disorders |