Anxiety, Depression, HIV/AIDS, Post-traumatic Stress Disorder, Substance Use Disorders
Conditions
Brief 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.
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.
Interventions
BEHAVIORALAdapted 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.
Sponsors
University of North Carolina, Chapel Hill
Michael J Mugavero, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>= 18 years. 2. Patient receiving HIV care at University of Alabama at Birmingham (UAB) 1917 Clinic. 3. Elevated symptoms of depression, anxiety, post-traumatic stress, or substance use disorder: At least one of the following: 1. Patient Health Questionnaire-9 score \>= 10; 2. Generalized Anxiety Disorder 7-Item Scale score \>= 10; 3. Post-Traumatic Stress Symptoms Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) score \>= 33; 4. ASSIST score \>=11 for alcohol or \>=4 for any other substance 4. At risk for suboptimal HIV care engagement: At least one of the following: 1. Engaged in HIV care for the first time within the past 6 months; 2. Have an HIV RNA viral load \>1,000 copies/mL within the past 6 months; 3. Antiretroviral regimen was changed due to treatment failure within the past 6 months; 4. No-showed to an HIV primary care appointment within the past year. 5. Willing to provide written informed consent.
Exclusion criteria
* 1\. Non-English speaking 2. Unable to attend counseling sessions 3. Unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Recruitment | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | 4 months post-baseline | Patient Health Questionnaire-9 (PHQ-9) score; minimum score is 0, maximum score is 27, with higher scores meaning a worse outcome. |
| Anxiety Symptoms | 4 months post-baseline | Generalized Anxiety Disorder-7 (GAD-7) anxiety subscale score; minimum score is 0, maximum score is 21, with higher scores meaning a worse outcome. |
| Number of Participants Suppressed HIV RNA Viral Load | 4 months post-baseline | HIV RNA viral load \<200 copies/mL |
| Substance Use Symptoms | 4 months post-baseline | 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. |
| HIV Kept Visit Attendance | From baseline to 12 months post-baseline | 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. |
| Post-traumatic Stress Symptoms | 4 months post-baseline | 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. |
| Number of Participants With Suppressed HIV RNA Viral Load | 9 months post-baseline | HIV RNA viral load \<200 copies/mL |
| HIV Appointment Attendance | From baseline to 12 months post-baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | CETA Protocol | Enhanced Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 39.8 years STANDARD_DEVIATION 9.4 | 44.0 years STANDARD_DEVIATION 13.4 | 41.9 years STANDARD_DEVIATION 11.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 23 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 6 Participants | 10 Participants |
| Region of Enrollment United States | 30 Participants | 30 Participants | 60 Participants |
| Sex/Gender, Customized Additional sex or gender | 0 Participants | 2 Participants | 2 Participants |
| Sex/Gender, Customized Female | 10 Participants | 12 Participants | 22 Participants |
| Sex/Gender, Customized Male | 18 Participants | 15 Participants | 33 Participants |
| Sex/Gender, Customized Transgender Female | 1 Participants | 1 Participants | 2 Participants |
| Sex/Gender, Customized Transgender Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: At treatment exit (approximately 9 months post-baseline)
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Arm Assignment in Screening Phase | Client Acceptability | 29.3 units on a scale | Standard Deviation 3 |
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.
Time frame: Duration of recruitment phase (9 months)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Arm Assignment in Screening Phase | Feasibility of Recruitment | 92 participants |
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.
Time frame: At the end of CETA completion or withdrawal, across all CETA participants
Population: The analysis population includes the total number of clients assigned to each counselor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Arm Assignment in Screening Phase | Fidelity | 3.3 units on a scale | Standard Deviation 0.72 |
| Enhanced Usual Care | Fidelity | 3.0 units on a scale | Standard Deviation 0 |
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.
Time frame: 4 months post-baseline
Population: The analysis population includes all participants with a completed interview at 4 months post-baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Arm Assignment in Screening Phase | Anxiety Symptoms | 10.4 score on a scale | Standard Deviation 5.4 |
| Enhanced Usual Care | Anxiety Symptoms | 9.3 score on a scale | Standard Deviation 5.9 |
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.
Time frame: 4 months post-baseline
Population: The analysis population includes all participants with a completed interview at 4 months post-baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Arm Assignment in Screening Phase | Depressive Symptoms | 11.1 score on a scale | Standard Deviation 6.8 |
| Enhanced Usual Care | Depressive Symptoms | 9.8 score on a scale | Standard Deviation 6.9 |
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.
Time frame: From baseline to 12 months post-baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Arm Assignment in Screening Phase | HIV Appointment Attendance | 22 Participants |
| Enhanced Usual Care | HIV Appointment Attendance | 22 Participants |
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.
Time frame: From baseline to 12 months post-baseline
Population: Analysis population includes all participants with data on their total number of HIV care visits collected from baseline to 12 months post-baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Arm Assignment in Screening Phase | HIV Kept Visit Attendance | 0.74 Proportion of HIV care visits | Standard Deviation 0.27 |
| Enhanced Usual Care | HIV Kept Visit Attendance | 0.70 Proportion of HIV care visits | Standard Deviation 0.27 |
Secondary
Number of Participants Suppressed HIV RNA Viral Load
HIV RNA viral load \<200 copies/mL
Time frame: 4 months post-baseline
Population: The analysis population includes all participants with a collected 4-month viral load.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Arm Assignment in Screening Phase | Number of Participants Suppressed HIV RNA Viral Load | 13 Participants |
| Enhanced Usual Care | Number of Participants Suppressed HIV RNA Viral Load | 18 Participants |
Secondary
Number of Participants With Suppressed HIV RNA Viral Load
HIV RNA viral load \<200 copies/mL
Time frame: 9 months post-baseline
Population: This analysis population includes all participants with a completed viral load at 9 months post-baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Arm Assignment in Screening Phase | Number of Participants With Suppressed HIV RNA Viral Load | 17 Participants |
| Enhanced Usual Care | Number of Participants With Suppressed HIV RNA Viral Load | 17 Participants |
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.
Time frame: 4 months post-baseline
Population: The analysis population includes all participants with a completed interview at 4 months post-baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Arm Assignment in Screening Phase | Post-traumatic Stress Symptoms | 33.7 score on a scale | Standard Deviation 19.2 |
| Enhanced Usual Care | Post-traumatic Stress Symptoms | 28.9 score on a scale | Standard Deviation 17.3 |
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.
Time frame: 4 months post-baseline
Population: The analysis population includes all participants with a completed interview at 4 months post-baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Arm Assignment in Screening Phase | Substance Use Symptoms | 10.0 score on a scale | Standard Deviation 8.1 |
| Enhanced Usual Care | Substance Use Symptoms | 7.9 score on a scale | Standard Deviation 7.5 |