Alcohol Use Disorder, Depression, HIV/AIDS, Post-traumatic Stress Disorder, Substance Use Disorders
Conditions
Brief summary
This is a randomized controlled trial (RCT) evaluating the effectiveness of an alcohol brief intervention alone compared to the brief intervention plus an evidence-based psychotherapy (CETA) in reducing alcohol misuse and co-occurring mental health problems among persons with HIV in Zambia.
Detailed description
Alcohol misuse is a major unaddressed barrier to ending the HIV/AIDS epidemic. Hazardous drinking increases HIV transmission, delays antiretroviral therapy (ART) uptake, reduces adherence and retention, and increases mortality. Comorbid mental health or substance misuse, similar to alcohol use alone, can also significantly undermine HIV treatment. The vast majority of people living with HIV globally live in low- and middle-income countries (LMIC). Similar to most HIV care settings in LMIC, in Zambia, the location of the current study, there are no readily available evidence-based treatments for alcohol misuse or mental health problems. This study will enroll persons living with HIV (PLWH) who have alcohol misuse in Zambia. Participants will be recruited and screened during regular HIV care visits. Participants will be recruited by their regular care providers (i.e., peer educators, counselors, nurses, physicians) and referred to study staff if they are interested. The investigators anticipate enrolling up to 320 participants, all of whom have hazardous alcohol use. N=160 participants will be high-risk drinkers due to having either a moderate-to-severe alcohol use disorder or mental health comorbidities, or both. These participants will be randomized into the RCT. Participants who have hazardous alcohol use (but not a moderate-to-severe AUD) without mental health comorbidities (a lower risk group of participants) will not be enrolled into the RCT but will be tracked as part of a parallel cohort study. The minimum age of research subjects will be 18. Eligibility will be assessed via audio computer assisted self-interviewing (ACASI). Participants in the 'cohort study' (i.e., lower risk participants) will receive a brief alcohol intervention. Participants in the RCT (i.e., higher risk participants) will be randomly assigned on a 1:1 basis (stratified by gender) to receive the brief intervention alone or the brief intervention plus CETA. All participants will be evaluated for outcomes at baseline and at a six month follow-up visit. For RCT participants, the investigators will compare the effectiveness of the brief intervention alone to the brief intervention plus CETA in reducing alcohol misuse and mental health problems. For cohort participants, the investigators will collect preliminary data on whether alcohol misuse reduced at the six month follow-up but there will be no comparison/control group. The findings from this pilot study will be used to inform future programming and research in Zambia and other LMIC to implement screening, brief intervention, and referral to treatment (SBIRT) programs for alcohol use in HIV care.
Interventions
BEHAVIORALBrief Intervention
The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services.
The Common Elements Treatment Approach, or CETA, is a transdiagnostic psychotherapy based on cognitive behavioral elements for mood, anxiety and trauma related problems, and for alcohol and substance misuse. CETA is based on the fact that most evidence-based mental health treatments (EBTs) consist of similar components. The objective of CETA is to provide a single training in a range of therapy components that are similar across EBTs and to then teach counselors how to design a specific course of treatment for each client based on the client's presenting problems.
Sponsors
Centre for Infectious Disease Research in Zambia
University of Alabama at Birmingham
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Primary outcomes are evaluated via Audio Computer Assisted Self-Interviewing (ACASI)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Initial inclusion criteria for overall enrollment (into either the Cohort or RCT study) will be: * HIV positive * Receiving HIV treatment services at one of the two study clinics * Current hazardous alcohol use, defined as an AUDIT score of ≥8 for men and ≥ 4 for women * Provides informed consent Secondary inclusion for enrollment into the RCT will be: * AUDIT scores that indicate a moderate-to-severe AUD (≥12 for women; ≥16 among men) * AND/OR: meeting validated symptom criteria for depression (≥16 on Center for Epidemiological Studies-Depression (CES-D), trauma/anxiety (≥2.5 on HTQ), and/or substance use (≥27 for any non-tobacco/alcohol substance on ASSIST)
Exclusion criteria
* HIV negative * Not receiving care at one of the study clinics * Currently psychotic or actively suicidal * Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline. | Baseline and 6 months post-baseline | AUDIT is a 10-item measure of hazardous alcohol use with possible range of 0-40 (total scale score). Higher scores are associated with more hazardous use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Center for Epidemiological Studies-Depression (CES-D) Scale Score From Baseline to 6-month Post-baseline. | Baseline and 6 months post-baseline | CES-D is a 20-item scale of depression with a possible range of 0-60 (total scale score). Higher scores are associated with greater depression symptom severity. |
| Change in Harvard Trauma Questionnaire (HTQ) Post-traumatic Stress Disorder (PTSD) Symptom Scale Score From Baseline to 6-month Post-baseline. | Baseline and 6 months post-baseline | The HTQ is a 39-item PTSD symptom scale with possible range of 1-4 (average scale score). Higher scores are associated with greater PTSD symptom severity. |
| Number of Participants With Any Recent Substance Use. | 6 months post-baseline | Any recent substance use will be defined as any use of the following substance types in the past 3 months: inhalants, marijuana, cocaine, amphetamines, sedatives, hallucinogens, opioids. |
Countries
Zambia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brief Intervention (BI) 30 minute alcohol brief intervention delivered by lay provider during HIV clinic visit.
Brief Intervention: The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services. | 78 |
| Brief Intervention + CETA 30 minute alcohol brief intervention delivered by lay provider during clinic visit followed by 6-12 weekly sessions of CETA.
Brief Intervention: The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services.
Common Elements Treatment Approach (CETA): The Common Elements Treatment Approach, or CETA, is a transdiagnostic psychotherapy based on cognitive behavioral elements for mood, anxiety and trauma related problems, and for alcohol and substance misuse. CETA is based on the fact that most evidence-based mental health treatments (EBTs) consist of similar components. The objective of CETA is to provide a single training in a range of therapy components that are similar across EBTs and to then teach counselors how to design a specific course of treatment for each client based on the client's presenting problems. | 82 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Moved from study area. | 0 | 2 |
| Overall Study | Not post-assessed. Study ended early due to COVID-19 | 20 | 16 |
Baseline characteristics
| Characteristic | Brief Intervention (BI) | Total | Brief Intervention + CETA |
|---|---|---|---|
| Age, Continuous | 41.8 Years STANDARD_DEVIATION 9 | 40.2 Years STANDARD_DEVIATION 9.3 | 38.6 Years STANDARD_DEVIATION 9.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 78 Participants | 160 Participants | 82 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Zambia | 78 participants | 160 participants | 82 participants |
| Sex: Female, Male Female | 34 Participants | 70 Participants | 36 Participants |
| Sex: Female, Male Male | 44 Participants | 90 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 78 | 0 / 82 |
| other Total, other adverse events | 0 / 78 | 0 / 82 |
| serious Total, serious adverse events | 1 / 78 | 0 / 82 |
Outcome results
Primary
Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline.
AUDIT is a 10-item measure of hazardous alcohol use with possible range of 0-40 (total scale score). Higher scores are associated with more hazardous use.
Time frame: Baseline and 6 months post-baseline
Population: Analysis conducted only among participants with complete data at 6-month follow-up, which include 56 completers out of 78 participants in BI group and 62 completers out of 82 participants in BI + CETA group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Brief Intervention (BI) | Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline. | -10.5 Score on a scale |
| Brief Intervention + CETA | Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline. | -13.7 Score on a scale |
Secondary
Change in Center for Epidemiological Studies-Depression (CES-D) Scale Score From Baseline to 6-month Post-baseline.
CES-D is a 20-item scale of depression with a possible range of 0-60 (total scale score). Higher scores are associated with greater depression symptom severity.
Time frame: Baseline and 6 months post-baseline
Population: Analysis conducted only among participants with complete data at 6-month follow-up, which include 56 completers out of 78 participants in BI group and 62 completers out of 82 participants in BI + CETA group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Brief Intervention (BI) | Change in Center for Epidemiological Studies-Depression (CES-D) Scale Score From Baseline to 6-month Post-baseline. | -4.2 Score on a scale |
| Brief Intervention + CETA | Change in Center for Epidemiological Studies-Depression (CES-D) Scale Score From Baseline to 6-month Post-baseline. | -8.9 Score on a scale |
Secondary
Change in Harvard Trauma Questionnaire (HTQ) Post-traumatic Stress Disorder (PTSD) Symptom Scale Score From Baseline to 6-month Post-baseline.
The HTQ is a 39-item PTSD symptom scale with possible range of 1-4 (average scale score). Higher scores are associated with greater PTSD symptom severity.
Time frame: Baseline and 6 months post-baseline
Population: Analysis conducted only among participants with complete data at 6-month follow-up, which include 56 completers out of 78 participants in BI group and 62 completers out of 82 participants in BI + CETA group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Brief Intervention (BI) | Change in Harvard Trauma Questionnaire (HTQ) Post-traumatic Stress Disorder (PTSD) Symptom Scale Score From Baseline to 6-month Post-baseline. | -0.3 Score on a scale |
| Brief Intervention + CETA | Change in Harvard Trauma Questionnaire (HTQ) Post-traumatic Stress Disorder (PTSD) Symptom Scale Score From Baseline to 6-month Post-baseline. | -0.5 Score on a scale |
Secondary
Number of Participants With Any Recent Substance Use.
Any recent substance use will be defined as any use of the following substance types in the past 3 months: inhalants, marijuana, cocaine, amphetamines, sedatives, hallucinogens, opioids.
Time frame: 6 months post-baseline
Population: Analysis conducted only among participants with complete data at 6-month follow-up, which include 56 completers out of 78 participants in BI group and 62 completers out of 82 participants in BI + CETA group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brief Intervention (BI) | Number of Participants With Any Recent Substance Use. | 14 Participants |
| Brief Intervention + CETA | Number of Participants With Any Recent Substance Use. | 16 Participants |