Cognitive Behavioral Therapy for Alcohol Use Disorder in HIV

(TALC Trial)

Recruiting at 8 trial locations

Overseen By Jahmil Harriette, Psy.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Active suicidality, Psychosis, Alcohol withdrawal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6-12 weeks

308 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is designed to examine the efficacy of a brief intervention plus a cognitive-behavioral intervention compared to brief intervention alone to address unhealthy alcohol use and comorbid mental health symptoms to improve HIV outcomes among people living with HIV in Alabama.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Alcohol Brief Intervention (BI) and Common Elements Treatment Approach (CETA) via Telemedicine for Alcohol Use Disorder in HIV?

Research shows that alcohol reduction interventions can decrease symptoms of depression and anxiety in people with HIV, although more focused treatments are needed for significant improvements. Additionally, telehealth has been used to deliver behavioral interventions effectively, suggesting potential benefits for this treatment approach. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Alcohol Use Disorder safe for people with HIV?

The research on computerized brief intervention using cognitive behavioral techniques for people with HIV and alcohol use disorder shows high levels of patient satisfaction and no reported safety concerns, suggesting it is generally safe. ^{3 6 7 8 9}

How is the Common Elements Treatment Approach (CETA) for alcohol use disorder in HIV different from other treatments?

CETA is unique because it is a multi-session therapy delivered via telemedicine that addresses both unhealthy alcohol use and mental health issues in people living with HIV. Unlike single-session interventions, CETA provides a more comprehensive approach by using lay counselors to deliver therapy, making it more accessible and effective, especially for those with additional mental health or substance use problems. ^{3 10 11 12 13}

Research Team

Karen Cropsey, Psy.D.

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults over 18 living with HIV in Alabama who drink alcohol at levels considered unhealthy. They must be getting care at certain clinics and able to use a mobile phone. People with active suicidal thoughts, psychosis, risk of severe alcohol withdrawal, or those who can't speak English well enough for therapy are not eligible.

Inclusion Criteria

I am 18 years old or older.

Living with HIV infection

Unhealthy alcohol use documented on the AUDIT survey delivered via PRO (i.e. 4 or greater points for women and greater than 8 points for men)

Exclusion Criteria

I am not currently experiencing thoughts of suicide or psychosis.

I cannot use a mobile phone because of cognitive or physical issues.

Risk for acute alcohol withdrawal or seizures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 1 phone session of Alcohol Brief Intervention (BI) or 6 to 12 weekly phone sessions of BI + Common Elements Treatment Approach (T-CETA) via telephone

6-12 weeks

1-12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-ups at 6 and 12 months

12 months

2 visits (virtual)

Treatment Details

Interventions

• Alcohol Brief Intervention (BI)
• Common Elements Treatment Approach (CETA) via Telemedicine

Trial Overview The study tests if adding cognitive-behavioral therapy (CETA) via telemedicine to a brief intervention helps reduce unhealthy alcohol use and improve mental health and HIV outcomes better than the brief intervention alone.

Participant Groups

Group I: Common Elements Treatment Approach (CETA) via Telemedicine Experimental Treatment 2 Interventions

Participants will be provided with 6 to 12 weekly CETA sessions via telephone.

Group II: Alcohol Brief Intervention (BI) Active Control 1 Intervention

At the time of trial enrollment, participants will receive a session of alcohol brief intervention (BI) via telephone.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

In a study involving ART clients with hazardous alcohol use in Vietnam, both cognitive behavioral therapy and motivational interviewing interventions led to reductions in depression and anxiety symptoms over 12 months, but no significant differences were found compared to standard care.

The findings suggest that while alcohol reduction interventions can improve mental health symptoms, more integrated approaches that specifically address both alcohol use and mental health are necessary for greater and lasting effects in people with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Two Alcohol Reduction Interventions on Depression and Anxiety Symptoms of ART Clients in Vietnam. Nguyen, MX., Reyes, HL., Pence, BW., et al.[2023]

A study of 2,075 Veterans diagnosed with HIV and alcohol use disorder found that rural Veterans received significantly fewer mental health treatment sessions via video telehealth compared to their urban counterparts, indicating a disparity in access to care.

Despite the potential benefits of video telehealth for rural Veterans, no differences were observed in face-to-face or audio-only treatment sessions, highlighting the need for targeted efforts to improve telehealth access for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rural Veterans with HIV and Alcohol Use Disorder receive less video telehealth than urban Veterans. Sheinfil, AZ., Day, G., Walder, A., et al.[2023]

Integrated Stepped Alcohol Treatment (ISAT) significantly increased the likelihood of participants receiving alcohol treatment medications compared to standard treatment, with 51% of ISAT participants receiving at least one medication versus 26% in the treatment as usual group.

Despite the increased access to treatment in the ISAT group, there was no significant difference in alcohol consumption between the ISAT and treatment as usual groups at week 24, indicating a need for improved strategies to enhance patient engagement and retention in alcohol-related care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated stepped alcohol treatment for patients with HIV and alcohol use disorder: a randomised controlled trial. Edelman, EJ., Maisto, SA., Hansen, NB., et al.[2022]

In a study of 212 individuals with HIV, 19% reported problem drinking, which was linked to a higher likelihood of taking medications off schedule (45% vs 26% for non-drinkers), indicating that alcohol use can negatively impact medication adherence.

Heavy and hazardous drinking were significantly associated with missed medication doses, suggesting that clinicians should evaluate alcohol use in patients to improve adherence to HIV treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem drinking and medication adherence among persons with HIV infection. Cook, RL., Sereika, SM., Hunt, SC., et al.[2022]

In a study involving 240 patients over 12 months, both telephone and clinic-based behavioral counseling improved short-term medication adherence compared to a control group, but the effects were modest.

Clinic-based counseling was more effective than telephone counseling in significantly reducing alcohol consumption, highlighting the need for more intensive interventions for patients at risk of treatment failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Community Trial Comparing Telephone versus Clinic-Based Behavioral Health Counseling for People Living with HIV in a Rural Setting. Kalichman, SC., Katner, H., Eaton, LA., et al.[2022]

Alcohol use disorders (AUDs) are linked to lower adherence to antiretroviral therapy in HIV-infected individuals, which can lead to poorer treatment outcomes.

The impact of AUDs on health care utilization among people living with HIV/AIDS is inconsistent, indicating that while AUDs negatively affect treatment adherence, their effect on health care access may vary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the impact of alcohol use disorders on HIV treatment outcomes, adherence to antiretroviral therapy and health care utilization. Azar, MM., Springer, SA., Meyer, JP., et al.[2022]

In a study involving 816 eligible patients with HIV and hazardous alcohol use, a computerized brief intervention (CBI) led to a significant average reduction of 9.1 drinks per week over 4-12 months, indicating its efficacy in reducing alcohol consumption.

Among participants who engaged with the CBI, the reduction was even greater at 11.7 drinks per week, and the intervention was well-received, especially by older and Black patients, highlighting its potential as a practical tool for alcohol reduction in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased Alcohol Consumption in an Implementation Study of Computerized Brief Intervention among HIV Patients in Clinical Care. McCaul, ME., Hutton, HE., Cropsey, KL., et al.[2022]

Among individuals diagnosed with alcohol use disorder, only 1.0% of people living with HIV (PLWH) and 0.14% were retained on medications for alcohol use disorder (MAUD), indicating a significant treatment gap.

PLWH were less likely to initiate MAUD compared to uninfected individuals, with factors like older age and being black associated with lower odds of starting treatment, highlighting the need for targeted strategies to improve access and retention in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of initiation of and retention on medications for alcohol use disorder among people living with and without HIV. Oldfield, BJ., McGinnis, KA., Edelman, EJ., et al.[2021]

Among 474 HIV+ women with hazardous drinking, only 19% reported using any alcohol treatment in the past 6 months, indicating a significant gap in treatment utilization.

Factors such as social support, lower income, higher levels of alcohol consumption, and illicit drug use were associated with increased likelihood of seeking alcohol treatment, highlighting the need for targeted interventions to improve access and support for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of Alcohol Treatment Among HIV-Positive Women with Hazardous Drinking. Hu, X., Harman, J., Winterstein, AG., et al.[2018]

Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) significantly reduces depression symptoms in individuals with HIV, especially those actively using substances, showing the greatest improvements immediately after treatment and at a 12-month follow-up.

The study, involving 89 participants in a randomized controlled trial, found that while active substance use at treatment initiation enhanced immediate treatment gains, the benefits of CBT-AD in reducing depression were maintained over time for both substance users and abstainers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression CBT treatment gains among HIV-infected persons with a history of injection drug use varies as a function of baseline substance use. Labbe, AK., O'Cleirigh, CM., Stein, M., et al.[2018]

In a randomized controlled trial involving 160 adults living with HIV in Zambia, the combination of a brief alcohol intervention and the Common Elements Treatment Approach (CETA) led to significantly greater reductions in unhealthy alcohol use compared to the brief intervention alone, with a mean difference of -3.2 in AUDIT scores.

CETA was particularly effective for participants with more mental health or substance use comorbidities, showing an increasing effect size with the number of comorbidities, indicating that this therapy could be a valuable treatment option for those with complex health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Common Elements Treatment Approach (CETA) for Unhealthy Alcohol Use Among Adults with HIV in Zambia: Results from a Pilot Randomized Controlled Trial. Kane, JC., Sharma, A., Murray, LK., et al.[2022]

This pilot randomized controlled trial will evaluate the effectiveness of the Common Elements Treatment Approach (CETA), a multi-session psychotherapy, in reducing unhealthy alcohol use and mental health issues among 160 people living with HIV in urban Zambia.

The study compares CETA to a single-session brief intervention, aiming to provide evidence for more comprehensive treatment options in sub-Saharan Africa, where current interventions are limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common Elements Treatment Approach (CETA) for unhealthy alcohol use among persons with HIV in Zambia: Study protocol of the ZCAP randomized controlled trial. Kane, JC., Sharma, A., Murray, LK., et al.[2022]

A review of 14 behavioral interventions aimed at reducing alcohol use among HIV-infected individuals showed mixed results, indicating that many interventions were not effective in significantly decreasing alcohol frequency or quantity.

There is a critical need for more effective intervention strategies to address alcohol use disorders in this population, as current approaches have shown limited success in reducing binge drinking and symptoms of alcohol abuse or dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to reduce alcohol use among HIV-infected individuals: a review and critique of the literature. Brown, JL., DeMartini, KS., Sales, JM., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Two Alcohol Reduction Interventions on Depression and Anxiety Symptoms of ART Clients in Vietnam. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Rural Veterans with HIV and Alcohol Use Disorder receive less video telehealth than urban Veterans. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Integrated stepped alcohol treatment for patients with HIV and alcohol use disorder: a randomised controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Problem drinking and medication adherence among persons with HIV infection. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Randomized Community Trial Comparing Telephone versus Clinic-Based Behavioral Health Counseling for People Living with HIV in a Rural Setting. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

A systematic review of the impact of alcohol use disorders on HIV treatment outcomes, adherence to antiretroviral therapy and health care utilization. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Decreased Alcohol Consumption in an Implementation Study of Computerized Brief Intervention among HIV Patients in Clinical Care. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Predictors of initiation of and retention on medications for alcohol use disorder among people living with and without HIV. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Utilization of Alcohol Treatment Among HIV-Positive Women with Hazardous Drinking. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Depression CBT treatment gains among HIV-infected persons with a history of injection drug use varies as a function of baseline substance use. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Efficacy of the Common Elements Treatment Approach (CETA) for Unhealthy Alcohol Use Among Adults with HIV in Zambia: Results from a Pilot Randomized Controlled Trial. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Common Elements Treatment Approach (CETA) for unhealthy alcohol use among persons with HIV in Zambia: Study protocol of the ZCAP randomized controlled trial. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Interventions to reduce alcohol use among HIV-infected individuals: a review and critique of the literature. [2022]