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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of combining brief intervention with cognitive-behavioral therapy (CBT) in reducing unhealthy alcohol use among people living with HIV. The study compares two groups: one receiving only a brief intervention and the other receiving both the brief intervention and CBT through telemedicine, known as the Common Elements Treatment Approach (CETA). It targets individuals with HIV who are already receiving care in Alabama, have a history of unhealthy alcohol use, and can use a mobile phone. As an unphased trial, this study allows participants to contribute to innovative research that could enhance treatment strategies for others facing similar health challenges.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Common Elements Treatment Approach (CETA) through Telemedicine is generally safe. Studies have found that CETA effectively reduces unhealthy alcohol use and improves mental health. In one study, participants who received both a brief intervention and CETA showed better results than those who only received the brief intervention. No major safety concerns have been reported with CETA.

CETA involves discussing problems and finding better coping strategies, which most people find manageable. Since this study does not involve medication or physical treatments, the risk of side effects is lower. Overall, CETA appears to be a safe option for addressing alcohol use and mental health issues in people living with HIV. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Common Elements Treatment Approach (CETA) via telemedicine for alcohol use disorder in individuals with HIV because it offers flexibility and accessibility that traditional in-person therapies like cognitive behavioral therapy (CBT) or motivational interviewing may lack. CETA is delivered over the phone, making it easier for participants to receive consistent support without the need for travel, which is particularly beneficial for those with mobility challenges or living in remote areas. Additionally, CETA incorporates multiple therapeutic elements tailored to address both alcohol use and the unique mental health challenges faced by individuals with HIV, providing a more holistic approach to treatment.

What evidence suggests that this trial's treatments could be effective for alcohol use disorder in HIV?

This trial will compare the effectiveness of two treatments for alcohol use disorder in individuals with HIV. Participants in one arm will receive the Common Elements Treatment Approach (CETA) via telemedicine, which has shown promise in reducing unhealthy alcohol use and mental health symptoms. Research indicates that CETA can significantly reduce alcohol use and depression, particularly compared to other interventions. Participants in the other arm will receive an Alcohol Brief Intervention (BI) as an active comparator. Previous studies have demonstrated that CETA might also improve HIV treatment outcomes by addressing mental health issues that can act as barriers. Overall, CETA appears promising in helping people with HIV manage alcohol use and improve their health. ^{1 2 3 4 6}

Who Is on the Research Team?

Karen Cropsey, Psy.D.

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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

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)

Receiving HIV care at 1 of 4 participating AQMG sites (Alabama Quality Management Group sites - i.e. Ryan White HIV/AIDS Program-funded community clinics in Alabama)

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8322829/

Efficacy of the Common Elements Treatment Approach ... In summary, BI plus referral to CETA led to a clinically and statistically significantly greater reduction in unhealthy alcohol use, depression ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05121064

Common Elements Treatment Approach HIV Alcohol ... In pilot study, the BI plus CETA reduced alcohol use and mental health symptoms more at 6 months than the BI alone. Whether the BI is superior to standard of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666560323000105

Integration of Common Elements Treatment Approach ... In a randomized controlled trial (RCT), we previously reported that CETA was clinically effective in reducing UAU and mental health comorbidities among PWH in ...

4. medrxiv.org medrxiv.org/content/10.1101/2025.10.14.25337970v1.full.pdf

Effectiveness of the Common Elements Treatment ... CETA has the potential to improve HIV treatment outcomes by addressing underlying barriers to retention and adherence (e.g., IPV and other co- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7330869/

Study protocol of the ZCAP randomized controlled trial The trial is a first step in establishing the effectiveness of CETA at reducing unhealthy alcohol use and comorbidities among PLWH in SSA.

6. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003056

A randomized controlled trial | PLOS Medicine Results showed that CETA was more effective than TAU-Plus in reducing IPV and hazardous alcohol use among high-risk couples in Zambia.