Telehealth Counseling for Alcohol Misuse in HIV

(ReACH3 Trial)

Overseen By Christopher Kahler, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brown University

Disqualifiers: Severe withdrawal symptoms, others

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

Compensation: Varies

Number of Visits: 6

Duration: Up to 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how telehealth counseling can assist people with HIV who drink heavily in reducing alcohol use and improving HIV health. Participants will receive either a single brief counseling session (known as Brief Intervention) or ongoing telehealth counseling with video sessions and text support. The researchers aim to track changes in drinking habits and HIV outcomes over two years. Individuals who receive HIV care at certain health centers and drink heavily might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance support for individuals with HIV.

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 seems focused on counseling for alcohol use, so you may not need to change your medication routine.

What prior data suggests that this telehealth counseling program is safe for people with HIV?

Research shows that telehealth counseling, including methods like Motivational Interviewing, is generally safe for people with HIV who drink heavily. Previous studies have not identified any safety issues with these approaches. Both short and longer telehealth counseling sessions are typically manageable for participants.

In the past, similar counseling sessions have helped people reduce their drinking without causing major problems. Therefore, those considering joining this trial can be assured that the treatment methods have a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for alcohol misuse in HIV patients, which often involve in-person counseling sessions and pharmacotherapy, this innovative approach combines brief intervention with telehealth counseling. Researchers are excited about this treatment because it offers a flexible and accessible option through video conferencing and includes a motivational interviewing technique that can be more engaging for patients. Additionally, the inclusion of a text messaging component to encourage reduced drinking over two years is a unique feature that could enhance long-term adherence and outcomes. This method stands out for its potential to reach individuals who may have difficulty accessing traditional in-person care due to geographical, logistical, or personal barriers.

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

Research has shown that telehealth counseling can help people with HIV reduce alcohol consumption and improve health. One study found that three in-person counseling sessions using motivational interviewing significantly reduced drinking among men who have sex with men and are living with HIV. In this trial, participants in one arm will receive a brief intervention followed by telehealth counseling, which builds on previous research by using video calls and text messages to support long-term change. Another study with a smartphone app called HealthCall found that staying engaged after a short intervention led to reduced drinking and improved HIV care. Early results suggest that this telehealth approach could effectively help manage alcohol use and enhance health in people with HIV. ^{1 2 6 7 8}

Who Is on the Research Team?

Christopher Kahler, PhD

Principal Investigator

Brown University School of Public Health

Are You a Good Fit for This Trial?

This trial is for people with HIV who are receiving care at one of the participating health centers and have a history of heavy drinking, defined as having at least one day with 4+ drinks or averaging more than 7 drinks per week in the last month. Those needing supervised detox due to severe withdrawal symptoms cannot participate.

Inclusion Criteria

If you receive HIV care at one of the 4 participating health centers, and you have had at least one day in the past month where you drank heavily (4 or more drinks), or if you drink more than 7 drinks per week on average.

Exclusion Criteria

You have a history of severe alcohol withdrawal symptoms, like seizures and delirium tremens, that require supervised medical treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments and are randomized to intervention groups

1 week

1 visit (in-person or virtual)

Treatment

Participants receive either a brief intervention or a brief intervention plus telehealth counseling

Up to 24 months

5 sessions (virtual) for telehealth counseling group

Follow-up

Participants are monitored for changes in alcohol use and HIV outcomes

24 months

Regular follow-ups (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Brief Intervention
• Telehealth Counseling
• Text messaging

Trial Overview The study is testing if telehealth counseling can help reduce alcohol use and improve HIV viral control. Participants will either get a single session of brief alcohol counseling or that plus a referral to an extended telehealth program with videoconferencing and text support.

How Is the Trial Designed?

Group I: Brief Intervention plus Telehealth Counseling Experimental Treatment 3 Interventions

A brief alcohol intervention followed by referral to a telehealth counseling protocol including 5 sessions of counseling based on Motivational Interviewing and delivered by videoconferencing. Telehealth counseling extends for up to two years and also includes a text messaging intervention to encourage reductions in drinking.

Group II: Brief intervention Active Control 1 Intervention

A brief alcohol intervention lasting about 10 minutes, delivered after the baseline assessments.

Brief Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Brief Intervention for:

• Alcohol misuse in HIV care
• Substance use disorder

Approved in European Union as Brief Intervention for:

• Alcohol misuse
• Substance use disorder

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

Published Research Related to This Trial

42% of non-treatment seeking individuals living with HIV (PLWH) and alcohol misuse agreed to participate in a computer-delivered brief alcohol intervention (CBI) in their primary care clinic, indicating a significant interest in addressing alcohol use.

Participants who agreed to CBI were more likely to have detectable viral loads and higher levels of alcohol use and mental health symptoms, suggesting that CBI effectively targets those most in need of support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Computer-delivered Brief Alcohol Intervention in HIV Clinical Settings: Who Agrees to Participate? Yang, C., Crane, HM., Cropsey, K., et al.[2022]

The study will evaluate the effectiveness of motivational interviewing (MI) compared to brief intervention (BI) in reducing alcohol use among 224 heavy-drinking men who have sex with men (MSM) living with HIV, using a factorial design to test various combinations of interventions.

It will also explore whether adding interactive text messaging (ITM) and extending the duration of the intervention improves outcomes, with assessments planned at 6 and 12 months to measure the impact on alcohol use and HIV-related health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth interventions to reduce alcohol use in men with HIV who have sex with men: Protocol for a factorial randomized controlled trial. Kahler, CW., Surace, A., Durst, A., et al.[2022]

In a study of 139 heavily drinking HIV patients, stronger commitment to change was linked to better drinking outcomes after a brief intervention, highlighting the importance of motivation in treatment effectiveness.

For alcohol dependent patients, the combination of Motivational Interviewing (MI) and HealthCall led to greater reductions in drinking when commitment strength was low, suggesting that HealthCall may enhance treatment effects even for those less committed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commitment strength, alcohol dependence and HealthCall participation: effects on drinking reduction in HIV patients. Aharonovich, E., Stohl, M., Ellis, J., et al.[2021]

A brief motivational intervention (MI) counseling did not show a significant overall reduction in alcohol consumption among persons living with HIV/AIDS in Kampala, Uganda, compared to standard counseling, with no difference in AUDIT-C scores between treatment groups over 6 months.

However, women in the MI group experienced a statistically significant decrease in their AUDIT-C scores, suggesting that MI may be particularly effective for female participants, highlighting the need for further studies focusing on gender differences in treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Single, Brief Alcohol Reduction Intervention among Men and Women Living with HIV/AIDS and Using Alcohol in Kampala, Uganda: A Randomized Trial. Wandera, B., Tumwesigye, NM., Nankabirwa, JI., 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]

This randomized controlled trial will assess the effectiveness of a telephone-delivered cognitive behavioral therapy protocol (T-CETA) on reducing unhealthy alcohol use among 308 adults with HIV in Alabama, aiming to improve both alcohol and HIV-related health outcomes.

The study will evaluate not only changes in alcohol use but also impacts on HIV care retention, viral suppression, mental health, and overall quality of life, highlighting the importance of integrated treatment for comorbid conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine for unhealthy alcohol use in adults living with HIV in Alabama using common elements treatment approach: A hybrid clinical efficacy-implementation trial protocol. Gagnon, KW., Levy, S., Figge, C., et al.[2023]

The MI+HealthCall intervention, which combines Motivational Interviewing with smartphone technology, showed high feasibility with a 95% daily use rate and excellent patient satisfaction (4.5 out of 5) among adults living with HIV.

Participants using MI+HealthCall experienced significantly greater reductions in drug use and spending compared to those receiving only Motivational Interviewing, indicating its potential effectiveness in addressing substance use issues that can hinder HIV treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HealthCall delivered via smartphone to reduce co-occurring drug and alcohol use in HIV-infected adults: A randomized pilot trial. Aharonovich, E., Stohl, M., Cannizzaro, D., et al.[2020]

In early 2021, a study of 370 clients at an outpatient substance use clinic found that 86% of counseling visits were conducted via telehealth, indicating a strong acceptance of this service modality.

However, individuals with unstable housing or serious mental illness were less likely to utilize telehealth, highlighting the need to address barriers for these vulnerable groups as telehealth becomes more integrated into substance use counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns & Predictors of Telehealth Utilization Among Individuals Who Use Substances: Implications for the Future of Virtual Behavioral Health Services. Matthews, EB., Lushin, V., Rzewinski, J.[2023]

Motivational interviewing in a single counseling session shows promise in helping HIV+ individuals reduce their risk of transmitting the virus during sexual activity.

As the population of healthy, sexually active HIV+ individuals grows, there is an urgent need to provide effective counseling strategies focused on safer sex practices to engage them in transmission risk reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-session motivational enhancement counseling to support change toward reduction of HIV transmission by HIV positive persons. Rutledge, SE.[2007]

Brief interventions (BI) for alcohol misuse in people living with HIV significantly reduce the number of drinks per day and heavy drinking days, with moderate effect sizes observed in 13 randomized clinical trials involving various participants.

BI also lowers the odds of mortality by 42% within 6-12 months, highlighting its potential impact on health outcomes for individuals with HIV and alcohol misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief interventions for alcohol misuse among people living with HIV: a meta-analysis. Ghosh, A., Singh, GK., Yadav, N., et al.[2023]

The study demonstrated that an Interactive Voice Response (IVR) system is a feasible and effective method for collecting sensitive data on substance use and sexual practices from rural individuals living with HIV/AIDS, involving 54 participants over a period of up to 10 weeks.

IVR reporting showed good to excellent agreement with traditional interview methods for alcohol consumption and sexual activity, indicating its reliability, although reports of illicit drug use were less consistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Agreement between prospective interactive voice response telephone reporting and structured recall reports of risk behaviors in rural substance users living with HIV/AIDS. Simpson, CA., Xie, L., Blum, ER., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04546971

Using Telehealth to Address Alcohol Misuse in HIV Care ... This project will test the effects of a telehealth counseling program on reducing alcohol use and improving HIV viral control among people with HIV who ...

2. reporter.nih.gov reporter.nih.gov/search/MbDgldi8PkefonL2bPd71Q/project-details/10879096

RePORT RePORTER - National Institutes of Health (NIH) | The purpose of the proposed study is to test the real-world effectiveness of the ReACH (Reducing Alcohol use and related Comorbidities in HIV care) telehealth ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04546971?cond=hiv&aggFilters=status%3A

Using Telehealth to Address Alcohol Misuse in HIV Care This project will test the effects of a telehealth counseling program on reducing alcohol use and improving HIV viral control among people with HIV who ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9167215/

HealthCall: A randomized trial assessing a smartphone ... We developed the “HealthCall” app to provide continued engagement after brief intervention, reduce drinking, and improve other aspects of HIV care with minimal ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2451865419302376

Telehealth interventions to reduce alcohol use in men with ... We recently found that compared to HIV treatment as usual, three sessions of in-person motivational interviewing (MI) substantially reduced drinking in MSM with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6831665/

Telehealth interventions to reduce alcohol use in men with ... We recently found that compared to HIV treatment as usual, three sessions of in-person motivational interviewing (MI) substantially reduced ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10495853/

A Digital Counselor-Delivered Intervention for Substance ... We aim to develop and pilot a digital counselor–delivered brief intervention for people with HIV who use drugs, called “C-Raven,” which is theory grounded and ...

8. withpower.com withpower.com/trial/phase-alcohol-drinking-4-2021-98c4e

Telehealth Counseling for Alcohol Misuse in HIV (ReACH3 Trial) The studies reviewed do not report any safety concerns related to telehealth counseling methods like Motivational Interviewing or Brief Interventions for ...