600 Participants Needed

Telehealth Counseling for Alcohol Misuse in HIV

(ReACH3 Trial)

CK
Overseen ByChristopher Kahler, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brown University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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 drink heavily. In total, 600 heavy drinkers with HIV will be assigned to either (a) a single session of brief counseling on alcohol use or (b) brief counseling plus referral to a telehealth counseling program that includes multiple sessions of counseling by videoconferencing and text messaging support. To understand the effects of the program, participants' alcohol use, HIV outcomes, and health will be assessed over a 2-year period.

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 data supports the effectiveness of this treatment for alcohol misuse in HIV patients?

Research shows that motivational interviewing (MI), when delivered in-person, can significantly reduce alcohol consumption in men with HIV. Additionally, using technology like interactive text messaging and smartphone apps to enhance MI has shown promise in reducing alcohol and drug use among people living with HIV.12345

Is telehealth counseling for alcohol misuse in HIV generally safe for humans?

The studies reviewed do not report any safety concerns related to telehealth counseling methods like Motivational Interviewing or Brief Interventions for alcohol misuse in people living with HIV, suggesting these approaches are generally safe for humans.36789

How is Telehealth Counseling for Alcohol Misuse in HIV different from other treatments?

Telehealth Counseling for Alcohol Misuse in HIV is unique because it uses virtual sessions to provide brief counseling and motivational interviewing, making it accessible for people in rural or underserved areas. This approach integrates alcohol misuse treatment with HIV care, potentially improving both alcohol use and HIV-related health outcomes.3581011

Research Team

CK

Christopher Kahler, PhD

Principal Investigator

Brown University School of Public Health

Eligibility Criteria

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

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)

Treatment Details

Interventions

  • Brief Intervention
  • Telehealth Counseling
  • Text messaging
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Brief Intervention plus Telehealth CounselingExperimental Treatment3 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 interventionActive Control1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials
480
Recruited
724,000+

Findings from Research

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

References

Telehealth interventions to reduce alcohol use in men with HIV who have sex with men: Protocol for a factorial randomized controlled trial. [2022]
Commitment strength, alcohol dependence and HealthCall participation: effects on drinking reduction in HIV patients. [2021]
HealthCall delivered via smartphone to reduce co-occurring drug and alcohol use in HIV-infected adults: A randomized pilot trial. [2020]
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. [2022]
Randomized Community Trial Comparing Telephone versus Clinic-Based Behavioral Health Counseling for People Living with HIV in a Rural Setting. [2022]
Single-session motivational enhancement counseling to support change toward reduction of HIV transmission by HIV positive persons. [2007]
Agreement between prospective interactive voice response telephone reporting and structured recall reports of risk behaviors in rural substance users living with HIV/AIDS. [2021]
Implementation of Computer-delivered Brief Alcohol Intervention in HIV Clinical Settings: Who Agrees to Participate? [2022]
Brief interventions for alcohol misuse among people living with HIV: a meta-analysis. [2023]
Telemedicine for unhealthy alcohol use in adults living with HIV in Alabama using common elements treatment approach: A hybrid clinical efficacy-implementation trial protocol. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Patterns & Predictors of Telehealth Utilization Among Individuals Who Use Substances: Implications for the Future of Virtual Behavioral Health Services. [2023]