Practice Facilitation for Alcohol Use Disorder in HIV Care

Recruiting at 2 trial locations

Overseen By JoAnna Mathena

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Underage, Cognitive impairment, Low AUDIT-C, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to help people with HIV who drink too much alcohol by using a practice coach to guide clinics in offering structured alcohol reduction treatments. The goal is to improve their adherence to HIV medication and overall health. The trial will test if this approach helps reduce alcohol use and improves HIV treatment outcomes.

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 focuses on alcohol use and HIV care, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of this treatment for alcohol use disorder in HIV care?

Research shows that integrated stepped care, which includes counseling and medication, can help reduce alcohol use in people with HIV. Studies have found that this approach, which adjusts treatment based on individual response, can improve both alcohol use and HIV-related health outcomes. ^{1 2 3 4 5}

Is the integrated stepped care approach for alcohol use disorder in HIV care safe for humans?

The research does not specifically address safety data for the integrated stepped care approach, but it is a structured treatment involving counseling and medication, which are generally considered safe when monitored by healthcare professionals. ^{1 2 3 4 6}

How is the Alcohol Stepped Care treatment for alcohol use disorder in HIV care different from other treatments?

The Alcohol Stepped Care treatment is unique because it uses a flexible, step-by-step approach that adjusts the level of care based on the patient's response, starting with brief interventions and potentially escalating to more intensive therapies like motivational enhancement therapy and pharmacotherapy, which is not commonly integrated in standard HIV care settings. ^{1 2 3 4 5}

Research Team

Geetanjali Chander, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for clinic staff over 18 years old, who work in certain HIV clinics and speak English. They must be able to complete surveys or interviews. It's not specified who can't join, so it seems open to all clinic staff meeting the inclusion criteria.

Inclusion Criteria

Patients: Confirmed to be a person with HIV (PWH) receiving HIV care and participating in CNICS at one of the three clinic sites

Patients: English speaking

I am over 18 years old.

Exclusion Criteria

I am under 18 years old.

I am a clinic staff member who does not speak English.

Patients: Scoring AUDIT-C <3 for women or <4 for men or <4 for transgender women or men

Timeline

Pre-implementation Planning

Tailor the practice facilitation intervention to each site using mixed methods

Not specified

Implementation with Formative Evaluation

Determine the effect of practice facilitation on reach, adoption, and maintenance of evidence-based alcohol treatment using mixed methods

12 months

Post-implementation Summative Evaluation

Determine the effects of practice facilitation on implementation of stepped care and alcohol use and HIV-related outcomes using interrupted time series analysis with synthetic controls

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Alcohol Stepped Care
• Practice Facilitation

Trial Overview The study tests if 'practice facilitation' helps HIV clinics better adopt alcohol treatment programs. A coach will help with tools and guidance to implement a stepped care model for treating unhealthy alcohol use, which includes brief interventions, therapy, and medication.

Participant Groups

Group I: Alcohol Stepped Care Experimental Treatment 2 Interventions

Based on severity of alcohol use, individuals receive brief alcohol intervention delivered in person or by computer, cognitive behavioral therapy by person or computer, or pharmacotherapy for alcohol use disorder

Alcohol Stepped Care is already approved in United States, European Union for the following indications:

Approved in United States as Alcohol Stepped Care for:

• Unhealthy Alcohol Use
• Alcohol Use Disorder

Approved in European Union as Alcohol Stepped Care for:

• Alcohol Dependence
• Harmful Drinking

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

Fenway Community Health

Collaborator

Trials

36

Recruited

5,833,000+

Findings from Research

Providers in HIV clinics recognize the importance of motivational tools to engage patients in addressing unhealthy alcohol use, but they desire more flexibility in the treatment approach.

The implementation of a stepped care model for unhealthy alcohol use is supported by its alignment with VA priorities and the providers' confidence in their ability to deliver the intervention, highlighting the need for ongoing skill development and alternative delivery models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of integrated stepped care for unhealthy alcohol use in HIV clinics. Edelman, EJ., Hansen, NB., Cutter, CJ., et al.[2018]

The STEP Trials are designed to evaluate the effectiveness of an integrated stepped care approach for treating unhealthy alcohol use among HIV-positive patients, involving 3 parallel randomized controlled trials across five Infectious Disease Clinics.

Participants with varying levels of alcohol use will receive tailored interventions, starting with brief interventions and potentially escalating to more intensive therapies, with the primary outcome being assessed at 24 weeks to measure changes in alcohol consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Starting Treatment for Ethanol in Primary care Trials (STEP Trials): Protocol for Three Parallel Multi-Site Stepped Care Effectiveness Studies for Unhealthy Alcohol Use in HIV-Positive Patients. Edelman, EJ., Maisto, SA., Hansen, NB., et al.[2022]

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]

The integrated stepped alcohol treatment (ISAT) was tested in a randomized trial with 93 participants, but it only recruited 37% of the target population, indicating challenges in engaging patients with HIV and at-risk alcohol use.

Despite the multi-step approach of ISAT, there was no significant difference in alcohol consumption between participants receiving ISAT and those receiving standard care after 24 weeks, suggesting that more effective strategies are needed to motivate and retain patients in alcohol treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated stepped alcohol treatment for patients with HIV and at-risk alcohol use: a randomized trial. Edelman, EJ., Maisto, SA., Hansen, NB., et al.[2021]

HIV care providers are in a key position to help HIV-infected patients reduce alcohol use through screening and brief interventions, but they face several barriers such as limited time and patients' reluctance to disclose alcohol use.

Facilitators for successfully implementing alcohol reduction strategies include having enough time for screenings, access to helpful resources, and using concise screening tools to engage patients effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators in implementing "prevention for positives" alcohol-reduction support: the perspectives of directors and providers in hospital-based HIV care centers. Strauss, SM., Munoz-Plaza, CE., Tiburcio, NJ., et al.[2021]

Oral naltrexone (NTX) and injectable extended-release naltrexone (XR-NTX) have been shown to effectively reduce alcohol use and improve viral suppression in individuals living with HIV/AIDS, based on a systematic review of 7 studies.

Both NTX and XR-NTX were found to be safe, with no significant adverse events reported, and did not negatively impact adherence to antiretroviral therapy (ART).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of naltrexone treatment for alcohol use disorders in HIV: a systematic review. Farhadian, N., Moradi, S., Zamanian, MH., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Implementation of integrated stepped care for unhealthy alcohol use in HIV clinics. [2018]

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

The Starting Treatment for Ethanol in Primary care Trials (STEP Trials): Protocol for Three Parallel Multi-Site Stepped Care Effectiveness Studies for Unhealthy Alcohol Use in HIV-Positive Patients. [2022]

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. England pubmed.ncbi.nlm.nih.gov

Integrated stepped alcohol treatment for patients with HIV and at-risk alcohol use: a randomized trial. [2021]

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

Barriers and facilitators in implementing "prevention for positives" alcohol-reduction support: the perspectives of directors and providers in hospital-based HIV care centers. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness of naltrexone treatment for alcohol use disorders in HIV: a systematic review. [2023]