What side effects are associated with this type of intervention?

Common treatments for HIV, particularly antiretroviral therapy (ART), are associated with a range of side effects. These can include metabolic complications, such as lipid abnormalities and insulin resistance, as well as gastrointestinal issues like nausea and diarrhea. Appearance-related side effects, such as lipodystrophy, can also occur. Drug-drug interactions and inappropriate dosing are frequent issues, potentially leading to adverse drug events. Newer ART drugs aim to reduce these side effects and improve adherence, but they still require careful management to minimize complications.

What prior FDA approvals exist?

The FDA has approved numerous antiretroviral drugs for the treatment of HIV, including nucleoside reverse transcriptase inhibitors (NRTIs) like zidovudine and lamivudine, non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as efavirenz, protease inhibitors (PIs) like ritonavir, and integrase strand transfer inhibitors (INSTIs) such as dolutegravir. These drugs are often used in combination to enhance efficacy and reduce the risk of resistance. The Practice Facilitation trial's focus on a stepped care model, which includes cognitive behavioral therapy and pharmacotherapy for alcohol use, aims to improve ART adherence and viral suppression, addressing a critical aspect of HIV management.

What other types of research exist?

Promising, novel alternatives to Practice Facilitation for HIV patients in 2024 include: 1) Digital Health Interventions, such as mobile health apps and telemedicine, which provide remote monitoring and support; 2) Peer Support Programs, where trained peers provide guidance and emotional support; 3) Integrated Care Models, combining HIV treatment with mental health and substance use services; and 4) Artificial Intelligence (AI)-driven personalized care plans, which use data analytics to tailor interventions to individual patient needs.

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Practice Facilitation for Alcohol Use Disorder in HIV Care

Q: What is the mechanism of action of this treatment?

The most common treatments for HIV involve combination antiretroviral therapy (ART), which includes drugs from different classes such as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. These drugs work by targeting various stages of the HIV life cycle: NRTIs and NNRTIs inhibit the reverse transcription of viral RNA into DNA, PIs prevent the maturation of viral proteins, INSTIs block the integration of viral DNA into the host genome, and entry inhibitors prevent the virus from entering host cells. Effective ART reduces viral load, improves immune function, and decreases the risk of HIV transmission. This is crucial for patients as it enhances their quality of life, prolongs survival, and reduces the likelihood of developing AIDS-related complications. The Practice Facilitation trial aims to improve ART adherence and outcomes by addressing barriers such as unhealthy alcohol use, which can interfere with medication adherence and overall treatment success.

N/A

Recruiting

Led By Geetanjali Chander, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinic Staff: Age > 18 years old

Patients: Age ≥ 18 years old

Must not have

Patients: Age < 18 years old

Clinic Staff: Unable to speak English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on implementing practice strategies rather than direct medical treatments, there are no traditional side effects like you'd expect from drugs or surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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

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I am unable to participate in alcohol use treatment due to cognitive reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Implementation as assessed by the percent of patients receiving an alcohol intervention

Secondary study objectives

Antiretroviral therapy adherence as assessed by a self report on a visual analog scale

Change in unhealthy alcohol use as assessed by the Alcohol Use Disorder Identification test-Consumption (AUDIT-C)

Viral Suppression as assessed by HIV-RNA copies

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Alcohol Stepped CareExperimental Treatment2 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Practice Facilitation

2007

N/A

~19370

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for HIV involve combination antiretroviral therapy (ART), which includes drugs from different classes such as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. These drugs work by targeting various stages of the HIV life cycle: NRTIs and NNRTIs inhibit the reverse transcription of viral RNA into DNA, PIs prevent the maturation of viral proteins, INSTIs block the integration of viral DNA into the host genome, and entry inhibitors prevent the virus from entering host cells. Effective ART reduces viral load, improves immune function, and decreases the risk of HIV transmission. This is crucial for patients as it enhances their quality of life, prolongs survival, and reduces the likelihood of developing AIDS-related complications. The Practice Facilitation trial aims to improve ART adherence and outcomes by addressing barriers such as unhealthy alcohol use, which can interfere with medication adherence and overall treatment success.

Data analysis issues for protocols with overlapping enrollment.Effect of female sex work-targeted community-based interventions along the HIV treatment cascade in sub-Saharan Africa: a systematic review protocol.[Guidelines for caring for HIV-infected adults and postexposure prophylaxis for HIV infection].