Telemedicine for Substance Use Disorders and HIV

(HEAT Trial)

Overseen By Stephen Tyler O'Rear

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Cognitive impairment, Psychosis, Suicidal, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether telemedicine (healthcare through video calls) can assist individuals with both HIV and substance use disorders. The researchers aim to determine if patients find this approach practical and welcoming. The trial seeks participants in Alabama who have HIV and have misused opioids or stimulants. Participants should be receiving care at local HIV clinics.

As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative healthcare solutions that could enhance access and convenience for those with similar conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that telemedicine is safe for people living with HIV and substance use disorders?

Research has shown that telemedicine is commonly used and accepted for treating substance use disorders. Many treatment centers have adopted telemedicine, with its use more than doubling from 2019 to 2020. This trend indicates that telemedicine is becoming a regular part of healthcare for these disorders.

Studies also highlight that both patients and healthcare providers value the benefits of telehealth, despite challenges like regulatory issues. Overall, telemedicine has proven safe and effective for providing care.

In summary, telemedicine is well-received and widely used in treating substance use disorders. Current evidence does not indicate any major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about telemedicine for treating substance use disorders and HIV because it offers a unique approach to care. Unlike traditional treatments that require frequent in-person visits to clinics or support groups, telemedicine allows patients to access support and medical advice from the comfort of their homes. This is especially beneficial for individuals in rural areas or those with mobility issues. Furthermore, telemedicine can provide real-time monitoring and immediate intervention, which might enhance adherence to treatment plans and improve health outcomes.

What evidence suggests that telemedicine is effective for substance use disorders and HIV?

Research shows that telemedicine, which participants in this trial will receive, has improved access to care for people with HIV and those with substance use issues. Telehealth, enabling patients to receive care remotely through technology, has shown promise in expanding treatment for opioid use disorder. It has safely supported recovery from substance use problems. During the COVID-19 pandemic, telehealth became essential for providing care to underserved groups, including those with HIV. Early evidence suggests that telemedicine can enhance both patient engagement and treatment outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Ellen Eaton, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

The HEAT Program is for individuals with substance use disorders, including opioid and stimulant use, who may also be living with or at risk for HIV. It's particularly focused on those in rural areas of the U.S. South where healthcare access is limited due to systemic issues like racism and lack of public health infrastructure.

Inclusion Criteria

Reported opioid and/or stimulant misuse

Receiving services at HIV clinics in Alabama

Exclusion Criteria

Currently psychotic

I need help to participate in interviews due to cognitive issues.

I have not attempted or thought about suicide recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Telemedicine Intervention

Participants receive telemedicine intervention for substance use disorder service delivery

3 months

Telemedicine visits

Follow-up

Participants are monitored for follow-up healthcare visits

3 months

Follow-up visits (telemedicine or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Telemedicine

Trial Overview This trial is exploring how telemedicine can help people with substance use disorders receive better care, especially when they have or are at risk for HIV. The study compares standard in-person care to remote care via telemedicine to see if it improves access and outcomes.

How Is the Trial Designed?

Group I: Patients living with HIV and substance use Experimental Treatment 2 Interventions

Patients living with HIV and substance use, aged 18 and over. These participants are receiving services at HIV clinics in Alabama and must have reported opioid and/or stimulant misuse.

Telemedicine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Telemedicine for:

• General medical consultations
• Chronic disease management
• Urgent care needs

Approved in European Union as Telemedicine for:

• General medical consultations
• Chronic disease management
• Urgent care needs

Approved in Canada as Telemedicine for:

• General medical consultations
• Chronic disease management
• Urgent care needs

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. reporter.nih.gov reporter.nih.gov/search/PRGr79_0tUeZOEwiVzOCnQ/project-details/10847444

Project Details - NIH RePORTER There are three overall aims of the proposed study: (1) to determine if the C-THR model increases engagement in HIV prevention compared to offsite referral and ...

2. reporter.nih.gov reporter.nih.gov/project-details/11262591

JCOIN phase II innovation hub PROJECT SUMMARY/ABSTRACT Access to substance use disorder (SUD) treatment remains inadequate for many groups, particularly those in Southern jails.

3. samhsa.gov samhsa.gov/libraries/evidence-based-practices-resource-center

Evidence-Based Practices Resource Center Substance Use Disorder Treatment Month · Substance Use & Misuse Prevention Month · Suicide Prevention Awareness Month · Support During the Holidays. Mental ...

4. link.springer.com link.springer.com/article/10.1007/s10461-024-04550-5

Telehealth Utilization Around the COVID-19 Pandemic ... Telehealth has the potential to extend access to lifesaving treatment for opioid use disorder (OUD) among underserved people living with HIV (PWH).

5. withpower.com withpower.com/trial/phase-substance-related-disorders-5-2024-d793f

Telemedicine for Substance Use Disorders and HIV ... Telemedicine has been used safely to support recovery from substance use disorders and improve access to care for people living with HIV.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12044217/

Understanding the use of telemedicine across different ... The COVID-19 pandemic has instigated the development of telemedicine-mediated provision of medications for opioid use disorder such as buprenorphine and ...

7. samhsa.gov samhsa.gov/data/report/telemedicine-services

Telemedicine Services in Substance Use and Mental ... The percentage of substance use treatment facilities with telemedicine services more than doubled in one year: from 27.5% in 2019 to 58.6% in 2020.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7577680/

Telehealth Benefits and Barriers - PMC - PubMed Central Patients and providers have enjoyed the benefits of telehealth, but widespread adoption has been hindered by regulatory, legal, and reimbursement barriers.

9. jmir.org jmir.org/2024/1/e54015/

Virtual Primary Care for People With Opioid Use Disorder This scoping review synthesized current literature on virtual primary care for people with opioid use disorder with a specific focus on benefits, challenges, ...

10. telehealth.hhs.gov telehealth.hhs.gov/research-articles

Research Articles and Papers This study looked at telehealth's impact on health care utilization and outcomes for Alaska Native patients with chronic diseases. Findings show that ...