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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This project is a pilot study to determine the feasibility and acceptability of a telemedicine intervention for substance use disorder service delivery in diverse people living with HIV in Alabama.

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 data supports the effectiveness of this treatment for substance use disorders and HIV?

Research shows that telemedicine and electronic patient-reported outcomes (ePROs) can improve screening and treatment access for people with HIV and substance use disorders. Telehealth has also been found to help retain appointments for individuals with substance use disorders, although challenges remain for those experiencing homelessness. ^{1 2 3 4 5}

Is telemedicine safe for treating 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. While there are some concerns about patient privacy and treatment avoidance, these are similar to challenges faced in traditional in-person care. ^{1 3 6 7 8}

How is telemedicine unique for treating substance use disorders and HIV?

Telemedicine is unique because it allows patients to receive care remotely, overcoming barriers of time and distance, and increasing access to treatment for substance use disorders and HIV. It also offers anonymity and can enhance engagement by using digital tools like electronic patient-reported outcomes. ^{1 3 9 10 11}

Research Team

Ellen Eaton, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

I am 18 years old or older.

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. Canada pubmed.ncbi.nlm.nih.gov

Delivery of the HIV Service and Telemedicine Through Effective Patient-Reported Outcomes (+STEP) Intervention to Increase Screening and Treatment of Mental Health and Substance Use Disorders for People Living With HIV in Alabama: Protocol for an Effectiveness-Implementation Study. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Missed appointments during COVID-19: The impact of telehealth for persons experiencing homelessness with substance use disorders. [2022]

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

Many Clinicians Implement Digital Equity Strategies To Treat Opioid Use Disorder. [2023]

4. India pubmed.ncbi.nlm.nih.gov

Service users' perception and attitude toward telemedicine-based treatment for substance use disorders: A qualitative study from India. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Opioid use disorder patients' perceptions of healthcare delivery platforms. [2020]

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

Substance Use Disorder Treatment via Telemedicine During Coronavirus Disease 2019. [2021]

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

How Is Telemedicine Being Used In Opioid And Other Substance Use Disorder Treatment? [2020]

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

Substance Use Disorder Treatment Through Telemedicine in the Age of CoVID-19. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Trends in telemedicine use in addiction treatment. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Pre-Paid Phone Distribution: A Tool for Improving Healthcare Engagement for People with Substance Use Disorder. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

A Digital Counselor-Delivered Intervention for Substance Use Among People With HIV: Development and Usability Study. [2023]