Substance Use DisordersHEATNCT06370481
HIV, Equity, and Addiction Training (HEAT) Program
A study testing Telemedicine in people with Substance Use Disorders and Hiv, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Hiv, Opioid Use Disorder
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving services at HIV clinics in Alabama
- Reported opioid and/or stimulant misuse
- 18 years of age or older
Who cannot join
- Receipt of SUD clinical care other than through HIV provider/clinic in the last 3 months
- Inability to engage in interviews independently without support (e.g., cognitive impairment)
- Currently psychotic
- Actively suicidal: presents with a suicide attempt or suicidal ideation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Tyler O'Rear, 2057214060, storear@uabmc.edu
Ellen F Eaton, MD, MSPH
About this study
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.
Read the detailed description
The contemporary drug crisis and the COVID-19 pandemic have exposed the complex syndemics of addiction and infectious diseases: rising rates of substance use disorder (SUD) have outpaced our ability to respond with a limited healthcare workforce and public health capacity. SUD is increasing in those living with and at risk for HIV, and infectious consequences of SUD, like hepatitis C, have continued, unmitigated, in rural parts of the U.S. where many states lack Medicaid expansion, syringe service programs, and public health infrastructure to respond to the drug crisis and comorbid infections. Systemic racism and regressive policies in the Deep South criminalize people who use drugs, creating additional barriers to care, HIV prevention, and addiction treatment. As a result, people who use drugs rarely receive comprehensive addiction and HIV treatment. Yet telemedicine has the potential to overcome these barriers and bypass the constraints of a brick-and-mortar clinic to link vulnerable people, including those with HIV, to care. Although telemedicine has become mainstream in recent years, few studies have evaluated telemedicine for SUD in the Deep South from the perspective of patients and providers.
- Being tested
- Telemedicine, Standard of care
- Keywords
- Alabama, Ryan White Clinics, HIV treatment, Substance use disorder treatment, Telemedicine
- Medical subject headings
- Substance-Related Disorders, Acquired Immunodeficiency Syndrome, Opioid-Related Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Routine care administered via telemedicine
Standard of careOther
Standard of care, as received in HIV clinic settings
| Study group | Role | What they receive |
|---|---|---|
| Patients living with HIV and substance use | Experimental | 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. Receives: Other: Telemedicine; Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants who have a follow-up healthcare visit
Follow up visit for care (either telemedicine or in person)
Measured: 1 month, 2 months, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start29 Jan 2026
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Ellen Eaton, University of Alabama at Birmingham
- Investigators
- Ellen F Eaton, MD, MSPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370481
- Sponsor's protocol ID
- IRB-300012349
- Other IDs
- K24DA060786
- Acronym
- HEAT
- Status last verified
- Feb 2026
- First submitted
- 12 Apr 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research will comply with the NIH Data Sharing policy and will coordinate collection and sharing of key data. Data are available upon request from the public and research community after main findings are published. To request data, the investigators ask that interested parties submit a detailed description of the aims and methods of their research to the PI, including contact information from the primary requester, institutional affiliation, current CV and qualifications, sources of financial support, and conflict of interest statement. The MPIs will review requests as submitted and determine the appropriateness of the request with collaborators or if additional safeguards are needed. Upon approval, data transfer agreements must be established and proof of IRB approval from the requester's institutional IRB must be presented. Our team will comply with HIPAA and Common Rule de-identification prior to data sharing to ensure protection of study participants
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV, Equity, and Addiction Training (HEAT) Program
- ClinicalTrials.gov ID
- NCT06370481
- Acronym / sponsor ID
- HEAT / IRB-300012349
- Keywords
- Alabama, Ryan White Clinics, HIV treatment, Substance use disorder treatment, Telemedicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The contemporary drug crisis and the COVID-19 pandemic have exposed the complex syndemics of addiction and infectious diseases: rising rates of substance use disorder (SUD) have outpaced our ability to respond with a limited healthcare workforce and public health capacity. SUD is increasing in those living with and at risk for HIV, and infectious consequences of SUD, like hepatitis C, have continued, unmitigated, in rural parts of the U.S. where many states lack Medicaid expansion, syringe service programs, and public health infrastructure to respond to the drug crisis and comorbid infections. Systemic racism and regressive policies in the Deep South criminalize people who use drugs, creating additional barriers to care, HIV prevention, and addiction treatment. As a result, people who use drugs rarely receive comprehensive addiction and HIV treatment. Yet telemedicine has the potential to overcome these barriers and bypass the constraints of a brick-and-mortar clinic to link vulnerable people, including those with HIV, to care. Although telemedicine has become mainstream in recent years, few studies have evaluated telemedicine for SUD in the Deep South from the perspective of patients and providers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients living with HIV and substance use | Experimental | Other: Telemedicine, Other: Standard of carePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Receiving services at HIV clinics in Alabama
- Reported opioid and/or stimulant misuse
- 18 years of age or older
Key exclusion criteria (4 listed)
- Receipt of SUD clinical care other than through HIV provider/clinic in the last 3 months
- Inability to engage in interviews independently without support (e.g., cognitive impairment)
- Currently psychotic
- Actively suicidal: presents with a suicide attempt or suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineRoutine care administered via telemedicine | Other | Patients living with HIV and substance use |
| Standard of careStandard of care, as received in HIV clinic settings | Other | Patients living with HIV and substance use |
Primary outcome
Percent of participants who have a follow-up healthcare visit
Time frame: 1 month, 2 months, 3 months
Follow up visit for care (either telemedicine or in person)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Yes. The research will comply with the NIH Data Sharing policy and will coordinate collection and sharing of key data. Data are available upon request from the public and research community after main findings are published. To request data, the investigators ask that interested parties submit a detailed description of the aims and methods of their research to the PI, including contact information from the primary requester, institutional affiliation, current CV and qualifications, sources of financial support, and conflict of interest statement. The MPIs will review requests as submitted and determine the appropriateness of the request with collaborators or if additional safeguards are needed. Upon approval, data transfer agreements must be established and proof of IRB approval from the requester's institutional IRB must be presented. Our team will comply with HIPAA and Common Rule de-identification prior to data sharing to ensure protection of study participants
Related trials for Substance Use Disorders
Recruiting
Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems
Alcohol Use, Adolescent
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruitingObservational study
Predicting Dropout and Outcome From Neuropsychological Functions in SUD Patients
Substance Use Disorder (SUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellen F Eaton, MD, MSPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Substance Use Disorders and Hiv, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen F Eaton, MD, MSPH (2059750661, eeaton@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants who have a follow-up healthcare visit (time frame: 1 month, 2 months, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.