HIV, Equity, and Addiction Training (HEAT) Program (HEAT)

February 16, 2026 updated by: Ellen Eaton, University of Alabama at Birmingham
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ellen F Eaton, MD, MSPH
  • Phone Number: 2059750661
  • Email: eeaton@uabmc.edu

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Principal Investigator:
          • Ellen F Eaton, MD, MSPH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Receiving services at HIV clinics in Alabama
  • Reported opioid and/or stimulant misuse
  • 18 years of age or older

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients living with HIV and substance use
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.
Other: Telemedicine
Routine care administered via telemedicine
Other: Standard of care
Standard of care, as received in HIV clinic settings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 month, 2 months, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Ellen F Eaton, MD, MSPH, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

April 12, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300012349
  • K24DA060786 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Available after studies are published and will be maintained for 5 years after study end date.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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