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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06370481
Other study ID # IRB-300012349
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date December 2029

Study information

Verified date April 2024
Source University of Alabama at Birmingham
Contact Ellen F Eaton, MD, MSPH
Phone 2059750661
Email eeaton@uabmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 2029
Est. primary completion date June 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Telemedicine
Routine care administered via telemedicine
Standard of care
Standard of care, as received in HIV clinic settings

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent of participants who have a follow-up healthcare visit Follow up visit for care (either telemedicine or in person) 1 month, 2 months, 3 months
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