NCT06370481

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
38mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jan 2026Jun 2029

First Submitted

Initial submission to the registry

April 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 29, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

April 12, 2024

Last Update Submit

February 16, 2026

Conditions

Substance Use DisordersHivOpioid Use DisorderStimulant Use (Diagnosis)

Keywords

AlabamaRyan White ClinicsHIV treatmentSubstance use disorder treatmentTelemedicine

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Other: TelemedicineOther: Standard of care

Interventions

TelemedicineOTHER

Routine care administered via telemedicine

Patients living with HIV and substance use
Standard of careOTHER

Standard of care, as received in HIV clinic settings

Patients living with HIV and substance use

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAt least 20% female, no more than 80% male
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related DisordersAcquired Immunodeficiency SyndromeOpioid-Related DisordersDisease

Interventions

TelemedicineStandard of Care

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNarcotic-Related DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationQuality Indicators, Health CareQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Ellen F Eaton, MD, MSPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen F Eaton, MD, MSPH

CONTACT

2059750661eeaton@uabmc.edu

Stephen Tyler O'Rear

CONTACT

2057214060storear@uabmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 12, 2024

First Posted

April 17, 2024

Study Start

January 29, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Available after studies are published and will be maintained for 5 years after study end date.

Locations

US(1)