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HIV + Service Delivery and Telemedicine Through Effective PROs

HIV + Service Delivery and Telemedicine Through Effective PROs (+STEP)

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04489667
Acronym
HIV+STEP
Enrollment
0
Registered
2020-07-28
Start date
2021-03-19
Completion date
2026-01-01
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS, Mental Health Issue, Substance Use Disorders

Keywords

Telemedicine, Patient reported outcomes, Focused training

Brief summary

This study will examine the impact of using a multicomponent intervention (patient reported outcomes, training, and telemedicine) to assist with the management of Mental Health (MH) and Substance Use Disorders (SUD) among people living with HIV (PLWH) engaged in care at UAB HIV Clinic, University of Alabama Family Clinic (Birmingham, AL), Thrive Federally Qualified Health Services Center (Huntsville), Health Services Center (Anniston), and Medical Advocacy and Outreach (Montgomery). The study will employ a hybrid type 2 implementation design. Because this intervention will be employed as the new standard of care at participating sites, all PLWH receiving care at the sites will receive this intervention. Patient-reported outcomes (PROs) will be integrated into routine care to screen PLWH for substance use and mental health disorders during routine clinical encounters. Training will be delivered to frontline clinicians so that they receive targeted knowledge on best practices for treatment of MH and SUD along with clinic-specific protocols for response to PROs on MH and SUD including treatment and referrals. Telemedicine services for MH and SUD will be offered to patients in need of expanded access to services due to a lack of clinic-level resources or additional barriers to traditional clinic visits such transportation, stigma, or substance using behaviors.

Interventions

OTHER+STEP Implementation

All patients receiving care at five RWHAP-funded clinics will receive the intervention (+STEP), in which patient-reported outcomes (PROs) on mental health and substance use disorder (SUD) will be integrated into routine care, targeted training will be provided for frontline clinicians on best practices for mental health and SUD treatment, and telemedicine for mental health and SUD will be offered to patients in need of expanded access to services.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years or older and receiving HIV care at one of the five participating sites

Exclusion criteria

* Below 18 years of age

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients completing PROsBaseline through Year 1We will quantify the percentage of patients completing a PRO related to mental health or substance use
Percentage of staff participating in trainingBaseline through Year 1We will use attendance logs to determine how many staff at each site complete training
Percentage of patients receiving a referral to a mental health or substance use serviceBaseline through Year 1We will use EMR and scheduling data to determine the number of referrals generated
Percentage of patients receiving mental health or substance use service based on attendanceBaseline through Year 1We will use EMR and scheduling data to determine the number of visits attended

Secondary

MeasureTime frameDescription
Percentage engaged in HIV careBaseline through Year 1We will determine the number of participants engage in HIV care
Percentage receiving antiretroviral therapy for HIVBaseline through Year 1We will determine the number of participants receiving HIV treatment
Number of Patients Achieving a Viral Load SuppressionBaseline through Year 1We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of \<20 copies per milliliter

Contacts

PRINCIPAL_INVESTIGATOREllen Eaton, MD, MSPH

University of Alabama at Birmingham (UAB)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026