MedPath

HIV + Service Delivery and Telemedicine Through Effective PROs

Not Applicable
Withdrawn
Conditions
Mental Health Issue
HIV/AIDS
Substance Use Disorders
Interventions
Other: +STEP Implementation
Registration Number
NCT04489667
Lead Sponsor
University of Alabama at Birmingham
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • 18 years or older and receiving HIV care at one of the five participating sites
Read More
Exclusion Criteria
  • Below 18 years of age
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
+STEP Implementation+STEP ImplementationAll patients will receive +STEP as new standard of care at their clinic. This intervention will include staff training, PROs as part of routine care to screen for substance use and mental health disorders, and telemedicine for health care delivery.
Primary Outcome Measures
NameTimeMethod
Percentage of patients receiving a referral to a mental health or substance use serviceYear 4 through Year 5

We will use EMR and scheduling data to determine the number of referrals generated

Percentage of patients completing PROsYear 4 through Year 5

We will quantify the percentage of patients completing a PRO related to mental health or substance use

Percentage of staff participating in trainingYear 4 through Year 5

We will use attendance logs to determine how many staff at each site complete training

Percentage of patients receiving mental health or substance use service based on attendanceYear 4 through Year 5

We will use EMR and scheduling data to determine the number of visits attended

Secondary Outcome Measures
NameTimeMethod
Number of Patients Achieving a Viral Load SuppressionYear 4 through Year 5

We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of \<20 copies per milliliter

Percentage engaged in HIV careYear 4 through Year 5

We will determine the number of participants engage in HIV care

Percentage receiving antiretroviral therapy for HIVYear 4 through Year 5

We will determine the number of participants receiving HIV treatment

Trial Locations

Locations (5)

Health Services Center

🇺🇸

Anniston, Alabama, United States

University of Alabama Family Clinic

🇺🇸

Birmingham, Alabama, United States

Unity Wellness Center

🇺🇸

Opelika, Alabama, United States

Medical Advocacy and Outreach (MAO)

🇺🇸

Montgomery, Alabama, United States

Thrive Federally Qualified Health Services Center

🇺🇸

Huntsville, Alabama, United States

© Copyright 2025. All Rights Reserved by MedPath