HIV + Service Delivery and Telemedicine Through Effective PROs

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV/AIDS, Mental Health Issue, Substance Use Disorders

Intervention / Treatment
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* Other: +STEP Implementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older and receiving HIV care at one of the five participating sites Exclusion Criteria: Below 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: +STEP Implementation<br>All 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. | Other: +STEP Implementation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients completing PROs | We will quantify the percentage of patients completing a PRO related to mental health or substance use | Baseline through Year 1 | 
| Percentage of patients completing PROs | We will quantify the percentage of patients completing a PRO related to mental health or substance use | Year 1 through Year 2 | 
| Percentage of patients completing PROs | We will quantify the percentage of patients completing a PRO related to mental health or substance use | Year 2 through Year 3 | 
| Percentage of patients completing PROs | We will quantify the percentage of patients completing a PRO related to mental health or substance use | Year 3 through Year 4 | 
| Percentage of patients completing PROs | We will quantify the percentage of patients completing a PRO related to mental health or substance use | Year 4 through Year 5 | 
| Percentage of staff participating in training | We will use attendance logs to determine how many staff at each site complete training | Baseline through Year 1 | 
| Percentage of staff participating in training | We will use attendance logs to determine how many staff at each site complete training | Year 1 through Year 2 | 
| Percentage of staff participating in training | We will use attendance logs to determine how many staff at each site complete training | Year 2 through Year 3 | 
| Percentage of staff participating in training | We will use attendance logs to determine how many staff at each site complete training | Year 3 through Year 4 | 
| Percentage of staff participating in training | We will use attendance logs to determine how many staff at each site complete training | Year 4 through Year 5 | 
| Percentage of patients receiving a referral to a mental health or substance use service | We will use EMR and scheduling data to determine the number of referrals generated | Baseline through Year 1 | 
| Percentage of patients receiving a referral to a mental health or substance use service | We will use EMR and scheduling data to determine the number of referrals generated | Year 1 through Year 2 | 
| Percentage of patients receiving a referral to a mental health or substance use service | We will use EMR and scheduling data to determine the number of referrals generated | Year 2 through Year 3 | 
| Percentage of patients receiving a referral to a mental health or substance use service | We will use EMR and scheduling data to determine the number of referrals generated | Year 3 through Year 4 | 
| Percentage of patients receiving a referral to a mental health or substance use service | We will use EMR and scheduling data to determine the number of referrals generated | Year 4 through Year 5 | 
| Percentage of patients receiving mental health or substance use service based on attendance | We will use EMR and scheduling data to determine the number of visits attended | Baseline through Year 1 | 
| Percentage of patients receiving mental health or substance use service based on attendance | We will use EMR and scheduling data to determine the number of visits attended | Year 1 through Year 2 | 
| Percentage of patients receiving mental health or substance use service based on attendance | We will use EMR and scheduling data to determine the number of visits attended | Year 2 through Year 3 | 
| Percentage of patients receiving mental health or substance use service based on attendance | We will use EMR and scheduling data to determine the number of visits attended | Year 3 through Year 4 | 
| Percentage of patients receiving mental health or substance use service based on attendance | We will use EMR and scheduling data to determine the number of visits attended | Year 4 through Year 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage engaged in HIV care | We will determine the number of participants engage in HIV care | Baseline through Year 1 | 
| Percentage engaged in HIV care | We will determine the number of participants engage in HIV care | Year 1 through Year 2 | 
| Percentage engaged in HIV care | We will determine the number of participants engage in HIV care | Year 2 through Year 3 | 
| Percentage engaged in HIV care | We will determine the number of participants engage in HIV care | Year 3 through Year 4 | 
| Percentage engaged in HIV care | We will determine the number of participants engage in HIV care | Year 4 through Year 5 | 
| Percentage receiving antiretroviral therapy for HIV | We will determine the number of participants receiving HIV treatment | Baseline through Year 1 | 
| Percentage receiving antiretroviral therapy for HIV | We will determine the number of participants receiving HIV treatment | Year 1 through Year 2 | 
| Percentage receiving antiretroviral therapy for HIV | We will determine the number of participants receiving HIV treatment | Year 2 through Year 3 | 
| Percentage receiving antiretroviral therapy for HIV | We will determine the number of participants receiving HIV treatment | Year 3 through Year 4 | 
| Percentage receiving antiretroviral therapy for HIV | We will determine the number of participants receiving HIV treatment | Year 4 through Year 5 | 
| Number of Patients Achieving a Viral Load Suppression | We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter | Baseline through Year 1 | 
| Number of Patients Achieving a Viral Load Suppression | We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter | Year 1 through Year 2 | 
| Number of Patients Achieving a Viral Load Suppression | We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter | Year 2 through Year 3 | 
| Number of Patients Achieving a Viral Load Suppression | We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter | Year 3 through Year 4 | 
| Number of Patients Achieving a Viral Load Suppression | We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter | Year 4 through Year 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Patient reported outcomes, Focused training