HIV+STEP: HIV + Service Delivery and Telemedicine Through Effective PROs
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: +STEP Implementation 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
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.
|
Outcome Measures
Primary Outcome Measures
- Percentage of patients completing PROs [Baseline through Year 1]
We will quantify the percentage of patients completing a PRO related to mental health or substance use
- Percentage of patients completing PROs [Year 1 through Year 2]
We will quantify the percentage of patients completing a PRO related to mental health or substance use
- Percentage of patients completing PROs [Year 2 through Year 3]
We will quantify the percentage of patients completing a PRO related to mental health or substance use
- Percentage of patients completing PROs [Year 3 through Year 4]
We will quantify the percentage of patients completing a PRO related to mental health or substance use
- Percentage of patients completing PROs [Year 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 training [Baseline through Year 1]
We will use attendance logs to determine how many staff at each site complete training
- Percentage of staff participating in training [Year 1 through Year 2]
We will use attendance logs to determine how many staff at each site complete training
- Percentage of staff participating in training [Year 2 through Year 3]
We will use attendance logs to determine how many staff at each site complete training
- Percentage of staff participating in training [Year 3 through Year 4]
We will use attendance logs to determine how many staff at each site complete training
- Percentage of staff participating in training [Year 4 through Year 5]
We 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 service [Baseline through Year 1]
We will use EMR and scheduling data to determine the number of referrals generated
- Percentage of patients receiving a referral to a mental health or substance use service [Year 1 through Year 2]
We will use EMR and scheduling data to determine the number of referrals generated
- Percentage of patients receiving a referral to a mental health or substance use service [Year 2 through Year 3]
We will use EMR and scheduling data to determine the number of referrals generated
- Percentage of patients receiving a referral to a mental health or substance use service [Year 3 through Year 4]
We will use EMR and scheduling data to determine the number of referrals generated
- Percentage of patients receiving a referral to a mental health or substance use service [Year 4 through Year 5]
We 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 attendance [Baseline through Year 1]
We will use EMR and scheduling data to determine the number of visits attended
- Percentage of patients receiving mental health or substance use service based on attendance [Year 1 through Year 2]
We will use EMR and scheduling data to determine the number of visits attended
- Percentage of patients receiving mental health or substance use service based on attendance [Year 2 through Year 3]
We will use EMR and scheduling data to determine the number of visits attended
- Percentage of patients receiving mental health or substance use service based on attendance [Year 3 through Year 4]
We will use EMR and scheduling data to determine the number of visits attended
- Percentage of patients receiving mental health or substance use service based on attendance [Year 4 through Year 5]
We will use EMR and scheduling data to determine the number of visits attended
Secondary Outcome Measures
- Percentage engaged in HIV care [Baseline through Year 1]
We will determine the number of participants engage in HIV care
- Percentage engaged in HIV care [Year 1 through Year 2]
We will determine the number of participants engage in HIV care
- Percentage engaged in HIV care [Year 2 through Year 3]
We will determine the number of participants engage in HIV care
- Percentage engaged in HIV care [Year 3 through Year 4]
We will determine the number of participants engage in HIV care
- Percentage engaged in HIV care [Year 4 through Year 5]
We will determine the number of participants engage in HIV care
- Percentage receiving antiretroviral therapy for HIV [Baseline through Year 1]
We will determine the number of participants receiving HIV treatment
- Percentage receiving antiretroviral therapy for HIV [Year 1 through Year 2]
We will determine the number of participants receiving HIV treatment
- Percentage receiving antiretroviral therapy for HIV [Year 2 through Year 3]
We will determine the number of participants receiving HIV treatment
- Percentage receiving antiretroviral therapy for HIV [Year 3 through Year 4]
We will determine the number of participants receiving HIV treatment
- Percentage receiving antiretroviral therapy for HIV [Year 4 through Year 5]
We will determine the number of participants receiving HIV treatment
- Number of Patients Achieving a Viral Load Suppression [Baseline through Year 1]
We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter
- Number of Patients Achieving a Viral Load Suppression [Year 1 through Year 2]
We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter
- Number of Patients Achieving a Viral Load Suppression [Year 2 through Year 3]
We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter
- Number of Patients Achieving a Viral Load Suppression [Year 3 through Year 4]
We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter
- Number of Patients Achieving a Viral Load Suppression [Year 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- 18 years or older and receiving HIV care at one of the five participating sites
Exclusion Criteria:
- Below 18 years of age
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Health Services Center | Anniston | Alabama | United States | 36202 |
| 2 | University of Alabama Family Clinic | Birmingham | Alabama | United States | 35233 |
| 3 | Thrive Federally Qualified Health Services Center | Huntsville | Alabama | United States | 35801 |
| 4 | Medical Advocacy and Outreach (MAO) | Montgomery | Alabama | United States | 36111 |
| 5 | Unity Wellness Center | Opelika | Alabama | United States | 36801 |
Sponsors and Collaborators
- University of Alabama at Birmingham
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Ellen Eaton, MD, MSPH, University of Alabama at Birmingham (UAB)
Study Documents (Full-Text)
None provided.More Information
Publications
- Ickovics JR, Hamburger ME, Vlahov D, Schoenbaum EE, Schuman P, Boland RJ, Moore J; HIV Epidemiology Research Study Group. Mortality, CD4 cell count decline, and depressive symptoms among HIV-seropositive women: longitudinal analysis from the HIV Epidemiology Research Study. JAMA. 2001 Mar 21;285(11):1466-74.
- Kozak MS, Mugavero MJ, Ye J, Aban I, Lawrence ST, Nevin CR, Raper JL, McCullumsmith C, Schumacher JE, Crane HM, Kitahata MM, Saag MS, Willig JH. Patient reported outcomes in routine care: advancing data capture for HIV cohort research. Clin Infect Dis. 2012 Jan 1;54(1):141-7. doi: 10.1093/cid/cir727. Epub 2011 Oct 31.
- Mehrotra A, Huskamp HA, Souza J, Uscher-Pines L, Rose S, Landon BE, Jena AB, Busch AB. Rapid Growth In Mental Health Telemedicine Use Among Rural Medicare Beneficiaries, Wide Variation Across States. Health Aff (Millwood). 2017 May 1;36(5):909-917. doi: 10.1377/hlthaff.2016.1461.
- Powell BJ, McMillen JC, Proctor EK, Carpenter CR, Griffey RT, Bunger AC, Glass JE, York JL. A compilation of strategies for implementing clinical innovations in health and mental health. Med Care Res Rev. 2012 Apr;69(2):123-57. doi: 10.1177/1077558711430690. Epub 2011 Dec 26. Review.
- Sohail M, Rastegar J, Long D, Rana A, Levitan EB, Reed-Pickens H, Batey DS, Ross-Davis K, Gaddis K, Tarrant A, Parmar J, Raper JL, Mugavero MJ. Data for Care (D4C) Alabama: Clinic-Wide Risk Stratification With Enhanced Personal Contacts for Retention in HIV Care via the Alabama Quality Management Group. J Acquir Immune Defic Syndr. 2019 Dec;82 Suppl 3:S192-S198. doi: 10.1097/QAI.0000000000002205.
- Springer SA, Dushaj A, Azar MM. The impact of DSM-IV mental disorders on adherence to combination antiretroviral therapy among adult persons living with HIV/AIDS: a systematic review. AIDS Behav. 2012 Nov;16(8):2119-43. doi: 10.1007/s10461-012-0212-3. Review.
- IRB-300005613
- 1R01MH124633-01