Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH124633-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not considered a clinical trial
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| +STEP Implementation | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| +STEP Implementation | Other | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ellen Eaton, MD, MSPH | University of Alabama at Birmingham (UAB) | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22042879 | Background | 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. | |
| 28461359 | Background | 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. |
Not provided
Not provided
The proposed project will comply with the NIH Data Sharing Policy, thus all data collected will be made available to outside investigators. To maintain HIPAA compliance, we will provide a limited-use dataset (i.e., stripped of identifying information). When possible, collaborative use of the data will be encouraged in order to enhance the quality of secondary analyses. Data will be made available as either a SPSS or Excel dataset, or as a tab-delimited ASCII file. Methods will be described through published papers, and relevant software and/or procedures documents.
All data collected for this protocol will be made available to outside investigators in a timely fashion (defined by the NIH as no later than the acceptance of the primary outcome paper for publication)
Requests for data will be handled on a case-by-case basis in consultation with the Co-Investigators and members of the team.
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| 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 |
| 11255423 | Background | 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. doi: 10.1001/jama.285.11.1466. |
| 22644066 | Background | 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. |
| 31764254 | Background | 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. |
| 22203646 | Background | 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. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |