Implementation Science, Mental Health Disorder, Stigmatization, Substance Use Disorder
Conditions
Keywords
Mental Health Disorder, Substance use Disorder, Human Immunodeficiency Virus, Comorbidity, Treatment, Implementation Science
Brief summary
This project consists of a pilot trial to assess the preliminary impact of a stigma-reduction training to reduce clinic-level stigma and the You℞ Decision prescribing platform to increase HIV care providers' self-efficacy related to prescribing psychiatric medication for depression, post-traumatic stress disorder (PTSD), and bipolar disorder as well as naltrexone for alcohol use disorder (AUD).
Detailed description
The study will pilot test a two-level strategy to improve integration of pharmacotherapy for serious mental health and alcohol use disorders among people living with HIV (PLHIV) in Ryan White-funded healthcare centers in Atlanta, Georgia. A small pilot trial will be conducted in the two clinic study sites to assess the acceptability, feasibility, adoption, and preliminary impact of a stigma-reduction training and the You℞ Decision prescribing platform. The researchers will fulfill the purpose of this study through the following aims: Aim 1: To conduct formative activities with PLHIV, HIV care providers, and our Community Collaborative Board (CCB) to adapt a stigma-reduction training to address mental health and substance abuse-related stigma among clinic staff and engage HIV care providers and an expert panel to develop the You℞ Decision prescribing platform to support HIV care providers to offer pharmacotherapy to treat depression, PTSD, bipolar disorder, and AUD (completed). Aim 2: To assess the acceptability of the stigma-reduction training among clinic staff and the feasibility, acceptability, and adoption of the You℞ Decision prescribing platform during clinical encounters among providers in HIV care settings. Aim 3: To use idiographic methods to conduct a pilot trial to assess the preliminary impact of the stigma-reduction training on clinic-level stigma and of the You℞ Decision prescribing platform on HIV care providers' self-efficacy to prescribe psychiatric medications and naltrexone as well as the impact of the stigma-reduction training and platform to increase the percentage of eligible patients who receive and accept prescriptions to treat depression, PTSD, bipolar disorder, and AUD. This implementation science study aims to reduce HIV-associated comorbidities by improving the integration of mental health and AUD treatment into Ryan White-funded care sites. If the findings indicate that the stigma-reduction training and prescribing platform are feasible, this study will be the impetus for the scale up these strategies to additional Ryan White-funded care sites in Georgia.
Interventions
BEHAVIORALModified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum
The Health Policy Project (HPP) training curriculum provides participatory training modules that address three key actionable drivers of HIV-stigma. The HPP curriculum was adapted through participatory workshops with the study's community collaborative board, including representatives from the HIV care and advocacy communities as well as community members. The training is a whole-site training to address stigma as a barrier to accessing substance use and mental health services by persons living with HIV. Consequently, staff at all levels (clinical and nonclinical) will be trained on stigma and discrimination as it relates to persons living with HIV in order to reduce stigma-related barriers to mental health and substance use healthcare in Positive Impact Health Centers and increase retention in healthcare services for persons living with HIV.
DEVICEYou℞ Decision prescribing platform
The You℞ Decision prescribing platform is a mobile application that serves as a reference to quickly inform providers about the medications recommended for serious mental health disorders and naltrexone to treat AUD; the appropriate dosing regimen; and potential contraindications or interactions related to antiretroviral therapy medications or other psychiatric medication. Information for the platform is adapted from the Department of Veteran Affairs' Manual for HIV Care in Primary Care settings.
Sponsors
SisterLove, Inc.
Positive Impact Health Centers
National Institute of Mental Health (NIMH)
RTI International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This study will include two levels of randomization: clinic level and provider level. We will randomize the two clinic study sites into one of two study conditions. One clinic will be randomized to the stigma-reduction training arm, and one clinic will be randomized to the no stigma-reduction training arm (but will receive the training at the end of the study). At the provider level, we will use a multiple baseline design that is fundamental to idiographic approaches. All providers will receive the You℞ Decision prescribing platform. Providers will be randomized to one of four intervention schedules: (a) 1-week baseline + 11-week intervention, (b) 2-week baseline + 10-week intervention, (c) 3-week baseline + 9-week intervention, and (d) 4-week baseline + 8-week intervention. Randomization will be stratified by clinic. Two providers (one from each site) will be randomized to each intervention schedule (for a total of 8 providers).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Stigma Reduction Training * be 18 years of age or older * be a staff member at the clinic study site randomized for the stigma-reduction training Clinic Staff Survey * work at one of the two clinic study sites * be 18 years of age or older Patient Survey * 18 or older * report being HIV positive * have received care from a clinic study site recently Pilot Trial * provide HIV care * be 18 years of age or older * be licensed to provide prescription medication * provide care at one of the two clinic study sites
Exclusion criteria
Stigma Reduction Training * Have been part of the formative activities Clinic Staff Survey * Have been part of the formative activities. Patient Survey * HIV negative * Have not attended a study clinic site recently * Have participated in the formative activities Pilot Trial * Not a prescribing provider * Not a provider at a study clinic site recently * Have been part of the formative activities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinic Staff-Level Outcome: Acceptability of Stigma Reduction Training | Immediately post-training | 4-item self-report measure to assess clinic staff's satisfaction with the stigma reduction training |
| Provider-Level Outcome: Acceptability of the YouRx Decision Prescribing Platform | 3 months follow-up | 4-item measure to assess provider satisfaction with the You℞ Decision platform |
| Provider-Level Outcome: Feasibility of the YouRx Decision Prescribing Platform | 3 months follow-up | 4-item measure to assess provider perception that the You℞ Decision platform can be integrated into usual care |
| Provider-Level Outcome: Adoption of the YouRx Decision Prescribing Platform | Weekly (12 weeks) | Provider use of the You℞ Decision prescribing platform |
| Provider-Level Outcome: Usability of the YouRx Decision Prescribing Platform | 3 months follow-up | 21-item survey to assess the ease of use of the You℞ Decision prescribing platform |
| Clinic Staff-Level Outcome: Observed Stigma Reduction | 3 months follow-up | Clinic staff observed stigmatizing behaviors toward those with serious mental health and/or substance use disorders |
| Health Consumer-Level Outcome: Observed Stigma Reduction | 3 months follow-up | Experienced or observed stigma and discrimination from clinic staff based on serious mental health or substance use disorder |
| Provider-Level Outcome: Provider Self-Efficacy | 3 months follow-up | 11-item survey to assess providers confidence to treat serious mental health disorders and AUD |
| Clinic-Level Outcome: Adoption of Psychiatric Medication and Naltrexone | 3 months follow-up | Percentage of eligible patients who receive a prescription for psychiatric medication or naltrexone or an in-house referral for psychiatric treatment from their HIV care provider. |
| Clinic-Level Outcome: Reach of Prescription of Psychiatric Medication and Naltrexone | 3 months follow-up | Percentage of eligible patients who fulfill a prescription for a psychiatric medication or naltrexone or in-house referrals at the clinic level Percentage of eligible patients who fill a prescription for psychiatric medication or naltrexone or attend an intake appointment with an in-house mental health or substance use provider. |
Countries
United States
Contacts
Primary ContactCourtney Peasant Bonner, PhD
Backup ContactWendee M Wechsberg, PhD
Outcome results
None listed