Mental Health Disorder Clinical Trial
— IMPROVOfficial title:
Improving the Integration of Mental Health and Substance Use Treatment Into Ryan White-Funded Care Sites in Atlanta Using an Implementation Science Approach
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).
Status | Not yet recruiting |
Enrollment | 333 |
Est. completion date | June 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Positive Impact Health Center--Decatur Location | Decatur | Georgia |
United States | Positive Impact Health Center--Duluth Location | Duluth | Georgia |
Lead Sponsor | Collaborator |
---|---|
RTI International | National Institute of Mental Health (NIMH), Positive Impact Health Centers, SisterLove, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinic Staff-Level Outcome: Acceptability of Stigma Reduction Training | 4-item self-report measure to assess clinic staff's satisfaction with the stigma reduction training | Immediately post-training | |
Primary | Provider-Level Outcome: Acceptability of the YouRx Decision Prescribing Platform | 4-item measure to assess provider satisfaction with the You? Decision platform | 3 months follow-up | |
Primary | Provider-Level Outcome: Feasibility of the YouRx Decision Prescribing Platform | 4-item measure to assess provider perception that the You? Decision platform can be integrated into usual care | 3 months follow-up | |
Primary | Provider-Level Outcome: Adoption of the YouRx Decision Prescribing Platform | Provider use of the You? Decision prescribing platform | Weekly (12 weeks) | |
Primary | Provider-Level Outcome: Usability of the YouRx Decision Prescribing Platform | 21-item survey to assess the ease of use of the You? Decision prescribing platform | 3 months follow-up | |
Primary | Clinic Staff-Level Outcome: Observed Stigma Reduction | Clinic staff observed stigmatizing behaviors toward those with serious mental health and/or substance use disorders | 3 months follow-up | |
Primary | Health Consumer-Level Outcome: Observed Stigma Reduction | Experienced or observed stigma and discrimination from clinic staff based on serious mental health or substance use disorder | 3 months follow-up | |
Primary | Provider-Level Outcome: Provider Self-Efficacy | 11-item survey to assess providers confidence to treat serious mental health disorders and AUD | 3 months follow-up | |
Primary | Clinic-Level Outcome: Adoption of Psychiatric Medication and Naltrexone | 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. | 3 months follow-up | |
Primary | Clinic-Level Outcome: Reach of Prescription of Psychiatric Medication and Naltrexone | 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. |
3 months follow-up |
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