Clinical trial NCT05415891: The IMPROV Project: Improving Mental Health and Substance Use Treatment Provision (IMPROV) Among People Living With HIV (Human Immunodeficiency Virus) in Atlanta
Official title: Improving the Integration of Mental Health and Substance Use Treatment Into Ryan White-Funded Care Sites in Atlanta Using an Implementation Science Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Disorder
Substance Use Disorder
Stigmatization
Implementation Science
Keywords: Mental Health Disorder
Substance use Disorder
Human Immunodeficiency Virus
Comorbidity
Treatment
Implementation Science
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: SisterLove, Inc.
name: Positive Impact Health Centers
name: National Institute of Mental Health (NIMH)
First posted: 2022-06-13
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinic Staff-Level Outcome: Acceptability of Stigma Reduction Training
timeFrame: Immediately post-training
measure: Provider-Level Outcome: Acceptability of the YouRx Decision Prescribing Platform
timeFrame: 3 months follow-up
measure: Provider-Level Outcome: Feasibility of the YouRx Decision Prescribing Platform
timeFrame: 3 months follow-up
measure: Provider-Level Outcome: Adoption of the YouRx Decision Prescribing Platform
timeFrame: Weekly (12 weeks)
measure: Provider-Level Outcome: Usability of the YouRx Decision Prescribing Platform
timeFrame: 3 months follow-up
measure: Clinic Staff-Level Outcome: Observed Stigma Reduction
timeFrame: 3 months follow-up
measure: Health Consumer-Level Outcome: Observed Stigma Reduction
timeFrame: 3 months follow-up
measure: Provider-Level Outcome: Provider Self-Efficacy
timeFrame: 3 months follow-up
measure: Clinic-Level Outcome: Adoption of Psychiatric Medication and Naltrexone
timeFrame: 3 months follow-up
measure: Clinic-Level Outcome: Reach of Prescription of Psychiatric Medication and Naltrexone
timeFrame: 3 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Positive Impact Health Center--Decatur Location
state: Georgia
city: Duluth
country: United States
facility: Positive Impact Health Center--Duluth Location
state: Georgia
Study officials:
affiliation: RTI International
name: Courtney Peasant Bonner, PhD
role: PRINCIPAL_INVESTIGATOR
References: