The IMPROV Project: Improving Mental Health and Substance Use Treatment Provision (IMPROV) Among People Living With HIV (Human Immunodeficiency Virus) in Atlanta

NCT05415891 | Unknown DMC

• 2 other identifiers: Pro00063322R34MH124628
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 2

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).

Conditions

Mental Health Disorder; Substance Use Disorder; Stigmatization; Implementation Science

Keywords

Mental Health Disorder; Substance use Disorder; Human Immunodeficiency Virus; Comorbidity; Treatment; Implementation Science

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• Provider-Level Outcome: Adoption of the YouRx Decision Prescribing Platform

  Provider use of the You℞ Decision prescribing platform

  Weekly (12 weeks)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Stigma-Reduction Training Arm + YouRx Prescribing Platform

EXPERIMENTAL

Staff working in the clinic in this arm will be offered a whole-site stigma reduction training. Participating HIV care providers will have access to the YouRx Prescribing Platform.

Behavioral: Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum; Device: You℞ Decision prescribing platform

YouRx Prescribing Platform Only

EXPERIMENTAL

Staff working in the clinic in this arm will not be offered a whole-site stigma reduction training. However, staff will be offered this training at the conclusion of the study. Participating HIV care providers will have access to the YouRx Prescribing Platform.

Device: You℞ Decision prescribing platform

Interventions

Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum BEHAVIORAL

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.

Stigma-Reduction Training Arm + YouRx Prescribing Platform

You℞ Decision prescribing platform DEVICE

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.

Stigma-Reduction Training Arm + YouRx Prescribing Platform; YouRx Prescribing Platform Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RTI International: lead
• SisterLove, Inc.: collaborator
• Positive Impact Health Centers: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Positive Impact Health Center--Decatur Location

Decatur, Georgia, 30030, United States

Location

Positive Impact Health Center--Duluth Location

Duluth, Georgia, 30096, United States

Location

MeSH Terms

Conditions

Mental Disorders; Substance-Related Disorders; Stereotyping; Acquired Immunodeficiency Syndrome

Interventions

N-(4'-fluorobutyrophenone)-4-(4-chlorophenyl)pyridinium

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Social Behavior; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Courtney Peasant Bonner, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Peasant Bonner, PhD

CONTACT

7709865052; cpbonner@rti.org

Wendee M Wechsberg, PhD

CONTACT

wmw@rti.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)