Mental Health DisorderIMPROVNCT05415891
The IMPROV Project: Improving Mental Health and Substance Use Treatment Provision (IMPROV) Among People Living With HIV (Human Immunodeficiency Virus) in Atlanta
A study testing Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum and You℞ Decision prescribing platform in people with Mental Health Disorder and Substance Use Disorder, run by RTI International at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Disorder, Substance Use Disorder, Stigmatization
- What is being tested?
- Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum and You℞ Decision prescribing platform
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- Stigma Reduction Training
- Have been part of the formative activities
- Clinic Staff Survey
- Have been part of the formative activities.
- Patient Survey
- HIV negative
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Wendee M Wechsberg, PhD contact
United States2 sites
Positive Impact Health Center--Decatur Location
Decatur, Georgia, 30030
Positive Impact Health Center--Duluth Location
Duluth, Georgia, 30096
About this study
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
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).
Read the 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.
- Being tested
- Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum, You℞ Decision prescribing platform
- Keywords
- Mental Health Disorder, Substance use Disorder, Human Immunodeficiency Virus, Comorbidity, Treatment, Implementation Science
- Medical subject headings
- Mental Disorders, Substance-Related Disorders, Stereotyping, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training CurriculumBehavioural
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.
You℞ Decision prescribing platformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: You℞ Decision prescribing platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 months follow-up
Provider-Level Outcome: Adoption of the YouRx Decision Prescribing Platform
Provider use of the You℞ Decision prescribing platform
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 333 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- SisterLove, Inc., Positive Impact Health Centers, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Courtney Peasant Bonner, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415891
- Sponsor's protocol ID
- Pro00063322
- Other IDs
- R34MH124628
- Acronym
- IMPROV
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05415891
- Acronym / sponsor ID
- IMPROV / Pro00063322
- Keywords
- Mental Health Disorder, Substance use Disorder, Human Immunodeficiency Virus, Comorbidity, Treatment, Implementation Science
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 333 participants (estimated)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- SisterLove, Inc., Positive Impact Health Centers, National Institute of Mental Health (NIMH)
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Stigma-Reduction Training Arm + YouRx Prescribing Platform | Experimental | Behavioral: Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum, Device: You℞ Decision prescribing platformStaff 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. |
| YouRx Prescribing Platform Only | Experimental | Device: You℞ Decision prescribing platformStaff 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (12 listed)
- Stigma Reduction Training
- Have been part of the formative activities
- Clinic Staff Survey
- Have been part of the formative activities.
- Patient Survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training CurriculumThe 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. | Behavioural | Stigma-Reduction Training Arm + YouRx Prescribing Platform |
| You℞ Decision prescribing platformThe 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. | Device | Stigma-Reduction Training Arm + YouRx Prescribing Platform, YouRx Prescribing Platform Only |
Primary outcome
Clinic Staff-Level Outcome: Acceptability of Stigma Reduction Training
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Weekly (12 weeks)
Provider use of the You℞ Decision prescribing platform
Provider-Level Outcome: Usability of the YouRx Decision Prescribing Platform
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendee M Wechsberg, PhD contact
Courtney Peasant Bonner, PhD principal investigator
RTI International
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum and You℞ Decision prescribing platform in people with Mental Health Disorder and Substance Use Disorder, run by RTI International at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Courtney Peasant Bonner, PhD (7709865052, cpbonner@rti.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinic Staff-Level Outcome: Acceptability of Stigma Reduction Training (time frame: Immediately post-training). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.