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| ID | Type | Description | Link |
|---|---|---|---|
| 4R33DA060625-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.
This study will be done in two phases. Aim 1, the R61 portion of the project will be a Pilot Study, and Aim 2, the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot.
The focus of this registration is Aim 2, the randomized controlled trial. The Aim 1 (R61) portion is registered with NCT06439329. In Aim 2 (R33), investigators will evaluate standard PN compared to PN+PC on participant outcomes, implementation outcomes and costs associated with implementing the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Patient Navigation (PN) | Active Comparator | PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked to PrEP/ART and SUD services. This manualized PN approach provides a complete assessment of participant needs, goal setting, and help with appointment scheduling. |
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| PN + Patient Choice (PC) (PN+PC) | Experimental | PNs working in the PN + PC arm will be trained to engage participants in selecting from a menu of service options in their community. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our Community Advisory Boards (CAB). PNs will also be trained to discuss sexual and substance use history with participants in order to provide education and motivation towards starting PrEP/ART and SUD treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard PN | Behavioral | Standard of care |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who initiate or re-initiate PrEP | Percentage of participants not living with HIV who initiate or re-initiate PrEP within the 6-month intervention period by self report | 6 months |
| Percentage of participants who initiate or re-initiate ART | Percentage of participants living with HIV who initiate or re-initiate ART within the 6-month intervention period by self report | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants that adhere to PrEP | Percentage of participants that adhere to PrEP | 6 and 12 months |
| Percentage of participants retaining on PrEP | Percentage of participants retaining on PrEP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra Springer, MD | Contact | 203-687-6680 | Sandra.springer@yale.edu | |
| Alysse Schultheis, MA | Contact | 203-231-2454 | alysse.schultheis@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sandra Springer, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | Recruiting | New Haven | Connecticut | 06510 | United States |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020403 | Patient Freedom of Choice Laws |
| ID | Term |
|---|---|
| D008329 | Managed Care Programs |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
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| Patient Choice | Behavioral | Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services. |
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| 6 and 12 months |
| HIV incidence | HIV incidence [binary] for those testing negative using rapid point of care (POC) test over time | 6 and 12 months |
| Percentage of participants that adhere to ART | Percentage of participants that adhere to ART | 6 and 12 months |
| ART retention | For persons living with HIV (PLH), ART retention [binary] | 6 and 12 months |
| Substance use treatment | Percentage of participants engaged in substance use disorder (SUD) treatment | 6 and 12 months |
| HIV viral suppression | For PLH, HIV viral suppression, for those with HIV at time of randomization: the percent who maintain or achieve HIV viral load < 200 copies/mL at 6 months | 6 months |
| Retention in HIV PrEP/ART | Retention in HIV PrEP/ART care [binary]: defined as attending 2 or more visits in 6-months | 6 months |
| Number of Participants Who Had Any Needle Sharing Activity to Assess HIV Risk Behavior | Number of Participants Who Had Any Needle Sharing Activity | 6 and 12 months |
| Number of Participants Who Had Sex Without a Condom to assess HIV Risk Behavior | Number of Participants Who Had Vaginal or Anal Sex Without a Condom | 6 and 12 months |
| Days of using opioids | Measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use | 6 and 12 months |
| Number of participants with with overdose events | Number of participants with non-fatal and fatal overdose events | 6 and 12 months |
| Percentage of participants with retention in SUD treatment | Retention in SUD treatment including but not exclusive to Medication for Opioid Use Disorder (MOUD) for Opioid Use Disorder (OUD) | 6 and 12 months |
| Quality of Life assessed using PROMIS-PROPr | PROMIS-PROPr assesses general societal health. Total summary score ranges from -0.022, worse than dead, to 1, perfect health. | 6 and 12 months |
| Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9) | Depression will be assessed using the PHQ-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety. | 6 and 12 months |
| Recidivism: Reasons | Number of participants per reason for arrest/ incarceration/return-to-custody | 6 and 12 months |
| Recidivism: Mean days in custody/incarcerated | Mean days in custody/incarcerated | 6 and 12 months |
| Recidivism: Mean days to return | Mean days to return to custody/incarcerated | 6 and 12 months |
| HIV and SU Stigma assessed using Substance Use Stigma Mechanisms Scale (SU-SMS) | Mean score for Enacted (6 items), Anticipated (6 items), and Internalized (6 items) scales. Each scale is scored 1-5, with higher scores indicating greater endorsement of substance use stigma | 6 and 12 months |
| Percentage of participants diagnosed with SUD | Percentage of participants diagnosed with SUD using DSM-5 | Baseline and 12 months |
| College of Medicine at the University of Kentucky | Recruiting | Lexington | Kentucky | 40506 | United States |
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| University of Texas Southwestern Medical Center (UTSW) | Recruiting | Dallas | Texas | 75390 | United States |
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| Texas Christian University's (TCU) School of Medicine | Recruiting | Fort Worth | Texas | 76109 | United States |
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| D004467 |
| Economics |
| D004472 | Health Care Economics and Organizations |
| D007878 | Legislation as Topic |
| D012926 | Social Control, Formal |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |