Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439329
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-28
Brief Title:
STOP Shared Decision Making to Treat Or Prevent HIV in Justice Populations
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
STOP Shared Decision Making to Treat Or Prevent HIV in Justice Populations
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEPART and substance usesubstance use disorder SUSUD 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
Detailed Description:
This study will be done in two phases Phase 1 the R61 portion of the project will be a Pilot Study and Phase 2 the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot
The focus of this registration is the pilot study In Year 1 R61 Aim 1 the intervention of the patient choice menu of options of PrEPART and SUD treatment services for justice involved people who use drugs PWUD to supplement established peer navigation PN PC will be developed and pilot tested in Western Connecticut only Fairfield Litchfield Southern New Haven Counties
Implementation procedures for this study include needs assessment survey and focus groups consisting of CAB members and PNs to assess the types of services available in their community as well as gaps in services and ideas of how services can be improved These needs assessment surveys and focus groups will occur 3 times throughout the study
The focus of this registration is the pilot study In Year 1 R61 Aim 1 the intervention of the patient choice menu of options of PrEPART and SUD treatment services for justice involved people who use drugs PWUD to supplement established peer navigation PN PC will be developed and pilot tested in Western Connecticut only Fairfield Litchfield Southern New Haven Counties
Implementation procedures for this study include needs assessment survey and focus groups consisting of CAB members and PNs to assess the types of services available in their community as well as gaps in services and ideas of how services can be improved These needs assessment surveys and focus groups will occur 3 times throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R61DA060625-01 | NIH | None | httpsreporternihgovquickSearch1R61DA060625-01 |