Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411223
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-07
Brief Title:
Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Project Tara Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs
Status:
RECRUITING
Status Verified Date:
2024-08
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 addresses real-world use of long-acting injectable cabotegravirrilpivirine CABRPV LA by evaluating implementation and clinical outcomes of a pharmacist-led collaborative drug therapy management model CDTM that will be expanded for telehealth outreach to women with health-related social needs HRSN
Detailed Description:
The purpose of this study is to evaluate the implementation and delivery of CABRPV LA to women with HRSN by adopting a pharmacist-led CDTM The project primarily addresses the real-world use of CAB RPV LA among women who are under-represented in clinical trials and assesses the feasibility and acceptability of CDTM and adoption of CABRPV LA among participants receiving the CDTM model
Investigators will enhance the existing CDTM to reduce important social and structural barriers to CABRPV LA for women with HRSN by increasing accessibility- using telehealth to deliver CDTM outreach to clinical and community sites without a clinician referral CDTM which is highly scalable In addition to assessing engagement with the CDTM intervention and impact on key implementation reach feasibility acceptability uptake and clinical outcomes CABRPV LA initiation investigators will also assess impact on patient engagement in non-HIV related care and psychological sexual and social well-being
Investigators will enhance the existing CDTM to reduce important social and structural barriers to CABRPV LA for women with HRSN by increasing accessibility- using telehealth to deliver CDTM outreach to clinical and community sites without a clinician referral CDTM which is highly scalable In addition to assessing engagement with the CDTM intervention and impact on key implementation reach feasibility acceptability uptake and clinical outcomes CABRPV LA initiation investigators will also assess impact on patient engagement in non-HIV related care and psychological sexual and social well-being
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None