Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565013
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Chemsex Health Evaluation With Extended Release System for HIV Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Increased Patient Engagement Associated With Cabotegravir CAB Rilpivirine RPV Long-acting LA Administered Every Two Months on Virologically Suppressed People Living With HIV Who Are Practicing Chemsex
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHEERS
Brief Summary:
CHEERS is an observational cohort for people living with HIV who are actively practicing chemsex and who are switching to CAB RPV LA after being virologically suppressed on a stable oral ART regimen This study aim to assess the impact of increased patient engagement associated with this LA regimen on linkage to psychosocial care and on global health outcomes such as quality of life substance use treatment satisfaction and virological control
Eligible participants will need to be currently out of care for psychosocial counselling and will need to express the wish to switch to CAB RPV LA The participants will be followed in this study for 11 months from their first LA administration according to the schedule of injections In addition to standard of care procedures such as blood draw and physical exam patient reported outcome questionnaires will be administered at certain visits and a semi-directed interview will be conducted at the beginning and at the end of the study CAB RPV LA will be used in line with the Canadian monography
Eligible participants will need to be currently out of care for psychosocial counselling and will need to express the wish to switch to CAB RPV LA The participants will be followed in this study for 11 months from their first LA administration according to the schedule of injections In addition to standard of care procedures such as blood draw and physical exam patient reported outcome questionnaires will be administered at certain visits and a semi-directed interview will be conducted at the beginning and at the end of the study CAB RPV LA will be used in line with the Canadian monography
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None