Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637436
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
PrEP Readiness Interventions for Sustained Motivation PRISM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing HIV Prevention for Highly Vulnerable Methamphetamine-using Sexual Minority Men
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
PRISM
Brief Summary:
This is a hybrid type I factorial randomized controlled trial to test the comparative and combined effectiveness of contingency management CM motivational interviewing MI and MICM for optimizing entry or re-entry into the PrEP care continuum A total of 840 participants will be randomized to CM n 280 MI n 280 or MICM n 280 all delivered via Telehealth Monthly follow-up assessments will be completed over 12 months to examine differential effectiveness for the primary outcome - filling a PrEP prescription verified using a digital photo or detectable tenofovir diphosphate Secondary outcomes will include self-reported PrEP clinical evaluation by a PrEP provider self-reported meth and other substance use severity ASSIST and self-reported receptive and insertive condomless anal sex CAS
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