Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631365
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
PrEPsmart 2-1-1 Pilot
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PrEPsmart Pilot a Trial to Evaluate a Mobile App to Support the Safe and Effective Use of On-demand Pre-exposure Prophylaxis PrEP Among Sexual Minority Men in the US
Status:
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:
None
Brief Summary:
This is a pilot study to assess the feasibility acceptability and preliminary effectiveness of pre-exposure prophylaxis PrEPsmart among cisgender sexual minority males SMM taking on-demand PrEP over a 6-month period
Upon project completion the investigators will have developed a highly innovative tool to support men who have sex with men MSM using on-demand PrEP ready for testing in a larger efficacy trial
Upon project completion the investigators will have developed a highly innovative tool to support men who have sex with men MSM using on-demand PrEP ready for testing in a larger efficacy trial
Detailed Description:
This study is designed to enroll a diverse population of English-speaking cisgender sexual minority males SMM in the United States The study team will enroll up to 60 participants who are taking or are interested in taking on-demand pre-exposure prophylaxis PrEP Participants will be randomized 21 to receive intervention arm or not receive control arm the PrEPsmart app at enrollment Participants will complete follow-up visits at 3 and 6 months
Participants newly starting 2-1-1 PrEP will be seen at the Bridge HIV clinic prescribed group while those already on PrEP may be seen at the clinic or complete visits virtually non-prescribed group Although no restrictions are put on the racialethnic make-up of the study participants the site will strive to enroll at least 50 African American or Latino SMM into this study The study will also strive to enroll at least 30 of participants who are newly starting or restarting 2-1-1 PrEP Upon project completion the study team will have developed a highly innovative tool to support men who have sex with men MSM using on-demand PrEP ready for testing in a larger efficacy trial
Participants newly starting 2-1-1 PrEP will be seen at the Bridge HIV clinic prescribed group while those already on PrEP may be seen at the clinic or complete visits virtually non-prescribed group Although no restrictions are put on the racialethnic make-up of the study participants the site will strive to enroll at least 50 African American or Latino SMM into this study The study will also strive to enroll at least 30 of participants who are newly starting or restarting 2-1-1 PrEP Upon project completion the study team will have developed a highly innovative tool to support men who have sex with men MSM using on-demand PrEP ready for testing in a larger efficacy trial
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