Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414408
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-09
Brief Title:
Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP
Status:
RECRUITING
Status Verified Date:
2024-10
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:
DOT-Doxy-PEP
Brief Summary:
Rates of bacterial sexually transmitted infections STIs are rising globally demanding innovative interventions beyond the scope of current efforts to prevent STIs The United States Doxycycline Post-exposure Prophylaxis DoxyPEP Study has demonstrated the efficacy of doxycycline post-exposure prophylaxis PEP among men who have sex with men and transgender women but puzzlingly doxycycline PEP was found ineffective in cisgender women in the Kenyan doxycycline Post-Exposure Prophylaxis dPEP study with preliminary data suggesting the low medication adherence may explain the null result By study end the investigators will have developed adherence measurement methods for doxycycline in hair blood and urine and will use these techniques to help interpret the Kenyan dPEP study and to examine the relative performance of these methods within the United States DoxyPEP trial establishing adherence metrics for current and future rollout studies of doxycycline post-exposure prophylaxis
Detailed Description:
None
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