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Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP

Study acronym: DOT-Doxy-PEP
StatusRecruiting
PhaseEarly Phase 1
Started2024-10-18
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 24 months later Sep 1, 2026 → Sep 1, 2028
See other at-risk trials from University of California, San Francisco

Amendment history

2026-09-02
Study Status v5
Primary completion pushed: 2026-09-01 → 2028-09-01
Completion pushed: 2028-09-01 → 2028-12-01
2026-04-08
Study Status v4
Re-verified, no change to tracked fields
2025-03-06
Study Status, Eligibility v3
Eligibility criteria+457 characters
[...] with blood testosterone levels demonstrating consistent use able to provide a hair sample of ~50-100 strands of hair that are non-gray, not bleached, and at least 1cm in length willing to NOT shave hair or have a very short haircut or apply bleach for the duration of the study has suitable venous access for consecutive blood draws Exclusion Criteria: any health condition that may interfere [...] o doxycycline. detectable doxycycline in hair at enrollment. unable to provide a hair sample of ~50-100 strands of hair that are non-gray, not bleached, and at least 1cm in length does not have suitable veno [...]
2024-11-05
Study Status, Eligibility v2
Eligibility criteria+135 characters
Inclusion Criteria: not currently at risk of a sexually transmitted infection (noand willing to use other methods, such as condoms, for STI inprevention; if the last 2 years and no partnerdiagnosed with an STI in the lastpast two years and/or a partner was diagnosed with an STI in the past year), is willing to use condoms for STI prevention; willing to provide hair, blood, and urine samples; not cur [...] olled in other STI prevention studies; able to speak English or Spanish; and transgender women participants should be currently using es [...]
2024-10-18
Not Yet Recruiting→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-09-01→confirmed 2024-10-18
Study sitesdetails revised at 1 of 1 site
Collaborators+61 characters
National Institute of Allergy and Infectious Diseases (NIAID)
2024-05-13
Original filing
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
Trial Details
NCT Number NCT06414408
Lead Sponsor University of California, San Francisco
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Sexually Transmitted Diseases, Bacterial
Enrollment 48 participants
Start Date 2024-10-18
Primary Completion 2028-09-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-04