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Doxycycline post-exposure prophylaxis: Weekly versus event-driven Intake for STI prevention among MSM and TGW taking PrEP (Doxy-WISE study)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524823-34-00
Enrollment
556
Registered
2026-03-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexually Transmitted Infections

Brief summary

Incidence rate ratio of NG, CT, and TP infections in the W-DoxyPEP vs ED-DoxyPEP arms

Detailed description

Rate ratio of tetracyclines, macrolides, cephalosporins, and penicillins in the W-DoxyPEP vs ED-DoxyPEP arms, MIC distribution (doxycycline/cefixime/ciprofloxacin) of commensal Neisseria spp., oral streptococci and E. coli in the W-DoxyPEP vs ED-DoxyPEP arms, Incidence rate ratio of symptomatic NG infections in the W-DoxyPEP vs ED-DoxyPEP arms, Incidence rate ratio of symptomatic CT infections in the W-DoxyPEP vs ED-DoxyPEP arms, Incidence rate ratio of symptomatic TP infections in the W-DoxyPEP vs ED-DoxyPEP arms, Incidence rate ratio of all NG infections in the W-DoxyPEP vs ED-DoxyPEP arms, Incidence rate ratio of all CT infections in the W-DoxyPEP vs ED-DoxyPEP arms, Incidence rate ratio of all TP infections in the W-DoxyPEP vs ED-DoxyPEP arms, Tetracycline MIC distribution of NG isolates in the W-DoxyPEP vs ED-DoxyPEP arms, participants' perception/experience, preference, and acceptability in using doxyPEP, Cost of integrating W-DoxyPEP vs ED-DoxyPEP in routine HIV-PrEP follow-up, if the strategy is proved to be effective, incremental cost per STI avoided/Quality of life Adjusted Life Years (QALY) gained

Interventions

DRUGDoxycycline Sandoz 100 mg tabletten

Sponsors

Institute Of Tropical Medicine
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence rate ratio of NG, CT, and TP infections in the W-DoxyPEP vs ED-DoxyPEP arms

Secondary

MeasureTime frame
Rate ratio of tetracyclines, macrolides, cephalosporins, and penicillins in the W-DoxyPEP vs ED-DoxyPEP arms, MIC distribution (doxycycline/cefixime/ciprofloxacin) of commensal Neisseria spp., oral streptococci and E. coli in the W-DoxyPEP vs ED-DoxyPEP arms, Incidence rate ratio of symptomatic NG infections in the W-DoxyPEP vs ED-DoxyPEP arms, Incidence rate ratio of symptomatic CT infections in the W-DoxyPEP vs ED-DoxyPEP arms, Incidence rate ratio of symptomatic TP infections in the W-DoxyPEP vs ED-DoxyPEP arms, Incidence rate ratio of all NG infections in the W-DoxyPEP vs ED-DoxyPEP arms, Incidence rate ratio of all CT infections in the W-DoxyPEP vs ED-DoxyPEP arms, Incidence rate ratio of all TP infections in the W-DoxyPEP vs ED-DoxyPEP arms, Tetracycline MIC distribution of NG isolates in the W-DoxyPEP vs ED-DoxyPEP arms, participants' perception/experience, preference, and acceptability in using doxyPEP, Cost of integrating W-DoxyPEP vs ED-DoxyPEP in routine HIV-PrEP follow-up,

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 7, 2026