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WHO-Recommended Periodic Presumptive Treatment versus Doxycycline Post-Exposure Prophylaxis for STI Control among Cisgender Men Who Have Sex with Men in Kenya

Phase 4
Conditions
bacterial sexually transmitted infections including gonorrhea, chlamydia, and syphilis
Registration Number
PACTR202407778358273
Lead Sponsor
ational Institute of Allergy and Infectious Diseases
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Male
Target Recruitment
2900
Inclusion Criteria

• 18-29 years old
• Assigned male sex at birth
• Identifies as male (cis-gender)
• Reports condomless anal intercourse with a man in the past 6 months
• Reports multiple male sex partners OR a male sex partner with a syndromic (urethritis, proctitis, or genital ulcer disease) or laboratory-diagnosed sexually transmitted infection in the past 6 months
• Willing and able to provide written informed consent and participate in all study procedures
• Planning to remain in the study area for 18 months

Exclusion Criteria

• Unable to understand the study purpose and procedures
• Allergy to cephalosporin (cefixime), macrolide (erythromycin or azithromycin), or tetracycline (doxycycline) class antibiotics
• Recent use of prolonged antibiotics (=14-day course in the month before enrolment)
• Use of medications that impact cefixime, azithromycin, or doxycycline metabolism (check versus list in screening SOP)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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