Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM

Launched by UNIVERSITY OF WASHINGTON · Jun 15, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how effective two different treatments are for preventing sexually transmitted infections (STIs) like gonorrhea and chlamydia in men who have sex with men (MSM) in Kenya. Researchers want to find out if giving participants a treatment called periodic presumptive treatment (PPT) or doxycycline post-exposure prophylaxis (doxyPEP) can help reduce the risk of these infections compared to the usual care. The study will involve about 2,900 participants, who will be followed for 18 months to gather important information that could improve STI prevention strategies in similar communities.

To be eligible for this trial, participants need to be between 18 and 29 years old, identify as male, and have had condomless anal intercourse with men in the past six months. They should also either have multiple male partners or have had a partner with a diagnosed STI recently. Participants will be asked to provide consent and stay in the study area for the entire duration. Those who have certain allergies to antibiotics or have recently taken antibiotics for an extended time may not be able to join. If you decide to participate, you can expect regular check-ups and tests to monitor your health and the effectiveness of the treatments. This trial aims to provide valuable insights that could benefit many men in Kenya and similar settings.

Gender

MALE

Eligibility criteria

• 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)