Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468462
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-01
Brief Title:
Periodic Presumptive Treatment vs doxyPEP for STI Control in Kenyan MSM
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
WHO-recommended Periodic Presumptive Treatment Versus Doxycycline Post-Exposure Prophylaxis for STI Control Among Cisgender Men Who Have Sex With Men in Kenya
Status:
NOT_YET_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:
None
Brief Summary:
Men who have sex with men MSM are at high risk for gonorrhea and chlamydia in Kenya where nucleic acid amplification testing is not feasible and most infections therefore go undiagnosed We propose an open-label randomized clinical trial with 2900 participants assigned to WHO-recommended periodic presumptive treatment PPT or doxycycline post-exposure prophylaxis doxyPEP compared to standard syndromic treatment with 18 months of follow-up and rigorous culture-based and molecular analysis of antimicrobial resistance in Neisseria gonorrhoeae This work will provide critical data needed to inform guidelines and improve STI control among MSM in sub-Saharan Africa and other resource-limited settings including modelled estimates of the health and economic impact of scaling up these two interventions on STI control among MSM and their partners in Kenya
Detailed Description:
Men who have sex with men MSM are at high risk for gonorrhoea and chlamydia in Kenya where nucleic acid amplification testing NAAT is not feasible and most infections therefore go undiagnosed In 2011 the WHO recommended periodic presumptive treatment PPT of Neisseria gonorrhoeae NG and Chlamydia trachomatis CT infections for MSM at high risk for HIV acquisition due to condomless anal intercourse with multiple sex partners or a recent STI exposure More recently trials in well-resourced settings have demonstrated the efficacy of doxycycline post-exposure prophylaxis doxyPEP for reducing NG CT and syphilis infections among high-risk MSM The goal of this study is to evaluate the impact and cost-effectiveness of WHO-recommended PPT versus doxyPEP compared to standard syndromic treatment among Kenyan MSM This study aims to 1 evaluate the effectiveness and impact on antimicrobial resistance in NG of WHO-recommended PPT given every 3 months and of doxy-PEP taken 24-72 hours after condomless sex for reducing STI burden among Kenyan MSM 2 assess the acceptability feasibility and safety of implementing WHO-recommended PPT and doxy-PEP compared to standard care among providers and patients and 3 model the health and economic impact of scaling up WHO-recommended STI PPT and doxyPEP compared to standard of care on STI control among MSM and their partners in Kenya We will conduct an open-label randomized trial with 2900 participants to evaluate these two interventions versus standard care assigned in a 221 ratio with 18 months of follow-up at three MSM-friendly research clinics in Kenya Results will inform parameters to update a stochastic model of STI transmission and cost-effectiveness analysis to project the impact of scaled-up STI PPT and doxyPEP in Kenya This work will provide the critical data needed to inform guidelines and improve STI control among this key population in sub-Saharan Africa and other resource-limited settings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AI179838-01 | NIH | None | None |