Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04762134
Status:
RECRUITING
Last Update Posted:
2023-06-28
First Post:
2021-02-12
Brief Title:
Doxycycline Intervention for Bacterial STI ChemoprOphylaxis DISCO
Sponsor:
Jonathan Troy Grennan
Organization:
British Columbia Centre for Disease Control
Study Overview
Official Title:
A Randomized Trial of Doxycycline Chemoprophylaxis for the Prevention of Sexually Transmitted Infections in Gay Bisexual and Other Men Who Have Sex With Men gbMSM
Status:
RECRUITING
Status Verified Date:
2024-08
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:
There is a growing epidemic of the bacterial sexually transmitted infections STIs syphilis chlamydia and gonorrhea worldwide similarly concerning trends have been noted in Canada where increases of over 160 have been seen in bacterial STIs over the last decade In Canada gay bisexual and other men who have sex with men gbMSM - including those living with HIV - are disproportionately impacted by bacterial STIs56These dramatic increases in bacterial STIs the potential development of serious complications including AMR and waning effectiveness of the promotion of conventional STI prevention tools eg condoms signals the need for novel STI prevention strategies and tools to mitigate STI-related complications A rigorous randomized controlled trial will be conducted to compare STI PrEP vs STI PEP and definitively assess the efficacy safety antimicrobial resistance profiles and costs associated with doxycycline-based STI prevention
Detailed Description:
With the rising rates of STIs among gbMSM populations in Canada there is an urgent need for novel interventions to prevent significant sequelae eg neurosyphilis and onward transmission of untreated infections Despite longstanding public health efforts to encourage conventional strategies of STI prevention gbMSM continue to bear the burden of syphilis which poses synergistic effects in the transmission of HIV This study will add to this field through providing the first methodologically rigorous prospective multicentre open-label randomized controlled trial RCT of doxycycline-based STI PrEP daily 100mg doxycycline versus STI PEP 200mg doxycycline after exposure event for the prevention of bacterial STIs among gbMSM over 15 months 60 weeks of follow-up with adequate power to address drug efficacy in the prevention of bacterial STIs Beyond the determination of efficacy our trial will provide insight to the unique challenges of medication adherence through assessing the acceptability tolerability and safety of therapy with doxycycline This study aims to provide health care providers one additional tool to address the burden of STIs in populations with an increased likelihood of infection
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?:
None
Is an FDA AA801 Violation?:
None