Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582966
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Weekly Doxycycline DOT for STI Prevention Among Cisgender Women Taking HIV PrEP in Kisumu Kenya
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Weekly Doxycycline DOT for STI Prevention Among Cisgender Women Taking HIV PrEP in Kisumu Kenya
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The first study of doxycycline postexposure prophylaxis for cisgender women did not reduce incident STIs likely due to low use of doxycycline We will conduct a pilot study of once-weekly doxyxycline to prevent bacterial STIs among Kenyan cisgender women using PrEP for HIV prevention
Detailed Description:
A study evaluating doxycycline prophylaxis to prevent sexually transmitted infections STIs in PrEP-taking African women who are a priority population for STI prevention given their high risk and engagement in longitudinal prevention services The primary study objective is to assess the acceptability of once weekly doxycycline prophylaxis and assess persistence in once weekly doxycycline delivered as directly observed therapy DOT STI prophylaxis carries substantial potential benefits but also important potential risks and we have framed our work as capturing key data to inform this question We hypothesize that weekly doxycycline will substantially reduce the incidence of curable STIs particularly C trachomatis the most common bacterial STI and the one responsible for greatest morbidity
Our secondary study objectives are to evaluate the impact on incidence rate of STIs in women given once-weekly doxycycline DOT in comparison with data collected among participants assigned to received standard of care in recently completed dPEP Kenya study as well as to assess tolerability of once weekly doxycycline prophylaxis We will collect samples for future doxycycline hair drug level testing antibiotic resistance testing and microbiome evaluation
Our secondary study objectives are to evaluate the impact on incidence rate of STIs in women given once-weekly doxycycline DOT in comparison with data collected among participants assigned to received standard of care in recently completed dPEP Kenya study as well as to assess tolerability of once weekly doxycycline prophylaxis We will collect samples for future doxycycline hair drug level testing antibiotic resistance testing and microbiome evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None