An observational study in STIs Prevention, sponsored by Kirby Institute. Active, not recruiting at 4 sites in Australia. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by Kirby Institute · Observational
The last decade has seen increasing rates of bacterial STIs in Australia in gay and bisexual men in particular. Although STIs are easy to diagnose and treatment is effective, untreated STIs can cause significant health issues.
Previous research has shown that taking two100mg doxycycline tablets within 24 hours of sex as prophylaxis reduces syphilis and chlamydia significantly. Also a pilot trial conducted in the US suggested that using 100mg doxycycline as prophylaxis reduced the incidence of gonorrhoea, syphilis and chlamydia. Thus the question of whether taking doxycycline daily in high risk population would reduce the rate of STIs arose.
We set up this study as a non-randomized observational cohort trial using a before and after comparison to evaluate if taking 100mg doxycycline daily would help high risk gay and bisexual men to reduce the possibility of acquiring gonorrhoea, syphilis and chlamydia. Our primary objectives are to:assess acceptability of a daily dosing regimen for doxycycline prophylaxis, and measure the efficacy of 100mg daily doxycycline STI prophylaxis against reinfection with gonorrhoea, chlamydia and syphilis. Our secondary objectives are to: describe patterns of doxycycline use and medication adherence to the recommended schedule participants; evaluate change in behavioral among all study participants; evaluate resistance in the gut microbiota and in those colonized by S aureus at baseline and end of study, in a subset of consenting participants.
The study will be conducted in 3 sexual health centres. Eligible participants will undergo standard care in their trimonthly visit recommended by STI testing guideline, and complete informed consent and a baseline survey. They will be given daily dose of 100mg oral doxycycline for 3 months during the visit, and instruction of how to take the medicine. Questionnaires will be sent out to participants in every 3 months electronically and data will be collected and stored directly into the study survey database. Each participant will be follow-up for 12 months.
121 studies on the registry are indexed under Chlamydia Infections; 21 are open to participants now.
This study's enrollment of 100 is below the median of 399 across 29 observational studies indexed under Chlamydia Infections.
Browse Chlamydia Infections studies →Kirby Institute is the lead sponsor of 94 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Men who report male to male sex in the last 3 months and who have had at least two screening for syphilis, chlamydia and gonorrhoea in the last 12 months, and at least once incidence of syphilis in the last two years, are eligible for the study.
Exclusion Criteria:
Participants will be asked to take Doxycycline 100mg/day for 12months duration
Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants
measured using data collected by the ACCESS study
Time frame: 1 year after the last participant complete their last follow-up visit
Patterns of daily doxycycline use and adherence to the medication schedule
measured among participants consenting to the adherence and behavioural online survey
Time frame: 1 year after the last participant complete their last follow-up visit
Evidence of clinically significant antibiotic resistance in in a subset of participants
including those who do contract STIs during the study and those who don't
Time frame: 1 year after the last participant who's recruited from the Melbourne site
Behavioural risk practices among study participants
in participants who consent to behavioral data collection online
Time frame: 1 year after the last participant complete their last follow-up visit
This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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