Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP (NCT06414408) | Clinical Trial Compass
RecruitingEarly Phase 1
Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP
United States48 participantsStarted 2024-10-18
Plain-language summary
Rates of bacterial sexually transmitted infections (STIs) are rising globally, demanding innovative interventions beyond the scope of current efforts to prevent STIs. The United States Doxycycline Post-exposure Prophylaxis (DoxyPEP) Study has demonstrated the efficacy of doxycycline post-exposure prophylaxis (PEP) among men who have sex with men and transgender women; but puzzlingly, doxycycline PEP was found ineffective in cisgender women in the Kenyan doxycycline Post-Exposure Prophylaxis (dPEP) study, with preliminary data suggesting the low medication adherence may explain the null result. By study end, the investigators will have developed adherence measurement methods for doxycycline in hair, blood, and urine, and will use these techniques to help interpret the Kenyan dPEP study, and to examine the relative performance of these methods within the United States DoxyPEP trial, establishing adherence metrics for current and future rollout studies of doxycycline post-exposure prophylaxis
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* not currently at risk of a sexually transmitted infection and willing to use other methods, such as condoms, for STI prevention;
* if diagnosed with an STI in the past two years and/or a partner was diagnosed with an STI in the past year, is willing to use condoms for STI prevention;
* willing to provide hair, blood, and urine samples;
* not currently enrolled in other STI prevention studies;
* able to speak English
* transgender women participants should be currently using estrogen gender affirming hormone therapy with blood estrogen levels demonstrating consistent use
* transgender men participants should be currently using testosterone gender affirming hormone therapy with blood testosterone levels demonstrating consistent use
* able to provide a hair sample of \~50-100 strands of hair that are non-gray, not bleached, and at least 1cm in length
* willing to NOT shave hair or have a very short haircut or apply bleach for the duration of the study
* has suitable venous access for consecutive blood draws
Exclusion Criteria:
* any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions;
* pregnancy or plans to become pregnant;
* liver cirrhosis or fulminant liver disease;
* known hypersensitivity reaction to doxycycline.
* detectable doxycycline in hair at enrollment.
* unable to provide a hair sample of \~50-100 strands of hair that are non-gray, not b…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.