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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI186641 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Dosing | Active Comparator | Participants will be randomized to take once daily doxycycline 200mg for six weeks. |
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| Three-times Weekly Dosing | Active Comparator | Participants will be randomized to take one doxycycline 200mg dose three times a week (Monday, Wednesday, and Friday) for six weeks. |
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| Weekly Dosing | Active Comparator | Participants will be randomized to take one doxycycline 200mg dose once week. |
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| Every Other Week Dosing | Active Comparator | Participants will be randomized to take one doxycycline 200mg dose every other week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline Pill | Drug | 200mg Dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Hair Doxycycline Concentration | Doxycycline concentrations will be measured using liquid chromatography tandem mass spectrometry within hair samples for each of the four dosing patterns within an intensive washout pharmacokinetic phase following initial dosing. | 4 weeks |
| Plasma Doxycycline Concentration | Doxycycline concentrations will be measured using liquid chromatography tandem mass spectrometry within plasma samples for each of the four dosing patterns within an intensive washout pharmacokinetic phase following initial dosing. | 4 weeks |
| Urine Doxycycline Concentration | Doxycycline concentrations will be measured using liquid chromatography tandem mass spectrometry within urine samples for each of the four dosing patterns within an intensive washout pharmacokinetic phase following initial dosing. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shivani Mahuvakar | Contact | 415-878-6384 | DOTDoxyPEP@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Spinelli, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco/San Francisco General Hospital | Recruiting | San Francisco | California | 94110 | United States |
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| ID | Term |
|---|---|
| D015231 | Sexually Transmitted Diseases, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012749 | Sexually Transmitted Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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Participants will be randomized to one of 4 doxycycline dosing patterns (daily, 3x weekly, weekly, every other week) and then will crossover to an alternate pattern once during the study.
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| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |