Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP

Sexually Transmitted Diseases, Bacterial Clinical Trial

— DOT-Doxy-PEP  

Official title:

Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06414408
• Other study ID #: AI186641
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: September 1, 2024
• Est. completion date: September 1, 2028

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: Kevin Sassaman
• Phone: 415-878-6384
• Email: DOTDoxyPEP[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: September 1, 2028
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• not currently at risk of a sexually transmitted infection (no STI in the last 2 years and no partner with an STI in the last year);
• willing to provide hair, blood, and urine samples;
• not currently enrolled in other STI prevention studies;
• able to speak English or Spanish; and
• 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

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.

Related Conditions & MeSH terms

• Sexually Transmitted Diseases
• Sexually Transmitted Diseases, Bacterial

Intervention

Drug:
• Doxycycline Pill
200mg Dose

Locations

Country	Name	City	State
United States	University of California, San Francisco/San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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