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Recruiting NCT06414408

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

Early Phase I Interventional Sexually Transmitted Diseases, Bacterial

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Doxycycline Pill.
Who it may be relevant to
Registry conditions: Sexually Transmitted Diseases, Bacterial. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Drug Doxycycline Pill
    200mg Dose

Primary outcome measures

  • Hair Doxycycline Concentration [Time frame: 4 weeks]
  • Plasma Doxycycline Concentration [Time frame: 4 weeks]
  • Urine Doxycycline Concentration [Time frame: 4 weeks]

Eligibility criteria

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 bleached, and at least 1cm in length
  • does not have suitable venous access for consecutive blood draws

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of California, San Francisco/San Francisco General Hospital — San Francisco

Identifiers

NCT: NCT06414408 · AI186641 · R01AI186641

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗