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

Description

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

Conditions

Sexually Transmitted Diseases, Bacterial

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Study Overview

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Study Details

Study 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

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

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

Condition
Sexually Transmitted Diseases, Bacterial
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco/San Francisco General Hospital, San Francisco, California, United States, 94110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of California, San Francisco,

Matthew Spinelli, MD, MAS, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2028-09-01