RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2024-10-18
Study Completion:2028-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06414408

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * not currently at risk of a sexually transmitted infection and willing to use other methods, such as condoms, for STI prevention;
  2. * 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;
  3. * willing to provide hair, blood, and urine samples;
  4. * not currently enrolled in other STI prevention studies;
  5. * able to speak English
  6. * transgender women participants should be currently using estrogen gender affirming hormone therapy with blood estrogen levels demonstrating consistent use
  7. * transgender men participants should be currently using testosterone gender affirming hormone therapy with blood testosterone levels demonstrating consistent use
  1. * any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions;
  2. * pregnancy or plans to become pregnant;
  3. * liver cirrhosis or fulminant liver disease;
  4. * known hypersensitivity reaction to doxycycline.
  5. * detectable doxycycline in hair at enrollment.

Contacts and Locations

Study Contact

Shivani Mahuvakar
CONTACT
415-878-6384
DOTDoxyPEP@ucsf.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Francisco

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-18
Study Completion Date2028-09-01

Study Record Updates

Study Start Date2024-10-18
Study Completion Date2028-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Sexually Transmitted Diseases, Bacterial