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

NCT ID: NCT06414408

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-18
• Study Completion Date: 2028-09-01

Brief 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

Conditions

Sexually Transmitted Diseases, Bacterial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Daily Dosing

Participants will be randomized to take once daily doxycycline 200mg for six weeks.

Group Type: ACTIVE_COMPARATOR

Doxycycline Pill

Intervention Type: DRUG

200mg Dose

Three-times Weekly Dosing

Participants will be randomized to take one doxycycline 200mg dose three times a week (Monday, Wednesday, and Friday) for six weeks.

Group Type: ACTIVE_COMPARATOR

Doxycycline Pill

Intervention Type: DRUG

200mg Dose

Weekly Dosing

Participants will be randomized to take one doxycycline 200mg dose once week.

Group Type: ACTIVE_COMPARATOR

Doxycycline Pill

Intervention Type: DRUG

200mg Dose

Every Other Week Dosing

Participants will be randomized to take one doxycycline 200mg dose every other week.

Group Type: ACTIVE_COMPARATOR

Doxycycline Pill

Intervention Type: DRUG

200mg Dose

Interventions

Doxycycline Pill

200mg Dose

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Spinelli, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco/San Francisco General Hospital

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shivani Mahuvakar

Role: CONTACT

DOTDoxyPEP@ucsf.edu

415-878-6384

Facility Contacts

Matthew A Spinelli, MD, MAS

Role: primary

matthew.spinelli@ucsf.edu

Other Identifiers

R01AI186641

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AI186641

Identifier Type: -

Identifier Source: org_study_id