GonorrheaPhase 4NCT06738407
Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections
A Phase 4 study testing Doxycycline hyclate delayed released 200 mg and Doxycycline hyclate delayed released 200 mg weekly in people with Gonorrhea and Chlamydia, run by Westat at 13 sites in United States.
Trial summary
The goal of this open-label, randomized trial is to assess the efficacy of doxycycline prophylaxis in reducing incidences of bacterial sexually transmitted infections (STIs) among adolescent and young adult females while also evaluating acceptability and antimicrobial resistance in order to inform public health policy. Read more about this study
- Who is it for?
- Ages 13 to 29 years, women only
- What is being tested?
- Doxycycline hyclate delayed released 200 mg and Doxycycline hyclate delayed released 200 mg weekly
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 13 sitesUnited States
- Study dates
- 27 Feb 2026to 30 Jun 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 29 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13-29 years, inclusive;
- Self-reports GC, CT, and/or early syphilis diagnosis in the 12 months prior to screening;
- Self-reports condomless (oral, vaginal, and/or anal) intercourse at least once in the 30 days prior to screening
- Is at least 45 kilograms (99.2 pounds) in weight
- Fluent in English (able to read, speak, and understand English);
- Willing to undergo all required study procedures; and
- Willing to provide written informed consent to participate in the study.
Who cannot join
- Is male;
- Is pregnant, breastfeeding, or planning to become pregnant in the next 12 months;
- Documented history of tetracycline allergy or self-reports an allergy to tetracyclines;
- Current or anticipated use of a medication (e.g., barbiturates, phenytoin, lithium, carbamazepine, systemic retinoids, warfarin) with a contraindicated interaction to doxycycline ;
- Current or planned use of doxycycline for a prolonged period (> 2 weeks) in the 30 days prior to enrollment, including current prescription for doxycycline for STI prophylaxis;
- Prolonged antibiotic use (> 2 weeks) within the last 30 days prior to enrollment;
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- Co-enrollment in any other concurrent interventional research or studies that may interfere with this study, such as an STI prevention trial, unless approved by Protocol Team in writing;
- Does not have consistent access (or anticipated weekly access for 52 weeks of survey completion) to smartphone that can access the HMP app; or
- Any other medical condition, medical/behavioral intervention, or other conditions that, in the opinion of the clinical site Project Lead (PL)/Investigator of Record (IoR) or designee, could interfere with adherence to study procedures or compromise interpretation of study results.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Ponce de Leon
Atlanta, Georgia, 30303
Christin Root, 404-251-8893, cmroot@emory.edu
Anandi Sheth
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Jessica Coleman, 3013854868, jcolem52@jh.edu
Allison Agwu, MD
- Recruiting
Chapel Hill
Chapel Hill, North Carolina, 27599
Mariam Chicurel-Bayard, 919-843-9922, chicurel@med.unc.edu
Lina Rosengren-Hovee
- Recruiting
University Illinois Chicago
Chicago, Illinois, 60612
Rachel Jackson, 312-996-6018, rjacks34@uic.edu
Kelly Bojan
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Litty Koshy, 832-822-1038, Litty.Koshy@bcm.edu
Mary Paul
- Recruiting
UCLA Care
Los Angeles, California, 90095
Emy Arango, 310-825-6413, earango@mednet.ucla.edu
Cherie Blair
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38015
Mary Dillard, 901-595-4083, Mary.dillard@stjude.org
Aditya Gaur
- Recruiting
Tulane University
New Orleans, Louisiana, 70112
Leslie Kozina, 504-988-5348, lkozina@tulane.edu
Tina Simpson
- Recruiting
Harlem Prevention Center
New York, New York, 10027
Yan Rivera, 917-846-9907, yr2267@cumc.columbia.edu
Yael Hirsch-Movermann
- Not yet recruiting
Penn Prevention
Philadelphia, Pennsylvania, 19104
Rosemarie Kappes, 267-229-2972, rkappes@pennmedicine.upenn.edu
Arianne Morrison
- Recruiting
San Francisco Department of Public Health
San Francisco, California, 94102
Emily Schaeffer, 628-217-7456, emily.schaeffer@sfdph.org
Albert Liu
- Recruiting
University of Florida
Tampa, Florida, 33612
Elizabeth Enriquez-Bruce, 813-250-2574, enriquezbruce@usf.edu
Patricia Emmanuel
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Justin Unternaher, 202-476-1030, junternahe@childrensnational.org
Natella Rakhmanina
About this study
Official title: Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections Among Adolescent and Young Adult Females in the United States
The goal of this open-label, randomized trial is to assess the efficacy of doxycycline prophylaxis in reducing incidences of bacterial sexually transmitted infections (STIs) among adolescent and young adult females while also evaluating acceptability and antimicrobial resistance in order to inform public health policy.
Read the detailed description
Participants will be randomized to receive on-demand doxycycline post-exposure prophylaxis (doxyPEP), weekly doxycycline, or standard of care (SOC) and will be followed quarterly to assess the impact of doxycycline use on the quarterly incidence of STIs (gonorrhea [GC], chlamydia [CT], and early syphilis), and within the doxycycline arms adherence and acceptability of weekly versus on-demand dosing.
Approximately 760 females will be randomized 1:1:1 to (1) on-demand doxyPEP (doxycycline 200 mg as soon as possible and within 72 hours after any condomless oral, vaginal, and/or anal sex), (2) weekly doxycycline (doxycycline 200 mg weekly regardless of sexual activity), or (3) SOC (quarterly STI testing/treatment and sexual health counseling). Participants will complete quarterly study visits over the course of 1 year during which they will receive STI testing (GC, CT, and syphilis), complete surveys, undergo safety monitoring, provide specimens for objective markers of doxycycline adherence and other laboratory assessments, and provide specimens (vaginal and rectal swabs [participant self-collected or staff-collected if the participant prefers]) for future testing, such as microbiome analysis. Resistance testing will be conducted on Staphylococcus (S.) aureus and Neisseria (N.) gonorrhoeae isolates to evaluate for doxycycline and tetracycline resistance, respectively. Participants will also complete weekly assessments of sexual activity and doxycycline adherence via the HealthMpowerment (HMP) application (app).
- Conditions
- Gonorrhea, Chlamydia, Syphilis, Sexually Transmitted Infections (STIs)
- Being tested
- Doxycycline hyclate delayed released 200 mg, Doxycycline hyclate delayed released 200 mg weekly, Per standard of care with quarterly STI testing/treatment and sexual health counseling
- Keywords
- Sexually Transmitted Infections, STIs, Doxycycline Prophylaxis, Doxycycline
- Medical subject headings
- Gonorrhea, Chlamydia Infections, Syphilis, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline hyclate delayed released 200 mgDrug
200 mg of doxycycline taken by mouth as soon as possible and within 72 hours after any condomless oral, vaginal, and/or anal sex along with STI screening and sexual health counseling
Doxycycline hyclate delayed released 200 mg weeklyDrug
200 mg of doxycycline taken by mouth weekly regardless of sexual activity along with STI screening and sexual health counseling
Per standard of care with quarterly STI testing/treatment and sexual health counselingOther
Quarterly STI testing/treatment and sexual health counseling
| Study group | Role | What they receive |
|---|---|---|
| On-demand doxyPEP | Experimental | Participants will take by mouth doxycycline 200 mg as soon as possible and within 72 hours after any condomless oral, vaginal, and/or anal sex in addition to standard of care STI testing/treatment and sexual health counseling. Receives: Drug: Doxycycline hyclate delayed released 200 mg |
| Weekly doxycycline | Experimental | Participants will take by mouth doxycycline 200 mg weekly regardless of sexual activity in addition to standard of care STI testing/treatment and sexual health counseling. Receives: Drug: Doxycycline hyclate delayed released 200 mg weekly |
| Quarterly STI testing/treatment and sexual health counseling | Other | Participants will be followed per standard of care with quarterly STI testing/treatment and sexual health counseling. Receives: Other: Per standard of care with quarterly STI testing/treatment and sexual health counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined incidence of GC, CT, and/or early syphilis infection
Overall combined incidence of GC, CT, and/or early syphilis infection by laboratory-based diagnosis (defined as positive GC or CT on nucleic acid amplification test [NAAT] or first positive rapid plasma reagin [RPR] with positive treponemal-specific antibody [Ab] or a new 4-fold rise in RPR titers) over the duration of follow-up.
Measured: One (1) year
Secondary outcomes (1)
Individual incidence diagnoses of GC, CT, and early syphilis infection
Individual incidence diagnoses of GC, CT, and early syphilis infection by laboratory-based diagnosis (defined as positive GC or CT on NAAT or first positive RPR with positive treponemal-specific Ab or a new 4-fold rise in RPR titers) per quarter, by arm.
Measured: One (1) year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start27 Feb 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1:1 to (1) on-demand doxyPEP (doxycycline 200 mg as soon as possible and within 72 hours after any condomless oral, vaginal, and/or anal sex), (2) weekly doxycycline (doxycycline 200 mg weekly regardless of sexual activity), or (3) SOC (quarterly STI testing/treatment and sexual health counseling). Participants will complete quarterly study visits over the course of 1 year during which they will receive STI testing (GC, CT, and syphilis), complete surveys, undergo safety monitoring, provide specimens for objective markers of doxycycline adherence and other laboratory assessments, and provide specimens (vaginal and rectal swabs \[participant self-collected or staff-collected if the participant prefers\]) for future testing, such as microbiome analysis.
- Masking
- None (open label)
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Westat
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), Florida State University, The Office of the Director, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Cherie Blaire, MD, PhD, Study chair, University of California, Los AngelesJenell Stewart, DO, MPH, Study chair, Hennepin Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738407
- Sponsor's protocol ID
- ATN173/HPTN 115
- Other IDs
- UM2HD111076, UM2HD111102
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No