Chlamydia, Gonorrhea, Sexually Transmitted Infections (STIs), Syphilis
Conditions
Keywords
Sexually Transmitted Infections, STIs, Doxycycline Prophylaxis, Doxycycline
Brief 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.
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).
Interventions
DRUGDoxycycline hyclate delayed released 200 mg
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
DRUGDoxycycline hyclate delayed released 200 mg weekly
200 mg of doxycycline taken by mouth weekly regardless of sexual activity along with STI screening and sexual health counseling
OTHERPer standard of care with quarterly STI testing/treatment and sexual health counseling
Quarterly STI testing/treatment and sexual health counseling
Sponsors
Westat
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)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined incidence of GC, CT, and/or early syphilis infection | One (1) year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual incidence diagnoses of GC, CT, and early syphilis infection | One (1) year | 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. |
Countries
United States
Contacts
CONTACTNancy Liu
CONTACTErin Ricketts
STUDY_CHAIRCherie Blaire, MD, PhD
University of California, Los Angeles
STUDY_CHAIRJenell Stewart, DO, MPH
Hennepin Healthcare
Outcome results
None listed