Health TrialsbyHealthPanel

Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections

ConditionsGonorrheaChlamydiaSyphilisSexually Transmitted Infections (STIs)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age13-29
SponsorWestat

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 ;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Doxycycline hyclate delayed released 200 mg

    Drug

    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 weekly

    Drug

    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 counseling

    Other intervention

    Quarterly STI testing/treatment and sexual health counseling

Treatment groups

760 Participants
are divided into 3 treatment groups
Group A: On-demand doxyPEPExperimental treatment 1 intervention
Group B: Weekly doxycyclineExperimental treatment 1 intervention
Group C: Quarterly STI testing/treatment and sexual health counselingOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
One (1) year

Other outcomes

1

First occurrence of a bacterial STI

First occurrence of a bacterial STI (GC, CT, and/or early syphilis) after study enrollment, based on testing during each quarterly follow-up visit or documented testing occurring at an outside clinical site, by arm.

Time frame
One (1) year
2

Proportion GC isolates that are detected as tetracycline-resistant

Proportion of GC isolates that are detected as tetracycline-resistant during follow-up, by arm.

Time frame
One (1) year
3

Proportion S. aureus isolates that are detected as doxycycline-resistant

Proportion of S. aureus isolates that are detected as doxycycline-resistant at 24 and 48 weeks, by arm.

Time frame
One (1) year
4

Adherence to doxycycline

Adherence to on-demand doxyPEP and weekly doxycycline assessed with objective doxycycline plasma, and/or DBS concentrations matched with expected detection of once-weekly dosing or based on self-reported sexual behavior, by arm.

Time frame
One (1) year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Westat

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Florida State University

Collaborator

The Office of the Director, National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov
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