Daily, Weekly, or Event-driven Doxycycline for STI Prevention Among Men Who Have Sex With Men (MSM) Engaging in Chemsex: The DOSE Non-inferiority Trial (DOSE)
The goal of this clinical trial is to learn if three different dosing strategies of doxycycline (daily, weekly, and on-demand) works to prevent sexually transmitted infections (gonorrhea, chlamydia, and syphilis) among men who use methamphetamine and who have sex with other men. The main question it aims to answer is:
Does daily, weekly, and on-demand doxycycline dosing strategies lower the incidence of quarterly STIs (gonorrhea, chlamydia, and syphilis)?
Participants will:
Take doxycycline either on-demand (within 72 hours after sex), daily, or weekly doxycycline for one year Visit the clinic once every 3 months to complete questionnaires, undergo HIV/STI testing, and collect samples. Additional visits may be needed to receive STI treatment.
Complete text surveys once every month
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
This study will evaluate the acceptability, effectiveness, and adherence of alternative doxycycline dosing strategies to optimize STI prophylaxis in this high-risk population. We will accomplish this through the following independent, yet interrelated Aims: 1) Determine effectiveness of fixed-dose daily, fixed-dose weekly, and event-driven dosing of doxycycline for STI prophylaxis; 2) Assess acceptability and preferences for doxycycline as STI prophylaxis through either fixed dose (daily or weekly) or event-driven (post-exposure) dosing strategies through individual interviews; 3) Evaluate and compare adherence and tolerability of daily, weekly, and event-driven doxycycline dosing strategies. We will conduct an open-label, non-inferior, randomized control trial (RCT) comparing fixed-dose daily, fixed-dose weekly, and event-driven doxycycline dosing strategies on quarterly incidence of STIs among MSM who use MA. We will screen 900 individuals to recruit a cohort of 300 MSM who self-report MA use in conjunction with condomless anal intercourse in the past month. At the Enrollment visit, participants will receive HIV, syphilis, and gonorrhea/chlamydia (GC/CT) testing as well as complete demographic and behavioral questionnaires. Enrolled participants will be randomly assigned 1:1:1 to either fixed-dose daily doxycycline (100mg daily; n=100), fixed-dose weekly doxycycline (200mg weekly; n=100), or event-driven doxyPEP (200mg taken up to 72 hours after a potential STI exposure; n=100; standard of care). All participants will participate in Quarterly follow-up visits where they will be assessed for HIV, bacterial STIs (GC/CT and syphilis), adherence to doxycycline, sexual behaviors/practices, substance use, nasal Staph aureus colonization and doxycycline resistance over 12 months. The primary outcome for this study will be quarterly incidence of, GC, CT, and/or early syphilis (defined as newly positive rapid plasma reagin [RPR] or four-fold rise in RPR titers), by arm.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 4
Kontakte und Standorte
Studienkontakt
- Name: UCLA Vine Street Clinic
- Telefonnummer: (323) 461-3106
- E-Mail: uclavsc@mednet.ucla.edu
Studienorte
-
-
California
-
Los Angeles, California, Vereinigte Staaten, 90038
- UCLA Vine Street Clinic
-
Kontakt:
- UCLA Vine Street Clinic
- Telefonnummer: (323) 461-3106
- E-Mail: uclavsc@mednet.ucla.edu
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Born male
- Age ≥ 18 years old
- Reports receiving an STI diagnosis (i.e., GC, CT, and/or syphilis) in the past 12 months
- Reports MA use in conjunction with CAI with a male partner in the 30 days prior to screening
- Not planning to relocate out of the study area in the 12-month follow-up period
- Willingness to engage in up to one year of repeated antibiotic exposure
- Willing and able to give written informed consent
Exclusion Criteria:
- Reported allergy to tetracyclines
- Current or anticipated use of a medication that interacts with doxycycline (prohibited medications listed below)
- Current or planned use of doxycycline for a prolonged period (> 2 weeks, with the exception of pre-enrollment doxyPEP)
- Prolonged antibiotic use (> 2 weeks, with the exception of pre-enrollment doxyPEP) in the 30 days prior to study enrollment
- Co-enrollment in any other concurrent study that may interfere with this study, such as an STI prevention trial, unless approved by the PI or designee
- Any other medical or psychiatric condition that, in the opinion of the PI or designee, may interfere with study participation or participant safety
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: On-demand doxycycline
Participants randomized to on-demand doxycycline will be instructed to take doxycycline hyclate 200mg once as needed within 24 and up to 72 hours after sex (not to exceed 200mg in 24 hours). |
Participants randomized to receive on-demand doxycycline hyclate 200mg will be instructed to take doxycycline hyclate 200mg once as needed within 24 hours and up to 72 hours after sex (not to exceed 200mg in 24 hours) |
|
Experimental: Weekly doxycycline
Participants randomized to receive fixed dose weekly doxycycline hyclate 200mg will be instructed to take doxycycline hyclate 200mg once weekly, regardless of sexual exposure. |
Participants randomized to receive weekly doxycycline hyclate 100mg will be instructed to take doxycycline hyclate 100mg once weekly |
|
Experimental: Daily doxycycline
Participants randomized to receive fixed dose daily doxycycline hyclate 100mg will be instructed to take doxycycline hyclate 100mg once daily, regardless of sexual exposure. |
Participants randomized to receive fixed dose daily doxycycline hyclate 100mg will be instructed to take doxycycline hyclate 100mg once daily |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Quarterly incidence of chlamydia, gonorrhea, and/or early syphilis infection
Zeitfenster: Quarterly incidence of C. trachomatis, N. gonorrhoeae, and/or early syphilis infection by laboratory-based diagnosis (over 1 year time period)
|
Quarterly incidence of C. trachomatis, N. gonorrhoeae, and/or early syphilis infection by laboratory-based diagnosis (over 1 year time period)
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Cherie Blair, MD, PhD, University of California, Los Angeles
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Pathologische Prozesse
- Krankheitsattribute
- Infektionen
- Übertragbare Krankheiten
- Bakterielle Infektionen
- Bakterielle Infektionen und Mykosen
- Gramnegative bakterielle Infektionen
- Spirochäten-Infektionen
- Chlamydiaceae-Infektionen
- Sexuell übertragbare Krankheiten, bakteriell
- Neisseriaceae-Infektionen
- Treponema-Infektionen
- Pathologische Zustände, Anzeichen und Symptome
- Sexuell übertragbare Krankheiten
- Chlamydien-Infektionen
- Tripper
- Syphilis
Andere Studien-ID-Nummern
- 26-1595
- 1R01DA066392-01A1 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .