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Trial record 19 of 39 for:    Recruiting, Not yet recruiting, Available Studies | Chlamydia

Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men

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ClinicalTrials.gov Identifier: NCT03980223
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborators:
University of Washington
National Institute of Allergy and Infectious Diseases (NIAID)
Mayne Pharma International Pty Ltd
San Francisco Department of Public Health
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE June 6, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date June 10, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
Incidence of GC, CT or syphilis [ Time Frame: 1 year ]
Combined incidence of GC, CT, or early syphilis infection by by laboratory-based diagnosis
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men
Official Title  ICMJE Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men
Brief Summary The purpose of this study is to understand if taking an antibiotic called doxycycline by mouth as soon as possible after sexual contact without a condom can reduce the risk of sexually transmitted infections (STIs), including gonorrhea, chlamydia and syphilis. The study will also look at the safety of doxycycline PEP and the impact that PEP may have on the bacteria that cause STIs as well as on bacteria that normally live on the body. While doxycycline is approved by the Food and Drug Administration (FDA), taking doxycycline immediately after sexual contact to prevent infection is investigational and is not approved by the FDA for this use. Participants will take part in the study for 1 year.
Detailed Description

The overarching goal is to assess the effectiveness of doxycycline PEP on incidence of STIs and tetracycline resistance among STIs and commensal bacteria to inform public health policy. Participants will be randomized 2:1, with a greater number receiving doxycycline PEP compared with the standard of care control, to maximize data on safety, tolerability, adherence coverage of sexual acts, and resistance data in participants randomized to doxycycline PEP, without negatively impacting power to measure effectiveness. Participants will be counseled about the preliminary effectiveness data from IPERGAY, and the potential for antimicrobial resistance (AMR) in STIs or other bacteria. Possibility of unreported doxycycline us in the control arm (contamination) will be monitored through retrospective batch testing of doxycycline metabolites in hair, to detect doxycycline use in the prior 3 months. 53

Eligible participants randomized 2:1 to receive PEP will receive open-label doxycycline 200 mg to be taken ideally within 24 hours but no later than 72 hours after condomless sexual contact (oral or anal). 200 mg of doxycycline will be taken at most once per 24 hour period regardless of the number of sexual acts occurring during this time period. Sexual activity will be recorded for both arms of the study (doxycycline PEP and control condition) by the participant using a smartphone application that will be adapted for study use; this will enable comparable assessment of risk in the two arms. PEP pill-taking will also be measured by the app to enable assessment of coverage of sex acts by PEP. Sexual activity and adherence will also be assessed in person at quarterly visits. STI testing will be conducted quarterly from three anatomic sites (pharyngeal, rectal and urinary) and blood for syphilis testing. Participants with a positive STI test will return for STI treatment and for swabs of the affected site for resistance testing; culture based for gonorrhea (GC) and molecular methods for CT and syphilis. Those with a serologic test that indicates a new syphilis infection will have swabs of any current active lesion as well as mucosal swabs from the oropharynx. Nares and oropharyngeal swabs will be obtained at baseline, 6 and 12 months to evaluate tetracycline resistance in S. aureus among carriers and in commensal Neisseria species.

Stool samples from 100 participants on the doxycycline PEP arm - 50 MSM living with HIV and 50 HIV uninfected MSM on pre-exposure prophylaxis (PrEP) - will be collected at baseline, 6 and 12 months to evaluate effects of intermittent doxycycline on the gut resistome, using 16s ribosomal RNA amplification to study tetracycline resistance genes. Rectal swabs will be collected and archived in all participants at baseline, 6, and 12 months for future studies of the impact of doxycycline PEP on the enteric microbiome and resistome.

Study population: This study will enroll 390 HIV-infected participants and 390 persons taking PrEP, for a total sample size of 780. An approximately equal number of participants in each of these cohorts (and in each study arm) will be enrolled in San Francisco and Seattle.

Current or planned initiation of PrEP use is an eligibility criterion for enrollment, because this population of MSM has high rates of STIs and are typically seen quarterly for PrEP visits. However, participants may opt to stop PrEP use at any time during the study without affecting their involvement in the study. Any HIV-uninfected participants who subsequently seroconvert will be managed clinically by the study site according to local practice (appropriate counseling, clinical evaluation and immediate linkage to clinical and psychosocial services). These participants will also be retained in the study unless they choose to discontinue study participation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Open-label randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Gonorrhea
  • Chlamydia
  • Syphilis
Intervention  ICMJE Drug: Doxycycline Hyclate Delayed-Release 200 mg
200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP)
Study Arms  ICMJE
  • Experimental: Doxy PEP
    Doxycycline 200mg in addition to standard of care STI testing and treatment
    Intervention: Drug: Doxycycline Hyclate Delayed-Release 200 mg
  • No Intervention: Control
    The control arm will consist of standard of care STI testing and treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2019)
780
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2024
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Willing and able to give written informed consent
  • Age ≥ 18 years
  • Male sex at birth
  • Previously HIV-diagnosed OR HIV-seronegative at the time of last test within the past month and a current prescription for PrEP (both daily or event-driven permitted) or plan to start PrEP within 30 days after the enrollment visit
  • Condomless anal or oral sexual contact with ≥ 1 male sex-at-birth partners in the past 12 months
  • Diagnosed with GC, CT or early syphilis (primary, secondary or early latent) in the past 12 months. Note: self report of STI is acceptable if documentation not available.
  • Willing to use a smartphone app to record sexual practices (all participants) and doxycycline PEP (if assigned to PEP arm) if the participant possesses a smartphone Note: Possession of smartphone is not required for study participation. Study personnel will assist in obtaining a smartphone through locally available resources if participant does not have a phone.

Exclusion Criteria:

  • Allergy to tetracycline class
  • Current medications which may impact doxycycline metabolism or that are contraindicated with doxycycline, as per the prescribing information. These include systemic retinoids, barbiturates, carbamazepine, and phenytoin.
  • Anticipated use of doxycycline during the coming 12 months for non-STI prevention (e.g., acne treatment).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Anne Luetkemeyer, MD 415-476-4082 ext 130 Annie.Luetkemeyer@ucsf.edu
Contact: Connie Celum, MD, MPH 206-520-3869 ccelum@uw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03980223
Other Study ID Numbers  ICMJE DoxyPEP
R01AI143439 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers outside of the study team
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • University of Washington
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Mayne Pharma International Pty Ltd
  • San Francisco Department of Public Health
Investigators  ICMJE
Principal Investigator: Anne Luetkemeyer, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP