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Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP (dPEP-KE)

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ClinicalTrials.gov Identifier: NCT04050540
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : February 7, 2020
Sponsor:
Collaborators:
Kenya Medical Research Institute
Kenya National AIDS & STI Control Programme
University of California, San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Jared Baeten, University of Washington

Brief Summary:
This is a randomized clinical trial of doxycycline post-exposure prophylaxis (dPEP) to reduce bacterial STIs among Kenyan women taking pre-exposure prophylaxis (PrEP). The overarching goal is to assess the effectiveness of dPEP on incidence of STIs while also balancing acceptability, cost, and impact on tetracycline resistance to inform public health policy. Participants will be randomized to receive dPEP and standard of care or the standard of care only. Questionnaires, focus group discussions, SMS, and in-depth interviews will be used to study acceptability and changes sexual behavior due to dPEP.

Condition or disease Intervention/treatment Phase
HIV Infections HIV/AIDS Neisseria Gonorrheae Infection Chlamydia Trachomatis Infection Syphilis Infection Drug: Doxycycline Phase 4

Detailed Description:

This study is an open-label 1:1 randomized clinical trial of doxycyline PEP to reduce bacterial STIs - Neisseria gonorrhoeae, Chlamydia trachomatis, and T. pallidum (syphilis) - among Kenyan women taking PrEP. Participants will be counseled about the preliminary effectiveness data from IPERGAY, and the potential for resistance in STIs or other bacteria.

The primary study objectives are to 1) evaluate the effectiveness of doxycycline PEP (dPEP) to reduce STI infections in HIV-uninfected Kenyan women taking HIV PrEP; 2) assess the safety, tolerability, and acceptability of dPEP; 3)assess adherence to dPEP; 4) investigate the impact of dPEP on tetracycline resistance in N. gonorrhoeae and C. trachomatis; 5) measure the cost of dPEP and estimate the cost per case averted, budget impact, and affordability

Subjects will be randomized 1:1 to dPEP versus standard of care; randomization will be done in variable-sized blocks and using opaque envelopes opened at randomization. Participants assigned to dPEP will be instructed to take doxycycline 200 mg (two 100mg capsules) orally within 24 hours and up to 72 hours after each condomless sex act (consistent with IPERGAY) as frequently as daily if indicated but not more than once daily.

At Months 0,3,6 and 9, women randomized to dPEP will receive doxycycline, sufficient for up to daily use for 3 months (i.e., 180 capsules). Unused capsules will be counted at each quarterly follow-up visit and additional doxycycline will be provided. Participants will also be offered single- or multi-dose pill carriers for ease of dosing dPEP following exposures. All participants will receive quarterly visits for standard of care prevention services and collection of clinical and behavioral data, for a total of 12 months of follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 446 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PrEP and dPEP: Doxycycline Post-exposure Prophylaxis for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV Pre-exposure Prophylaxis
Actual Study Start Date : February 5, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : September 2021


Arm Intervention/treatment
Experimental: dPEP Intervention Arm
Participants assigned to dPEP will be instructed to take doxycycline 200 mg (two 100mg capsules) orally within 24 hours and up to 72 hours after each condomless sex act
Drug: Doxycycline
200 mg of doxycycline to be taken orally within 24 hours and up to 72 hours after each condomless sex act

No Intervention: Standard of Care Arm
Participants assigned to Standard of Care



Primary Outcome Measures :
  1. Incidence of N. gonorrhoeae, C. trachomatis, or early syphilis infection by laboratory-based diagnosis [ Time Frame: 12 months post enrolment ]
    Combined incidence of N. gonorrhoeae, C. trachomatis, or early syphilis infection by by laboratory-based diagnosis (e.g., positive N. gonorrhoeae or C. trachomatis based on NAAT or syphilis based on four-fold increase in non-treponemal titers).



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing and able to give written informed consent
  • Age ≥18 years and ≤30 years old
  • Female sex at birth
  • HIV-seronegative at the time of last test within the past month and a current prescription for PrEP according to the national guidelines of Kenya (define PrEP eligibility as: partner of HIV-infected person not on ART or on ART for <6 months, >1 partner of unknown status, transactional sex, recent STI, recurrent HIV PEP use, inconsistent condom use, or injection drug use).

Exclusion Criteria:

  • Pregnant
  • Breastfeeding a child
  • 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, phenytoin, and warfarin.
  • Recent use of prolonged (more than 14 day course) antibiotics in the month prior to enrollment
  • Active, clinically significant medical or psychiatric conditions that would interfere with study participation, at the discretion of the site investigator or designee.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050540


Contacts
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Contact: Jenell Stewart, DO, MPH 206-520-3800 jenells@uw.edu

Locations
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Kenya
Kenya Medical Research Institute Recruiting
Kisumu, Kenya
Contact: Josephine Odoyo, KRCHN, MPH         
Contact: Zachary Kwena, PhD         
Principal Investigator: Elizabeth Bukusi, MBChB, PhD         
Sponsors and Collaborators
University of Washington
Kenya Medical Research Institute
Kenya National AIDS & STI Control Programme
University of California, San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Jared Baeten, MD, PhD University of Washington

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Responsible Party: Jared Baeten, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT04050540    
Other Study ID Numbers: STUDY00007487
R01AI145971 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jared Baeten, University of Washington:
Sexually Transmitted Infections
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Gonorrhea
Sexually Transmitted Diseases
Syphilis
Virus Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections
Treponemal Infections
Spirochaetales Infections
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents