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 : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections HIV/AIDS Neisseria Gonorrheae Infection Chlamydia Trachomatis Infection Syphilis Infection||Drug: Doxycycline||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||446 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||October 30, 2022|
|Estimated Study Completion Date :||June 30, 2024|
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
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
- 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).
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
|Contact: Jenell Stewart, DO, MPHfirstname.lastname@example.org|
|Kenya Medical Research Institute||Recruiting|
|Contact: Josephine Odoyo, KRCHN, MPH|
|Contact: Zachary Kwena, PhD|
|Principal Investigator: Elizabeth Bukusi, MBChB, PhD|
|Principal Investigator:||Jared Baeten, MD, PhD||University of Washington|