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

Sponsor

University of Washington (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04050540

Collaborator

Kenya Medical Research Institute (Other), Kenya National AIDS & STI Control Programme (Other), University of California, San Francisco (Other), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

449

Enrollment

Location

Arms

52.8

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

449 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 :

Feb 5, 2020

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of N. gonorrhoeae, C. trachomatis, or early syphilis infection by laboratory-based diagnosis [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.