Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP

NCT04050540 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: STUDY00007487R01AI145971
• Study Type: interventional
• Target: 449
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; HIV/AIDS; Neisseria Gonorrheae Infection; Chlamydia Trachomatis Infection; Syphilis Infection

Keywords

Sexually Transmitted Infections

Outcome Measures

Primary Outcomes (1)

• Incidence of N. Gonorrhoeae, C. Trachomatis, or Early Syphilis Infection by Laboratory-based Diagnosis

  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).

  12 months post enrolment

Study Arms (2)

dPEP Intervention Arm

EXPERIMENTAL

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

Standard of Care Arm

NO INTERVENTION

Participants assigned to Standard of Care

Interventions

Doxycycline DRUG

200 mg of doxycycline to be taken orally within 24 hours and up to 72 hours after each condomless sex act

dPEP Intervention Arm

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• Kenya Medical Research Institute: collaborator
• Kenya National AIDS & STI Control Programme: collaborator
• University of California, San Francisco: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Kenya Medical Research Institute

Kisumu, Kenya

Location

Related Publications (3)

• Kwach B, Kwena Z, Violette LR, Rono B, Odoyo JB, Oware K, Bukusi EA, Baeten JM, Mkandawire-Valhmu L, Stewart J; dPEP Kenya Study Team. Understanding barriers and facilitators to doxycycline post-exposure prophylaxis adherence among young women in western kenya: a qualitative study. BMC Infect Dis. 2025 Jul 1;25(1):855. doi: 10.1186/s12879-025-11209-6.

  PMID: 40597823 DERIVED

• Stewart J, Oware K, Donnell D, Violette LR, Odoyo J, Soge OO, Scoville CW, Omollo V, Mogaka FO, Sesay FA, McClelland RS, Spinelli M, Gandhi M, Bukusi EA, Baeten JM; dPEP Kenya Study Team. Doxycycline Prophylaxis to Prevent Sexually Transmitted Infections in Women. N Engl J Med. 2023 Dec 21;389(25):2331-2340. doi: 10.1056/NEJMoa2304007.

  PMID: 38118022 DERIVED

• Stewart J, Bukusi E, Sesay FA, Oware K, Donnell D, Soge OO, Celum C, Odoyo J, Kwena ZA, Scoville CW, Violette LR, Morrison S, Simoni J, McClelland RS, Barnabas R, Gandhi M, Baeten JM. Doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections among Kenyan women using HIV pre-exposure prophylaxis: study protocol for an open-label randomized trial. Trials. 2022 Jun 16;23(1):495. doi: 10.1186/s13063-022-06458-8.

  PMID: 35710444 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Gonorrhea; Sexually Transmitted Diseases

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Jenell Stewart
• Organization: University of Washington, Department of Global Health

jenells@uw.edu

206 520 3866

Study Officials

• Jared Baeten, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: February 5, 2020
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: July 10, 2024
• Results First Posted: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)