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

NCT04050540 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 449

Last updated 2024-07-10

Study results available
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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

Interventions

DRUG

Doxycycline

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

Sponsors & Collaborators

Principal Investigators

  • Jared Baeten, MD, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-05
Primary Completion
2022-10-30
Completion
2022-10-30
FDA Drug
Yes

Countries

  • Kenya

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04050540 on ClinicalTrials.gov