Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) for HIV Pre-Exposure Prophylaxis (PrEP)

  • STATUS
    Recruiting
  • participants needed
    720
  • sponsor
    ANRS, Emerging Infectious Diseases
Updated on 27 June 2022

Summary

The study ANRS 174 Doxyvac is a clinical trial that will use Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex with Men and using oral TDF/FTC for HIV Pre-Exposure Prophylaxis (PrEP) and vaccination with Bexsero.

Description

This is a randomized study with a factorial design for the 2 biomedical interventions (interventions 1 and 2).

Subjects will be randomized and assigned to two different interventions:

  • Intervention 1: PEP with doxycycline or no PEP. Subjects will be randomized 2/1 to receive doxycycline PEP or no PEP
  • Intervention 2: Meningococcal B vaccine (Bexsero) or no vaccine Subjects will be randomized 1/1 to received 2 doses of Bexsero vaccine (at the first visit and two months later) or no vaccine

Participants will be randomized in one of the following arms:

  • Arm 1: doxycycline and Bexsero vaccine (240 participants)
  • Arm 2: doxycycline and no Bexsero vaccine (240 participants)
  • Arm 3: no doxycycline and Bexsero vaccine (120 participants)
  • Arm 4: no doxycycline and no Bexsero vaccine (120 participants)

Randomization will be stratified by whether or not the participant enters in the ancillary study "intestinal microbiota".

Details
Condition Unprotected Sex, risk taking
Treatment Experimental: doxycycline, Bexsero® vaccine
Clinical Study IdentifierNCT04597424
SponsorANRS, Emerging Infectious Diseases
Last Modified on27 June 2022

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