Authorised Therapeutic confirmatory (Phase III) bacterial sexually transmitted infections

A double-blind, multi-centre, randomized, placebo-controlled cross-over clinical trial to assess the efficacy of doxyPEP in reducing the incidence of bacterial STIs among MSM and TGW living with HIV in Belgium

EU CTIS ID: 2025-521153-16-00

What this study is testing

Assess if there is a difference in the incidence rate of symptomatic Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and all Treponema pallidum (TP) infections among MSM and TGW living with HIV in Belgium whilst individuals are using doxyPEP compared with placebo.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Able and willing to provide informed consent and adhere to the study procedures
  • Aged 18 years or older
  • Assigned male sex at birth
  • Identifying as gay, bisexual or other men who have sex with men or transgender women
  • Living with HIV
  • Having an undetectable viral load (<200 copies/mL) for 6 months or more

You likely can't join if

  • Hypersensitivity to doxycycline or other tetracyclines, any substance used in the IMP or placebo, or any of the excipients listed in section 6.1 of the SmPC.
  • Concomitant use of medication with significant interactions with doxycycline
  • Any contra-indication to the use of doxycycline, as mentioned in the summary of product characteristics
See the full eligibility criteria
Who can join
  • Able and willing to provide informed consent and adhere to the study procedures
  • Aged 18 years or older
  • Assigned male sex at birth
  • Identifying as gay, bisexual or other men who have sex with men or transgender women
  • Living with HIV
  • Having an undetectable viral load (<200 copies/mL) for 6 months or more
  • Having had at least one bacterial sexually transmitted infection in the preceding 24 months or having had >= 5 sex partners in the previous 6 months
What rules you out
  • Hypersensitivity to doxycycline or other tetracyclines, any substance used in the IMP or placebo, or any of the excipients listed in section 6.1 of the SmPC.
  • Concomitant use of medication with significant interactions with doxycycline
  • Any contra-indication to the use of doxycycline, as mentioned in the summary of product characteristics

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.