Evaluating on-demand HIV prevention in men who have sex with men in Thailand and France

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy, acceptability, and safety of an event-driven pre-exposure prophylaxis (PrEP) regimen using a fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) in HIV-uninfected cisgender men who have sex with men (MSM). Participants will be randomly assigned to either the experimental F/TAF regimen or a control regimen using tenofovir disoproxil fumarate (F/TDF). The study will enroll participants over two years and follow them for up to three years, with regular study visits for health assessments and adherence monitoring. The goal is to determine how effectively this approach reduces the risk of HIV acquisition compared to standard methods.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male at birth age ≥ 18 years old
* Reporting having sex with men
* Negative 4th generation HIV-1 and HIV-2 test
* Reporting condomless anal sex with men not more often than two days during the previous month and able to plan their sexual activity
* Risk of HIV acquisition based on self-report of at least one of the following behaviors during the 6 months before enrollment: condomless anal sex with at least 2 different sexual partners, sexually transmitted infection (rectal chlamydia and/or rectal gonorrhea and/or syphilis), provided or received money goods or favor in exchange of sex, binge drinking or use of non-injectable recreational drugs.
* Consenting to participate and agreeing to follow the clinical trial procedures, including adherence to study visits every 3 months
* In France: Person affiliated with or benefiting from a social security system (article L1121-11of the public health code in France)
* May be either PrEP-naïve or PrEP-experienced, but must not have used any long-acting PrEP product in the past 2 years.

Non-inclusion criteria:

* Symptoms and/or clinical signs consistent with an acute HIV infection
* Women and trans women
* Taking feminizing hormone therapy
* Positive HIV test result at screening or enrollment even if HIV infection is not confirmed
* Positive hepatitis B surface antigen test
* ALT or AST \> 4 ULN
* Estimated glomerular filtration rate \< 60mL/min/1.73m²
* History of chronic kidney disease, osteoporosis, osteopenia or pathological fracture not related to trauma
* Hypersensitivity to the study products F/TDF or F/TAF
* Past or concurrent participation in a HIV vaccine trial or concurrent participation in another clinical trial without the agreement of the principal investigators of the two trials
* Use of intravenous drugs within the last 12 months
* Person under legal guardianship
* Not likely to comply with the clinical trial procedures or with any condition incompatible with study participation, upon the investigator's judgement.
* Ongoing Post-Exposure Prophylaxis (PEP) for HIV

Where it's running

• St Louis Hospital
  Paris, France Recruiting
• AP-HP - Hospital Lariboisière
  Paris, France Recruiting
• Thai Red Cross AIDS and Infectious Diseases Research Centre
  Bangkok, Bangkok, Thailand Recruiting
• Lampang Hospital
  Lampang, Changwat Lampang, Thailand Recruiting
• MPLUS Clinic
  Chiang Mai, Chiang Mai, Thailand Recruiting
• STIs Clinic of the Office of Disease Prevention and Control Region 1
  Chiang Mai, Chiang Mai, Thailand Recruiting

Study contacts

• Study coordinator: Geoffroy LIEGEON, MD, PhD
• Email: geoffroy.liegeon@aphp.fr
• Phone: +33 142494991

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.