Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT03459157
Eligibility Criteria:
Inclusion Criteria:
* Male (or transgender male person at birth)
* At least 18 years old
* HIV-seronegative
* Having had at least one anal sex episode with another man within the previous 6 months
* Having at least one of the following criteria:
* Have a sexual partner (male or female) infected with HIV without evidence of virological suppression
* Have had anal or vaginal sex episodes without condoms with more than one partner within the previous 6 months
* Have had a sexually-transmitted infection (STI) within the previous 6 months (syndromic or biological approach, or mentioned by the participant)
* Have received post-exposure prophylaxis for HIV within the previous 6 months
* Wishing to reinforce its means of prevention through the use of PrEP
* Accepting to participate in the study and signing the informed consent form
Exclusion Criteria:
* Clinical manifestations suggesting a primary HIV infection
* Recent probable HIV exposure
* Creatinine clearance \<60 mL/min calculated according to the Cockroft \& Gault formula
* Positive or undetermined HBsAg
* Allergy or contraindication to any of the components of PrEP
* Participation in another biomedical and/or behavioral study on HIV or STIs (excluding CohMSM)
* Disability of the person making it difficult, if not impossible, to participate in the study or understanding of the information given to him
* Predictable non-compliance with the protocol (geographical distance, non-compliance with monitoring or other reasons)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03459157
Study Brief:
Protocol Section:
NCT03459157