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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT03866759
Eligibility Criteria:
Inclusion Criteria:
1. HIV-uninfected as defined as negative HIV-Ab-Elisa, negative HIV viral load or negative HIV Ag-Test at time point of screening.
2. 18-55 years of age
3. Male sex - (at birth, chosen or intersex)
4. Able and willing to give informed consent
5. Able to read and write in local or English language
6. Willing to show identification card
7. Willing to be followed for at least 12 months in the study and undergo study procedures including testing for HIV and receipt of HIV test results
8. Willing to provide contact information for themselves and, if available, one personal contact who would know their whereabouts during the study period
9. Willing to provide information regarding risk behaviors
10. Demonstrates any one of the following risk factors:
1. reports condomless anal intercourse with at least two unique male partners (unknown HIV status or HIV+ untreated individuals) in the past 24 weeks or
2. documented history (lab work, physician's note etc) of syphilis, rectal neisseria gonorrhea, mycoplasma genitalium, chlamydia or acute Hepatitis C virus (HCV) infection in the past 24 weeks
Exclusion Criteria:
1. Any significant condition (including medical, psychologic/psychiatric and social) which, in the judgment of the study investigator, might interfere with the conduct of the study or be detrimental to the participant.
2. Prior or concurrent participation in a candidate HIV vaccine study, unless documented placebo recipient.
3. Concurrent participation in investigational HIV treatment or prevention studies (Please note: previous participation is not an exclusion criterion).
4. Employees of the study sites cannot participate but are eligible to participate at a different study site.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03866759
Study Brief:
Protocol Section:
NCT03866759