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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT04426656
Eligibility Criteria:
Inclusion Criteria:
* Part 1: HIV-negative men who have sex with men (MSM): must self-report: being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal sex with another man, identify as a Chinese citizen, own a smartphone, able to being willing to sign written informed consent and participate in the study as procedures required.
Part 2: HIV-negative men who have sex with men (MSM): same characteristics as in Part 1.
AND, they must report :
* Having a smartphone with WeChat installed.
* Being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal sex with another man, currently reside in Guangzhou, China, identifying as a Chinese citizen, able to sign written informed consent and participate in the study as procedures require. AND
* At least one criterion associated with high risk of HIV infection in the past 6 months prior to enrollment as follows:
* Unprotected (condomless) anal intercourse with male partner(s)
* More than two male partners (regardless of condom use and HIV serostatus)
* Reported STI, such as syphilis, Herpes Simplex Virus-2 (HSV-2), gonorrhea, chlamydia, chancroid, or lymphogranuloma venereum.
* Reported use of post-exposure prophylaxis (PEP)
* Have a sexual partner living with HIV
Exclusion Criteria:
* Part 1: Individuals who report any following status will be excluded from participating Part 1:
* HIV-positive
* Mental health issues which may compromise participant adherence or safety, including memory loss, cognitive impairment, intellectual disability, or communication disorders.
* Part 2:
* HIV-positive (self-report or lab-confirmed)
* Currently taking oral PrEP based on self-report
* Symptoms of acute HIV infection within the prior 30 days
* Contradictions to taking oral PrEP
* Personal diagnosis or family history of hemophilia
* Chronic Hepatitis B (self-report)
* Participating in another research study related to HIV and antiretroviral therapy or other intervention study
* Having serious chronic disease, including metabolic diseases (such as diabetes), neurological, and psychiatric disorders
* Mental health issues which may compromise participant adherence or safety, including memory loss, cognitive impairment, intellectual disability, or communication disorders
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04426656
Study Brief:
Protocol Section:
NCT04426656