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Table 2 Inclusion and exclusion criteria for participants in the CROPrEP project

From: Protocol for a multicenter, real-world study of HIV pre-exposure prophylaxis among men who have sex with men in China (CROPrEP)

Inclusion criteria
 • Aged 18–65 years old
 • Test results demonstrate HIV negative
 • Behavioral eligibility criteria
 Participants of male sex at birth and who have sex with men, reporting at least one criterion associated with high risk for HIV infection in the 6 months prior to enrolment as follows:
  - Unprotected (condom-less) receptive anal intercourse with male partners
  - More than two male partners (regardless of condom use and HIV serostatus)
  - Reported STI, such as syphilis, HSV-2, gonorrhea, chlamydia, chancroid, or lymphogranuloma venereum
  - Reported a history of post-exposure prophylaxis
 Note: Individuals in a monogamous relationship with an HIV-1 seronegative partner or a virologically suppressed HIV-1+ partner for > 1 year will not be eligible for participation.
 • Through comprehensive physical examination, including routine urine examinations, hepatic and renal function tests, blood glucose and lipids, and BMD; no serious liver or kidney dysfunction and negative for HBs antigen, without serology indicating osteoporosis, and other indicators are normal
 • Able and being willing to sign written informed consent and participate in the study as procedures require
 • Chinese citizens
Exclusion criteria
 • HIV-1 infected, or having clinical signs or symptoms consistent with acute viral infection
 • Atopic individual or allergic to the ingredients of the experimental drug or ART
 • Having serious chronic disease, including metabolic diseases (such as diabetes), neurological, and psychiatric disorders
 • Weight < 40 kg or > 140 kg
 • Having osteoporosis: aged ≥50 years with BMD T-score ≤ −2.5; aged < 50 years with BMD Z-score ≤ − 2 and fragility fracture
 • Mental health issues which may compromise participant adherence or safety, including memory loss, cognitive impairment, intellectual disability, or communication disorders
 • Currently, or 30 days prior to enrolment, taking interferon, interleukin, or other immunoregulators
 • Currently taking products containing antiretrovirals
 • Participating in another research study related to HIV and antiretroviral therapy or other intervention study