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