Protocol RV 583 Multinational Observational Cohort of HIV and Other Infections

Criteria the registry did not label

• Step 1 Inclusion Criteria: Female or male aged 14-55 years; Documented negative HIV test according to site-specific HIV testing procedures at entry/screening; Able and willing to provide informed consent; Willing to provide biometric identification; Available for follow-up for the planned study duration; Understands English or the local language as approved by the IRB, including people who are illiterate; Willing to provide contact information for themselves and one personal contact who would know their whereabouts during the study period; Willing to provide information regarding HIV risk behaviors and to undergo testing for HIV and other STIs; Considered to be vulnerable to HIV and other STIs based on any one or more of the following test results and/or self-reported behaviors:
• Documented history of newly diagnosed syphilis, gonorrhea, chlamydia, Mycoplasma genitalium, herpes simplex virus, or acute hepatitis C virus infection in the 24 weeks prior to screening
• Self-reported vaginal, oral, or anal intercourse in exchange for money as a regular source of income in the 24 weeks prior to screening
• Self-reported condomless vaginal or anal intercourse with at least three different partners living with HIV or of unknown status in the 24 weeks prior to screening
• Self- reported injection drug use (IDU) in the 24 weeks prior to screening
• Self-reported insertive or receptive anal intercourse with one or more different male or transgender partners in the 24 weeks prior to screening Step 1 Exclusion Criteria: Any significant condition (medical, psychologic/psychiatric or social) that, in the judgment of the study investigator, might interfere with the conduct of the study; Active drug or alcohol use or dependence that, in the judgement of the study investigator, would interfere with adherence to study requirements; Current or past participation in a preventive or therapeutic HIV vaccine study, unless known placebo recipient; Positive β-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) at screening for people of child-bearing potential and people who are amenorrheic for less than 12 consecutive months.
  • Step 2 Inclusion Criteria: New diagnosis of HIV in the last 90 days during Step 1 as determined by site-specific HIV testing procedures; Able and willing to continue follow-up for the planned study duration Step 2 Exclusion Criteria: Any significant condition (medical, psychologic/psychiatric or social) that, in the judgment of the study investigator, might interfere with the conduct of the study; Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements