Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC

Other

• Participants who do not fulfill the criteria as listed above are ineligible.

• Participant can understand and is willing to sign a written informed consent document.
• HIV positive. Documentation of HIV-1 infection by means of any one of the following:
  • Documentation of an HIV diagnosis in the medical record by a licensed health care provider;
  • Documentation of receipt of antiretroviral therapy (ART) (i.e., at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \[PrEP\]) by a licensed health care provider. Documentation may be a record of an ART prescription in the medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name;
  • HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL;
  • Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.
  • Note: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., U.S. FDA).
  • WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay, or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), a Western blot, or a plasma HIV-1 RNA viral load.
• Patient was diagnosed with or treated for cancer within the last 5 years. Participants will qualify under one of three categories:
  • New, primary or recurrent diagnosis -Considering or currently receiving cancer treatment
  • Metastatic or locally advanced cancer - This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
  • Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
• Age ≥ 18 years.
• Participant presents to an AMC domestic clinical trial site for either clinical care or research.