Feasibility Study of Ocular Surface Squamous Neoplasia Surgical Excision in People Living With HIV in Sub-Saharan Africa

Prior treatment

• 3.3.1 Participants who are receiving any other investigational agents within 30 days before enrollment for surgery, except for investigational ART regimens, which will be permitted.
• 3.3.3 Uncontrolled intercurrent illness within 4 weeks before enrollment, including but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.

Other illness

• 3.3.2 Participants with known history of ocular surface lesions including OSSN, other ocular neoplasm, pterygia, or limbal vernal keratoconjunctivitis.

• 3.2.1 Participants with suspected unilateral, non-invasive OSSN lesions that the AMC-certified ophthalmologist determines can be resected with 3 mm clinical margins, sparing involvement of the superior and inferior fornices as well as 6 clock hours of the corneal scleral limbus. This assessment must be carried out within 4 weeks before surgery.
• 3.2.2 HIV positive. Documentation of HIV-1 infection by means of any one of the following:
• Documentation of receipt of ART by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's 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. Antiretroviral drug regimens used for pre-exposure prophylaxis (PrEP) may not satisfy this requirement.;
• HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL confirmed by a licensed screening antibody and/or HIV antibody/antigen combination assay;
• 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 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 enzyme or chemiluminescence assay (E/CIA) that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.
  • 3.2.3 Performance status ≤ 2 on the WHO Scale (see Appendix III).