Surgical removal of eye-surface squamous tumors in people living with HIV in Sub-Saharan Africa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

People living with HIV who have a single, non-invasive ocular surface squamous neoplasia (OSSN) lesion that an AMC-certified ophthalmologist deems resectable with 3 mm margins will undergo surgical excision. Lesions will be swabbed before surgery for HPV DNA testing in PrimeStore MTM and the excised tissue will be processed locally for histopathology and sent to Stellenbosch University for confirmatory testing. Participants will return for follow-up visits at 1 week, 6 weeks, 6 months, and 12 months to monitor healing, recurrence, and test results. The study will enroll up to 84 participants across multiple sites in sub‑Saharan Africa to determine feasibility of larger multi‑center prospective studies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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).

Exclusion Criteria:

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.

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

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.

Where it's running

• Uganda Cancer Institute
  Kampala, Uganda Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.