Incidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin America

PRIMARY OBJECTIVES:

I. To determine the number of diagnosed cancers in people living with HIV/AIDS (PLWHA) presenting to participating clinical sites in Latin America, and estimate site-specific prevalence based on all presenting cancers (new diagnosis, recurrence, and surveillance cases) and site-specific incidence based on newly diagnosed cancers.

SECONDARY OBJECTIVES:

I. Obtain information on the use of diagnostic testing and treatment for the cohort of diagnosed HIV-associated cancer participants.

II. To collect information on participant characteristics for diagnosed HIV-associated cancers (e.g., antiretroviral therapy [ART] regimen, current CD4 count, current viral load, etc.).

OUTLINE:

Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks.

Inclusion criteria

• 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);
• HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL, and 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.
• 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/Custom Industrial Analysis (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.
• Must have a current or prior (within the last 5 years) diagnosis of cancer, but there is no restriction of the number or type of prior treatments. Participants will qualify under one of three categories:

• New diagnosis: no prior treatment for current malignancy. May be prior to, or currently receiving the first line of therapy.
• Prior diagnosis (within 5 years), in remission: Not currently on cancer treatment other than combination antiretroviral therapy (cART). Prior treatment for malignancy can include surgery, radiation, or chemotherapy (or cART initiation in Kaposi sarcoma [KS]). No restriction on number of prior lines of therapy.
• Prior diagnosis, recurrent: considering or currently receiving treatment that is not first line. No restriction on the number of prior lines of therapy.
• Date of birth and age should be determined based on best possible information or documentation available.
• Ability to understand and the willingness to provide informed consent document.

Exclusion criteria

• Participants not meeting all criteria above are ineligible.