Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AIDS Malignancy Consortium A Trial of the AIDS Malignancy Consortium (AMC)

AIDS Malignancy Consortium16 sites in 2 countries462 target enrollmentJuly 25, 2023

ConditionsHIV-Associated Malignant Neoplasm HIV Infections Cancer AIDS Related Lymphoma AIDS-related Kaposi Sarcoma AIDS-Related Malignancy Anal Cancer HPV-Related Malignancy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HIV-Associated Malignant Neoplasm
Sponsor: AIDS Malignancy Consortium
Enrollment: 462
Locations: 16
Primary Endpoint: Number of cancers in people with HIV (PWH) who present for care at domestic AMC sites
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is being done to understand how many people with HIV (PWH) present for cancer care across the AIDS Malignancy Consortium in the United States and if there are reasons that some PWH choose to participate, or not in cancer clinical trials. Optional quality of life surveys will be used to learn more about how HIV and cancer and HIV and cancer treatment affect people.

Registry

clinicaltrials.gov

Start Date

July 25, 2023

End Date

June 2, 2025

Last Updated

4 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AIDS Malignancy Consortium

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Number of cancers in people with HIV (PWH) who present for care at domestic AMC sites

Time Frame: Enrollment

For each cancer group listed below, the number of new and existing cases per month will be estimated. The distribution of cancer types will be computed as percentages and compared to the cancer type distribution in the HIV/AIDS Cancer Match (HACM) Study: 1. Solid organ tumors associated with human papillomavirus (HPV) infection 2. Solid organ tumors unrelated to HPV 3. Kaposi sarcoma 4. Hematologic malignancies