Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC
- Conditions
- CancerAIDS-related Kaposi SarcomaAIDS-Related MalignancyAnal CancerHIV InfectionsAIDS Related LymphomaHIV-Associated Malignant NeoplasmHPV-Related Malignancy
- Interventions
- Other: Non-InterventionalOther: Non-Interventional Follow-up
- Registration Number
- NCT05510908
- Lead Sponsor
- AIDS Malignancy Consortium
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 720
-
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.
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Participant presents to an AMC domestic clinical trial site for either clinical care or research.
- Participants who do not fulfill the criteria as listed above are ineligible.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description New, primary or recurrent disease Non-Interventional Considering or currently receiving cancer treatment New, primary or recurrent disease Non-Interventional Follow-up Considering or currently receiving cancer treatment Metastic or locally advanced cancer Non-Interventional 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 cancer Non-Interventional Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy. Metastic or locally advanced cancer Non-Interventional Follow-up 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.
- Primary Outcome Measures
Name Time Method Number of cancers in people with HIV (PWH) who present for care at domestic AMC sites 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
- Secondary Outcome Measures
Name Time Method Proportion of participants eligible for AMC trials who are successfully enrolled Baseline and 12 weeks This will be calculated by the number of participants enrolled who meet site-based AMC trial eligibility compared to the number of eligible participants at each site who meet site-based AMC trial eligibility.
Trial Locations
- Locations (16)
University of Miami Miller School of Medicine-Sylvester Cancer Center
🇺🇸Miami, Florida, United States
Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
George Washington University Cancer Center
🇺🇸Washington, District of Columbia, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Weill Cornell Medicine - Cornell Clinical Trials Unit
🇺🇸New York, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Abramson Cancer Center at Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Huntsman Cancer Institute - University of Utah
🇺🇸Salt Lake City, Utah, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of Puerto Rico
🇵🇷San Juan, Puerto Rico