Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC
2 other identifiers
observational
460
2 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2022
CompletedFirst Posted
Study publicly available on registry
August 22, 2022
CompletedStudy Start
First participant enrolled
July 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2025
CompletedResults Posted
Study results publicly available
March 25, 2026
CompletedMarch 25, 2026
March 1, 2026
1.6 years
August 1, 2022
March 4, 2026
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites
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
Enrollment
Secondary Outcomes (1)
Proportion of Participants Eligible for AMC Trials Who Are Successfully Enrolled
Baseline and 12 weeks
Other Outcomes (6)
Describe the Sociodemographic, HIV-related, and Cancer Diagnostic and Treatment Characteristics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.
Baseline and 12 weeks
Describe the Health-related QOL of Cancer Patients With HIV at Domestic AMC Sites Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
Baseline
Describe the Supportive Care Needs of Cancer Patients With HIV at Domestic AMC Sites Using Supportive Care Needs Survey Short Form 34 [SCNS-SF34]
Baseline
- +3 more other outcomes
Study Arms (3)
New, primary or recurrent disease
Considering or currently receiving cancer treatment
Metastic 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 cancer
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Interventions
Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
Eligibility Criteria
Participants with a dual diagnosis of both cancer (current or diagnosed within 5 years) and underlying HIV infection, who present for care at AMC domestic sites.
You may qualify if:
- 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.
- Participant presents to an AMC domestic clinical trial site for either clinical care or research.
You may not qualify if:
- Participants who do not fulfill the criteria as listed above are ineligible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AIDS Malignancy Consortiumlead
- National Cancer Institute (NCI)collaborator
Study Sites (16)
Moores UCSD Cancer Center
La Jolla, California, 92903, United States
George Washington University Cancer Center
Washington D.C., District of Columbia, 20037, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Weill Cornell Medicine - Cornell Clinical Trials Unit
New York, New York, 10010, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Abramson Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute - University of Utah
Salt Lake City, Utah, 84112, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
University of Puerto Rico
San Juan, 00921, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Deukwoo Kwon
- Organization
- Consortium for Advancing Management and Prevention of Cancer in People with HIV
Study Officials
- STUDY CHAIR
Anna E Coghill, PhD, MPH
AIDS Malignancy Consortium
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2022
First Posted
August 22, 2022
Study Start
July 25, 2023
Primary Completion
February 28, 2025
Study Completion
June 2, 2025
Last Updated
March 25, 2026
Results First Posted
March 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share