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Completed

NCT Number: NCT05510908

Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC

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.

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Key information

Conditions

HIV-Associated Malignant Neoplasm AIDS Related Lymphoma AIDS-Related Kaposi Sarcoma AIDS-Related Malignancy Acquired Immunodeficiency Syndrome Anal Cancer Anus Diseases Anus Neoplasms Blood-Borne Infections Cancer Colorectal Neoplasms Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HIV Infections HPV-Related Malignancy Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Immunoproliferative Disorders Infections Intestinal Diseases Intestinal Neoplasms Lentivirus Infections Lymphatic Diseases Lymphoma Lymphoma, AIDS-Related Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Vascular Tissue RNA Virus Infections Rectal Diseases Rectal Neoplasms Retroviridae Infections Sarcoma Sarcoma, Kaposi Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Puerto Rico, San Juan, Puerto Rico

Loading trial locations.

About this study

Primary Objective: To estimate the number of cancers in people with HIV (PWH) who present for care at domestic AMC sites

Secondary Objectives: To characterize participants that are eligible but not enrolled onto AMC clinical trials to understand site-specific and trial-specific accrual barriers

Exploratory Objectives: 1. To standardize and expand the quantity and quality of sociodemographic and cancer diagnostic and treatment characteristics collected for PWH receiving care at domestic AMC sites. 2. To describe cancer patient health-related QOL for PWH at domestic AMC sites using validated tools: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30] and Supportive Care Needs Survey Short Form 34 [SCNS-SF34]

Outline: Participants identified via screening of electronic medical records or institutional databases. All eligible participants attend one visit for the collection of broad demographic and clinical data. Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit. Data collection at study visits will occur via survey procedures and/or medical record review.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

Exclusion criteria

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

Treatment and study plan

Non-Interventional

Other

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.

Non-Interventional Follow-up

Other

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.

Primary outcomes

  1. 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:

    • Solid organ tumors associated with human papillomavirus (HPV) infection
    • Solid organ tumors unrelated to HPV
    • Kaposi sarcoma
    • Hematologic malignancies

Secondary outcomes

  1. Proportion of Participants Eligible for AMC Trials Who Are Successfully Enrolled

    Time frame: 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.

Other outcomes

  1. Describe the Sociodemographic, HIV-related, and Cancer Diagnostic and Treatment Characteristics of Cancer Patients With HIV Receiving Care at Domestic AMC Sites.

    Time frame: Baseline and 12 weeks

    The distribution of participant characteristics will be summarized. Continuous variables [e.g. age, height, weight] will be summarized as mean (std) if they are normally distributed, otherwise they will be summarized as median (IQR). Categorical variables [e.g. tobacco use, ART medications, comorbidities] will be summarized as frequency (%).

  2. 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]

    Time frame: Baseline

    EORTC QLQ-C30 subscale and overall scores will be used to describe participant symptom and health-related quality of life burden. Baseline EORTC QLQ-C30 scores will be compared according to successful enrollment versus not. The EORTC QLQ-C30 is a 30-item core cancer specific questionnaire measuring QOL in cancer patients. It incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and single items assessing additional symptoms and perceived financial impact of the disease. Most questions use a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=higher response level.

  3. Describe the Supportive Care Needs of Cancer Patients With HIV at Domestic AMC Sites Using Supportive Care Needs Survey Short Form 34 [SCNS-SF34]

    Time frame: Baseline

    Supportive Care Needs Survey Short Form 34 [SCNS-SF34] scores will be used to categorize participants based on the degree to which their needs are met. Baseline SCNS-SF34 scores will be compared according to successful enrollment versus not. The SCNS-SF34 is a 34-item questionnaire measuring the supportive care need and level of need for people diagnosed with cancer in the last month. It incorporates the underlying domains: physical and daily living, psychological, sexuality and health system, information and patient support. All the questions use 5-point scale (1 'Not applicable' to 5 'High need); with a higher score indicating a higher level of need.

  4. Change of Quality of Life at 12 Weeks From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]

    Time frame: Baseline and 12 weeks

    EORTC QLQ-C30 will be summarized, both overall and at the ~12-week follow-up, according to participant characteristics and cancer groups. Overall change in QOL will be compared with paired tests and change according to groups will be compared using t-tests, ANOVA, or nonparametric tests. The EORTC QLQ-C30 is a 30-item core cancer specific questionnaire measuring QOL in cancer patients. It incorporates five functional scales (physical, role,cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms and perceived financial impact of the disease. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=higher response level.

  5. Change of Needs From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using Supportive Care Needs Short Survey Form 34 [SCNS-SF34]

    Time frame: Baseline and 12 weeks

    Supportive Care Needs Short Survey Form 34 [SCNS-SF34] scores will be summarized, both overall and at the ~12-week follow-up, according to participant characteristics and cancer groups. Overall change in scores will be compared with paired tests and change according to groups will be compared using t-tests, ANOVA, or nonparametric tests. The SCNS-SF34 is a 34-item questionnaire measuring the supportive care need and level of need for people diagnosed with cancer in the last month. It incorporates the underlying domains: physical and daily living, psychological, sexuality and health system, information and patient support. All the questions use 5-point scale (1 'Not applicable' to 5 'High need). Scores are averaged, and transformed to 0-100 scale;, with a higher score indicating a higher level of need.

  6. 3. State of Planned Cancer Therapy for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment

    Time frame: 12 weeks

    The frequency of planned cancer treatment regimens (at baseline) successfully initiated will be summarized.

Sponsors and collaborators

Lead sponsor

AIDS Malignancy Consortium

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2022
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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