Health-Related Symptom Questionnaires in Measuring Quality of Life in HIV-Infected Participants Treated or Monitored for Anal Lesions

Study Overview
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Brief Summary
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This research trial studies health-related symptom questionnaires in measuring quality of life in human immunodeficiency virus (HIV)-infected participants treated with or monitored for anal lesions. Collecting information and symptoms from patients diagnosed with anal lesions may help reduce the risk of anal cancer.

Detailed Description
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PRIMARY OBJECTIVES: I. To develop an Anal Cancer/HSIL Outcomes Research Study (ANCHOR) high-grade squamous intraepithelial lesion (HSIL) health-related quality of life (HRQoL) Index (HQI) using state-of-the-art measure development methodology that captures the most important HRQoL symptoms and concerns of those persons diagnosed with anal HSIL and either treated or untreated for anal HSIL. OUTLINE: Participants complete the ANCHOR HSIL HRQoL interview over 45-60 minutes, comparing the list of symptoms, concerns, or HRQOL impacts related to HSIL diagnosis and treatment. Some patients also complete a cognitive interview for up to 3 sessions.

Official Title
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Development of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)

Conditions
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HIV Infection, High Grade Anal Canal Squamous Intraepithelial Neoplasia

Intervention / Treatment
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* Other: Concept Elicitation
* Other: Comprehension Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-1 infection Biopsy-proven anal HSIL within the prior six months Life expectancy of greater than 5 years Exclusion Criteria: History of anal cancer Inability to understand a written consent form

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (ANCHOR HRQoL interview, cognitive interview)<br>Participants complete the ANCHOR HSIL HRQoL interview over 45-60 minutes, comparing the list of symptoms, concerns, or HRQOL impacts related to HSIL diagnosis and treatment. Some patients also undergo a cognitive interview for up to 3 sessions. | Other: Concept Elicitation<br>* Complete cognitive interview to elicit relevant HSIL symptoms, compare to study index of symptoms, and rank symptoms in relation to effect on health-related quality of life<br>* Other names: Cognitive Interview;Other: Comprehension Assessment<br>* Comprehension assessment of draft quality of life assessment<br>* Other names: Cognitive Interview;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of an HQI using state-of-the-art measure development methodology that captures the most important HRQoL symptoms and concerns of those persons diagnosed with anal HSIL and either treated or untreated for anal HSIL. |  | Up to 4 months |