HIV Infection Clinical Trial
Official title:
Development of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)
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.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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