Clinical trial · Observational
Health-Related Symptom Questionnaires in Measuring Quality of Life in HIV-Infected Participants Treated or Monitored for Anal Lesions
Development of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)
NCT02418494CI-TRIAL-00022538completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Grade Anal Canal Squamous Intraepithelial Neoplasia | High Grade Anal Canal Intraepithelial Neoplasia | ALIAS | 0.90 |
| HIV Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comprehension Assessment | Other | — | UNRESOLVED |
| Concept Elicitation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (ANCHOR HRQoL interview, cognitive interview)
- description
- 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.
- interventionNames
- Other: Concept Elicitation
- Other: Comprehension Assessment
Primary outcomes (1)
- measure
- 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.
- timeFrame
- Up to 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.