Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men

Not Applicable

Completed

• Conditions: Anal Cancer; Nonneoplastic Condition; Precancerous Condition
• Interventions: Other: Papanicolaou test

• Registration Number: NCT00955591
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

RATIONALE: Doctors use a swab to collect cell samples when testing for anal cancer and human papillomavirus. It is not yet known which type of swab is more effective in collecting cell samples for anal Pap tests and human papillomavirus tests in men who have sex with men.

PURPOSE: This clinical trial is comparing two types of swabs in collecting cell samples for anal Pap tests and human papillomavirus tests in men who have sex with men.

Detailed Description

OBJECTIVES:

* To determine whether the anal cytology screening outcome derived from specimens collected by a flocked nylon swab are equivalent to those derived from Dacron swab specimens in men who have sex with men.

* To determine whether the number and type-specific identification for human papillomavirus derived from specimens collected by a flocked nylon swab are equivalent to those derived from Dacron swab specimens.

OUTLINE: Dry sterile Dacron swabs and flocked nylon swabs are used to collect intra-anal cytology specimens for anal Pap testing and human papillomavirus typing. Participants undergo a digital rectal examination and high-resolution anoscopy. If lesions are identified, an anal biopsy is performed for histological examination.

Study Timeline

• Study Start: 2009-03-12
• Study First Submitted: 2009-08-07
• Study First Submitted QC: 2009-08-07
• Study First Posted: 2009-08-10
• Primary Completion: 2011-12-12
• Status Verified: 2016-09
• Study Completion: 2016-10-14
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

• HIV-infected or -uninfected adult men who have sex with men
• Concurrent enrollment in the Multicenter AIDS Cohort Study required

Exclusion Criteria

• history of anal perforation or other medical contraindications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
swab test	Papanicolaou test	-

Primary Outcome Measures

Name	Time	Method
Comparison of anal cytology screening outcome derived from specimens collected by a flocked nylon swab vs a Dacron swab	a day

Trial Locations

Locations (1)

UCLA; 🇺🇸 Los Angeles, California, United States