Clinical study to evaluate the efficacy and tolerability of the Meneguetti brush for self-collection of anal specimens to screen for anal cancer and sexually transmitted infections

Not Applicable

• Conditions: Anal Cancer; Sexually Transmitted Diseases (STD); C04.588.274.476.411.307.790

• Registration Number: RBR-6nxst93
• Lead Sponsor: Instituto Nacional de Infectologia Evandro Chagas - Fiocruz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-09
• Last Update Posted: 29 May 2023
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

We will include participants 18 years or older, with no history of anal cancer or pelvic radiotherapy, who did not participate in Phase 1 of the study, who are being followed up for HIV or HIV prevention at the Instituto Nacional de Infectologia Evandro Chagas-INI/Fiocruz.

Exclusion Criteria

Participants under the age of 18, participants who have had topical anal medication within the past 30 days or surgical treatment within the past 6 months, anal cytology performed within the past 3 months, or who have anal complaints at the time of recruitment.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate that the sample obtained by means of the Meneguetti brush is suitable for analysis by liquid cytology.

Secondary Outcome Measures

Name	Time	Method
Demonstrate the safety of the brush to allow collection in the home environment and basic health units or in clinical analysis laboratories.