Anal HSIL Screening Algorithm

NCT05531799 | Completed

• 1 other identifier: IHRI013
• Study Type: interventional
• Target: 950
• Locations: 1 country
• Sites: 1

Brief Summary

This the propose to use the Multiphase Optimization Strategy Trial (MOST) design to identify an anal HSIL screening algorithm which is most suitable in terms of effectiveness, efficiency, and economy. Specifically, The Investigators will use a factorial design as the main strategy in the MOST, as this allows the evaluation of multiple intervention components that are candidates for ultimate inclusion in the algorithm. The Investigators will then implement the most suitable anal HSIL screening algorithm in the clinic, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to guide its design, implementation, and evaluation. An interrupted time series will be used to compare anal HSIL screening uptake among men who have sex with men clients in the clinic, prior to and after the implementation of the new anal HSIL screening algorithm, and mixed-methods approaches will be used to evaluate components of the RE-AIM framework.

Conditions

Anal High-grade Squamous Intraepithelial Lesion

Keywords

Anal cytology; Human papillomavirus(HPV); High resolution anoscopy (HRA)

Outcome Measures

Primary Outcomes (2)

• Identify new cases of anal HSIL by Anal HSIL screening algorithm

  identify anal HSIL in at least 20% of HIV-positive MSM/TGW and 10% of HIV-negative MSM/TGW within visit schedule.

  18 months

• Compare anal HSIL screening method to new anal HSIL screening method algorithm

  Evaluate anal HSIL screening method uptake among MSM/TGW clients in the clinic compare to the implementation of the new anal HSIL screening method algorithm.

  24 months

Study Arms (12)

Group 1 DARE/CYTOLOGY/HPV/HRA

OTHER

Participant request physician assessment for Digital anal rectal exam, Anal cytology, Anal HPV test and High resolution anoscopy for every 6 months within 12 months period

Procedure: OPTIMIZATION PHASE

Group 2 DARE/CYTOLOGY/HPV

OTHER

Participant request physician assessment for Digital anal rectal exam, Anal cytology, Anal HPV test for every 6 months within 12 months period

Procedure: OPTIMIZATION PHASE

Group 3 DARE/CYTOLOGY/HRA

OTHER

Participant request physician assessment for Digital anal rectal exam, Anal cytology and High resolution anoscopy for every 6 months within 12 months period

Procedure: OPTIMIZATION PHASE

Group 4 DARE/CYTOLOGY

OTHER

Participant request physician assessment for Digital anal rectal exam, Anal cytology for every 6 months within 12 months period

Procedure: OPTIMIZATION PHASE

Group 5 DARE/HPV/HRA

OTHER

Participant request physician assessment for Digital anal rectal exam, Anal HPV test and High resolution anoscopy for every 6 months within 12 months period

Procedure: OPTIMIZATION PHASE

Group 6 DARE/HPV

OTHER

Participant request physician assessment for Digital anal rectal exam and Anal HPV test for every 6 months within 12 months period

Procedure: OPTIMIZATION PHASE

Group 7 DARE/HRA

OTHER

Participant request physician assessment for Digital anal rectal exam and High resolution anoscopy for every 6 months within 12 months period

Procedure: OPTIMIZATION PHASE

Group 8 DARE

OTHER

Participant request physician assessment for Digital anal rectal exam for every 6 months within 12 months period

Procedure: OPTIMIZATION PHASE

Self-collection CYTOLOGY/HPV

OTHER

Participant request Self-sampling collection for Anal cytology and Anal HPV test for every 6 months within 12 months period

Procedure: OPTIMIZATION PHASE

Self-collection CYTOLOGY

OTHER

Participant request Self-sampling collection for Anal cytology for every 6 months within 12 months period

Procedure: OPTIMIZATION PHASE

Self-collection HPV

OTHER

Participant request Self-sampling collection for Anal HPV test for every 6 months within 12 months period

Procedure: OPTIMIZATION PHASE

Self-collection control group CYTOLOGY/HPV

OTHER

Participant request Self-sampling collection for Anal cytology and Anal HPV only at month 12

Procedure: OPTIMIZATION PHASE

Interventions

OPTIMIZATION PHASE PROCEDURE

The goal of the optimization phase of MOST is to identify the most promising combination of experimental components in changing an outcome given a set of environmental constraints. Looking at effectiveness, efficiency, economy, and scalability criteria, we will focus on the proportion of anal HSIL identified (effectiveness), unit cost (efficiency and economy), and accumulating cost to the client over a 12-month period (economy). Meeting these criteria will likely imply scalability. The most appropriate anal HSIL screening algorithm would ideally be one which could \- identify anal HSIL in at least 20% of HIV-positive MSM and 10% of HIV-negative MSM at baseline and

Group 1 DARE/CYTOLOGY/HPV/HRA; Group 2 DARE/CYTOLOGY/HPV; Group 3 DARE/CYTOLOGY/HRA; Group 4 DARE/CYTOLOGY; Group 5 DARE/HPV/HRA; Group 6 DARE/HPV; Group 7 DARE/HRA; Group 8 DARE; Self-collection CYTOLOGY; Self-collection CYTOLOGY/HPV; Self-collection HPV; Self-collection control group CYTOLOGY/HPV

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clients for MSM and TGW:
• Thai nationality, men with self-identifies as MSM and/or TGW
• HIV-positive MSM/TGW aged 30 years or older or
• HIV-negative MSM/TGW aged 40 years or older
• Clinic staff:
• \- Has worked in the study clinic during phase III
• Government stakeholders:
• \- Involved in health policy development in Thailand

You may not qualify if:

• Clients for MSM and TGW:
• Unable to perform any study procedures, or unable to commit to attend all study visits.
• Clinic staff:
• \- Not willing to participate in the evaluation
• Government stakeholders:
• \- Not willing to participate in the evaluation

Sponsors & Collaborators

• Institute of HIV Research and Innovation Foundation, Thailand: lead
• National Institutes of Health (NIH): collaborator
• amfAR, The Foundation for AIDS Research: collaborator

Study Sites (1)

Institute of HIV Research and Innovation

Pathum Wan, Bangkok, 10330, Thailand

Location

Study Officials

• Nittaya Phanuphak, MD,PhD.

  Institute of HIV Research and Innovation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: September 8, 2022
• Study Start: May 18, 2022
• Primary Completion: December 20, 2025
• Study Completion: March 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

TH (1)