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Anal HSIL Screening Algorithm

NCT05531799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 950

Last updated 2026-04-02

No results posted yet for this study

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

Interventions

PROCEDURE

OPTIMIZATION PHASE

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • amfAR, The Foundation for AIDS Research

    collaborator OTHER

  • Institute of HIV Research and Innovation Foundation, Thailand

    lead OTHER

Principal Investigators

  • Nittaya Phanuphak, MD,PhD. · Institute of HIV Research and Innovation

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2025-12-20
Completion
2026-03-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05531799 on ClinicalTrials.gov