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Completed

NCT Number: NCT05531799

Anal HSIL Screening Algorithm

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.

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Key information

Conditions

Anal High-grade Squamous Intraepithelial Lesion

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of HIV Research and Innovation

Pathum Wan, Bangkok, 10330, Thailand

About this study

I. PREPARATION PHASE Purpose To lay groundwork for optimization of anal high-grade squamous intraepithelial lesion screening algorithm for MSM, and identify which test and component(s) should be included in the anal HSIL screening algorithm.

II. OPTIMIZATION PHASE Purpose To form an anal high-grade squamous intraepithelial lesion screening algorithm that meets the optimization criteria.

III. EVALUATION PHASE Purpose To establish whether the optimized anal high-grade squamous intraepithelial lesion screening algorithm has a statistically significant effect on service uptake among MSM compared to the standard of care.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Clients for MSM and TGW:

  • Unable to perform any study procedures, or unable to commit to attend all study visits.
  • Had Anal cancer lesion at enrollment visit, this exclusion for participation in phase II study.

Clinic staff:

  • Not willing to participate in the evaluation

Government stakeholders:

  • Not willing to participate in the evaluation

Treatment and study plan

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

Primary outcomes

  1. Identify new cases of anal HSIL by Anal HSIL screening algorithm

    Time frame: 18 months

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

  2. Compare anal HSIL screening method to new anal HSIL screening method algorithm

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

Institute of HIV Research and Innovation Foundation, Thailand

Other

Collaborators

  • National Institutes of Health (NIH)
  • amfAR, The Foundation for AIDS Research

Registry information

Official study title

Optimizing an Anal High-grade Squamous Intraepithelial Lesion Screening Algorithm for Thai Men Who Have Sex With Men and Transgender Women

Acronym: 0007/65

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Sep 8, 2022
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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