Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Squamous Intraepithelial Lesions of the Cervix

Carcinoma

Carcinoma, Squamous Cell

Carcinoma in Situ

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Cervical Intraepithelial Neoplasia

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

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

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

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

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

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

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

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

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

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

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

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

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

OPTIMIZATION PHASE

Nittaya Phanuphak, MD,PhD.

Siriporn Nonenoy, RN.MPH.

Nittaya Phanuphak, MD.,Ph.D.

Napasawan Chinlaertworasiri

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.

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.

Anal HSIL Screening Algorithm

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

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Anal HSIL Screening Algorithm	NCT05531799	Anal High-grade...	OPTIMIZATION PH...	30 Years -	Institute of HIV Research and Innovation Foundation, Thailand
Anal HSIL Screening Algorithm	NCT05531799	Anal High-grade...	OPTIMIZATION PH...	30 Years -	Institute of HIV Research and Innovation Foundation, Thailand

Spots Global Cancer Trial Database for human papillomavirus(hpv)