Anal HSIL Screening Algorithm (0007/65)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anal High-grade Squamous Intraepithelial Lesion
• Intervention / Treatment: Procedure: OPTIMIZATION PHASE

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 950
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nittaya Phanuphak, MD,PhD.; Phone Number: 661 825 3544; Email: nittaya.p@ihri.org
• Study Contact Backup: Name: Siriporn Nonenoy, RN.MPH.; Phone Number: 661 818 4143; Email: siriporn.n@ihri.org

Study Locations

• Thailand
  • Bangkok
    • Pathum wan, Bangkok, Thailand, 10330
      • Recruiting
      • Institute of HIV Research and Innovation
      • Contact: Nittaya Phanuphak, MD.,Ph.D.; Phone Number: +66 2 1605371; Email: nittaya.p@ihri.org
      • Contact: Napasawan Chinlaertworasiri; Phone Number: +66 2 1605371; Email: napasawan@ihir.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1 DARE/CYTOLOGY/HPV/HRA; 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; 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
Other: Group 2 DARE/CYTOLOGY/HPV; 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; 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
Other: Group 3 DARE/CYTOLOGY/HRA; 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; 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
Other: Group 4 DARE/CYTOLOGY; Participant request physician assessment for Digital anal rectal exam, Anal cytology for every 6 months within 12 months period	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
Other: Group 5 DARE/HPV/HRA; 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; 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
Other: Group 6 DARE/HPV; Participant request physician assessment for Digital anal rectal exam and Anal HPV test for every 6 months within 12 months period	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
Other: Group 7 DARE/HRA; Participant request physician assessment for Digital anal rectal exam and High resolution anoscopy for every 6 months within 12 months period	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
Other: Group 8 DARE; Participant request physician assessment for Digital anal rectal exam for every 6 months within 12 months period	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
Other: Self-collection CYTOLOGY/HPV; Participant request Self-sampling collection for Anal cytology and Anal HPV test for every 6 months within 12 months period	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
Other: Self-collection CYTOLOGY; Participant request Self-sampling collection for Anal cytology for every 6 months within 12 months period	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
Other: Self-collection HPV; Participant request Self-sampling collection for Anal HPV test for every 6 months within 12 months period	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
Other: Self-collection control group CYTOLOGY/HPV; Participant request Self-sampling collection for Anal cytology and Anal HPV only at month 12	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institute of HIV Research and Innovation Foundation, Thailand
• Collaborators: National Institutes of Health (NIH); amfAR, The Foundation for AIDS Research
• Investigators: Principal Investigator: Nittaya Phanuphak, MD,PhD., Institute of HIV Research and Innovation

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Anal cytology; Human papillomavirus(HPV); High resolution anoscopy (HRA)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Cervical Diseases; Uterine Diseases; Precancerous Conditions; Neoplasms, Squamous Cell; Uterine Cervical Dysplasia; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Carcinoma in Situ; Carcinoma, Squamous Cell; Squamous Intraepithelial Lesions of the Cervix
• Other Study ID Numbers: IHRI013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No