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Anal HSIL Screening Algorithm (0007/65)

Primary Purpose

Anal High-grade Squamous Intraepithelial Lesion

Status

Recruiting

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

OPTIMIZATION PHASE

About this trial

This is an interventional screening trial for Anal High-grade Squamous Intraepithelial Lesion focused on measuring Anal cytology, Human papillomavirus(HPV), High resolution anoscopy (HRA)

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Institute of HIV Research and InnovationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Other

Arm Label

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/HPV

Self-collection CYTOLOGY

Self-collection HPV

Self-collection control group CYTOLOGY/HPV

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05531799

First Posted

June 8, 2022

Last Updated

September 27, 2023

Sponsor

Institute of HIV Research and Innovation Foundation, Thailand

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05531799

Brief Title

Anal HSIL Screening Algorithm

Acronym

0007/65

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2022 (Actual)

Primary Completion Date

December 20, 2027 (Anticipated)

Study Completion Date

December 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of HIV Research and Innovation Foundation, Thailand

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anal High-grade Squamous Intraepithelial Lesion

Keywords

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

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

950 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 DARE/CYTOLOGY/HPV/HRA

Arm Type

Other

Arm Description

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

Arm Title

Group 2 DARE/CYTOLOGY/HPV

Arm Type

Other

Arm Description

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

Arm Title

Group 3 DARE/CYTOLOGY/HRA

Arm Type

Other

Arm Description

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

Arm Title

Group 4 DARE/CYTOLOGY

Arm Type

Other

Arm Description

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

Arm Title

Group 5 DARE/HPV/HRA

Arm Type

Other

Arm Description

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

Arm Title

Group 6 DARE/HPV

Arm Type

Other

Arm Description

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

Arm Title

Group 7 DARE/HRA

Arm Type

Other

Arm Description

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

Arm Title

Group 8 DARE

Arm Type

Other

Arm Description

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

Arm Title

Self-collection CYTOLOGY/HPV

Arm Type

Other

Arm Description

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

Arm Title

Self-collection CYTOLOGY

Arm Type

Other

Arm Description

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

Arm Title

Self-collection HPV

Arm Type

Other

Arm Description

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

Arm Title

Self-collection control group CYTOLOGY/HPV

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

OPTIMIZATION PHASE

Intervention Description

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 Outcome Measure Information:

Title

Identify new cases of anal HSIL by Anal HSIL screening algorithm

Description

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

Time Frame

18 months

Title

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

Description

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.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nittaya Phanuphak, MD,PhD.

Phone

661 825 3544

nittaya.p@ihri.org

First Name & Middle Initial & Last Name or Official Title & Degree

Siriporn Nonenoy, RN.MPH.

Phone

661 818 4143

siriporn.n@ihri.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nittaya Phanuphak, MD,PhD.

Organizational Affiliation

Institute of HIV Research and Innovation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of HIV Research and Innovation

City

Pathum wan

State/Province

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nittaya Phanuphak, MD.,Ph.D.

Phone

+66 2 1605371

nittaya.p@ihri.org

First Name & Middle Initial & Last Name & Degree

Napasawan Chinlaertworasiri

Phone

+66 2 1605371

napasawan@ihir.org

12. IPD Sharing Statement

Learn more about this trial

Anal HSIL Screening Algorithm

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