Anal HSIL Screening Algorithm (0007/65)

Institute of HIV Research and Innovation Foundation, Thailand

Status: Enrolling

Conditions: Anal High-grade Squamous Intraepithelial Lesion

Treatments: Procedure: OPTIMIZATION PHASE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05531799

IHRI013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 950 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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950 participants in 12 patient groups

Group 1 DARE/CYTOLOGY/HPV/HRA

Other group

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

Treatment:

Procedure: OPTIMIZATION PHASE

Group 2 DARE/CYTOLOGY/HPV

Other group

Description:

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

Treatment:

Procedure: OPTIMIZATION PHASE

Group 3 DARE/CYTOLOGY/HRA

Other group

Description:

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

Treatment:

Procedure: OPTIMIZATION PHASE

Group 4 DARE/CYTOLOGY

Other group

Description:

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

Treatment:

Procedure: OPTIMIZATION PHASE

Group 5 DARE/HPV/HRA

Other group

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

Treatment:

Procedure: OPTIMIZATION PHASE

Group 6 DARE/HPV

Other group

Description:

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

Treatment:

Procedure: OPTIMIZATION PHASE

Group 7 DARE/HRA

Other group

Description:

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

Treatment:

Procedure: OPTIMIZATION PHASE

Group 8 DARE

Other group

Description:

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

Treatment:

Procedure: OPTIMIZATION PHASE

Self-collection CYTOLOGY/HPV

Other group

Description:

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

Treatment:

Procedure: OPTIMIZATION PHASE

Self-collection CYTOLOGY

Other group

Description:

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

Treatment:

Procedure: OPTIMIZATION PHASE

Self-collection HPV

Other group

Description:

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

Treatment:

Procedure: OPTIMIZATION PHASE

Self-collection control group CYTOLOGY/HPV

Other group

Description:

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

Treatment:

Procedure: OPTIMIZATION PHASE