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Clinical Trials/NCT05531799
NCT05531799RecruitingNot Applicable

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

Institute of HIV Research and Innovation Foundation, Thailand2 sites in 1 country950 target enrollmentStarted: May 18, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
950
Locations
2
Primary Endpoint
Compare anal HSIL screening method to new anal HSIL screening method algorithm

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
30 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Institute of HIV Research and Innovation Foundation, Thailand
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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