Clinical trial NCT05531799: Anal HSIL Screening Algorithm
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
Overall status: RECRUITING
Phase: NA
Conditions: Anal High-grade Squamous Intraepithelial Lesion
Keywords: Anal cytology
Human papillomavirus(HPV)
High resolution anoscopy (HRA)
Lead sponsor: Institute of HIV Research and Innovation Foundation, Thailand
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: amfAR, The Foundation for AIDS Research
First posted: 2022-09-08
Enrollment: 950
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Identify new cases of anal HSIL by Anal HSIL screening algorithm
timeFrame: 18 months
measure: Compare anal HSIL screening method to new anal HSIL screening method algorithm
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pathum wan
country: Thailand
facility: Institute of HIV Research and Innovation
state: Bangkok
Study officials:
affiliation: Institute of HIV Research and Innovation
name: Nittaya Phanuphak, MD,PhD.
role: PRINCIPAL_INVESTIGATOR
References: