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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Thailand
Institute of HIV Research and Innovation
RECRUITING
Pathum Wan
Contact Information
Primary
Nittaya Phanuphak, MD,PhD.
nittaya.p@ihri.org
661 825 3544
Backup
Siriporn Nonenoy, RN.MPH.
siriporn.n@ihri.org
661 818 4143
Time Frame
Start Date: 2022-05-18
Estimated Completion Date: 2029-12-30
Participants
Target number of participants: 950
Treatments
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
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
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
Other: Group 4 DARE/CYTOLOGY
Participant request physician assessment for Digital anal rectal exam, Anal cytology for every 6 months within 12 months period
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
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
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
Other: Group 8 DARE
Participant request physician assessment for Digital anal rectal exam for every 6 months within 12 months period
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
Other: Self-collection CYTOLOGY
Participant request Self-sampling collection for Anal cytology for every 6 months within 12 months period
Other: Self-collection HPV
Participant request Self-sampling collection for Anal HPV test for every 6 months within 12 months period
Other: Self-collection control group CYTOLOGY/HPV
Participant request Self-sampling collection for Anal cytology and Anal HPV only at month 12
Related Therapeutic Areas
Sponsors
Collaborators: National Institutes of Health (NIH), amfAR, The Foundation for AIDS Research
Leads: Institute of HIV Research and Innovation Foundation, Thailand

This content was sourced from clinicaltrials.gov