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Trial Title:
Anal HSIL Screening Algorithm
NCT ID:
NCT05531799
Condition:
Anal High-grade Squamous Intraepithelial Lesion
Conditions: Official terms:
Squamous Intraepithelial Lesions of the Cervix
Carcinoma, Squamous Cell
Carcinoma in Situ
Conditions: Keywords:
Anal cytology
Human papillomavirus(HPV)
High resolution anoscopy (HRA)
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
OPTIMIZATION PHASE
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
Arm group label:
Group 1 DARE/CYTOLOGY/HPV/HRA
Arm group label:
Group 2 DARE/CYTOLOGY/HPV
Arm group label:
Group 3 DARE/CYTOLOGY/HRA
Arm group label:
Group 4 DARE/CYTOLOGY
Arm group label:
Group 5 DARE/HPV/HRA
Arm group label:
Group 6 DARE/HPV
Arm group label:
Group 7 DARE/HRA
Arm group label:
Group 8 DARE
Arm group label:
Self-collection CYTOLOGY
Arm group label:
Self-collection CYTOLOGY/HPV
Arm group label:
Self-collection HPV
Arm group label:
Self-collection control group CYTOLOGY/HPV
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.
Criteria for 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
Gender:
All
Minimum age:
30 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Institute of HIV Research and Innovation
Address:
City:
Pathum wan
Zip:
10330
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Nittaya Phanuphak, MD.,Ph.D.
Phone:
+66 2 1605371
Email:
nittaya.p@ihri.org
Contact backup:
Last name:
Napasawan Chinlaertworasiri
Phone:
+66 2 1605371
Email:
napasawan@ihir.org
Start date:
April 20, 2022
Completion date:
December 30, 2029
Lead sponsor:
Agency:
Institute of HIV Research and Innovation Foundation, Thailand
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
amfAR, The Foundation for AIDS Research
Agency class:
Other
Source:
Institute of HIV Research and Innovation Foundation, Thailand
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05531799
