Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
950 participants
INTERVENTIONAL
2022-05-18
2029-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SCREENING
NONE
Study Groups
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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
OPTIMIZATION PHASE
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
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
OPTIMIZATION PHASE
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
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
OPTIMIZATION PHASE
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
Group 4 DARE/CYTOLOGY
Participant request physician assessment for Digital anal rectal exam, Anal cytology for every 6 months within 12 months period
OPTIMIZATION PHASE
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
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
OPTIMIZATION PHASE
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
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
OPTIMIZATION PHASE
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
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
OPTIMIZATION PHASE
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
Group 8 DARE
Participant request physician assessment for Digital anal rectal exam for every 6 months within 12 months period
OPTIMIZATION PHASE
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
Self-collection CYTOLOGY/HPV
Participant request Self-sampling collection for Anal cytology and Anal HPV test for every 6 months within 12 months period
OPTIMIZATION PHASE
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
Self-collection CYTOLOGY
Participant request Self-sampling collection for Anal cytology for every 6 months within 12 months period
OPTIMIZATION PHASE
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
Self-collection HPV
Participant request Self-sampling collection for Anal HPV test for every 6 months within 12 months period
OPTIMIZATION PHASE
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
Self-collection control group CYTOLOGY/HPV
Participant request Self-sampling collection for Anal cytology and Anal HPV only at month 12
OPTIMIZATION PHASE
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
Interventions
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OPTIMIZATION PHASE
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
amfAR, The Foundation for AIDS Research
OTHER
Institute of HIV Research and Innovation Foundation, Thailand
OTHER
Responsible Party
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Principal Investigators
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Nittaya Phanuphak, MD,PhD.
Role: PRINCIPAL_INVESTIGATOR
Institute of HIV Research and Innovation
Locations
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Institute of HIV Research and Innovation
Pathum Wan, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IHRI013
Identifier Type: -
Identifier Source: org_study_id
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