Anal High-grade Squamous Intraepithelial Lesion0007/65NCT05531799
Anal HSIL Screening Algorithm
A study testing OPTIMIZATION PHASE in people with Anal High-grade Squamous Intraepithelial Lesion, run by Institute of HIV Research and Innovation Foundation, Thailand at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anal High-grade Squamous Intraepithelial Lesion
- What is being tested?
- OPTIMIZATION PHASE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 950 participants
- Where
- 1 siteThailand
- Study dates
- 18 May 2022to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Institute of HIV Research and Innovation
Pathum Wan, Bangkok, 10330
About this study
Official title: Optimizing an Anal High-grade Squamous Intraepithelial Lesion Screening Algorithm for Thai Men Who Have Sex With Men and Transgender Women
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.
Read the detailed description
- 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.
- Being tested
- OPTIMIZATION PHASE
- Keywords
- Anal cytology, Human papillomavirus(HPV), High resolution anoscopy (HRA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIMIZATION PHASEProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 DARE/CYTOLOGY/HPV/HRA | Other | 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 Receives: Procedure: OPTIMIZATION PHASE |
| Group 2 DARE/CYTOLOGY/HPV | Other | Participant request physician assessment for Digital anal rectal exam, Anal cytology, Anal HPV test for every 6 months within 12 months period Receives: Procedure: OPTIMIZATION PHASE |
| Group 3 DARE/CYTOLOGY/HRA | Other | Participant request physician assessment for Digital anal rectal exam, Anal cytology and High resolution anoscopy for every 6 months within 12 months period Receives: Procedure: OPTIMIZATION PHASE |
| Group 4 DARE/CYTOLOGY | Other | Participant request physician assessment for Digital anal rectal exam, Anal cytology for every 6 months within 12 months period Receives: Procedure: OPTIMIZATION PHASE |
| Group 5 DARE/HPV/HRA | Other | Participant request physician assessment for Digital anal rectal exam, Anal HPV test and High resolution anoscopy for every 6 months within 12 months period Receives: Procedure: OPTIMIZATION PHASE |
| Group 6 DARE/HPV | Other | Participant request physician assessment for Digital anal rectal exam and Anal HPV test for every 6 months within 12 months period Receives: Procedure: OPTIMIZATION PHASE |
| Group 7 DARE/HRA | Other | Participant request physician assessment for Digital anal rectal exam and High resolution anoscopy for every 6 months within 12 months period Receives: Procedure: OPTIMIZATION PHASE |
| Group 8 DARE | Other | Participant request physician assessment for Digital anal rectal exam for every 6 months within 12 months period Receives: Procedure: OPTIMIZATION PHASE |
| Self-collection CYTOLOGY/HPV | Other | Participant request Self-sampling collection for Anal cytology and Anal HPV test for every 6 months within 12 months period Receives: Procedure: OPTIMIZATION PHASE |
| Self-collection CYTOLOGY | Other | Participant request Self-sampling collection for Anal cytology for every 6 months within 12 months period Receives: Procedure: OPTIMIZATION PHASE |
| Self-collection HPV | Other | Participant request Self-sampling collection for Anal HPV test for every 6 months within 12 months period Receives: Procedure: OPTIMIZATION PHASE |
| Self-collection control group CYTOLOGY/HPV | Other | Participant request Self-sampling collection for Anal cytology and Anal HPV only at month 12 Receives: Procedure: OPTIMIZATION PHASE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify new cases of anal HSIL by Anal HSIL screening algorithm
identify anal HSIL in at least 20% of HIV-positive MSM/TGW and 10% of HIV-negative MSM/TGW within visit schedule.
Measured: 18 months
Compare anal HSIL screening method to new anal HSIL screening method algorithm
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start18 May 2022
- Primary completion20 Dec 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal High-grade Squamous Intraepithelial LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 950 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, Thailand
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), amfAR, The Foundation for AIDS Research
- Responsible party
- Sponsor
- Investigators
- Nittaya Phanuphak, MD,PhD., Principal investigator, Institute of HIV Research and Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531799
- Sponsor's protocol ID
- IHRI013
- Acronym
- 0007/65
- Status last verified
- Apr 2026
- First submitted
- 8 Jun 2022
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing an Anal High-grade Squamous Intraepithelial Lesion Screening Algorithm for Thai Men Who Have Sex With Men and Transgender Women
- ClinicalTrials.gov ID
- NCT05531799
- Acronym / sponsor ID
- 0007/65 / IHRI013
- Keywords
- Anal cytology, Human papillomavirus(HPV), High resolution anoscopy (HRA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 950 participants (actual)
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, ThailandUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), amfAR, The Foundation for AIDS Research
- Study start
- 18 May 2022 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Group 1 DARE/CYTOLOGY/HPV/HRA | Other | Procedure: OPTIMIZATION PHASEParticipant 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 |
| Group 2 DARE/CYTOLOGY/HPV | Other | Procedure: OPTIMIZATION PHASEParticipant request physician assessment for Digital anal rectal exam, Anal cytology, Anal HPV test for every 6 months within 12 months period |
| Group 3 DARE/CYTOLOGY/HRA | Other | Procedure: OPTIMIZATION PHASEParticipant request physician assessment for Digital anal rectal exam, Anal cytology and High resolution anoscopy for every 6 months within 12 months period |
| Group 4 DARE/CYTOLOGY | Other | Procedure: OPTIMIZATION PHASEParticipant request physician assessment for Digital anal rectal exam, Anal cytology for every 6 months within 12 months period |
| Group 5 DARE/HPV/HRA | Other | Procedure: OPTIMIZATION PHASEParticipant request physician assessment for Digital anal rectal exam, Anal HPV test and High resolution anoscopy for every 6 months within 12 months period |
| Group 6 DARE/HPV | Other | Procedure: OPTIMIZATION PHASEParticipant request physician assessment for Digital anal rectal exam and Anal HPV test for every 6 months within 12 months period |
| Group 7 DARE/HRA | Other | Procedure: OPTIMIZATION PHASEParticipant request physician assessment for Digital anal rectal exam and High resolution anoscopy for every 6 months within 12 months period |
| Group 8 DARE | Other | Procedure: OPTIMIZATION PHASEParticipant request physician assessment for Digital anal rectal exam for every 6 months within 12 months period |
| Self-collection CYTOLOGY/HPV | Other | Procedure: OPTIMIZATION PHASEParticipant request Self-sampling collection for Anal cytology and Anal HPV test for every 6 months within 12 months period |
| Self-collection CYTOLOGY | Other | Procedure: OPTIMIZATION PHASEParticipant request Self-sampling collection for Anal cytology for every 6 months within 12 months period |
| Self-collection HPV | Other | Procedure: OPTIMIZATION PHASEParticipant request Self-sampling collection for Anal HPV test for every 6 months within 12 months period |
| Self-collection control group CYTOLOGY/HPV | Other | Procedure: OPTIMIZATION PHASEParticipant request Self-sampling collection for Anal cytology and Anal HPV only at month 12 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Has worked in the study clinic during phase III
- Involved in health policy development in Thailand
Key exclusion criteria (7 listed)
- 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.
- Not willing to participate in the evaluation
- Not willing to participate in the evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPTIMIZATION PHASEThe 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 | Procedure or surgery | Group 1 DARE/CYTOLOGY/HPV/HRA, Group 2 DARE/CYTOLOGY/HPV, Group 3 DARE/CYTOLOGY/HRA, Group 4 DARE/CYTOLOGY, Group 5 DARE/HPV/HRA, Group 6 DARE/HPV, Group 7 DARE/HRA, Group 8 DARE, Self-collection CYTOLOGY, Self-collection CYTOLOGY/HPV, Self-collection HPV, Self-collection control group CYTOLOGY/HPV |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
Related trials for Anal High-grade Squamous Intraepithelial Lesion
RecruitingPhase 2
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
Active, not recruitingObservational study
Anal High-risk HPV, HSIL, and Microbiome Among Hispanic Peoples Living With HIV (PLWH)
Human Immunodeficiency Virus, Human Papillomavirus-Related Anal Squamous Cell Carcinoma
Not yet recruitingPhase 1
Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV
Human Papilloma Virus, Human Immunodeficiency Virus
RecruitingPhase 1
Safety of Anal Curcumin
Anal High Grade Squamous Intraepithelial Lesion
Recruiting
Screening for Anal Cancer in Men Who Have Sex With Men Using Pre-Exposure Prophylaxis
Anal Cancer, Squamous Intraepithelial Lesions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nittaya Phanuphak, MD,PhD. principal investigator
Institute of HIV Research and Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPTIMIZATION PHASE in people with Anal High-grade Squamous Intraepithelial Lesion, run by Institute of HIV Research and Innovation Foundation, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify new cases of anal HSIL by Anal HSIL screening algorithm (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.