Human Papillomavirus InfectionNCT03032575
Anal HPV Infection and Risk for Anal High-grade Squamous Intraepithelial Lesion Among Thai MSM With Acute HIV Infection
A study testing SEARCH010/RV254 in people with Human Papillomavirus Infection, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial summary
1. To determine the prevalence and incidence of anal HSIL and associated risk factors among MSM who initiate ART during AHI. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- SEARCH010/RV254
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2017to Oct 2023
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or above.
- Born biological male.
- Self-identifies as MSM or transgender woman.
- Enrolled in the SEARCH010/RV254 cohort.
- In the stage of acute HIV infection diagnosed within 7 days (Fiebig I-V).
- Agrees to start ART during acute HIV infection.
- Had sex with a male partner at least once in the previous 3 months
- Consents to participate in the study
Who cannot join
- 1. Any history of previous HSIL diagnosis or treatment.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
The Thai Red Cross AIDS Research Centre
Pathum Wan, Bangkok, 10330
About this study
Official title: SEARCH Thailand and Thai Red Cross AIDS Research Centre
- To determine the prevalence and incidence of anal HSIL and associated risk factors among MSM who initiate ART during AHI.
Read the detailed description
Anal human papillomavirus (HPV) infection is very common in men who have sex with men (MSM).1-3 HIV-positive MSM have a higher prevalence of anal HPV infection than HIV-negative MSM and are more likely to have infection with multiple HPV types.1,2 Spontaneous clearance of anal HPV infection is less common among HIV- positive compared with HIV-negative MSM.2 Persistent anal HPV infection, particularly with high-risk HPV types, is an important risk factor for the development of anal cancer.4-6 The incidence of anal cancer among HIV-positive MSM is very high, ranging from 75 to 137 per 100,000 person-years, and is five times higher than that in HIV-negative MSM.7-10 Anal high-grade squamous intraepithelial lesion (HSIL) is the putative precursor of anal cancer.11-13 Anal squamous intraepithelial lesion has a dynamic picture of temporal progression and regression, but HSIL is much less likely to regress than low-grade squamous intraepithelial lesion (LSIL).10,14 A recent systematic review and meta-analysis showed the pooled prevalence of anal HSIL to be 29.1% in HIV-positive MSM and 21.5% in HIV-negative MSM.15 Anal HSIL incidence ranged from 8.5 to 15.4% per year in HIV-positive MSM and 3.3 to 6.0% per year in HIV-negative MSM. Although data are limited, previous studies have shown a 9-15% progression rate from anal HSIL to anal cancer during a median follow-up of 3 - 5 years. 11-13 Previous research at the Thai Red Cross AIDS Research Centre has demonstrated high rates of HPV infection and anal HSIL among Thai MSM, with HIV-positive MSM disproportionately affected. Prevalence of anal infection with high-risk HPV types was 57.5% in HIV-positive and 36.6% in HIV-negative MSM (p = 0.008).16 Prevalence of anal HSIL was 18.9% in HIV-positive MSM and 11.4% in HIV-negative MSM (p = 0.1), while incidence of anal HSIL over 12 months was 29% and 8%, respectively (p=0.001).17 HIV-positive MSM in that study, however, were mainly naïve to antiretroviral therapy (ART) at enrollment (87% not on ART) and only 10% had undetectable HIV viral load at baseline.
It is not clear if the higher rates of HPV infection and persistence of infection are due to HIV infection or to different risk behavior among HIV-positive MSM. Data are inconclusive on whether the use of ART has an effect on anal HPV infection among HIV-positive MSM.18-19 Furthermore, there is no data on the effect that "early diagnosis" of HIV infection and "early treatment" with ART might have on incidence and persistence of HPV infection or on the development of anal HSIL.
We propose a longitudinal, observational study of HPV infection and anal HSIL among HIV-positive Thai MSM who initiate ART during acute HIV infection (AHI). The hypothesis is that early HIV diagnosis and early ART within the first 4 weeks of infection will mitigate immunological and virological factors that increase HPV persistence and anal HSIL incidence in HIV-positive MSM such that these measure will be significantly lower when compared to historical controls of chronically-infected HIV-positive Thai MSM.
- Conditions
- Human Papillomavirus Infection
- Being tested
- SEARCH010/RV254
- Keywords
- HIV
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEARCH010/RV254Behavioural
| Study group | Role | What they receive |
|---|---|---|
| sample size 100 | Other | Study Design: This is a prospective observational cohort of Thai MSM who initiated ART at the time of AHI, defined as the first 30 days after HIV acquisition (Fiebig stages 1 through 5). Volunteers will be examined at baseline to determine the prevalence of HPV infection and HSIL at HIV diagnosis. They will then be followed longitudinally for new incidence of HPV and HSIL, as well as progression or regression of existing lesions. Receives: Behavioral: SEARCH010/RV254 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence and incidence of anal HSIL among MSM who initiate ART during AHI will be lower than among chronically-infected HIV-positive MSM, Anal HSIL is diagnosed based on histology specimen and cytology (2001 Bethesda system)
The prevalence of anal HSIL and the incidence of anal HSIL during the follow-up period. Anal HSIL is diagnosed based on histology specimen. A composite anal HSIL outcome (including both cytologic HSIL/ASC-H and histologic HSIL) will also be used.
Incidence of HSIL during the follow-up period will be calculated as the number of new diagnoses per person time at risk. 95% confidence intervals (CI) will be calculated assuming a Poisson distribution. Cox proportional hazards regression will be used to identify factors associated with incident HSIL.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2022
- Study completionOct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus InfectionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- SEARCH Research Foundation, amfAR, The Foundation for AIDS Research, TREAT Asia
- Responsible party
- Sponsor
- Investigators
- Nittaya Phanuphak, M.D.,Ph.D., Principal investigator, Thai Red Cross AIDS Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032575
- Sponsor's protocol ID
- HPV in MSM with AHI
- Status last verified
- Apr 2024
- First submitted
- 17 Jan 2017
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thitipatarakorn S, Teeratakulpisarn N, Nonenoy S, Klinsukontakul A, Suriwong S, Makphol J, Hongchookiat P, Chaya-Ananchot T, Chinlaertworasiri N, Mingkwanrungruang P, Sacdalan C, Poltavee K, Pankam T, Kerr SJ, Ramautarsing R, Colby D, Phanuphak N. Prevalence and incidence of anal high-grade squamous intraepithelial lesions in a cohort of cisgender men and transgender women who have sex with men diagnosed and treated during acute HIV acquisition in Bangkok, Thailand. J Int AIDS Soc. 2024 May;27(5):e26242. doi: 10.1002/jia2.26242.
PubMed 38695517
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEARCH Thailand and Thai Red Cross AIDS Research Centre
- ClinicalTrials.gov ID
- NCT03032575
- Acronym / sponsor ID
- HPV in MSM with AHI
- Conditions
- Human Papillomavirus Infection
- Keywords
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- SEARCH Research Foundation, amfAR, The Foundation for AIDS Research, TREAT Asia
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Oct 2023 (actual)
- First posted
- 26 Jan 2017 (estimated)
- 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.
- To determine the prevalence and incidence of anal HSIL and associated risk factors among MSM who initiate ART during AHI.
Detailed description
Anal human papillomavirus (HPV) infection is very common in men who have sex with men (MSM).1-3 HIV-positive MSM have a higher prevalence of anal HPV infection than HIV-negative MSM and are more likely to have infection with multiple HPV types.1,2 Spontaneous clearance of anal HPV infection is less common among HIV- positive compared with HIV-negative MSM.2 Persistent anal HPV infection, particularly with high-risk HPV types, is an important risk factor for the development of anal cancer.4-6 The incidence of anal cancer among HIV-positive MSM is very high, ranging from 75 to 137 per 100,000 person-years, and is five times higher than that in HIV-negative MSM.7-10 Anal high-grade squamous intraepithelial lesion (HSIL) is the putative precursor of anal cancer.11-13 Anal squamous intraepithelial lesion has a dynamic picture of temporal progression and regression, but HSIL is much less likely to regress than low-grade squamous intraepithelial lesion (LSIL).10,14 A recent systematic review and meta-analysis showed the pooled prevalence of anal HSIL to be 29.1% in HIV-positive MSM and 21.5% in HIV-negative MSM.15 Anal HSIL incidence ranged from 8.5 to 15.4% per year in HIV-positive MSM and 3.3 to 6.0% per year in HIV-negative MSM. Although data are limited, previous studies have shown a 9-15% progression rate from anal HSIL to anal cancer during a median follow-up of 3 - 5 years. 11-13 Previous research at the Thai Red Cross AIDS Research Centre has demonstrated high rates of HPV infection and anal HSIL among Thai MSM, with HIV-positive MSM disproportionately affected. Prevalence of anal infection with high-risk HPV types was 57.5% in HIV-positive and 36.6% in HIV-negative MSM (p = 0.008).16 Prevalence of anal HSIL was 18.9% in HIV-positive MSM and 11.4% in HIV-negative MSM (p = 0.1), while incidence of anal HSIL over 12 months was 29% and 8%, respectively (p=0.001).17 HIV-positive MSM in that study, however, were mainly naïve to antiretroviral therapy (ART) at enrollment (87% not on ART) and only 10% had undetectable HIV viral load at baseline.
It is not clear if the higher rates of HPV infection and persistence of infection are due to HIV infection or to different risk behavior among HIV-positive MSM. Data are inconclusive on whether the use of ART has an effect on anal HPV infection among HIV-positive MSM.18-19 Furthermore, there is no data on the effect that "early diagnosis" of HIV infection and "early treatment" with ART might have on incidence and persistence of HPV infection or on the development of anal HSIL.
We propose a longitudinal, observational study of HPV infection and anal HSIL among HIV-positive Thai MSM who initiate ART during acute HIV infection (AHI). The hypothesis is that early HIV diagnosis and early ART within the first 4 weeks of infection will mitigate immunological and virological factors that increase HPV persistence and anal HSIL incidence in HIV-positive MSM such that these measure will be significantly lower when compared to historical controls of chronically-infected HIV-positive Thai MSM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sample size 100 | Other | Behavioral: SEARCH010/RV254Study Design: This is a prospective observational cohort of Thai MSM who initiated ART at the time of AHI, defined as the first 30 days after HIV acquisition (Fiebig stages 1 through 5). Volunteers will be examined at baseline to determine the prevalence of HPV infection and HSIL at HIV diagnosis. They will then be followed longitudinally for new incidence of HPV and HSIL, as well as progression or regression of existing lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or above.
- Born biological male.
- Self-identifies as MSM or transgender woman.
- Enrolled in the SEARCH010/RV254 cohort.
- In the stage of acute HIV infection diagnosed within 7 days (Fiebig I-V).
Key exclusion criteria (1 listed)
- 1. Any history of previous HSIL diagnosis or treatment.
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 |
|---|---|---|
| SEARCH010/RV254 | Behavioural | sample size 100 |
Primary outcome
The prevalence and incidence of anal HSIL among MSM who initiate ART during AHI will be lower than among chronically-infected HIV-positive MSM, Anal HSIL is diagnosed based on histology specimen and cytology (2001 Bethesda system)
Time frame: 12 months
The prevalence of anal HSIL and the incidence of anal HSIL during the follow-up period. Anal HSIL is diagnosed based on histology specimen. A composite anal HSIL outcome (including both cytologic HSIL/ASC-H and histologic HSIL) will also be used. Incidence of HSIL during the follow-up period will be calculated as the number of new diagnoses per person time at risk. 95% confidence intervals (CI) will be calculated assuming a Poisson distribution. Cox proportional hazards regression will be used to identify factors associated with incident HSIL.
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 25 Nov 2024.
- Derived from this study: PubMed 38695517Thitipatarakorn S, Teeratakulpisarn N, Nonenoy S, Klinsukontakul A, Suriwong S, Makphol J, Hongchookiat P, Chaya-Ananchot T, Chinlaertworasiri N, Mingkwanrungruang P, Sacdalan C, Poltavee K, Pankam T, Kerr SJ, Ramautarsing R, Colby D, Phanuphak N. Prevalence and incidence of anal high-grade squamous intraepithelial lesions in a cohort of cisgender men and transgender women who have sex with men diagnosed and treated during acute HIV acquisition in Bangkok, Thailand. J Int AIDS Soc. 2024 May;27(5):e26242. doi: 10.1002/jia2.26242.
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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, M.D.,Ph.D. principal investigator
Thai Red Cross AIDS Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEARCH010/RV254 in people with Human Papillomavirus Infection, run by Thai Red Cross AIDS Research Centre 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 1 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 25 Nov 2024. 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?
The prevalence and incidence of anal HSIL among MSM who initiate ART during AHI will be lower than among chronically-infected HIV-positive MSM, Anal HSIL is diagnosed based on histology specimen and cytology (2001 Bethesda system) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03032575, which also lists 1 linked publication.
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 25 Nov 2024.