HPV TestingNCT02155231
Study on Anal Human Papillomavirus Infection and Anal Intraepithelial Neoplasia Among Men Who Have Sex With Men in Indonesia, Malaysia, and Thailand
An observational study of HPV Testing, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial summary
OBJECTIVES 1. To determine the prevalence and incidence of anal HPV infection, including infection with high-risk HPV types, among MSM in Indonesia, Malaysia, and Thailand. 2. To study the prevalence and incidence of HGAIN among these MSM. 3. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Testing
- How many people
- 430 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2013to Dec 2022
- Phase
- Observational
- 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 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: An approximately 75 HIV-positive and 75 HIV-negative MSM who attended the study clinic in Kuala Lumpur, Jakarta, and Bangkok will be enrolled. The study will also enroll 185 HIV-positive and 95 HIV-negative MSM who are previous participants of the MSM VCT study. There will be approximately 260 HIV-positive and 170 HIV-negative MSM in total in this study.
Who may be able to join
- Male with history of anal sex with men or previous participants of the MSM VCT study.
- Age 18 years old or older.
- Indonesian or Malaysian or Thai citizen as identified by the Indonesian or Malaysian or Thai National Identification card.
- Willing to provide location or contact information and allow contact.
- Available for follow-up for the planned study duration.
- Understand the study and sign informed consent form.
Who cannot join
- History of prior treatment for anal cancer OR had anal cytology or high-resolution anoscopy or infrared coagulation within 12 months prior to enrollment OR had trichloroacetic acid or podophyllin application of the intraanal area in the past month OR evidence of active concurrent intraanal or perianal bacterial or herpes simplex infection.
- Persons who have a history of a medical or psychiatric disorder by investigator's interview and physical examination according to standard practices, that in the judgment of the investigator(s), would interfere with ability to give informed consent.
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: The Thai Red Cross AIDS Research Centre
OBJECTIVES
- To determine the prevalence and incidence of anal HPV infection, including infection with high-risk HPV types, among MSM in Indonesia, Malaysia, and Thailand.
- To study the prevalence and incidence of HGAIN among these MSM.
- To evaluate risk factors, including HIV status, for anal high-risk HPV infection and HGAIN among these MSM.
Study population An approximately 75 HIV-positive and 75 HIV-negative MSM who attended the study clinic in Kuala Lumpur, Jakarta, and Bangkok will be enrolled. The study will also enroll 185 HIV-positive and 95 HIV-negative MSM who are previous participants of the MSM VCT study. There will be approximately 260 HIV-positive and 170 HIV-negative MSM in total in this study.
Read the detailed description
This is a prospective cohort study that will newly enroll approximately 150 MSM in Kuala Lumpur, Jakarta, and Bangkok and follow them prospectively with a group of 280 MSM who are previous participants of a study entitled "Multidisciplinary services to enhance HIV testing and linkage to care among MSM" (MSM VCT study) in Jakarta, Bali, and Bangkok. Newly enrolled MSM will have three study visits at baseline, month 6, and at month 12. MSM who are previous participants of the MSM VCT study will only have one study visit.
- Conditions
- HPV Testing
- Keywords
- Male with history of anal sex with men or previous participants of the MSM VCT study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| previous enrolled | Not described | |
| New Enrolled | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence and incidence of anal HPV infection, including infection with high-risk HPV types, among MSM in Indonesia, Malaysia, and Thailand.
Measured: December 1,2014 (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2020
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV TestingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Verein Aids Life through TREAT Asia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155231
- Sponsor's protocol ID
- Anal HPV and AIN among MSM
- Status last verified
- Nov 2024
- First submitted
- 28 May 2014
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
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
- The Thai Red Cross AIDS Research Centre
- ClinicalTrials.gov ID
- NCT02155231
- Acronym / sponsor ID
- Anal HPV and AIN among MSM
- Conditions
- HPV Testing
- Keywords
- Male with history of anal sex with men or previous participants of the MSM VCT study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- Verein Aids Life through TREAT Asia
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 4 Jun 2014 (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.
OBJECTIVES
- To determine the prevalence and incidence of anal HPV infection, including infection with high-risk HPV types, among MSM in Indonesia, Malaysia, and Thailand.
- To study the prevalence and incidence of HGAIN among these MSM.
- To evaluate risk factors, including HIV status, for anal high-risk HPV infection and HGAIN among these MSM.
Study population An approximately 75 HIV-positive and 75 HIV-negative MSM who attended the study clinic in Kuala Lumpur, Jakarta, and Bangkok will be enrolled. The study will also enroll 185 HIV-positive and 95 HIV-negative MSM who are previous participants of the MSM VCT study. There will be approximately 260 HIV-positive and 170 HIV-negative MSM in total in this study.
Detailed description
This is a prospective cohort study that will newly enroll approximately 150 MSM in Kuala Lumpur, Jakarta, and Bangkok and follow them prospectively with a group of 280 MSM who are previous participants of a study entitled "Multidisciplinary services to enhance HIV testing and linkage to care among MSM" (MSM VCT study) in Jakarta, Bali, and Bangkok. Newly enrolled MSM will have three study visits at baseline, month 6, and at month 12. MSM who are previous participants of the MSM VCT study will only have one study visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| previous enrolled | – | – |
| New Enrolled | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- An approximately 75 HIV-positive and 75 HIV-negative MSM who attended the study clinic in Kuala Lumpur, Jakarta, and Bangkok will be enrolled. The study will also enroll 185 HIV-positive and 95 HIV-negative MSM who are previous participants of the MSM VCT study. There will be approximately 260 HIV-positive and 170 HIV-negative MSM in total in this study.
Key inclusion criteria (6 listed)
- Male with history of anal sex with men or previous participants of the MSM VCT study.
- Age 18 years old or older.
- Indonesian or Malaysian or Thai citizen as identified by the Indonesian or Malaysian or Thai National Identification card.
- Willing to provide location or contact information and allow contact.
- Available for follow-up for the planned study duration.
Key exclusion criteria (2 listed)
- History of prior treatment for anal cancer OR had anal cytology or high-resolution anoscopy or infrared coagulation within 12 months prior to enrollment OR had trichloroacetic acid or podophyllin application of the intraanal area in the past month OR evidence of active concurrent intraanal or perianal bacterial or herpes simplex infection.
- Persons who have a history of a medical or psychiatric disorder by investigator's interview and physical examination according to standard practices, that in the judgment of the investigator(s), would interfere with ability to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence and incidence of anal HPV infection, including infection with high-risk HPV types, among MSM in Indonesia, Malaysia, and Thailand.
Time frame: December 1,2014 (up to 2 years)
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV Testing, 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 6 inclusion and 2 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?
prevalence and incidence of anal HPV infection, including infection with high-risk HPV types, among MSM in Indonesia, Malaysia, and Thailand. (time frame: December 1,2014 (up to 2 years)). 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 25 Nov 2024.