Men Who Have Sex With Men and Transgender WomenNCT03580512
Study to Evaluate the Feasibility of Integrating the Point-of-care Testing for Sexually Transmitted Infections and HIV Into Community-based Clinics for MSM and TGW in Thailand
An observational study of Men Who Have Sex With Men and Transgender Women, run by Thai Red Cross AIDS Research Centre at 6 sites in Thailand.
Trial summary
This will be a prospective study that will enroll up to 2000 MSM and TG from community-based clinics in Bangkok, Chonburi, Chiang Mai, and Songkhla. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Men Who Have Sex With Men and Transgender Women
- How many people
- 2,000 participants
- Where
- 6 sitesThailand
- Study dates
- 15 Apr 2017to 15 Mar 2024
- 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 years and older
- Men only
- Adult, Older adult
Study population: Approximately 2000 MSM and TG
Who may be able to join
- Thai nationality
- Age ≥ 18 years old
- Men or transgender women who have sex with men
- Have at least one of the following risks for HIV acquisition in the past 6 months:
- Any unprotected receptive anal sex
- More than 5 sexual partners, regardless of condom use and serostatus
Show all 9Show fewer
- History of syphilis, chlamydia or gonorrhea diagnosed or treated
- Any stimulant drug use
- Have signed the consent form
Who cannot join
- None
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Thailand6 sites
1.Swing Dic,
Bangkok
2.Rsat Dic,
Bangkok
5. Mplus DIC,
Chiang Mai
3.Swing Dic
Chon Buri
4. Sisters DIC,
Chon Buri
6.Rsat Dic,
Songkhla
About this study
Official title: The Thai Red Cross AIDS Research Centre
This will be a prospective study that will enroll up to 2000 MSM and TG from community-based clinics in Bangkok, Chonburi, Chiang Mai, and Songkhla.
Read the detailed description
Eligible participants will be followed up until the completion of a 12-month period. All participants will be followed up every 3 months. An additional follow up visit at month 1 will be made for participants who PrEP is initiated at entry visit (those who already received PrEP prior to the study will not need the additional visit).
Study Sites
The study will take place at the following community-based clinics:
- SWING DIC, Bangkok, Thailand
- RSAT DIC, Bangkok, Thailand
- SWING DIC, Chonburi, Thailand
- Sisters DIC, Chonburi, Thailand
- Mplus DIC, Chiang Mai, Thailand
- RSAT DIC, Songkhla, Thailand
- Medical subject headings
- Homosexuality
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 |
|---|---|---|
| Group 1 | - 800 existing clients who already received PrEP | |
| Group 2 | * 800 new clients who present for HIV testing and are HIV-negative. All will be offered PrEP * 600 clients who will refuse PrEP * 200 clients who will receive PrEP | |
| Group 3 | - 400 new clients who are HIV-positive or new clients who present for HIV testing and are HIV-positive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who receive same-day diagnosis and treatment of CT/NG in community-based clinics
Measured: 1 years
Proportion of participants who receive same-day diagnosis of HIV infection in community-based clinics
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start15 Apr 2017
- Primary completion26 Oct 2022
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Men Who Have Sex With Men and Transgender WomenStudies 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nittaya Phanuphak, MD, PhD, Principal investigator, Thai Red Cross AIDS Research Centre (TRCARC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580512
- Sponsor's protocol ID
- POC HIV&STI
- Status last verified
- Nov 2024
- First submitted
- 31 May 2018
- Last updated
- 25 Nov 2024
- Results posted
- No
Publications
Hiransuthikul A, Sungsing T, Jantarapakde J, Trachunthong D, Mills S, Vannakit R, Phanuphak P, Phanuphak N. Correlations of chlamydia and gonorrhoea among pharyngeal, rectal and urethral sites among Thai men who have sex with men: multicentre community-led test and treat cohort in Thailand. BMJ Open. 2019 Jun 27;9(6):e028162. doi: 10.1136/bmjopen-2018-028162.
PubMed 31253622Hiransuthikul A, Janamnuaysook R, Sungsing T, Jantarapakde J, Trachunthong D, Mills S, Vannakit R, Phanuphak P, Phanuphak N. High burden of chlamydia and gonorrhoea in pharyngeal, rectal and urethral sites among Thai transgender women: implications for anatomical site selection for the screening of STI. Sex Transm Infect. 2019 Nov;95(7):534-539. doi: 10.1136/sextrans-2018-053835. Epub 2019 Apr 13.
PubMed 30982000
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
- NCT03580512
- Acronym / sponsor ID
- POC HIV&STI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 9 Jul 2018 (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 will be a prospective study that will enroll up to 2000 MSM and TG from community-based clinics in Bangkok, Chonburi, Chiang Mai, and Songkhla.
Detailed description
Eligible participants will be followed up until the completion of a 12-month period. All participants will be followed up every 3 months. An additional follow up visit at month 1 will be made for participants who PrEP is initiated at entry visit (those who already received PrEP prior to the study will not need the additional visit).
Study Sites
The study will take place at the following community-based clinics:
- SWING DIC, Bangkok, Thailand
- RSAT DIC, Bangkok, Thailand
- SWING DIC, Chonburi, Thailand
- Sisters DIC, Chonburi, Thailand
- Mplus DIC, Chiang Mai, Thailand
- RSAT DIC, Songkhla, Thailand
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –- 800 existing clients who already received PrEP |
| Group 2 | – | –* 800 new clients who present for HIV testing and are HIV-negative. All will be offered PrEP * 600 clients who will refuse PrEP * 200 clients who will receive PrEP |
| Group 3 | – | –- 400 new clients who are HIV-positive or new clients who present for HIV testing and are HIV-positive |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Approximately 2000 MSM and TG
Key inclusion criteria (9 listed)
- Thai nationality
- Age ≥ 18 years old
- Men or transgender women who have sex with men
- Have at least one of the following risks for HIV acquisition in the past 6 months:
- Have signed the consent form
Key exclusion criteria (1 listed)
- None
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
Proportion of participants who receive same-day diagnosis and treatment of CT/NG in community-based clinics
Time frame: 1 years
Proportion of participants who receive same-day diagnosis of HIV infection in community-based clinics
Time frame: 1 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.
- Derived from this study: PubMed 31253622Hiransuthikul A, Sungsing T, Jantarapakde J, Trachunthong D, Mills S, Vannakit R, Phanuphak P, Phanuphak N. Correlations of chlamydia and gonorrhoea among pharyngeal, rectal and urethral sites among Thai men who have sex with men: multicentre community-led test and treat cohort in Thailand. BMJ Open. 2019 Jun 27;9(6):e028162. doi: 10.1136/bmjopen-2018-028162.
- Derived from this study: PubMed 30982000Hiransuthikul A, Janamnuaysook R, Sungsing T, Jantarapakde J, Trachunthong D, Mills S, Vannakit R, Phanuphak P, Phanuphak N. High burden of chlamydia and gonorrhoea in pharyngeal, rectal and urethral sites among Thai transgender women: implications for anatomical site selection for the screening of STI. Sex Transm Infect. 2019 Nov;95(7):534-539. doi: 10.1136/sextrans-2018-053835. Epub 2019 Apr 13.
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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, MD, PhD principal investigator
Thai Red Cross AIDS Research Centre (TRCARC)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Men Who Have Sex With Men and Transgender Women, run by Thai Red Cross AIDS Research Centre at 6 sites 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 9 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 6 sites 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?
Proportion of participants who receive same-day diagnosis and treatment of CT/NG in community-based clinics (time frame: 1 years). 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?
On the ClinicalTrials.gov record for NCT03580512, which also lists 2 linked publications.
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.