PrEP Test and TreatPrEPNCT02369887
Evaluation of a Facility-based Test, Treat, and Prevent HIV Program Among Men Who Have Sex With Men and Transgender Women in Thailand
An observational study of PrEP Test and Treat, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial summary
This is a prospective observational cohort study that aims to enroll a total of 2000 Thai MSM and TG at five health facilities in four provinces of Thailand. Each participant will be followed for 18 months. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- PrEP Test and Treat
- How many people
- 2,000 participants
- Where
- 1 siteThailand
- Study dates
- 15 Sep 2014to 16 Feb 2023
- How long will I take part?
- 12 Months
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Thai nationals not known to be HIV-infected aged ≥18 years old who are men or transgender women who report unprotected anal sex with a man in the past 6 months and are eligible for the study.
Who may be able to join
- Thai national
- Age >18 year
- Male or transgender women who reports anal intercourse with a man without using a condom at least one time in the past 6 months
- Not known to be HIV-infected
- Able to read and write Thai
- Additional inclusion criteria for PrEP:
Show all 10Show fewer
- A negative HIV test result
- No signs or symptoms of acute HIV infection (fever, sore throat, fatigue, rash, swollen glands, nausea, diarrhea, white spots in the mouth) during the previous month
- Creatinine clearance >60 ml/min
- No contraindication to PrEP medication
Who cannot join
- Participating in community-based Test and Treat study
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Disease Control (DDC), Ministry of Public Health (MOPH)
Nonthaburi, 11000
About this study
Official title: Bureau AIDS, TB, and STI, Thailand Ministry of Public Health
This is a prospective observational cohort study that aims to enroll a total of 2000 Thai MSM and TG at five health facilities in four provinces of Thailand. Each participant will be followed for 18 months. Baseline and historical rates of HIV testing/re-testing, initial CD4 counts, retention in care, and ART adherence at the study clinics, at the study clinics combined, and national data (if available) will be compared with rates after implementation of the Test and Treat strategy. Analysis will also include an assessment of HIV prevalence and incidence. This study will use similar objectives, indicators, and procedures as those used in an ongoing Test and Treat study by the Thai Red Cross AIDS Research Centre in three tertiary care hospitals, and a study to be conducted with PEPFAR Key Populations Implementation Science (KPIS) funding through United States Agency for International Development (USAID), in community-based centers, allowing comparison of uptake and follow-up of MSM and TG using the Test and Treat strategy in a variety of settings.
- Conditions
- PrEP Test and Treat
- Keywords
- MSM/TG who agree to start PrEP
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Exposure Prophylaxis of HIV
Participants must be Thai MSM or TG, aged 18 years or older, who report unprotected anal sex with a man during the previous 6 months, can read and write Thai, and are not known to be HIV-infected. To receive PrEP, participants must have a negative HIV test result, no signs or symptoms of acute HIV infection during the previous month, a creatinine clearance result > 60 ml/min, and no contraindication to PrEP medication.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study start15 Sep 2014
- Primary completion15 Aug 2020
- Study completion16 Feb 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 PrEP Test and TreatStudies 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
- Cross-sectional
- Enrolment
- 2,000 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369887
- Sponsor's protocol ID
- Test and Treat PrEP
- Acronym
- PrEP
- Status last verified
- Oct 2021
- First submitted
- 5 Feb 2015
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Suraratdecha C, Stuart RM, Manopaiboon C, Green D, Lertpiriyasuwat C, Wilson DP, Pavaputanon P, Visavakum P, Monkongdee P, Khawcharoenporn T, Tharee P, Kittinunvorakoon C, Martin M. Cost and cost-effectiveness analysis of pre-exposure prophylaxis among men who have sex with men in two hospitals in Thailand. J Int AIDS Soc. 2018 Jul;21 Suppl 5(Suppl Suppl 5):e25129. doi: 10.1002/jia2.25129.
PubMed 30033559
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bureau AIDS, TB, and STI, Thailand Ministry of Public Health
- ClinicalTrials.gov ID
- NCT02369887
- Acronym / sponsor ID
- PrEP / Test and Treat PrEP
- Conditions
- PrEP Test and Treat
- Keywords
- MSM/TG who agree to start PrEP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Study start
- 15 Sep 2014 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 24 Feb 2015 (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.
This is a prospective observational cohort study that aims to enroll a total of 2000 Thai MSM and TG at five health facilities in four provinces of Thailand. Each participant will be followed for 18 months. Baseline and historical rates of HIV testing/re-testing, initial CD4 counts, retention in care, and ART adherence at the study clinics, at the study clinics combined, and national data (if available) will be compared with rates after implementation of the Test and Treat strategy. Analysis will also include an assessment of HIV prevalence and incidence. This study will use similar objectives, indicators, and procedures as those used in an ongoing Test and Treat study by the Thai Red Cross AIDS Research Centre in three tertiary care hospitals, and a study to be conducted with PEPFAR Key Populations Implementation Science (KPIS) funding through United States Agency for International Development (USAID), in community-based centers, allowing comparison of uptake and follow-up of MSM and TG using the Test and Treat strategy in a variety of settings.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Thai nationals not known to be HIV-infected aged ≥18 years old who are men or transgender women who report unprotected anal sex with a man in the past 6 months and are eligible for the study.
Key inclusion criteria (10 listed)
- Thai national
- Age >18 year
- Male or transgender women who reports anal intercourse with a man without using a condom at least one time in the past 6 months
- Not known to be HIV-infected
- Able to read and write Thai
Key exclusion criteria (1 listed)
- Participating in community-based Test and Treat study
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
Pre-Exposure Prophylaxis of HIV
Time frame: 36 months
Participants must be Thai MSM or TG, aged 18 years or older, who report unprotected anal sex with a man during the previous 6 months, can read and write Thai, and are not known to be HIV-infected. To receive PrEP, participants must have a negative HIV test result, no signs or symptoms of acute HIV infection during the previous month, a creatinine clearance result > 60 ml/min, and no contraindication to PrEP medication.
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 17 Feb 2023.
- Derived from this study: PubMed 30033559Suraratdecha C, Stuart RM, Manopaiboon C, Green D, Lertpiriyasuwat C, Wilson DP, Pavaputanon P, Visavakum P, Monkongdee P, Khawcharoenporn T, Tharee P, Kittinunvorakoon C, Martin M. Cost and cost-effectiveness analysis of pre-exposure prophylaxis among men who have sex with men in two hospitals in Thailand. J Int AIDS Soc. 2018 Jul;21 Suppl 5(Suppl Suppl 5):e25129. doi: 10.1002/jia2.25129.
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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 PrEP Test and Treat, 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 10 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 17 Feb 2023. 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?
Pre-Exposure Prophylaxis of HIV (time frame: 36 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 NCT02369887, 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 17 Feb 2023.