HIV Test and TreatNCT02383602
Study to Evaluate the Feasibility of Community-based Test and Treat Strategies Among Men Who Have Sex With Men and Transgender Women to Increase the Uptake of HIV Testing and Treatment Services in Thailand
An observational study of HIV Test and Treat, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial summary
HIV counseling and testing, risk reduction counseling, provision of condoms and lubricants Same-day result HIV testing along with pre-test and post-test counseling, including risk reduction counseling, will be provided according to the standard practice at each study site at enrollment and every 6 months in… 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
- HIV Test and Treat
- How many people
- 6,000 participants
- Where
- 1 siteThailand
- Study dates
- 15 Aug 2014to 16 Feb 2023
- How long will I take part?
- 18 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 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. SWING Drop-In Center, Bangkok, Thailand 2. RSAT Drop-In Center, Bangkok, Thailand 3. Chiang Mai Buddy Station, Northern Thailand 4. SWING Drop-In Center, Pattaya, Chonburi, Eastern Thailand 5. Sisters Drop-In Center, Pattaya, Chonburi, Eastern Thailand 6. RSAT Drop-In Center, Songkhla, Southern Thailand
Who may be able to join
- Thai national
- Age >18 years
- Men or transgender women who report unprotected anal intercourse with a man at least one time in the past 6 months
- Not known to be HIV-positive, i.e., never tested for HIV or previous HIV test(s) negative
- Willing to participate in the study
- Provide written informed consent
Who cannot join
- 1. Known HIV-positive serostatus
Trial locations and contacts
1 site in 1 country.
Thailand1 site
The Thai Red Cross AIDS Research Centre
Ratchaburi, Bangkok, 10330
About this study
Official title: Thai Red Cross AIDS Research Centre (TRC-ARC)
HIV counseling and testing, risk reduction counseling, provision of condoms and lubricants Same-day result HIV testing along with pre-test and post-test counseling, including risk reduction counseling, will be provided according to the standard practice at each study site at enrollment and every 6 months in HIV-negative participants. HIV-negative participants can also access non-occupational post-exposure prophylaxis service and symptomatic STD service if these are available at study sites. HIV-positive participants will also receive risk reduction counseling every 3 months. Condoms and lubricants will be provided free of charge.
Read the detailed description
This study is a prospective observational cohort study that will enroll up to 6,000 Thai MSM and TG from drop-in centers in Bangkok, Chiang Mai, Chonburi and Songkhla. Each participant will have HIV testing at baseline and will be followed up for 18 months.
HIV-negative participants will be asked to have HIV re-testing every 6 months. HIV-positive participants will have POC CD4 testing and ART initiation regardless of CD4 count will be offered. Those who accept ART will be followed up at week 2, week 4, month 2, month 3 and every 3 months thereafter. Those who deny ART will be followed up every 3 months.
Uptake of HIV re-testing will be determined. Access to POC CD4 testing and acceptability of ART initiated at HIV diagnosis regardless of CD4 count along with ART adherence will also be determined.
- Conditions
- HIV Test and Treat
- Keywords
- 6,000 Thai MSM and TG from study sites in Bangkok, Chiang Mai, Chonburi and Songkhla
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 |
|---|---|---|
| Retention strategies | In addition to telephone call(s) made within 1 week prior to scheduled visit, participants will receive at least biweekly communications from the study staff in order to establish and maintain a good relationship between participants and study sites. These communications will make use of various social networking tools (for example, Grindr, LINE and/or WhatsApp and/or SMS and/or Facebook and/or electronic mail). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the uptake of HIV testing among MSM and TG as a result of the community-based Test and Treat approach
- Increase in the number of individuals tested who have not previously had an HIV test
- Increase in the number of HIV-positive individuals tested who did not previously know their HIV status
- Increase in the proportion of HIV-negative individuals who are retested at least twice a year, every six months
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 posted9 Mar 2015 (estimated)
- Study start15 Aug 2014
- Primary completion20 Oct 2020
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 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
- Prospective
- Enrolment
- 6,000 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Ministry of Health, Thailand, The Government Pharmaceutical Organization, National Health Security Office, Thailand
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383602
- Sponsor's protocol ID
- Community-based Test and Treat
- Status last verified
- Apr 2022
- First submitted
- 5 Feb 2015
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
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
- Thai Red Cross AIDS Research Centre (TRC-ARC)
- ClinicalTrials.gov ID
- NCT02383602
- Acronym / sponsor ID
- Community-based Test and Treat
- Conditions
- HIV Test and Treat
- Keywords
- 6,000 Thai MSM and TG from study sites in Bangkok, Chiang Mai, Chonburi and Songkhla
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Ministry of Health, Thailand, The Government Pharmaceutical Organization, National Health Security Office, Thailand
- Study start
- 15 Aug 2014 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 9 Mar 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.
HIV counseling and testing, risk reduction counseling, provision of condoms and lubricants Same-day result HIV testing along with pre-test and post-test counseling, including risk reduction counseling, will be provided according to the standard practice at each study site at enrollment and every 6 months in HIV-negative participants. HIV-negative participants can also access non-occupational post-exposure prophylaxis service and symptomatic STD service if these are available at study sites. HIV-positive participants will also receive risk reduction counseling every 3 months. Condoms and lubricants will be provided free of charge.
Detailed description
This study is a prospective observational cohort study that will enroll up to 6,000 Thai MSM and TG from drop-in centers in Bangkok, Chiang Mai, Chonburi and Songkhla. Each participant will have HIV testing at baseline and will be followed up for 18 months.
HIV-negative participants will be asked to have HIV re-testing every 6 months. HIV-positive participants will have POC CD4 testing and ART initiation regardless of CD4 count will be offered. Those who accept ART will be followed up at week 2, week 4, month 2, month 3 and every 3 months thereafter. Those who deny ART will be followed up every 3 months.
Uptake of HIV re-testing will be determined. Access to POC CD4 testing and acceptability of ART initiated at HIV diagnosis regardless of CD4 count along with ART adherence will also be determined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retention strategies | – | –In addition to telephone call(s) made within 1 week prior to scheduled visit, participants will receive at least biweekly communications from the study staff in order to establish and maintain a good relationship between participants and study sites. These communications will make use of various social networking tools (for example, Grindr, LINE and/or WhatsApp and/or SMS and/or Facebook and/or electronic mail). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. SWING Drop-In Center, Bangkok, Thailand 2. RSAT Drop-In Center, Bangkok, Thailand 3. Chiang Mai Buddy Station, Northern Thailand 4. SWING Drop-In Center, Pattaya, Chonburi, Eastern Thailand 5. Sisters Drop-In Center, Pattaya, Chonburi, Eastern Thailand 6. RSAT Drop-In Center, Songkhla, Southern Thailand
Key inclusion criteria (6 listed)
- Thai national
- Age >18 years
- Men or transgender women who report unprotected anal intercourse with a man at least one time in the past 6 months
- Not known to be HIV-positive, i.e., never tested for HIV or previous HIV test(s) negative
- Willing to participate in the study
Key exclusion criteria (1 listed)
- 1. Known HIV-positive serostatus
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
To determine the uptake of HIV testing among MSM and TG as a result of the community-based Test and Treat approach
Time frame: 36 months
1. Increase in the number of individuals tested who have not previously had an HIV test 2. Increase in the number of HIV-positive individuals tested who did not previously know their HIV status 3. Increase in the proportion of HIV-negative individuals who are retested at least twice a year, every six months
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.
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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 HIV 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 6 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?
To determine the uptake of HIV testing among MSM and TG as a result of the community-based Test and Treat approach (time frame: 36 months). 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 17 Feb 2023.