HIV PreventionPrEP-30NCT02437981
Evaluation of PrEP-30: a Demonstration Project of Pre-exposure Prophylaxis for MSM and Other High-risk Group Clients at the Thai Red Cross Anonymous Clinic
An observational study of HIV Prevention, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial summary
PrEP-30 is a demonstration project to assess the feasibility of providing oral PrEP to MSM and other individuals at-risk for HIV in Bangkok, Thailand as a service that is funded entirely through user fees. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- PrEP
- Type of treatment
- Pill or oral medicine
- How many people
- 20,000 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2014to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: MSM and other individuals at risk for HIV infection
Who may be able to join
- Age > 18 years
- HIV test negative
- Creatinine clearance > 60 ml/min
- No contraindication or allergy to PrEP medications (TDF/FTC)
- At least one risk factor for HIV infection within the previous 6 months:
- sex partner known to be HIV positive
Show all 15Show fewer
- works as commercial sex worker
- use of PEP for sexual exposure
- injection drug use
- any STI (syphilis, gonorrhea, chlamydia)
- > 5 sex partners
- inconsistent condom use with high-risk partners, including MSM, IDU
- MSM: any insertive or receptive anal sex without condom
- Women: any sex without condom with high-risk male partner (MSM, IDU, multiple female partners)
- Heterosexual men: any sex without condom with high-risk female partner (commercial sex worker, IDU, multiple male partners)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Thai Red Cross AIDS Research Centre (TRC-ARC)
PrEP-30 is a demonstration project to assess the feasibility of providing oral PrEP to MSM and other individuals at-risk for HIV in Bangkok, Thailand as a service that is funded entirely through user fees. Tenofovir disoproxil fumarate/emtricitabine PrEP is provided part of a combined HIV prevention program that includes risk-reduction counseling, regular HIV testing, and the provision of condoms and lubricants. PrEP-30 is implemented at the Thai Red Cross AIDS Research Centre, at the site of the largest HIV counseling and testing center in Thailand.
- Conditions
- HIV Prevention
- Being tested
- PrEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEPDrug
Oral pre-exposure prophylaxis (PrEP) for HIV infection using a daily combination tablet of tenofovir disoproxil fumarate and emtricitabine
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measures:
- Assess the uptake of fee-based oral PrEP by MSM and other at-risk individuals who present for HIV testing or other services.
- Assess the acceptability, tolerance and safety of oral PrEP.
- Assess patient satisfaction with oral PrEP delivered through a fee-based system in an HIV testing center.
- Assess the effectiveness of oral PrEP in a fee-based model.
- Assess the cost-effectiveness of oral PreP delivered in a fee-based system.
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 posted8 May 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2024 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies 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
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437981
- Sponsor's protocol ID
- PrEP-30 demonstration project
- Acronym
- PrEP-30
- Status last verified
- Nov 2024
- First submitted
- 24 Apr 2015
- 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
- Thai Red Cross AIDS Research Centre (TRC-ARC)
- ClinicalTrials.gov ID
- NCT02437981
- Acronym / sponsor ID
- PrEP-30 / PrEP-30 demonstration project
- Conditions
- HIV Prevention
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 8 May 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.
PrEP-30 is a demonstration project to assess the feasibility of providing oral PrEP to MSM and other individuals at-risk for HIV in Bangkok, Thailand as a service that is funded entirely through user fees. Tenofovir disoproxil fumarate/emtricitabine PrEP is provided part of a combined HIV prevention program that includes risk-reduction counseling, regular HIV testing, and the provision of condoms and lubricants. PrEP-30 is implemented at the Thai Red Cross AIDS Research Centre, at the site of the largest HIV counseling and testing center in Thailand.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- MSM and other individuals at risk for HIV infection
Key inclusion criteria (15 listed)
- Age > 18 years
- HIV test negative
- Creatinine clearance > 60 ml/min
- No contraindication or allergy to PrEP medications (TDF/FTC)
- At least one risk factor for HIV infection within the previous 6 months:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PrEPOral pre-exposure prophylaxis (PrEP) for HIV infection using a daily combination tablet of tenofovir disoproxil fumarate and emtricitabine | Drug | – |
Primary outcome
Primary outcome measures:
Time frame: 12 months
1. Assess the uptake of fee-based oral PrEP by MSM and other at-risk individuals who present for HIV testing or other services. 2. Assess the acceptability, tolerance and safety of oral PrEP. 3. Assess patient satisfaction with oral PrEP delivered through a fee-based system in an HIV testing center. 4. Assess the effectiveness of oral PrEP in a fee-based model. 5. Assess the cost-effectiveness of oral PreP delivered in a fee-based system.
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
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 Prevention, 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 15 inclusion and 0 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: enrolling by invitation, 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?
This study is still under way. Results are not available in the source record yet.
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?
Primary outcome measures: (time frame: 12 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 25 Nov 2024.