HIV InfectionsPrEPNCT04781426
PrEP Among MSM and TG in Myanmar
An observational study of HIV Infections, run by Myanmar Oxford Clinical Research Unit at 1 site in Burma.
Trial summary
HIV is concentrated among key populations in Myanmar. Globally, HIV-prevalence among transgender (TG) women is one of the highest; laboratory-confirmed prevalence is reported up to 40%. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tenofovir Disoproxil Fumarate (TDF) 300 mg
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteBurma
- Study dates
- 28 Oct 2020to 31 Aug 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals self-identified as belonging to the MSM and/or TG population who are eligible in line with selection criteria
Who may be able to join
- HIV-negative
- No suspicion of acute HIV infection
- Substantial risk of HIV infection
- Creatinine clearance is more than 30 ml/min
- Willingness to use PrEP as prescribed, including periodic HIV testing
- Willingness to sign informed consent
Who cannot join
- Anyone who is not eligible with the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-exposure Prophylaxis of HIV Infection Among Men Who Have Sex With Men (MSM) and Transgender Women (TG) in Suburban Yangon, Myanmar
HIV is concentrated among key populations in Myanmar. Globally, HIV-prevalence among transgender (TG) women is one of the highest; laboratory-confirmed prevalence is reported up to 40%. In September 2015, WHO recommended the use of Pre-Exposure Prophylaxis (PrEP) for people at substantial risk of HIV as part of a combination HIV prevention strategy. A demonstration project will take place to implement and evaluate the uptake and effectiveness of PrEP among MSM, and TG women in a clinic in Hlaingtharyar township, Yangon. The aim is to describe PrEP uptake, as well as HIV-seroconversion and STI infection rates among those who use PrEP.
- Conditions
- HIV Infections
- Being tested
- Tenofovir Disoproxil Fumarate (TDF) 300 mg
- Keywords
- Pre-exposure prophylaxis of HIV infection, PrEP, MSM, TG
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil Fumarate (TDF) 300 mgDrug
Also called Lamivudine (3TC) 300mg
PrEP regimens of Tenofovir Disoproxil Fumarate (TDF) 300 mg/Lamivudine (3TC) 300mg per oral (PO) daily
| Study group | Role | What they receive |
|---|---|---|
| HIV-negative MSM/TG | Oral pre-exposure prophylaxis (PrEP) will be offered to HIV negative MSM, TG identified to be at substantial risk for HIV infection and those motivated to take daily PrEP. Receives: Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake rate of PrEP
The proportion of HIV-negative MSM and TG women who are taking PrEP among those who are eligible to take PrEP.
Measured: through study completion, an average of 1 year
HIV seroconversion rate among PrEP user
The portion of PrEP taking HIV negative MSM and TG women who become HIV positive while he is taking PrEP among those who are taking PrEP.
Measured: through study completion, an average of 1 year
STI infection rates among PrEP user(Syphilis test, Gram stain for gonorrhoea and Xpert CT/NG)
The number of positive episodes for either syphilis or gonorrhea or chlamydia infection among the PrEP taking MSM and Transgender women per number of testing among them.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start28 Oct 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myanmar Oxford Clinical Research Unit
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Action Myanmar, Institute of Tropical Medicine, Belgium
- Responsible party
- Sponsor
- Investigators
- NiNi Tun, MB BS, Principal investigator, Medical Action Myanmar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781426
- Sponsor's protocol ID
- OXTREC 49-20
- Acronym
- PrEP
- Status last verified
- Mar 2022
- First submitted
- 25 Feb 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-exposure Prophylaxis of HIV Infection Among Men Who Have Sex With Men (MSM) and Transgender Women (TG) in Suburban Yangon, Myanmar
- ClinicalTrials.gov ID
- NCT04781426
- Acronym / sponsor ID
- PrEP / OXTREC 49-20
- Conditions
- HIV Infections
- Keywords
- Pre-exposure prophylaxis of HIV infection, PrEP, MSM, TG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Myanmar Oxford Clinical Research UnitUniversity, hospital or other
- Collaborators
- Medical Action Myanmar, Institute of Tropical Medicine, Belgium
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 4 Mar 2021 (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.
HIV is concentrated among key populations in Myanmar. Globally, HIV-prevalence among transgender (TG) women is one of the highest; laboratory-confirmed prevalence is reported up to 40%. In September 2015, WHO recommended the use of Pre-Exposure Prophylaxis (PrEP) for people at substantial risk of HIV as part of a combination HIV prevention strategy. A demonstration project will take place to implement and evaluate the uptake and effectiveness of PrEP among MSM, and TG women in a clinic in Hlaingtharyar township, Yangon. The aim is to describe PrEP uptake, as well as HIV-seroconversion and STI infection rates among those who use PrEP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-negative MSM/TG | – | Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mgOral pre-exposure prophylaxis (PrEP) will be offered to HIV negative MSM, TG identified to be at substantial risk for HIV infection and those motivated to take daily PrEP. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals self-identified as belonging to the MSM and/or TG population who are eligible in line with selection criteria
Key inclusion criteria (6 listed)
- HIV-negative
- No suspicion of acute HIV infection
- Substantial risk of HIV infection
- Creatinine clearance is more than 30 ml/min
- Willingness to use PrEP as prescribed, including periodic HIV testing
Key exclusion criteria (1 listed)
- Anyone who is not eligible with the inclusion criteria
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 |
|---|---|---|
| Tenofovir Disoproxil Fumarate (TDF) 300 mgAlso: Lamivudine (3TC) 300mgPrEP regimens of Tenofovir Disoproxil Fumarate (TDF) 300 mg/Lamivudine (3TC) 300mg per oral (PO) daily | Drug | HIV-negative MSM/TG |
Primary outcome
Uptake rate of PrEP
Time frame: through study completion, an average of 1 year
The proportion of HIV-negative MSM and TG women who are taking PrEP among those who are eligible to take PrEP.
HIV seroconversion rate among PrEP user
Time frame: through study completion, an average of 1 year
The portion of PrEP taking HIV negative MSM and TG women who become HIV positive while he is taking PrEP among those who are taking PrEP.
STI infection rates among PrEP user(Syphilis test, Gram stain for gonorrhoea and Xpert CT/NG)
Time frame: through study completion, an average of 1 year
The number of positive episodes for either syphilis or gonorrhea or chlamydia infection among the PrEP taking MSM and Transgender women per number of testing among them.
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 11 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
NiNi Tun, MB BS principal investigator
Medical Action Myanmar
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 Infections, run by Myanmar Oxford Clinical Research Unit at 1 site in Burma.
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 11 Mar 2022. 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 Burma. 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?
Uptake rate of PrEP (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 11 Mar 2022.