PrEP Among MSM and TG in Myanmar

Pre-exposure Prophylaxis of HIV Infection Among Men Who Have Sex With Men (MSM) and Transgender Women (TG) in Suburban Yangon, Myanmar

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04781426

Acronym

PrEP

Enrollment

200

Registered

2021-03-04

Start date

2020-10-28

Completion date

2021-08-31

Last updated

2022-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Pre-exposure prophylaxis of HIV infection, PrEP, MSM, TG

Brief 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%. 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.

Interventions

DRUGTenofovir Disoproxil Fumarate (TDF) 300 mg

PrEP regimens of Tenofovir Disoproxil Fumarate (TDF) 300 mg/Lamivudine (3TC) 300mg per oral (PO) daily

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

• Anyone who is not eligible with the inclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Uptake rate of PrEP	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	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)	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.

Countries

Burma

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026