PrEP Among MSM and TG in Myanmar

Myanmar Oxford Clinical Research Unit

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg

Study type: Observational

Funder types: Other

Identifiers

NCT04781426

OXTREC 49-20

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Volunteers: No 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

Trial design

200 participants in 1 patient group

HIV-negative MSM/TG

Description:

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.

Treatment:

Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg