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NCT04781426 Clinical Trial

PrEP Among MSM and TG in Myanmar

HIV Infections Clinical Trial

— PrEP  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04781426
Other study ID # OXTREC 49-20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 28, 2020
Est. completion date August 31, 2021

Study information
Verified date March 2022
Source Myanmar Oxford Clinical Research Unit
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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%. 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Myanmar Medical Action Myanmar Clinics Yangon

Sponsors (3)
Lead Sponsor Collaborator
Myanmar Oxford Clinical Research Unit Institute of Tropical Medicine, Belgium, Medical Action Myanmar

Country where clinical trial is conducted

Myanmar, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. through study completion, an average of 1 year
Primary 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. through study completion, an average of 1 year
Primary 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. through study completion, an average of 1 year
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