PrEP Among MSM and TG in Myanmar (PrEP)

March 9, 2022 updated by: Myanmar Oxford Clinical Research Unit

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Myanmar
      • Yangon, Myanmar
        • Medical Action Myanmar Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals self-identified as belonging to the MSM and/or TG population who are eligible in line with selection criteria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg
PrEP regimens of Tenofovir Disoproxil Fumarate (TDF) 300 mg/Lamivudine (3TC) 300mg per oral (PO) daily
Other Names:
  • Lamivudine (3TC) 300mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myanmar Oxford Clinical Research Unit

Collaborators

Institute of Tropical Medicine, Belgium
Medical Action Myanmar

Investigators

  • Principal Investigator: NiNi Tun, MB BS, Medical Action Myanmar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2020

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXTREC 49-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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