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OpenTrials
Completed

NCT Number: NCT04781426

PrEP Among MSM and TG in 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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Action Myanmar Clinics

Yangon, Burma

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tenofovir disoproxil fumarate (TDF) 300 mg

Drug

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

Other names: Lamivudine (3TC) 300mg

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Myanmar Oxford Clinical Research Unit

Other

Collaborators

  • Institute of Tropical Medicine, Belgium
  • Medical Action Myanmar

Registry information

Official study title

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

Acronym: PrEP

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2021
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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