PrEP Among MSM and TG in Myanmar

NCT04781426 | Completed

• 1 other identifier: OXTREC 49-20
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

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

Interventions

Tenofovir Disoproxil Fumarate (TDF) 300 mg DRUG

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

Also known as: Lamivudine (3TC) 300mg

HIV-negative MSM/TG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Myanmar Oxford Clinical Research Unit: lead
• Medical Action Myanmar: collaborator
• Institute of Tropical Medicine, Belgium: collaborator

Study Sites (1)

Medical Action Myanmar Clinics

Yangon, Burma

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir; Lamivudine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• NiNi Tun, MB BS

  Medical Action Myanmar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 4, 2021
• Study Start: October 28, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

BU (1)