PrEP Among MSM and TG in Myanmar

Completed

• Conditions: HIV Infections
• Interventions: Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg

• Registration Number: NCT04781426
• Lead Sponsor: Myanmar Oxford Clinical Research Unit

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-28
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-04
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV-negative MSM/TG	Tenofovir Disoproxil Fumarate (TDF) 300 mg	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.

Primary Outcome Measures

Name	Time	Method
Uptake rate of PrEP	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.
HIV seroconversion rate among PrEP user	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.
STI infection rates among PrEP user(Syphilis test, Gram stain for gonorrhoea and Xpert CT/NG)	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.

Trial Locations

Locations (1)

Medical Action Myanmar Clinics; 🇲🇲 Yangon, Myanmar