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Enrolling by invitation NCT02437981

Evaluation of PrEP-30: a Demonstration Project of Pre-exposure Prophylaxis for MSM and Other High-risk Group Clients at the Thai Red Cross Anonymous Clinic

Observational HIV Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PrEP.
Who it may be relevant to
Registry conditions: HIV Prevention. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Thai Red Cross AIDS Research Centre (TRC-ARC)

Overview

PrEP-30 is a demonstration project to assess the feasibility of providing oral PrEP to MSM and other individuals at-risk for HIV in Bangkok, Thailand as a service that is funded entirely through user fees. Tenofovir disoproxil fumarate/emtricitabine PrEP is provided part of a combined HIV prevention program that includes risk-reduction counseling, regular HIV testing, and the provision of condoms and lubricants. PrEP-30 is implemented at the Thai Red Cross AIDS Research Centre, at the site of the largest HIV counseling and testing center in Thailand.

Interventions

  • Drug PrEP
    Oral pre-exposure prophylaxis (PrEP) for HIV infection using a daily combination tablet of tenofovir disoproxil fumarate and emtricitabine

Primary outcome measures

  • Primary outcome measures: [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Age > 18 years
  • HIV test negative
  • Creatinine clearance > 60 ml/min
  • No contraindication or allergy to PrEP medications (TDF/FTC)
  • At least one risk factor for HIV infection within the previous 6 months:
  • sex partner known to be HIV positive
  • works as commercial sex worker
  • use of PEP for sexual exposure
  • injection drug use
  • any STI (syphilis, gonorrhea, chlamydia)
  • > 5 sex partners
  • inconsistent condom use with high-risk partners, including MSM, IDU
  • MSM: any insertive or receptive anal sex without condom
  • Women: any sex without condom with high-risk male partner (MSM, IDU, multiple female partners)
  • Heterosexual men: any sex without condom with high-risk female partner (commercial sex worker, IDU, multiple male partners)

Exclusion Criteria: -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Thailand · 1 center
  • Thai Red Cross AIDS Research Centre — Bangkok

Identifiers

NCT: NCT02437981 · PrEP-30 demonstration project

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗