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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 (PrEP-30)

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ClinicalTrials.gov Identifier: NCT02437981
Recruitment Status : Enrolling by invitation
First Posted : May 8, 2015
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Thai Red Cross AIDS Research Centre

Brief Summary:
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.

Condition or disease Intervention/treatment
HIV Prevention Drug: PrEP

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Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thai Red Cross AIDS Research Centre (TRC-ARC)
Study Start Date : December 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


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


Primary Outcome Measures :
  1. Primary outcome measures: [ Time Frame: 12 months ]
    1. Assess the uptake of fee-based oral PrEP by MSM and other at-risk individuals who present for HIV testing or other services.
    2. Assess the acceptability, tolerance and safety of oral PrEP.
    3. Assess patient satisfaction with oral PrEP delivered through a fee-based system in an HIV testing center.
    4. Assess the effectiveness of oral PrEP in a fee-based model.
    5. Assess the cost-effectiveness of oral PreP delivered in a fee-based system.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
MSM and other individuals at risk for HIV infection
Criteria

Inclusion Criteria:

  1. Age > 18 years
  2. HIV test negative
  3. Creatinine clearance > 60 ml/min
  4. No contraindication or allergy to PrEP medications (TDF/FTC)
  5. 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: -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437981


Locations
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Thailand
Thai Red Cross AIDS Research Centre
Bangkok, Pathumwan, Thailand, 10330
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
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Responsible Party: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT02437981    
Other Study ID Numbers: PrEP-30 demonstration project
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020