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)

Thai Red Cross AIDS Research Centre (TRC-ARC)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: HIV Prevention
• Intervention / Treatment: Drug: PrEP

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

Study Locations

• Thailand
  • Pathumwan
    • Bangkok, Pathumwan, Thailand, 10330
      • Thai Red Cross Aids Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

MSM and other individuals at risk for HIV infection

Description

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: -

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Thai Red Cross AIDS Research Centre

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 24, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (Estimated): May 8, 2015

Study Record Updates

• Last Update Posted (Actual): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PrEP-30 demonstration project