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

• Conditions: HIV Prevention

• Registration Number: NCT02437981
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-04-24
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25
• Primary Completion: 2024-12
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measures:	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.

Trial Locations

Locations (1)

Thai Red Cross AIDS Research Centre; 🇹🇭 Bangkok, Pathumwan, Thailand