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

HIV Prevention Clinical Trial

— PrEP-30  

Official title:

Thai Red Cross AIDS Research Centre (TRC-ARC)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02437981
• Other study ID #: PrEP-30 demonstration project
• Status: Enrolling by invitation
• Start date: December 2014
• Est. completion date: January 2027

Study information

• Verified date: February 2023
• Source: Thai Red Cross AIDS Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20000
• Est. completion date: January 2027
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• HIV Prevention

Intervention

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

Locations

Country	Name	City	State
Thailand	Thai Red Cross AIDS Research Centre	Bangkok	Pathumwan

Sponsors (1)

Lead Sponsor	Collaborator
Thai Red Cross AIDS Research Centre

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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