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

NCT02437981 | Enrolling By Invitation

• 1 other identifier: PrEP-30 demonstration project
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (1)

• Primary outcome measures:

  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.

  12 months

Interventions

PrEP DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

MSM and other individuals at risk for HIV infection

You may qualify if:

• 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)

Sponsors & Collaborators

• Thai Red Cross AIDS Research Centre: lead

Study Sites (1)

Thai Red Cross AIDS Research Centre

Bangkok, Pathumwan, 10330, Thailand

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: May 8, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2024
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

TH (1)