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 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.

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Key information

Conditions

HIV Prevention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thai Red Cross AIDS Research Centre

Bangkok, Pathumwan, 10330, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

Treatment and study plan

PrEP

Drug

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

Primary outcomes

Primary outcome measures:

Time frame: 12 months
- 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.

Sponsors and collaborators

Lead sponsor

Thai Red Cross AIDS Research Centre

Other

Registry information

Official study title

Thai Red Cross AIDS Research Centre (TRC-ARC)

Acronym: PrEP-30

Important dates

Study start: 2014
Primary completion: 2024
Study completion: 2027
First posted: May 8, 2015
Registry last updated: Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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