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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2027-01-31

Brief Summary

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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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Detailed Description

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Conditions

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HIV Prevention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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PrEP

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes