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

• Sponsor: Thai Red Cross AIDS Research Centre (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT02437981
• Collaborator: (none)
• Enrollment: 20,000
• Location: 1
• Duration (Months): 145
• Patients Per Site Per Month: 137.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Prevention	Drug: PrEP

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Thai Red Cross AIDS Research Centre (TRC-ARC)
• Study Start Date: Dec 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Jan 1, 2027

Outcome Measures

Primary Outcome Measures

1. Primary outcome measures: [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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: -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thai Red Cross AIDS Research Centre	Bangkok	Pathumwan	Thailand	10330

Sponsors and Collaborators

• Thai Red Cross AIDS Research Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thai Red Cross AIDS Research Centre
• ClinicalTrials.gov Identifier: NCT02437981
• Other Study ID Numbers: PrEP-30 demonstration project
• First Posted: May 8, 2015
• Last Update Posted: Jul 12, 2021
• Last Verified: Jul 1, 2021

Study Results

No Results Posted as of Jul 12, 2021