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Study to Evaluate the Feasibility of Integrating the Point-of-care Testing for Sexually Transmitted Infections and HIV Into Community-based Clinics for MSM and TGW in Thailand

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ClinicalTrials.gov Identifier: NCT03580512
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Thai Red Cross AIDS Research Centre

Study Description
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Brief Summary:
This will be a prospective study that will enroll up to 2000 MSM and TG from community-based clinics in Bangkok, Chonburi, Chiang Mai, and Songkhla.

Condition or disease
Men Who Have Sex With Men and Transgender Women

Detailed Description:

Eligible participants will be followed up until the completion of a 12-month period. All participants will be followed up every 3 months. An additional follow up visit at month 1 will be made for participants who PrEP is initiated at entry visit (those who already received PrEP prior to the study will not need the additional visit).

Study Sites

The study will take place at the following community-based clinics:

  1. SWING DIC, Bangkok, Thailand
  2. RSAT DIC, Bangkok, Thailand
  3. SWING DIC, Chonburi, Thailand
  4. Sisters DIC, Chonburi, Thailand
  5. Mplus DIC, Chiang Mai, Thailand
  6. RSAT DIC, Songkhla, Thailand
Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Thai Red Cross AIDS Research Centre
Actual Study Start Date : April 15, 2017
Estimated Primary Completion Date : October 26, 2023
Estimated Study Completion Date : December 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort
Group 1
- 800 existing clients who already received PrEP
Group 2
  • 800 new clients who present for HIV testing and are HIV-negative. All will be offered PrEP
  • 600 clients who will refuse PrEP
  • 200 clients who will receive PrEP
Group 3
- 400 new clients who are HIV-positive or new clients who present for HIV testing and are HIV-positive


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants who receive same-day diagnosis and treatment of CT/NG in community-based clinics [ Time Frame: 1 years ]
  2. Proportion of participants who receive same-day diagnosis of HIV infection in community-based clinics [ Time Frame: 1 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Sampling Method:   Probability Sample
Study Population
Approximately 2000 MSM and TG
Criteria

Inclusion Criteria:

  1. Thai nationality
  2. Age ≥ 18 years old
  3. Men or transgender women who have sex with men

  4. Have at least one of the following risks for HIV acquisition in the past 6 months:

    • Any unprotected receptive anal sex
    • More than 5 sexual partners, regardless of condom use and serostatus
    • History of syphilis, chlamydia or gonorrhea diagnosed or treated
    • Any stimulant drug use
  5. Have signed the consent form

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580512


Contacts
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Contact: Nittaya Phanuphak, M.D., Ph.D. +6681 825 3544 nittaya.p@trcarc.org
Contact: Reshmie Ramautarsing, M.D.,Ph.D 662 253 0996 reshmie@trcarc.org

Locations
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Thailand
1.Swing Dic, Recruiting
Bangkok, Thailand
2.Rsat Dic, Recruiting
Bangkok, Thailand
5. Mplus DIC, Recruiting
Chiang Mai, Thailand
3.Swing Dic Recruiting
Chon Buri, Thailand
4. Sisters DIC, Recruiting
Chon Buri, Thailand
6.Rsat Dic, Recruiting
Songkhla, Thailand
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
Investigators
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Principal Investigator: Nittaya Phanuphak, MD, PhD Thai Red Cross AIDS Research Centre (TRCARC)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT03580512    
Other Study ID Numbers: POC HIV&STI
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022