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

November 22, 2024 updated by: Thai Red Cross AIDS Research Centre

The Thai Red Cross AIDS Research Centre

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • 1.Swing Dic,
      • Bangkok, Thailand
        • 2.Rsat Dic,
      • Chiang Mai, Thailand
        • 5. Mplus DIC,
      • Chon Buri, Thailand
        • 3.Swing Dic
      • Chon Buri, Thailand
        • 4. Sisters DIC,
      • Songkhla, Thailand
        • 6.Rsat Dic,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Approximately 2000 MSM and TG

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants who receive same-day diagnosis and treatment of CT/NG in community-based clinics
Time Frame: 1 years
1 years
Proportion of participants who receive same-day diagnosis of HIV infection in community-based clinics
Time Frame: 1 years
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thai Red Cross AIDS Research Centre

Investigators

  • Principal Investigator: Nittaya Phanuphak, MD, PhD, Thai Red Cross AIDS Research Centre (TRCARC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2017

Primary Completion (Actual)

October 26, 2022

Study Completion (Actual)

March 15, 2024

Study Registration Dates

First Submitted

May 31, 2018

First Submitted That Met QC Criteria

June 25, 2018

First Posted (Actual)

July 9, 2018

Study Record Updates

Last Update Posted (Actual)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • POC HIV&STI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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