Study to Evaluate the Feasibility of Community-based Test and Treat Strategies Among Men Who Have Sex With Men and Transgender Women to Increase the Uptake of HIV Testing and Treatment Services in Thailand

February 15, 2023 updated by: Thai Red Cross AIDS Research Centre

Thai Red Cross AIDS Research Centre (TRC-ARC)

HIV counseling and testing, risk reduction counseling, provision of condoms and lubricants Same-day result HIV testing along with pre-test and post-test counseling, including risk reduction counseling, will be provided according to the standard practice at each study site at enrollment and every 6 months in HIV-negative participants. HIV-negative participants can also access non-occupational post-exposure prophylaxis service and symptomatic STD service if these are available at study sites. HIV-positive participants will also receive risk reduction counseling every 3 months. Condoms and lubricants will be provided free of charge.

Study Overview

Status

Completed

Conditions

Detailed Description

This study is a prospective observational cohort study that will enroll up to 6,000 Thai MSM and TG from drop-in centers in Bangkok, Chiang Mai, Chonburi and Songkhla. Each participant will have HIV testing at baseline and will be followed up for 18 months.

HIV-negative participants will be asked to have HIV re-testing every 6 months. HIV-positive participants will have POC CD4 testing and ART initiation regardless of CD4 count will be offered. Those who accept ART will be followed up at week 2, week 4, month 2, month 3 and every 3 months thereafter. Those who deny ART will be followed up every 3 months.

Uptake of HIV re-testing will be determined. Access to POC CD4 testing and acceptability of ART initiated at HIV diagnosis regardless of CD4 count along with ART adherence will also be determined.

Study Type

Observational

Enrollment (Actual)

6000

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

    • Bangkok
      • Ratchaburi, Bangkok, Thailand, 10330
        • The Thai Red Cross AIDS Research Centre

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

  1. SWING Drop-In Center, Bangkok, Thailand
  2. RSAT Drop-In Center, Bangkok, Thailand
  3. Chiang Mai Buddy Station, Northern Thailand
  4. SWING Drop-In Center, Pattaya, Chonburi, Eastern Thailand
  5. Sisters Drop-In Center, Pattaya, Chonburi, Eastern Thailand
  6. RSAT Drop-In Center, Songkhla, Southern Thailand

Description

Inclusion Criteria:

  1. Thai national
  2. Age >18 years
  3. Men or transgender women who report unprotected anal intercourse with a man at least one time in the past 6 months
  4. Not known to be HIV-positive, i.e., never tested for HIV or previous HIV test(s) negative
  5. Willing to participate in the study
  6. Provide written informed consent

Exclusion Criteria:

1. Known HIV-positive serostatus

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
Retention strategies
In addition to telephone call(s) made within 1 week prior to scheduled visit, participants will receive at least biweekly communications from the study staff in order to establish and maintain a good relationship between participants and study sites. These communications will make use of various social networking tools (for example, Grindr, LINE and/or WhatsApp and/or SMS and/or Facebook and/or electronic mail).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the uptake of HIV testing among MSM and TG as a result of the community-based Test and Treat approach
Time Frame: 36 months
  1. Increase in the number of individuals tested who have not previously had an HIV test
  2. Increase in the number of HIV-positive individuals tested who did not previously know their HIV status
  3. Increase in the proportion of HIV-negative individuals who are retested at least twice a year, every six months
36 months

Collaborators and Investigators

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

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)

August 15, 2014

Primary Completion (Actual)

October 20, 2020

Study Completion (Actual)

February 16, 2023

Study Registration Dates

First Submitted

February 5, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Community-based Test and Treat

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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