Completed

NCT Number: NCT02383602

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Test and Treat

Age range

18 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

The Thai Red Cross AIDS Research Centre

Ratchaburi, Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Known HIV-positive serostatus

Treatment and study plan

Primary outcomes

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
- Increase in the number of individuals tested who have not previously had an HIV test
- Increase in the number of HIV-positive individuals tested who did not previously know their HIV status
- Increase in the proportion of HIV-negative individuals who are retested at least twice a year, every six months

Sponsors and collaborators

Lead sponsor

Thai Red Cross AIDS Research Centre

Other

Collaborators

Ministry of Health, Thailand
National Health Security Office, Thailand
The Government Pharmaceutical Organization
United States Agency for International Development (USAID)

Registry information

Official study title

Thai Red Cross AIDS Research Centre (TRC-ARC)

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2023
First posted: Mar 9, 2015
Registry last updated: Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.