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 Test and Treat Clinical Trial

Official title:

Thai Red Cross AIDS Research Centre (TRC-ARC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383602
• Other study ID #: Community-based Test and Treat
• Status: Completed
• Start date: August 15, 2014
• Est. completion date: February 16, 2023

Study information

• Verified date: April 2022
• Source: Thai Red Cross AIDS Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: February 16, 2023
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Test and Treat

Locations

Country	Name	City	State
Thailand	The Thai Red Cross AIDS Research Centre	Ratchaburi	Bangkok

Sponsors (5)

Lead Sponsor	Collaborator
Thai Red Cross AIDS Research Centre	Ministry of Health, Thailand, National Health Security Office, Thailand, The Government Pharmaceutical Organization, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the uptake of HIV testing among MSM and TG as a result of the community-based Test and Treat approach	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	36 months