Clinical trial NCT03580512: 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
Official title: The Thai Red Cross AIDS Research Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Men Who Have Sex With Men and Transgender Women
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 2000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 2000 MSM and TG

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.

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

Eligibility 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

Primary outcomes:
measure: Proportion of participants who receive same-day diagnosis and treatment of CT/NG in community-based clinics
timeFrame: 1 years
measure: Proportion of participants who receive same-day diagnosis of HIV infection in community-based clinics
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: 1.Swing Dic,
city: Bangkok
country: Thailand
facility: 2.Rsat Dic,
city: Chiang Mai
country: Thailand
facility: 5. Mplus DIC,
city: Chon Buri
country: Thailand
facility: 3.Swing Dic
city: Chon Buri
country: Thailand
facility: 4. Sisters DIC,
city: Songkhla
country: Thailand
facility: 6.Rsat Dic,
Study officials:
affiliation: Thai Red Cross AIDS Research Centre (TRCARC)
name: Nittaya Phanuphak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hiransuthikul A, Sungsing T, Jantarapakde J, Trachunthong D, Mills S, Vannakit R, Phanuphak P, Phanuphak N. Correlations of chlamydia and gonorrhoea among pharyngeal, rectal and urethral sites among Thai men who have sex with men: multicentre community-led test and treat cohort in Thailand. BMJ Open. 2019 Jun 27;9(6):e028162. doi: 10.1136/bmjopen-2018-028162.
citation: Hiransuthikul A, Janamnuaysook R, Sungsing T, Jantarapakde J, Trachunthong D, Mills S, Vannakit R, Phanuphak P, Phanuphak N. High burden of chlamydia and gonorrhoea in pharyngeal, rectal and urethral sites among Thai transgender women: implications for anatomical site selection for the screening of STI. Sex Transm Infect. 2019 Nov;95(7):534-539. doi: 10.1136/sextrans-2018-053835. Epub 2019 Apr 13.