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Completed

NCT Number: NCT03745495

HIV Self-Testing AND Uptake and Retention of PrEP Among Older Adolescent MSM and TGW

This will be a prospective study that will enroll up to 600 older adolescent MSM and TGW from community-based clinics in Bangkok, Chonburi, Chiang Mai, and Songkhla.

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Key information

Conditions

Men or Transgender Women Who Have Sex With Men Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary

Age range

15 year–19 year

Sex eligibility

Male

Study type

Observational

Primary location

1.Swing Dic,, Bangkok, Thailand

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About this study

All eligible participants will be followed up at month 3, 6, 9, and 12; month 6 and 12 will be mandatory clinic visits, while month 3 and 9 will be either clinic or a virtual visits. For participants accepting PrEP, additional follow-up visit at month 1, 2, 4, and 5 will be appointed; all visits will be either clinic or virtual visits.

Study Sites

The study will take place at the following community-based clinics:

  • SWING DIC, Bangkok, Thailand
  • RSAT DIC, Bangkok, Thailand
  • SWING DIC, Chonburi, Thailand
  • Sister DIC, Chonburi, Thailand
  • Caremat DIC, Chiang Mai, Thailand
  • MPlus DIC, Chiang Mai, Thailand
  • RSAT DIC, Songkhla, Thailand

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Thai nationality
  • Age 15-19 years old
  • Men or transgender women who have sex with men
  • HIV-negative at the time of screening
  • Have at least one of the following risks for HIV acquisition in the past 6 months:
  • Any unprotected receptive anal sex with a male partner
  • More than 5 male partners, regardless of condom use and serostatus
  • Has had a bacterial sexually transmitted infection (STI)
  • Any injected drug use
  • Calculated creatinine clearance (CrCl) ≥ 75 mL/min, as estimated by the Cockcroft- Gault equation
  • Alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • Have signed the informed consent form

Exclusion criteria

  • HIV-positive
  • Hepatitis B infection as indicated by positive hepatitis B surface antigen (HBsAg) test at time of screening
  • Known allergy/sensitivity to tenofovir or emtricitabine

Treatment and study plan

Primary outcomes

  1. Proportion of participants starting PrEP among those who use and do not use HIVST

    Time frame: 3 years

  2. Proportion of participants taking PrEP retaining in care among those who use and do not use HIVST

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Thai Red Cross AIDS Research Centre

Other

Collaborators

  • United States Agency for International Development (USAID)

Registry information

Official study title

Study to Determine the Effect of HIV Self-testing on the Uptake of and Retention in Pre-exposure Prophylaxis Service Among Older Adolescent Men Who Have Sex With Men and Transgender Women

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Nov 19, 2018
Registry last updated
Nov 26, 2024

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.

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