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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03745495

Enrollment

600

Registered

2018-11-19

Start date

2018-10-15

Completion date

2021-10-26

Last updated

2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Men or Transgender Women Who Have Sex With Men

Brief summary

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.

Detailed description

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: 1. SWING DIC, Bangkok, Thailand 2. RSAT DIC, Bangkok, Thailand 3. SWING DIC, Chonburi, Thailand 4. Sister DIC, Chonburi, Thailand 5. Caremat DIC, Chiang Mai, Thailand 6. MPlus DIC, Chiang Mai, Thailand 7. RSAT DIC, Songkhla, Thailand

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

15 Years to 19 Years

Healthy volunteers

Yes

Inclusion criteria

1. Thai nationality 2. Age 15-19 years old 3. Men or transgender women who have sex with men 4. HIV-negative at the time of screening 5. Have at least one of the following risks for HIV acquisition in the past 6 months: 1. Any unprotected receptive anal sex with a male partner 2. More than 5 male partners, regardless of condom use and serostatus 3. Has had a bacterial sexually transmitted infection (STI) 4. Any injected drug use 6. Calculated creatinine clearance (CrCl) ≥ 75 mL/min, as estimated by the Cockcroft- Gault equation 7. Alanine aminotransferase (ALT) ≤ 2.5 x ULN 8. Have signed the informed consent form

Exclusion criteria

1. HIV-positive 2. Hepatitis B infection as indicated by positive hepatitis B surface antigen (HBsAg) test at time of screening 3. Known allergy/sensitivity to tenofovir or emtricitabine

Design outcomes

Primary

Measure	Time frame
Proportion of participants starting PrEP among those who use and do not use HIVST	3 years
Proportion of participants taking PrEP retaining in care among those who use and do not use HIVST	3 years

Countries

Thailand

Outcome results