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

Completed

• Conditions: Men or Transgender Women Who Have Sex With Men

• Registration Number: NCT03745495
• Lead Sponsor: Thai Red Cross AIDS Research Centre

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

Study Timeline

• Study Start: 2018-10-15
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-19
• Primary Completion: 2020-12-15
• Study Completion: 2021-10-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

2. Rsat Dic,; 🇹🇭 Bangkok,, Thailand

5. Caremat DIC,; 🇹🇭 Chiang Mai, Thailand

6. MPlus DIC,; 🇹🇭 Chiang Mai, Thailand

7. Rsat Dic,; 🇹🇭 Songkhla, Thailand

4. Sister DIC,; 🇹🇭 Chon Buri, Thailand

3. Swing Dic,; 🇹🇭 Chon Buri, Thailand

1.Swing Dic,; 🇹🇭 Bangkok, Thailand