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

Men or Transgender Women Who Have Sex With Men Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03745495
• Other study ID #: STANDUP-TEEN
• Status: Active, not recruiting
• Start date: October 15, 2018
• Est. completion date: December 2025

Study information

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

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: December 2025
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Men or Transgender Women Who Have Sex With Men

Locations

Country	Name	City	State
Thailand	1.Swing Dic,	Bangkok
Thailand	2. Rsat Dic,	Bangkok,
Thailand	5. Caremat DIC,	Chiang Mai
Thailand	6. MPlus DIC,	Chiang Mai
Thailand	3. Swing Dic,	Chon Buri
Thailand	4. Sister DIC,	Chon Buri
Thailand	7. Rsat Dic,	Songkhla

Sponsors (2)

Lead Sponsor	Collaborator
Thai Red Cross AIDS Research Centre	United States Agency for International Development (USAID)

Country where clinical trial is conducted

Thailand, 

Outcome

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