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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Approximately 600 older adolescent MSM and TGW

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group 1; 300 To determine the effect of HIVST on PrEP uptake among older adolescent MSM and TGW
Group 2; 300 To determine the effect of HIVST on retention of older adolescent MSM and TGW in HIV service

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Thai Red Cross AIDS Research Centre
• Collaborators: United States Agency for International Development (USAID)

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): October 26, 2021

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STANDUP-TEEN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No