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
1 other identifier
observational
600
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2018
CompletedFirst Submitted
Initial submission to the registry
November 14, 2018
CompletedFirst Posted
Study publicly available on registry
November 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2021
CompletedNovember 26, 2024
November 1, 2024
2.2 years
November 14, 2018
November 22, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
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
Eligibility Criteria
Approximately 600 older adolescent MSM and TGW
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
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, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2018
First Posted
November 19, 2018
Study Start
October 15, 2018
Primary Completion
December 15, 2020
Study Completion
October 26, 2021
Last Updated
November 26, 2024
Record last verified: 2024-11