- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03745495
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
Study Overview
Status
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:
- SWING DIC, Bangkok, Thailand
- RSAT DIC, Bangkok, Thailand
- SWING DIC, Chonburi, Thailand
- Sister DIC, Chonburi, Thailand
- Caremat DIC, Chiang Mai, Thailand
- MPlus DIC, Chiang Mai, Thailand
- RSAT DIC, Songkhla, Thailand
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Nittaya Phanuphak, MD,PhD
- Phone Number: +662 253 0996
- Email: nittaya.p@prevention-trcarc.org
Study Locations
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-
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Bangkok, Thailand
- 1.Swing Dic,
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Bangkok,, Thailand
- 2. Rsat Dic,
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Chiang Mai, Thailand
- 5. Caremat DIC,
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Chiang Mai, Thailand
- 6. MPlus DIC,
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Chon Buri, Thailand
- 3. Swing Dic,
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Chon Buri, Thailand
- 4. Sister DIC,
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Songkhla, Thailand
- 7. Rsat Dic,
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
Time Frame: 3 years
|
3 years
|
Proportion of participants taking PrEP retaining in care among those who use and do not use HIVST
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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