Combination Prevention Effectiveness Study for Young MSM
- Conditions
- HIV Infection PreventionHIVCombination preventionYoung MSMPrEPEffectivenessCost-
- Registration Number
- TCTR20170408001
- Lead Sponsor
- S National Institutes of Health (NIH)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 1240
•Biological male sex at birth
•Self-report of having sold or traded sex to another man for money, drugs, or other goods or services in the previous 12 months.
•Age 18 through 26 years at enrollment
•Self-reported living in the greater Bangkok Metropolitan area or Pattaya City
•Willing to complete study instruments, with or without assistance, Thai and/or English.
•Thai citizenship
•Willing to provide contact and locator information
•Self-reported negative or unknown HIV status
•Negative rapid HIV test result at the screening visit
•Unable or unwilling to provide consent for study participation
•Rapid HIV test results at the screening visit suggesting HIV infection
•Did not complete baseline assessment (Section 3.1 above)
•Any condition that would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
•Concurrently enrolled in another PrEP (oral or topical or injectable) intervention trial or preventive HIV vaccine trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method effectiveness of an open-label combination HIV preventive intervention within 12 months after PrEP initiation compare HIV incidence densities among participants with and without PrEP
- Secondary Outcome Measures
Name Time Method Cost-Effectiveness of Combination prevention intervention with PrEP 2 year after last participant complete follow-up Assess the incremental costs associated with combined HIV prevention with PrEP use