HIV Infection Prevention HIV Combination prevention Young MSM PrEP Effectiveness Cost-
Conditions
Interventions
non-
randomized assessment of daily oral tenofovir/emtricitabine (Truvada®) pre-
exposure prophylaxis (PrEP) with adherence support
Sham Comparator Drug
Combination prevention intervention with and without PrEP
Sponsors
US National Institutes of Health (NIH)
Ministry of Public Health (MOPH),
Department of disease control
Eligibility
Sex/Gender
Male
Age
18 Years to 26 Years
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactPachara Sirivongrangson
Department of Disease Control, Thailand Ministry of Public Health
Outcome results
None listed