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An HIV Pre-Exposure Prophylaxis (PrEP) Demonstration Project and Safety Study for Young MSM.

An HIV Pre-Exposure Prophylaxis (PrEP) Demonstration Project and Safety Study for Young MSM.
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Hosek S, Rudy B, Landovitz R, Kapogiannis B, Siberry G, Rutledge B, Liu N, Brothers J, Mulligan K, Zimet G, Lally M, Mayer K, Anderson P, Kiser J, Rooney J, Wilson CM, ,


Hosek S, Rudy B, Landovitz R, Kapogiannis B, Siberry G, Rutledge B, Liu N, Brothers J, Mulligan K, Zimet G, Lally M, Mayer K, Anderson P, Kiser J, Rooney J, Wilson CM, , (click to view)

Hosek S, Rudy B, Landovitz R, Kapogiannis B, Siberry G, Rutledge B, Liu N, Brothers J, Mulligan K, Zimet G, Lally M, Mayer K, Anderson P, Kiser J, Rooney J, Wilson CM, ,

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Journal of acquired immune deficiency syndromes (1999) 2016 9 13()

Abstract
BACKGROUND
Young men who have sex with men (YMSM) are a key population for implementation of PrEP interventions. This open-label study examined adherence to PrEP and assessed sexual behavior among a diverse sample of YMSM in 12 U.S. cities.

METHODS
Eligible participants were 18-22 year old HIV-uninfected MSM who reported HIV transmission risk behavior in the past 6 months. Participants were provided daily TDF/FTC (Truvada®). Study visits occurred at baseline, monthly through week 12, then quarterly through week 48. Dried blood spots (DBS) were serially collected for the quantification of tenofovir diphosphate (TFV-DP).

RESULTS
Between March-September 2013, 2186 individuals were approached and 400 were found to be preliminarily eligible. Of those 400, 277 were scheduled for an in-person screening visit and 200 were enrolled (mean age=20.2; 54.5% Black, 26.5% Latino). Diagnoses of sexually transmitted infections (STIs), including urethral and rectal chlamydial/gonococcal infection and syphilis, at baseline was 22% and remained high across visits. At week 4, 56% of participants had TFV-DP levels consistent with ≥4 pills/week. By week 48, 34% of participants had TFV-DP levels consistent with ≥4 pills/week, with a noticeable drop-off occurring at Week 24. Four HIV seroconversions occurred on study (3.29/100 person-years). Condomless sex was reported by >80% of participants and condomless anal sex with last partner was associated with higher TFV-DP levels.

CONCLUSIONS
Acceptability of PrEP was high and most participants achieved protective drug levels during monthly visits. As visit frequency decreased, so did adherence. YMSM in the US may need PrEP access in youth-friendly settings with tailored adherence support and potentially augmented visit schedules.

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