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Background: Tenofovir disoproxil fumarate/emtricitabine preexposure prophylaxis (PrEP) is effective against HIV acquisition when taken as prescribed. Strategies that identify and intervene with those challenged by adherence to daily medication are needed., Setting: PATH-PrEP was an open-label single-arm interventional cohort study conducted at 2 community-based clinical sites in Los Angeles, CA., Methods: We enrolled self-identified men who have sex with men and transgender women ≥18 years of age at an elevated risk of HIV acquisition. Participants received a postexposure prophylaxis (PEP)-based or PrEP-based HIV prevention package for at least 48 weeks. Plasma tenofovir levels from each PrEP visit assessed as below the limit of quantitation (<10 ng/mL) triggered increased adherence support., Results: Three hundred one participants enrolled. Forty-eight-week retention in the PrEP cohort was 75.1%. Biomarker evidence of PrEP adherence consistent with ≥4 doses per week at weeks 4, 12, 24, 36, and 48 was found in 83.1%, 83.4%, 75.7%, 71.6%, and 65.5% of participants, respectively; younger and African American participants were less likely to have protective drug levels. Most of those with suboptimal adherence had adherence improvement after brief intervention. One seroconversion occurred in a participant who discontinued PrEP. Nearly half (46.4%) of participants were diagnosed with at least 1 incident sexually transmitted infection during 48 weeks of study follow-up., Conclusions and Relevance: PrEP was acceptable and well tolerated in a diverse population of men who have sex with men in Los Angeles. A brief intervention triggered from biomarkers of poor adherence was associated with improved adherence. Drug level monitoring has the potential to allow targeting of additional adherence support to those struggling with daily tablet adherence.

Introduction: High viremia combined with HIV-infection status unawareness and increased sexual risk behavior contributes to a disproportionate amount of new HIV infections., Methods: From August 2011 to July 2015, the Los Angeles Lesbian, Gay, Bisexual, and Transgender Center conducted 66,546 HIV tests. We compared factors, including the presence of concomitant sexually transmitted infections, number of recent sex partners and reported condomless anal intercourse between men who have sex with men (MSM) diagnosed with an acute HIV infection and a nonacute HIV infection using multivariable logistic regression., Results: Of 1082 unique MSM who tested HIV-infected for the first time, 165 (15%) had an acute infection and 917 had a nonacute infection. HIV rapid antibody testing was 84.8% sensitive for detecting HIV infection (95% confidence interval (CI): 82.9% to 87.1%). Median HIV viral load among acutely infected MSM was 842,000 copies per milliliter (interquartile range = 98,200-4,897,318). MSM with acute infection had twice the number of sex partners in the prior 30 days (median = 2) and prior 3 months (median = 4) before diagnosis compared with those diagnosed with nonacute infection (P ≤ 0.0001). The odds of acute HIV infection were increased with the numbers of recent sex partners after controlling for age and race/ethnicity (adjusted odds ratio (aOR) >5 partners in past 30 days = 2.74; 95% CI: 1.46 to 5.14; aOR >10 partners in past 3 months = 2.41; 95% CI: 1.36 to 4.25). Non-African American MSM had almost double the odds of being diagnosed with an acute HIV infection compared with African American MSM (aOR = 1.97; 95% CI: 1.10 to 3.52)., Conclusions: MSM with acute HIV infection had nearly twice as many sex partners in the past 30 days and 3 months compared with MSM with newly diagnosed nonacute HIV infection. Those diagnosed with acute HIV infection had decreased odds of being African American MSM.