Clinical infectious diseases : an official publication of the Infectious Diseases Society of America | 2021
Results from a PrEP Demonstration Project for At-Risk Cisgender Women in the United States.
Abstract
BACKGROUND\nDaily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is effective for reducing HIV acquisition among cisgender women. We report results from the first United States observational open-label demonstration project of PrEP among at-risk cisgender women.\n\n\nMETHODS\nAdherence Enhancement Guided by Individualized Texting and Drug Levels (AEGiS) was a 48-week single-arm open-label demonstration study of daily oral TDF/FTC in cisgender women ≥18 years old at-risk for HIV. Adherence was supported using two-way text messaging and titrated adherence counseling based on rapid-turnaround tenofovir diphosphate concentrations from dried blood spots. Study visits occurred at baseline, and at weeks 4, 12, and quarterly through week 48. Outcomes included TDF/FTC adherence, retention and persistence.\n\n\nRESULTS\nFrom June 2016 to October 2018, 136 cisgender women enrolled [mean age 40 (SD 11); 38% non-Hispanic (NH) Black and 19% Latina]. At 48 weeks, 84 (62%) participants were retained and 62 (46%) remained on PrEP. Over one-third (12/31) of those on study but off PrEP throughout study discontinued TDF/FTC due to side effects, and one adverse event led to study discontinuation. Of 120 participants with drug concentrations measured, 67 (56%) had at least one concentration consistent with ≥6 doses/week (d/w); 22 (18%) had consistent ≥6 d/w across all study visits attended. There were no incident HIV infections and 4 incident bacterial STIs.\n\n\nCONCLUSION\nAdequate PrEP adherence for protective drug concentrations was not achieved for most study participants. More work needs to be done to fully explicate the reasons for non-adherence and low retention in cisgender women.