Patient Experiences of Men Who Have Sex with Men Using Pre-Exposure Prophylaxis to Prevent HIV Infection.

In the United States (US), new HIV infections are increasingly concentrated among men who have sex with men (MSM). Although MSM represent only 4% of males in the US, they account for 61% of all new infections. Despite demonstrated efficacy of antiretroviral pre-exposure prophylaxis (PrEP) in reducing HIV acquisition, evaluation of PrEP uptake and use outside of research settings remains limited. Commonly cited barriers to PrEP implementation include limited awareness about PrEP, concerns about side-effects, adherence, cost, access, low perceived risk of HIV acquisition, and stigma. Whether and how these barriers affect PrEP uptake and PrEP clinical programs in real-world settings is unknown. Similarly, other than in efficacy trials that found that individuals on PrEP did not engage in higher risk behaviors after PrEP initiation, little is known about changes in sexual risk behaviors following PrEP initiation. To understand PrEP patients’ experiences in real-world settings, we conducted in-depth qualitative interviews with MSM prescribed PrEP at an infectious diseases outpatient center in Providence, Rhode Island. Interviews explored overall experiences taking PrEP, sexual risk behaviors and decision-making, self-reported experiences with payers, and normative recommendations for how best to raise community awareness about PrEP. The study was approved by the Lifespan Institutional Review Board (IRB). Study inclusion criteria included being HIV-negative and taking PrEP for at least 3 months. Interviews were structured to allow flexible responses and introduction of additional topics by both interviewer and participant. We conducted interviews until reaching saturation, when no additional information emerged. Each interview was digitally recorded, professionally transcribed, and de-identified. A grounded theory approach was used to interpret interview findings. Transcripts were coded using contextual themes, and our findings were organized in analytical memos. Results are presented here. Table 1 summarizes demographic characteristics of participants. Table 2 summarizes the primary findings. Patients generally reported positive experiences with PrEP and experienced few adverse clinical outcomes. PrEP users generally reported consistent adherence patterns; however, these results should be interpreted with caution, given that self-reported adherence to PrEP may not always correlate with drug levels. Despite this challenge, our results are consistent with prior research suggesting that facilitators of medication adherence include establishing a daily routine, using a pill-box, receiving daily text message reminders, and setting alarms. PrEP medication costs were generally covered by insurance companies, including public and private payers. Most patients’ insurance covered the majority of PrEP costs, but several patients reported high co-payments for PrEP and related clinical and laboratory services. Industry-sponsored patient assistance programs helped offset many, but not all, of these costs. Overall, out-of-pocket costs were inconvenient for a few patients but did not present insurmountable barriers for most participants. Some patients reported that pre-authorization requests for PrEP payments and requirements that patients pick-up medications from a specialty pharmacy as minor obstacles, but they did not generally hinder patients from initiating or continuing to take PrEP. However, our staff spent considerable time navigating both industry and clinicsponsored patient assistance programs to reduce patients’ out-of-pocket costs. Other clinics may require additional staff resources to provide these important support services to PrEP clients. Participants overwhelmingly reported no increases in number of sexual partners or decreases in condom use. It should be noted that nearly three-quarters of patients in our study engaged in condomless anal sex or concurrent sexual partnerships before initiating PrEP and maintained these behaviors while taking PrEP. Our findings echo those of another recent qualitative study that found that patients who