Time to Make the Jump: Translating HIV Pre-exposure Prophylaxis Research Into Real-World Public Health Impact
We applaud the analyses elucidating the differences in HIV pre-exposure prophylaxis (PrEP) access in states with different public insurance programs (Doblecki-Lewis et al’s1 “Healthcare Access and PrEP Continuation in San Francisco and Miami”). Their open-label demonstration study evaluated 173 patients in San Francisco and Miami after completion of a National Institutes of Health–sponsored PrEP demonstration project.2 PrEP was originally provided free of charge at these sites during a 3-year study. However, although 92% (159/173) reported interest in continuing PrEP after the study's conclusion, only 40% (69/171) of participants reported continuing PrEP 4–6 months after the study ended. Moreover, among individuals who did continue PrEP, 33% (23/69) reported a gap in taking medication; the average gap was close to 2 months. These important findings highlight the challenges associated with transitioning participants in research studies and demonstration projects to real-world clinical care programs; these challenges are particularly acute for men who have sex with men (MSM) of color who bear a disproportionate share of the HIV disease burden in the United States.
There are several reasons why patients may be better retained in PrEP care in research studies and demonstration projects than in real-world clinical settings. First, research patients are often not charged for their visits or for PrEP medications, which can be cost-prohibitive for some patients, particularly those without or with limited insurance coverage. Patients may also forego high deductibles or copayments that many insurance companies require for PrEP medications, laboratory work, and related clinical services.
Second, many research studies have staff resources to promote retention in care, which usually includes consistent outreach, regularly scheduled patient visits and reminders, transportation support, and other important case management services. Furthermore, research participants are usually financially compensated for attending visits, which bolsters retention in PrEP care. By contrast, in many nonresearch settings, support staff to promote retention in care are limited, patients are not compensated for attending routine clinical visits, and patients with limited insurance coverage often forego important PrEP services and medications. These phenomena may explain why rates of retention in PrEP care dropped precipitously when the San Francisco and Miami demonstration projects concluded.
Our own work highlights challenges with retaining patients in PrEP clinic care. In a 3-site study in real-world clinical settings, 57% (98/171) of patients were retained in PrEP care at 6 months.3 These findings were consistent across 3 diverse clinical settings in Jackson, Mississippi (61%; 37/61); Providence, Rhode Island (53%; 42/80); and Saint Louis, Missouri (63%; 19/30, P = 0.51). However, our higher rates of retention in care reflect our efforts to integrate PrEP into clinical infrastructure rather than stand-alone research studies or demonstration projects. It is worth noting, however, that retention in care was also suboptimal across all 3 of our clinical sites.
In randomized-controlled PrEP efficacy trials, many participants reported taking PrEP, but had low levels of the medication in their blood.4,5 Discordance between self-reported adherence and tenofovir blood levels may be because patients received other clinical care and financial compensation for study participation, and therefore continued to come to study visits even after discontinuing PrEP or having suboptimal adherence rates. This discordance was noted in the Vaginal and Oral Intervention to Control the Epidemic (VOICE) PrEP trial.6 Furthermore, in randomized-controlled trials in which the product's efficacy had not yet been determined, patients' perceptions about taking placebos may also undermine adherence.7
Our own PrEP programs demonstrated that patients retained in care were overwhelmingly adherent to PrEP, and that their self-reported adherence was confirmed with dried blood spots (L. Mena, MD, MPH, Unpublished data, 2016; R. R. Patel, Unpublished data, 2016).