Abstract
In the United States, uptake of daily oral pre-exposure prophylaxis (PrEP) to prevent HIV continues to grow albeit at a slower than desired pace. Innovations in PrEP delivery systems may partially address structural challenges related to PrEP uptake and PrEP persistence, such as difficulty in attending clinic visits or completing laboratory testing. To study PrEP services offered by a telehealth company called Nurx, we conducted 31 in-depth interviews with prospective or current patients. We hypothesized that patients would find the quarterly laboratory monitoring requirements to be onerous especially in light of receiving all other aspects of PrEP care through a telehealth delivery system. However, interviewees characterized navigating laboratory systems as relatively easy and complying with the quarterly monitoring as a supplementary benefit of PrEP use. Our research illustrates that quarterly monitoring requirements are meaningful to some telehealth PrEP users and may facilitate persistent engagement in receipt of PrEP care.
What Do We Already Know about This Topic?
Patient perspectives on laboratory monitoring requirements as a barrier or facilitator to sustained use of HIV pre-exposure prophylaxis (PrEP) is understudied quantitatively and to our knowledge, no qualitative studies have examined this topic.
How Does Your Research Contribute to the Field?
Our research makes an important contribution to the field of PrEP implementation research in that it builds our understanding of the role played by an integral component of PrEP services—laboratory monitoring requirements.
What Are Your Research’s Implications Toward theory, Practice, or Policy?
Our research concludes with recommendations that may influence clinician practice and health system policies regarding PrEP.
Introduction
HIV pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) is a highly effective HIV prevention strategy when used as directed. 1 -3 The US Food and Drug Administration approved use of TDF/FTC for HIV PrEP in 2012. Accessing PrEP through traditional sources such as a primary care setting or sexual health clinic requires routine clinic visits and laboratory testing. The extent to which otherwise healthy individuals are willing and able to comply with the frequent in person visits and testing that PrEP use demands remain an important and understudied phenomenon.
Since its approval in 2012, uptake of PrEP has grown albeit at a slower than desired pace. 4,5 With increased rates of PrEP implementation, the phenomenon of PrEP discontinuation is now an emerging issue. 6 Distinguishing instances of appropriate discontinuation (ie, when an individual replaces PrEP with alternate HIV prevention method[s]), from inappropriate discontinuation when an individual discontinues use, but continues to have an ongoing indication for PrEP is challenging 7 and therefore difficult to accurately measure. Recent research on reasons for discontinuation (regardless of whether ongoing PrEP is indicated) include cost, loss of insurance, stigma, change in risk perception, and concern about long-term side effects. 8 -10 In addition, required quarterly follow-up clinic visits and laboratory testing have been considered a potential barrier to longer term persistence in PrEP care. 11 -15 Indeed, a recent study conducted in San Francisco, a location with robust PrEP care, found that the most common reason for discontinuation was difficulty attending clinic visits or completing laboratory tests. 16
Technological innovations in PrEP delivery systems may help address structural and social challenges related to PrEP uptake and continuity, such as fear of discrimination on the basis of one’s sexual identity, difficulty attending clinic visits, or completing laboratory testing. A recent review of advances in telehealth and PrEP care in the United States outlined 5 unique provider-to-patient delivery models. 17 One such telehealth service is Nurx, which launched PrEP services in California in 2016, and has since expanded to numerous states across the United States. Pre-exposure prophylaxis delivered through Nurx and likely any other telehealth PrEP services includes a traditional element of PrEP care: patients must physically present to a laboratory prior to initiating PrEP, and quarterly follow-up laboratory results are required for prescription renewal.
Limited preliminary data signal the possibility for effective capitalization on technology-based service delivery models. However, both in-depth and longitudinal research are needed to understand whether and how telehealth plays a role in supporting PrEP initiation and continuation. To understand how laboratory monitoring requirements influenced the use or nonuse of Nurx services, we conducted qualitative interviews with individuals who sought out their PrEP services. In this analysis, we present data on the acceptability of laboratory monitoring for current and would-be telehealth PrEP users.
Nurx Telehealth PrEP Services
Unlike some telehealth PrEP programs where coordination of a synchronous visit is required (eg, telephone appointments for all follow-up visits [PrEPTECH]), 18 Nurx encounters typically take place online, and there is no pressure to schedule an appointment. Nurx allows either synchronous or asynchronous communication via a secure portal with a chat feature to “speak” with a medical provider.
Individuals interested in receiving PrEP through Nurx submit an online request, complete a medical history questionnaire, upload insurance information, and await a response from a Nurx provider. Nurx providers follow the US Centers for Disease Control and Prevention (CDC) PrEP guidelines 19 and direct prospective patients to an affiliated laboratory nearby. HIV and creatinine testing occur every 3 months; although not required, bacterial sexually transmitted infection (STI) testing is encouraged every 3 to 6 months. After Nurx reviews laboratory test results, if a patient is approved for PrEP use, a 90-day supply of medication (FTC/TDF) is mailed to the patient, including instructions for renewal.
One significant advantage Nurx has over traditional PrEP delivery models is that systems-level support is an inherent component of the service design. Nurx patients receive automated messages in advance of their prescription renewal date with instructions explaining laboratory testing requirements for continuing with PrEP. A new prescription cycle is kicked off when patients submit a renewal PrEP request; they then complete laboratory testing as in the initial phase and update insurance information as necessary. Once laboratory results are reviewed and approved, another 90-day supply is shipped to the patient.
Methods
We conducted in-depth interviews (IDIs) with men and women who had requested PrEP services through the Nurx platform. Nurx staff facilitated introduction to prospective participants by approaching all PrEP requesters in California, New York, Florida, and Illinois—the states where they were operating at the time of data collection. Ninety-three individuals expressed interest and were directed to the research team. We applied a purposive sampling frame 20 whereby each potential participant’s Nurx profile was reviewed prior to enrollment to ensure adequate representation of those who requested and did not initiate PrEP as well as those who requested and did initiate PrEP use.
We intended to interview until patterns were evident and anticipated sampling approximately at least 8 to 12 persons 21,22 in the categories of PrEP requesters and PrEP users. The researchers e-mailed individuals who expressed interest with information about the study and scheduled telephone interviews at a mutually convenient time. We designed the interview guide to explore, among other things, experiences with laboratory testing (interview guide available upon request). The general laboratory questions included: (1) “Tell me about your experiences with lab testing,” and (2) “Being on PrEP requires you to do lab testing for HIV, creatinine/kidney functioning, as well as STI screening if you want; what are your thoughts on this type of ongoing monitoring?” Interviews were audio-recorded and lasted 60 to 90 minutes. Following the interview, we verbally collected basic demographic information and presented the participant with a US$40 Amazon gift card.
All data were transcribed verbatim and entered into Dedoose, 23 a web-based program designed for managing qualitative data. Authors (K.A.K. and S.D.H.) reviewed each interview, writing memos to capture initial impressions and insights. We developed a codebook comprised of deductive and inductive codes. 24 Each transcript was coded by a primary analyst and reviewed by a secondary analyst. For the analysis presented below, authors (K.A.K and S.D.H.) held a series of analysis sessions to review the text associated with “lab attitudes.” During these sessions, text was read aloud, discussed, and summarized. Ultimately, we produced an analytic memo 25 used to develop the findings presented below.
Ethical Approval and Informed Consent
The University of California, San Francisco Committee on Human Research reviewed and approved all research activities associated with this study (approval #: 16-20521). We obtained verbal informed consent from all participants.
Findings
We conducted 31 IDIs between April and July 2017. Median age of participants was 28.5 years; 68% were nonwhite; and the majority were cisgender males (n = 26 cisgender men/5 cisgender women; Table 1). Participants included active and former Nurx PrEP patients, as well as those who requested PrEP services, but did not ultimately initiate PrEP. Participants were insured through employers, public programs, or a parent’s plan. Participants addressed both the act of testing (physically presenting at a laboratory) and the meaning or value they attributed to quarterly testing. Data provided by 5 female PrEP requesters were excluded from this analysis. All were assessed as low risk and advised by Nurx providers that PrEP may not be necessary. Active and former (2 individuals had recently stopped using Nurx) Nurx patients characterized navigating laboratory systems as relatively easy and complying with the quarterly monitoring as a supplementary benefit of PrEP use. The combination of (1) relatively uncomplicated access to laboratories, (2) appreciation for the structure provided by required quarterly testing, and (3) the reassurance laboratory results provided seemed to promote an overall sense of sexual wellness among active Nurx users. Among those who did not initiate PrEP use, only one participant described the required monitoring as an impediment. Note, additional quotes are presented in Table 2 at the end of the Findings section.
Participant Demographics.
Abbreviations: PrEP, pre-exposure prophylaxis; ACA, Affordable Care Act.
a Medications were being shipped at time of interview.
Themes and Exemplary Quotes.
Abbreviation: PrEP, pre-exposure prophylaxis.
Easy Access to Laboratories Facilitates Compliance with Monitoring
We initially hypothesized that individuals accessing PrEP through an otherwise virtual interface would find the required laboratory testing inconvenient and therefore unappealing. However, participants reported few complaints about presenting for testing, or to drop-off specimens, and instead described why complying with monitoring was not considered burdensome. The commercial laboratory with which Nurx had partnered offered many locations, expansive hours, online appointment scheduling, and drop-in visits. Participants repeatedly highlighted easy access to laboratory facilities as a benefit. There’s so many [labs] around here or there’s a fair amount, at least. They have good hours and that was much easier to fit into my schedule than going to a doctor’s office. (PT04, 31-year-old, Latino male)
Interviewees often expressed being attracted to Nurx because the service was perceived as compatible with their busy lives and, in some cases, seeking PrEP from Nurx was far more accessible than seeking it out through traditional primary care settings. Two participants specifically explained that their motivation to use Nurx was due to their lack of time to seek health care between the hours of 9 I like having to go like that [every 3 months]. For me, it’s definitely not a burden at all. Especially if I can do everything else online and all I have to do is just go get the test once every 3 months. (PT32, 31-year-old, African American male)
Many participants noted the I think the only reason why I didn’t actually end up taking PrEP was, one, because I had no need for it, or a perceived need, at the time, and, 2, because I’m lazy and didn’t want to go to the lab. (PT19, 23-year-old, Asian male)
Requirements Create a Helpful Structure
Many participants described the quarterly requirements as creating a beneficial structure for regular HIV and STI screening. This forcing function was often treated as a welcome motivation for participants to prioritize HIV and STI testing. Numerous participants explained that even with good intentions, it was difficult to prioritize routine testing: Obviously, the reduction in contracting HIV is the best part of PrEP, but if I had to choose the close second, it would be the required, regular, routine testing. Even though these are really important things they’re testing for…It’s just so easy to not be in a routine of getting tested…especially when I think people will often fear the results. It’s so easy to convince yourself to put it off. The fact that it’s tied to getting your supply of PrEP, I think, adds an extra incentive that gets people in what I would call a good habit of getting tested. (PT04, 31-year-old, Latino male) Because I have to get tested every time I renew the prescription…I absolutely think of it as a benefit because I wouldn’t be doing it otherwise…it makes me do it…I’m happy about that. (PT10, 28-year-old, White male) [Routine screening is] the most positive thing about being on PrEP because it forces you to be very engaged with your own health. Even though it’s not required that you’re tested for other STIs in most cases, I still choose to be because I’m getting tested for HIV once every 3 months, so why not do a full range testing? I feel really great about it. (PT04, 25-year-old, Asian male) Honestly in my opinion not as often as I should have. Probably like once a year…There [was] definitely a thing of like I’m going to avoid getting tested because waiting and getting the results is scary to me…it definitely had an element of that. But, also the whole thing of making an appointment and go to the doctor and get blood drawn. Like the whole, it’s just logistically, like there [were] inconveniences, so I think that [was] somewhat deterring. (PT10, 28-year-old, White male) I’m fine with it…I feel like because for most gay people…a lot of people are told, you know, you should be getting tested every 3 months anyways for your safety and for the safety of your partners…So, I was already doing, like, tests every 3 to 4 months anyways. So, I’d say it wasn’t, like, a huge, big deal. (PT24, 39-year-old, Mixed Race male)
Results of Laboratory Work Provide Reassurance and Underscore the Benefits of the PrEP Package
Although some informants reported deriving a sense of satisfaction from fulfilling the monitoring requirements, the screening was not done for this reason alone—the results of the screening were an essential component of what made the testing meaningful and influenced participants’ sense of well-being. Many participants embraced testing as a way to know oneself—whether one was healthy or in need of intervention.
In the most extreme example of the desirability of testing, one participant had negotiated with the Nurx physician for “standing orders” at the laboratory—meaning he could test for HIV and STIs monthly if he wished. Further, not only the frequency but the type of testing offered by Nurx was actually part of the service’s appeal. I was completely amazed that, when I signed up for Nurx and they sent my requisition to [the lab], they were doing a much more advanced screening for these types of STIs and STDs, particularly the HIV panel, which was fourth generation and…much more accurate than the third generation exam. So there was that relief. (PT01, 26-year-old, Latino male) I don’t get myself in situations where I’d be worried. It’s just nice to know. And if I ever were in a situation where I would be worried, I would go in and get tested, I wouldn’t wait for the next regular test. (PT03, 29-year-old Asian male) I definitely recognize the importance, now more so than I ever have before about my sexual life, of having these services done for me to keep myself healthy. The fact that I have to take 20 minutes out of my day, today, and go have someone take my blood, eh, inconvenient, but I know just how important it is for me. (PT16, 29-year-old, Mixed Race male) If [PrEP users] are exposed to something, they can get it caught within 3 months, rather than either never or, like, once a year when they actually go in for their checkup, you know? So, I feel like it prevents a lot of other STIs spread, or at least inhibits it somewhat better. (PT24, 39-year-old, Mixed Race male) I kind of want to add that in, too, is another reason why I feel a lot more comfortable not using condoms is because I know people are getting tested for other STDs while they’re getting tested for HIV to get their PrEP prescriptions. (PT30, 27-year-old, White male)
Discussion
In this analysis, we focused on participant narratives related to quarterly laboratory testing requirements to assess how these requirements might facilitate or deter PrEP continuation. Our research illustrates that individuals accessing PrEP through a telehealth service characterized navigating laboratory systems as relatively easy. Three intertwined benefits of monitoring included being nudged into complying with recommended HIV and STI testing frequencies for sexually active men who have sex with men (MSM); obtaining reassurance that PrEP was safe, effective, and compatible with general good health; and to some extent, being able to think of oneself as an active participant in enhancing the health of the gay community.
Most participants opted into Nurx PrEP services specifically because of the convenience and flexibility associated with telehealth. 26 Our sample is unique in that participants coupled asynchronous virtual clinic visits with in-person laboratory visits. Understanding this backdrop is important to interpreting participant narratives on laboratory monitoring experiences. Participants often contrasted their difficulties seeking general health care against the ease they experienced fulfilling PrEP-related laboratory work. Laboratories were described as accessible, convenient, and, in general, more patient-centered than brick-and-mortar clinic settings. The average health-care facility cannot compete with a stand-alone laboratory system offering state-of-the-art online scheduling systems and plentiful, convenient locations. From the vantage point of some Nurx PrEP users, a face-to-face primary care visit was perceived as overly burdensome, in contrast to their perceptions about a quarterly laboratory visit. The additional effort required to make and keep an appointment for a quarterly, face-to-face primary care visit might have left a different impression and potentially have affected PrEP continuation.
In addition to reducing new HIV infections, widespread uptake of PrEP may also produce added sexual health benefits at the population level. Assuming laboratory monitoring guidelines associated with PrEP are followed, modeling indicates that PrEP users test for STIs more frequently than they would otherwise. 27 Our research bears this out. One study modeled a scenario among MSM on PrEP in the United States in which STI incidence decreased, even accounting for risk compensation, as long as regular STI screening occurred. 27 However, underlying the model is a presumption that PrEP providers will strictly follow the monitoring guidelines. Another study reported that this was not the case among PrEP prescribers working in health department–funded community health clinics. Importantly, compliance with the CDC guidelines was better among clinics that had rolled out a panel management initiative focused on PrEP monitoring. 16 This research illustrates the independent as well as interdependent roles played by PrEP prescribers and PrEP users. Each party may be more successful in fulfilling their duties as prescriber or user when systems-level support (ie, structured reminders) is present. Nurx services are intentionally designed to offer these supports to both parties.
Researchers are beginning to consider whether reducing the number of health-care tasks patients must navigate to secure PrEP would benefit the patient (ie, reducing the required clinic visits and/or laboratory monitoring from 4 times per year to 2). 28,29 However, our findings illustrate that, in the context of receiving PrEP through a telehealth service, some PrEP users see monitoring as a secondary benefit and as another method of preventing STIs. Careful consideration should precede any decision to reduce the frequency of required laboratories while on PrEP—particularly since at least some men are making decisions about sexual practices based on the notion that PrEP users are being tested 4 times per year.
In situations when required follow-up presents an obstacle, we suggest deeper investigation into the specific issue(s) presenting the challenge. As our data suggest, the problem may be more about difficulty attending primary care visits than frequency of required lab work. In such cases, reducing the number of required laboratory visits from 4 to 2 per year would not ease the burden. However, this reduction in frequency might reduce the value of PrEP for some users. Rigorously identifying precisely where challenges arise will be essential to develop adaptations to PrEP care that can optimize the patient experience.
Numerous structural components must be in place for effective uptake and continued use of PrEP to prevent HIV. These components include access to a payer source, a prescriber, a laboratory, and a pharmacy. In addition, other factors are at play: trust in the medical establishment, ability to submit to routine blood draws, and willingness to adhere to a daily pill. Disruptions may occur anywhere along the PrEP continuum of care. We developed a list of practical recommendations for providers (Table 3) intended to limit these disruptions. For example, patients may benefit from an explicit justification about testing frequency and to reassure patients that FTC/TDF is a safe medication. 30 -32
Key Recommendations to Encourage Laboratory Monitoring Compliance.
Abbreviation: PrEP, pre-exposure prophylaxis; STI, sexually transmitted infection.
Our study has several limitations. First, the qualitative design permits us to describe these findings as transferable but not generalizable. 33,34 Our sample was recruited from a very particular setting and the type of PrEP users attracted to Nurx. Thus, our sample might share characteristics or circumstances that would make presenting to a laboratory less of a burden for them than for other types of PrEP users. At the time this research was designed, to our knowledge, Nurx was one of the first PrEP telehealth services in operation.
Future research should compare the findings reported here against those from other PrEP telehealth platforms and users in other locations where laboratory services may be differently configured. Future studies also should examine whether telehealth clinic visits can sufficiently offset the inconvenience of traditional clinic visits and thereby increase motivation to fulfill quarterly laboratory testing requirements.
Conclusion
To date, no research has assessed whether presenting for laboratory work every 3 months is problematic for telehealth PrEP users. In our study, participants considered the effort involved in adhering to quarterly testing to be worth it. Convenient access to laboratories is an obvious factor that can drive compliance with PrEP monitoring requirements—a structural intervention that led to greater levels of testing among our interviewees. This access also enables PrEP users to more easily derive value from the quarterly lab work. Rather than looking at quarterly testing requirements strictly as a barrier to PrEP persistence, these individuals derived real benefit from regular screening. Our research illustrates that quarterly monitoring requirements are meaningful to telehealth PrEP users and may facilitate persistent engagement in receipt of PrEP care.
Footnotes
Authors’ Note
Nurx personnel provided relevant and necessary background information of the company, its services, and users. The study design, data collection and analysis as well as the manuscript production were conducted independently by the researchers.
Acknowledgments
The authors wish to thank the Nurx staff for assisting them with the recruitment activities. The authors also wish to thank their interns, Eve Kelly and Mirabel Levine, for their assistance with data organization and management. Finally, the authors extend their sincere appreciation to all the men and women who participated in their study.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was supported by a grant from the National Institutes of Health, University of California San Francisco-Gladstone Institute of Virology & Immunology Center for AIDS Research (P30 AI027763). Publication made possible in part by support from the UCSF Open Access Publishing Fund.
