Johns Hopkins University School of Medicine, Baltimore, Maryland, USAUnited States
Philadelphia FIGHT, Philadelphia, PA, USAUnited States
Columbia University College of Physicians and Surgeons, NYC, NY, USAUnited States
Department of Public Health, Philadelphia, PA, USAUnited States
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USAUnited States
Also available as PDF (figures and tables appear in the PDF).
Objectives To assess reasons for patients being lost-to-care (LTC) at an urban health center (Philadelphia, PA, USA) that provides access to oral tenofovir/emtricitabine(TDF/FTC) as pre- exposure prophylaxis(PrEP) to patients ages 13-30 years through a drop-in model of care. Methods Ninety-nine patients were identified as LTC based on not visiting a clinician in ≥4 months during the period April 2016-January 2017. Patients were contacted by phone/email to participate in a voluntary telephone survey regarding reasons for falling out of care. Results were analyzed descriptively. Results Of the 99 patients preliminarily identified as LTC, 19 completed the survey. Reason(s) for becoming LTC included: 47%(9) relocation, 11%(2) transportation difficulties to/from clinic, 26%(5) financial/insurance problems, 5%(1) perceived medication side effects, 16%(3) trouble remembering to attend appointments regularly, 5%(1) difficulty with daily medication adherence, and 0% social stigma. Furthermore, 21%(4) remain at high-risk of HIV/STI acquisition after becoming LTC. The main study limitations are selection bias and small sample size, where the small sample size did not allow for statistical significance. Conclusion While the major cause for becoming LTC was relocation, these findings suggest 37% of LTC incidences may be preventable with additional/up-front support. Because 21% of LTC patients remain at high-risk of HIV/STI acquisition, proactive re-engagement initiatives are potentially useful.
Keywords: HIV/AIDS; Pre-exposure prophylaxis; Retention and care; Socioeconomic factors; Adolescent Health; Lesbian/Gay/Bisexual/Transgender Persons
Ninety-nine patients were identified as LTC based on not visiting a clinician in ≥4 months during the period April 2016-January 2017. Patients were contacted by phone/email to participate in a care. Results were analyzed descriptively.
Of the 99 patients preliminarily identified as LTC, 19 completed the survey. Reason(s) for becoming LTC included: 47%(9) relocation, 11%(2) transportation difficulties to/from clinic, 26%(5) effects, 16%(3) trouble remembering to attend appointments regularly, 5%(1) difficulty with daily medication adherence, and 0% social stigma. Furthermore, 21%(4) remain at high-risk of HIV/STI acquisition after becoming LTC. The main study limitations are selection bias and small sample size, where the small sample size did not allow for statistical significance.
While the major cause for becoming LTC was relocation, these findings suggest 37% of LTC incidences may be preventable with additional/up-front support. Because 21% of LTC patients remain at high-risk of HIV/STI acquisition, proactive re-engagement initiatives are potentially useful.
HIV/AIDS; Pre-exposure prophylaxis; Retention and care; Socioeconomic factors; Adolescent Health; Lesbian/Gay/Bisexual/ Transgender Persons.
n July 2012, the US Food and Drug Administration (FDA) approved oral tenofovir/emtricitabine (TDF/FTC, or Truvada™) I as pre-exposure prophylaxis (PrEP) for individuals at high-risk of contracting human immunodeficiency virus (HIV), marking an
cc Copyright 2019 by Jayaraman S. This is an open-access article distributed under Creative Commons Attribution 4.0 International License (CC BY 4.0), which voluntary telephone survey regarding reasons for falling out of
financial/insurance problems, 5%(1) perceived medication side
important step toward the 90:90:90 initiative.1 Currently, PrEP is being prescribed in urban areas of 23 states and Washington, DC, USA.2 Because of its efficacy in preventing the spread of HIV, PrEP has great potential to be a public health tool for the medically underserved. To move toward ending the epidemic, determining the best model to deliver HIV PrEP to high-risk populations is
critical, and many scholars have examined the most effective way to deliver PrEP to large populations.
Thus far, the importance of creating socially and culturally competent programs that incorporate PrEP into HIV and sexually transmitted infection (STI) prevention services in clinics and primary care services has been established. While some believe a traditional primary care setting is the most feasible venue for PrEP care,5 many healthcare providers are enthusiastic about PrEP being prescribed in a larger variety of clinical and public health settings that serve high-risk patients such as harm-reduction programs (i.e. needle exchange programs), STI clinics, and mobile vans that provide HIV testing and other preventive health services.6 Furthermore, STI clinics have been found to initiate and retain more clients in PrEP care compared to a large health maintenance organization (HMO) and HIV-specific reproductive health programs.7 One of the reasons that STI clinics may be so effective in providing PrEP is because they provide short-term, immediate care on a drop-in basis, which can include services such as same-day PrEP initiation.
Despite the benefits drop-in models may provide to PrEP care, aspects of the drop-in clinic model have also been identified as potential reasons for patients being lost-to-follow-up (LTF). For example, there is the perceived concern about suboptimal retention in care due to regular follow-up with patients not being standard in some drop-in model structures.4 Additionally, these programs may have limited resources, and many do not have the capacity to provide broader social services necessary to address the multiple needs of an at-risk population.
Furthermore, previous studies on PrEP care in urban men who have sex with men (MSM) patients have identified issues at every level of care that could result in LTF, including inability to afford medication, lack of transportation to medical facilities, medical side effect intolerance, problematic dosing schedules, decreased risk perception, and lack of time.9 Stigma has also been cited as an added barrier to PrEP access, specifically stigma from peers or providers who believe PrEP care may lead to riskier behavior and diversion of resources away from HIV-positive people,7 from parents who may be unsupportive, from religious communities, or from partners who may view PrEP as lack of trust.
In 2013, our clinic, housed within an urban, community health and drop-in center in Philadelphia, Pennsylvania, USA began the “I Am Men’s Health” Program, which provides access to oral PrEP among several other HIV prevention and primary care services to high-risk, low-income youth (ages 13-30 years) who are predominantly African-American men who have sex with men (MSM) and transgender women (TGW) who have sex with men. This program utilizes a drop-in model of care and is the largest program of its kind in Philadelphia focusing on preventing HIV seroconversion in this high-risk group. However, while the clinic focuses on PrEP and allots several hours each day to walk-in care, the clinic aims to help patients navigate the healthcare system and to increase their overall access to healthcare. Therefore, patients are actively encouraged to schedule new and follow-up appointments for preventive medicine, primary care, and social services as well.
Studies on PrEP implementation are still in their infancy with much of the programmatic literature focusing on planning for roll-out, and only recently have studies begun to look at PrEP 4 10,11 10 retention and causes for loss to care. However, to our knowledge, there has yet to be a study that evaluates retention and causes for loss to care in a PrEP program that utilizes a drop-in model of care. The purpose of the current study is to address the knowledge gap regarding real-life challenges in PrEP program implementation in urban areas of the United States, specifically with regards to a program that utilizes a drop-in model of care. The present study aims to: 1) evaluate reasons for patients becoming lost-tocare (LTC) (i.e. relocations, medical side effects, stigma, logistical concerns, etc.), 2) assess the patient experience of a modified dropin model of care, and 3) assess ongoing risk factors for HIV-1 seroconversion in patients who are LTC. Results of this study may suggest modifications or improvements that can be made to PrEP care delivery models.
Young adult (18+) patients within this clinic’s electronic medical record (EMR) who had not attended a PrEP or primary care visit in ≥4 months were defined as LTC and contacted to participate in a voluntary telephone survey that assessed several factors hypothe- 8 4,7-10 sized to affect retention based on previous studies. All parts of the survey were optional. Minors, non-english speaking patients, patients with no documented contact information in the EMR system, patients who were currently incarcerated, and patients who had documentation of transitioning care to another clinical center were excluded. Informed consent was obtained verbally from all subjects prior to administering the survey. This study was approved by the Institutional Review Board at Philadelphia FIGHT.
The survey was developed using the social-ecological model of 10 12,13 health behavior (Figure 1). The questions were based on validated survey tools, including the Consumer Assessment of Healthcare Providers and Systems survey, and were broken into sections to reflect the various individual, interpersonal, organizational, and societal factors that affect retention of PrEP patients in care (Appendixes A and B).
Survey data were entered into a password-protected database (REDCap). Descriptive statistics were performed through RED- Cap and Microsoft Excel. Composite scores for each question with numeric responses were calculated to provide a quantitative measure of patients’ responses. Means and standard deviations were calculated around each composite score.
Figure 1. Social-ecological Model of Health for PrEP and
Patients were contacted over a 10-month period, April 2016 to January 2017. Of the 99 patients initially identified as LTC, 19.2% (19) completed the survey, 67.7% (67) could not be contacted, 6.1% (6) refused, 4.0% (4) had transitioned care to an affiliated clinical center, 2.0% (2) stopped PrEP voluntarily, and 1.0% (1) was incarcerated and therefore not contacted (Figure 2). Of the 19 patients who completed at least a portion of the survey, 10 were not interested in re-enrolling in PrEP care, 5 were interested in re-enrolling into the PrEP program and 2 did, in fact, re-enroll. Therefore, out of 99 total LTC patients, 2% (2) re-enrolled.
Figure 2. Flow Chart Showing How Patients Responded to Contact Out of the 19 survey respondents, 47% (9) reported coming to the clinic for primary care and PrEP services, while 54% (10) reported coming solely for PrEP. 26% (5) of respondents did not return after receiving their first PrEP prescription, 2 of whom were receiving primary care at the clinic while 3 of whom received
no services other than PrEP. Of the remaining 14 respondents, the average time on PrEP before becoming LTC was 7.29-months (range of 1 to 32-months).
All 19 survey respondents answered this section. They reported the following regarding access to the PrEP clinic: 47% (9) moved out of the area (relocation), 11% (2) were unable to get transportation on a regular basis (i.e. lack of cab/public transit fare), 26% HIV care (Adapted from CDC)
(5) experienced financial/insurance problems (i.e. losing insurance, being unable to afford copays, PrEP was too expensive for them), and 26% (5) were unable to get time off work. Of note, those who stated relocation as their reason for becoming LTC, had all moved for work or school purposes.
Seventy-nine percent (15) of respondents answered questions related to social stigma. 0% reported feeling pressure to stop PrEP or experiencing judgment from family, intimate partner(s), or peers. Similarly, 0% felt their personal or religious beliefs conflicted with taking PrEP. Therefore overall, 0% felt stigma was a barrier to their PrEP care.
Sixteen percent (3) of respondents cited trouble remembering to come to appointments on a regular basis. 5% (1) became LTC due to perceived medication side effects (sexual arousal). 5% (1) found taking the pill every day to be difficult (this patient also noted that they were working three jobs at the time). 5% (1) stated that they were in a monogamous relationship, therefore taking PrEP no longer seemed “worth it”.
Table 1. Patient Responses:“Have Any of the Following Reasons Affected Your Desire or Ability to Come to the Clinic Regularly?” Reason Number (%) Responding “Yes” I moved out of the Philadelphia area 9 (47.4) I was unable to get transportation 2 (10.5) I do not like coming to [the clinic] 2 (10.5)
I had trouble remembering to come to 3 (15.8) [the clinic] Taking my pill every day was difficult 1 (5.3) I did not like the side-effects I felt after 1 (5.3) taking PrEP I was unable to get time off of work 5 (26.3) I thought PrEP was too expensive or I was 5 (26.3) frustrated by insurance
Seventy-four percent (14) of respondents answered questions related to their experience at the clinic. This section of the survey had the following response options: 4–always, 3–usually, 2–sometimes, 1–never. Questions and response averages can be found in Tables 1 and 2. Averages for each question are not statistically significant from one another.
Table 2. Averages for Survey Questions about Patient Experience at the Clinic Question How often were medical staff courteous? 3.93±0.27 How often did clinicians treat you with courtesy and respect during your appointment? How often did clinicians listen? 3.86±0.36
How often were you easily able to schedule an appointment?
How often was PrEP care explained in a way that was easy to understand?
How often were you seen in a reasonable amount of time for a walk-in appointment?
Seventy-nine percent (15) of respondents answered survey questions related to ongoing HIV risk (Table 3). Of these, 6.7% (1) endorsed being diagnosed with an STI since becoming LTC and 13% (2) believed they might have been exposed to HIV since their last PrEP visit. 73% (11) reported that PrEP did not cause them to have riskier sex, while the rest reported they had or would consider taking greater risks since starting PrEP. 5% (1) specified that the medication made it seem that they had an extra safety net, thus they would contemplate riskier behavior “but not necessarily act on it.”
Table 3. Patient Reported Stigma, Conflicting Beliefs, and Sexual Risk (n=15) Question Number (%) Responding “Yes” Did you feel pressure to stop PrEP or judgment from family, intimate partner(s), or peers? Do your personal or religious beliefs conflict with taking PrEP? 0 (0)
Did you feel taking PrEP caused you to have riskier sex than you did before you started 4 (26.7) taking PrEP?
Have you been diagnosed with a sexually transmitted disease in the last 3 months?
Do you have any reason to believe you might have been exposed to HIV in the last 3 months?
Are you interested in finding out how you might re-enroll in [PrEP]?
Re-engagement and retention in HIV care are important for ending the HIV epidemic, as 61% of new HIV infections arise from “persons who are not adequately retained in care”. Because our results demonstrated that at least 19% of PrEP patients who are LTC are still at-risk for HIV, retention in PrEP care is similarly important to ensure that more people do not become infected. Because retention in care is known to improve health outcomes, a focus on retention in PrEP care for underserved urban populations 16,17 may also decrease health disparities. Public health entities that regulate funding and make recommendations for programs that provide PrEP may be informed by this and other studies. In addition, foundations and other organizations that support advancing health for adolescents/young adults, urban youth, and/or groups Response Average±Standard at high risk of HIV acquisition, may look to fund initiatives for Deviation community-based organizations that address these barriers to care.
In order to evaluate and improve retention in PrEP care, 3.93±0.27 we aimed to understand why patients became LTC. While becoming LTC did not seem to be affected by the specific health care delivery model of the clinic, our finding that the most commonly ex- 3.23±1.17 perienced barriers to PrEP retention were due to issues with clinic 3.79±0.58 access (i.e., relocation, transportation, medical costs) suggests that more resources may be needed to accompany PrEP-prescribing 3.54±0.52 programs for urban youth and young adults. Transportation issues, financial/insurance issues, and problems attending appointments due to work have been noted to be barriers to care in other studies for patients who struggle to maintain their PrEP care, including 7,9 urban MSM patients.7,9
Our study found that 37% of LTC incidences could have been prevented with additional/up-front support, such as proactive transportation assistance or education on insurance loss not prohibiting PrEP care, and that at least 21% of LTC patients remain at high-risk of HIV and STI acquisition. These solutions are not limited to benefitting PrEP programs, but may also be useful for clinics that provide HIV care and primary care services to populations at high-risk for acquiring HIV, and could include greater financial support for provisions such as up-front vouchers/tokens for local transportation, a greater emphasis on how to continue care if health insurance is lost, and additional written or online educational resources related to PrEP and HIV healthcare at the first visit. Furthermore, because a significant proportion of 0 (0) LTC patients remain at high-risk of HIV acquisition, proactive reengagement initiatives, such as periodic attempts to contact LTC 0 (0) patients, are potentially useful. This is recommended by the International Association of Providers of AIDS Care (IAPAC)18 and has been shown to re-engage a significant proportion of patients to HIV care.
1 (6.7) Three participants had trouble remembering to come to 3 (20) appointments regularly and 1 had trouble remembering to take their pill regularly. This suggests a role for implementing/expand- 5 (33.3) ing reminders prior to appointments in the form of emails, text messages, or phone calls–this has been studied in several populations20 but has not been studied in urban young adults taking PrEP (a group at particularly high risk of HIV acquisition). The IAPAC also recommends approaches such as this for optimizing the HIV care continuum, and additional studies have shown that increased 17,21 15 personal contact increases visit adherence. For patients who have trouble remembering to take PrEP regularly, programs might
consider providing small devices, such as a medication keychain (which this site recently began providing to patients), that can serve as reminders in accordance with IAPAC recommendations.18
This study may have been limited by selection bias, as subjects who agreed to participate in the study may have reported a different array of barriers than those we could not reach. Additionally, this study has a small sample size. Of the 99 patients initially identified as LTC, only 25 were successfully contacted, only 19 completed the survey, and lack of information on the patients we could not contact may skew our results. The small sample size also did not allow for statistical analyses of significance or effect size.
This in itself has policy ramifications, as the difficulty with re-engagement despite a robust dedicated effort suggests that re-engagement efforts for patients taking PrEP for HIV prevention likely need to be done much earlier and ideally before patients are lost to care. An additional limitation of the study is generalizability, as the results may not be generalizable to other PrEP clinics that are unable to provide care to uninsured patients, clinics in other geographic settings, or clinics with other patient populations.
Our findings suggest several LTC incidences could have been prevented with additional/up-front support from the provider organization for problems such as transportation, finances/insurance, and PrEP care logistics such as remembering to take medication and attend appointments. Furthermore, because LTC patients remain at high-risk of HIV acquisition, proactive re-engagement initiatives can be useful. LTC studies such as this can be beneficial to improve retention for PrEP programs, although additional studies are needed to assess reasons for LTC among different PrEP populations. Overall, improving PrEP implementation and retention is critical for ending the HIV epidemic, and our findings have policy implications for public health agencies and funding organizations who support HIV prevention initiatives for urban youth.
The authors declare that they have no competing interests.