Gay, bisexual, and other men who have sex with men (GBM) are estimated to make up approximately 3% of the population of the United States,1 yet they accounted for more than two thirds of all new human immunodeficiency virus (HIV) infections and 86% of all diagnoses among males in 2016.2 A promising biomedical HIV prevention mechanism currently available is a once-daily pill called preexposure prophylaxis (PrEP).3 Preexposure prophylaxis—in the currently available once-daily dosing form—is a combination pill (emtricitabine and tenofovir disproxil fumarate) approved by the US Food and Drug Administration for prophylactic use with at-risk, HIV-negative individuals in 2012.4 Before approval, PrEP had undergone multiple clinical trials and was shown to be safe and efficacious in preventing HIV-seroconversion.5 Preexposure prophylaxis demonstration trials have since found evidence of effectiveness with high reductions in HIV infections reported.6–10 However, PrEP only protects against HIV acquisition and some research has shown an increase in sexually transmitted infection (STI) diagnoses among users,9,10 likely the result of decreasing condom use.10,11
In 2014, the Centers for Disease Control and Prevention (CDC) recommended PrEP for individuals at substantial HIV risk and released PrEP care guidelines for medical providers, which included guidelines for PrEP maintenance activities including ongoing HIV and STI counseling and testing.12 Recommendations for use includes any HIV-negative individual who is in a relationship with a serodiscordant partner, or GBM who engage in condomless anal sex (CAS) or has been diagnosed with an STI in the past 6 months. To be prescribed PrEP, individuals must first test negative for HIV, and continuation requires in person follow-up visits at least every 3 months. During these appointments, users must receive an HIV test, medication counseling, sexual behavior risk reduction support, side effect assessment, STI symptom evaluation, and renal function testing. The CDC guidelines also indicate that users should be tested for bacterial STIs at least every 6 months12; however, recent research suggests STI testing every 6 months may miss a large amount of new STI acquisitions, and ongoing STI testing should be conducted at all quarterly PrEP care visits.13 Specifically, 13% of PrEP users were diagnosed with an STI at the 3-month follow-up of a demonstration project, but 77% of these infections were asymptomatic and discovered only via routine testing procedures. Similarly, 15% of patients were diagnosed with an STI and 68% of those were asymptomatic at the 9-month follow-up assessment. Overall, if STI testing had only been conducted at the CDC recommended 6-month follow-up, diagnosis, treatment, and care for 24% of patients would have been delayed,13 increasing the chance of onward transmission.
Although clinical guidelines are important in efforts to increase PrEP implementation within the United States, an important concept that has been referred to as the “purview paradox” merits mention. Krakower et al14 found that HIV specialists thought primary care venues were best suited as primary PrEP venues, but those primary care providers (PCPs) with a dual role as HIV specialists thought specialists were better suited for PrEP provision. This highlights the uncertainty providers have in the implementation of PrEP within their respective clinical domains, and this paradox may leave some potential users unsure of where to go to get a prescription. Questions remain regarding the level of PrEP care received by patients receiving their PrEP maintenance activities (e.g., ongoing HIV/STI testing) from PCPs compared with HIV specialist clinics and providers, which could provide additional evidence in determining where individuals can best receive PrEP care. As such, we sought to examine where PrEP-using gay and bisexual men in New York City are accessing PrEP care services, and determine the comprehensiveness of their routine PrEP maintenance care.
A sample of GBM who were active PrEP users at the time of enrollment were recruited for the PrEP & Me study from November 2015 to November 2016.15 We used targeted sampling for recruitment,16,17 which included advertising and preliminary screening for the study in gay concentrated neighborhoods and settings (e.g., gay bars, pride events, at lesbian, gay, bisexual and transgender community centers). We also used digital recruitment methods by advertising on gay hookup websites and apps and social media. Individuals who clicked on a digital ad were routed to an online survey to assess preliminary eligibility. Anyone considered preliminarily eligible was asked for their contact information and called for a telephone-based screening with our research study team, and an in-person assessment at our research office was scheduled if eligible.
To be eligible, individuals had to: (1) be 18 years or older; (2) be cisgender male; (3) identify as gay or bisexual; (4) have been taking PrEP for at least 30 days, but not via a research study that provided the PrEP medication (e.g., demonstration project, clinical trial); (5) reside in the New York City area; and (6) have Internet access. A review of individuals' PrEP prescription bottles (and pills) was conducted at their first study visit to verify PrEP use at enrollment. About half of the sample self-reported club drug use (ketamine, methylenedioxymethamphetamine/ecstasy, Gamma-hydroxybutyric acid, cocaine, or methamphetamine) in the past 30 days, which was the result of targeted sampling because of the goal of the parent study to examine the role of club drug use on PrEP adherence; club drug use was not considered relevant to the current article. Surveys were conducted using a computer-assisted self-interview, and participants were provided US $40 after completion of their baseline assessment. All procedures were approved by the institutional review board of the City University of New York.
Demographics, PrEP Use, and CAS
We asked participants to report their age, race/ethnicity, educational attainment, and length of time on PrEP. Participants were asked where they received their PrEP-related care, which was coded into (1) PCP or (2) specialist care provider or clinic. The number of CAS events was assessed using a 30-day timeline follow-back interview.18
PrEP-related Care Received at Last PrEP Care Visit
Participants were asked to report which of the following services they received at their last visit to their medical care provider regarding PrEP: (1) we talked about my sexual behavior, (2) I gave a blood sample, (3) I gave a urine sample, (4) I gave a rectal sample (rectal swab), and (5) I gave a throat sample (throat swab). Individuals were coded as having received comprehensive care if they received all 5 of these HIV/STI counseling and testing services.
We examined bivariate associations of demographics (age, race/ethnicity, and education), number of CAS events in the past 30 days, length of time on PrEP, and health care provider type (PCP vs specialty care provider or clinic) on receiving comprehensive care at last PrEP care visit using chi-squared comparisons and logistic regressions. We then assessed factors associated with receiving comprehensive care at last PrEP care visit using fully adjusted binary logistic regression. Due to small sample size concerns, we conducted a sensitivity analysis wherein we tested number of CAS events in the past 30 days, length of time on PrEP, and health care provider type individually using binary logistic regressions, adjusting for age, race/ethnicity, and education.
One hundred four GBM who were active PrEP users enrolled in the PrEP & Me study (see Table 1). Average participant age was 32.5 years, 50% were white, and 71% had a bachelor's degree or more education. More than half (65%) were on PrEP for less than 1 year, and nearly two thirds (66%) received their PrEP-related care from a PCP. On average, GBM had 4.5 CAS events in the past 30 days. Nearly all (94%) gave a blood sample for testing at their last PrEP care visit, and 88% provided a urine sample (see Table 1). Although most participants reported receiving blood and urine testing services, 51% and 48% had a rectal or oral swab, respectively. Many (77%) discussed their sexual behavior with their provider; however, 32% received comprehensive PrEP care at their last visit encompassing receiving all testing-based services and a discussion of sexual behavior.
In our fully-adjusted binary logistic regression (see Table 1), younger men (adjusted odds ratio [AOR], 0.92; 95% confidence interval [CI], 0.85–0.99) and men with a Bachelor's degree or more education (AOR, 4.74; 95% CI, 1.28–17.54) had a higher odds of receiving comprehensive care at their last PrEP care visit. Gay and bisexual men who reported more CAS also had higher odds of receiving comprehensive care (AOR, 1.19; 95% CI, 1.07–1.32), and those receiving PrEP-related care from a specialist (compared with a PCP) had higher odds of receiving comprehensive care (AOR, 2.49; 95% CI, 0.90–6.94); however, the finding about health care provider type was not statistically significant. Results of our sensitivity analyses of the multivariable model using partial adjustment procedures were similar to the fully-adjusted findings, thus we report only our fully-adjusted results. See Table 1 for a complete reporting of bivariate and multivariable results.
Despite increasing awareness of bacterial STIs associated with decreasing condom use among PrEP users,9–11 The PrEP-using GBM in New York City are overwhelmingly not receiving comprehensive PrEP care services. We found that over two thirds of PrEP users did not receive all HIV/STI counseling and testing services at their last PrEP care visit, with the most commonly reported services not provided being throat and rectal swabs for STI testing and a discussion regarding sexual behaviors. This is particularly striking because rectal and oral swab sampling has been found to be more important in identifying bacterial STIs among GBM compared to urine-based STI screening19; only using urine-based STI screening would result in 84% of chlamydia and gonorrhea infections being missed.20 Men engaging in more CAS were more likely to receive a full panel of testing, as were men who were younger and had higher education. Younger men and those engaging in more sexual HIV transmission risk could be receiving comprehensive care because of their heightened HIV risk,2 and individuals with higher education could be advocating for better care. We assessed if participants were asked about their sexual behavior, but not to what degree. It is possible that those who are younger and have a college degree were asking different questions or engaging in this conversation for longer, which may lead to more in-depth testing (i.e., rectal and oral swab). It is also possible that providers are tailoring their STI screening based on sexual behavior reported by the patient, but barriers exist for patient-provider communication21 and nearly a quarter of participants reported that they did not discuss sexual behavior with their provider. Nonetheless, all men on PrEP should be receiving comprehensive PrEP care—including HIV/STI counseling and testing—at every quarterly visit based on PrEP care guidelines in need of modification because of newer evidence.12,13 We would like to mention that providers might be adhering to current (at the time of data collection) published PrEP care guidelines of STI testing every 6 months; however, we are unable to differentiate whether participants' visits were on the 3-month or 6-month cycles of their PrEP care. New PrEP care guidelines were published in March 2018,22 but ambiguity still exists for the frequency of STI testing recommended, which is now recommended every 3 to 6 months for all and every 3 months for those with a prior STI.
We observed considerable—albeit non-significant—differences between the PrEP care provided from PCPs compared with specialty care providers and clinics; 74% of men receiving PrEP care from a PCP did not receive comprehensive services at their last PrEP-related visit, compared with 57% who received care from a specialty clinic or provider. This adds to a body of evidence indicating the need to better prepare health care providers to provide PrEP prescription and maintenance care more broadly,14,23–25 but also suggests PCPs are in greater need for education and training regarding PrEP care compared to HIV and related specialists. This is important because of findings from a nationally-representative sample of GBM that indicated 57% of men not yet on PrEP would prefer to receive their PrEP-related care from a PCP,26 which provides evidence that both PCPs and specialists need to be prepared to prescribe PrEP and provide PrEP maintenance care. This is particularly relevant given the large number of people who are considered candidates for PrEP by CDC guidelines, which would make receiving PrEP care from HIV specialists a challenge; HIV specialists alone could not feasibly support the potential patient caseload of all GBM on PrEP. Increasing PrEP care quality for GBM also includes the need to increase competence in care specific to the needs of GBM as well21; tailored interventions for health care providers providing PrEP are sorely needed.
Additional efforts are also needed to expand or adapt PrEP-related care to the needs of GBM. Several strategies could be used to meet these needs, such as self-sampling for HIV/STI testing and conducting routine PrEP-related care from their home. The latter—called home-based PrEP26—is one mechanism that incorporates both, where PrEP users conduct HIV/STI self-sampling from home and send their samples to a laboratory for analysis. Notably, 72% of GBM preferred home-based PrEP care compared to participating in routine clinic-based care in a national sample; younger HIV-negative men and those engaging in greater HIV risk were more interested in this type of care, indicating home-based PrEP care could be an avenue to increase PrEP uptake for GBM most in need.26 Moreover, clinic-based self-sampling could be an avenue to increase routine STI testing care, removing potential barriers for patients and providers to conduct this type of testing. Human immunodeficiency virus self-testing and STI self-sampling are feasible and well received by GBM.19,27,28 Further implementation of these types of services is needed, especially if it results in greater PrEP uptake and maintenance care for GBM. One potential downfall for home-based PrEP care could be the loss of a discussion between the user and provider about their sexual behavior. Development of home-based PrEP care should also aim to implement personalized feedback on recent sexual behavior and the importance of continued STI and HIV risk reduction strategies.
Although we argue for more training of health care providers in the prescription and maintenance of patients on PrEP, and an expansion of PrEP and routine HIV/STI testing care, there is also a need for reducing barriers to the provision of comprehensive PrEP care services to patients. Health care providers may be unable to provide comprehensive care to PrEP users because of issues associated with insurance and/or cost documented in prior research,14,29,30 and potential laboratory testing barriers (e.g., validation studies required to support rectal swab STI testing based on testing device approval for urine screening only), making rectal testing inaccessible for some.
Findings from this study are not without limitation. The modest sample size of PrEP users composed entirely of cisgender males living in New York City who are largely white and highly educated reduces generalizability to other populations, including GBM living outside major metropolitan areas; however, the sample is generalizable to who was able to gain access to PrEP from 2015 to 2016 (i.e., those who had health insurance). Although the sample may not reflect who is in need of PrEP, it does reflect who was going on PrEP at this time. The small sample size increases the risk of error and relative bias in our multivariable model31; we report all statistical values to increase interpretability and recommend future research with a larger sample of PrEP users as the number of PrEP users continues to grow, but acknowledge the large confidence intervals resulting from small cell sizes. Additionally, the sample contains only individuals who identify as gay or bisexual. It is possible that men who are engaging in sex with other men but not identifying as gay or bisexual may receive different care based on the sexual activity they report. Similarly, individuals reported on if they talked about their sexual behavior, but we did not ask about specifics of that discussion. There is a variety of ways this question could have been answered, and it may be important to more fully examine the content of these discussions. These limitations highlight areas where further research may be needed to fully understand what PrEP care is being provided and how it can be improved.
The majority of PrEP-using men who have sex with men did not receive comprehensive care consisting of a discussion about their sexual behavior, blood and urine samples, and both rectal and oral swabs at their last PrEP care visit. Compared with men who more recently initiated PrEP, those who have been on PrEP longer, engaged in more CAS, and received care from a specialized clinic were more likely to receive comprehensive care. It is potentially problematic that better care is being provided at specialized clinics considering that the majority of users receive PrEP care from a PCP. It is imperative that guidelines and interventions be implemented so that all PrEP users are receiving the best care possible regardless of their age, education, and provider.
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