Abstract
Preexposure prophylaxis (PrEP) for HIV has the potential to reduce HIV incidence in highly affected areas. The Southeastern United States is disproportionately impacted by HIV, and 3 counties in South Florida have the highest incidence of new HIV infections in the United States. This study explored the feasibility, acceptability, and uptake of PrEP in South Florida. Focus groups consisting of providers, administrators, and case managers at HIV-servicing community health centers and federally qualified health centers in South Florida reported broad support but low implementation of PrEP. Generally, participants indicated that the centers were appropriate locations for implementation. However, practical concerns and perceived limitations due to financial, insurance, and immigration status of those who would potentially benefit from the intervention were widely reported. Addressing provider concerns appears necessary for successful expansion of PrEP implementation in highly impacted areas such as South Florida.
Background
Preexposure prophylaxis (PrEP) for HIV using antiretroviral medication is an effective method for preventing HIV and is recommended for individuals at increased risk for infection. 1,2 Although clinical guidelines are available to assist providers in PrEP implementation, questions remain regarding the most appropriate location for PrEP prescribing, the resources required to deliver PrEP effectively, and the most equitable way to ensure the availability of PrEP to those who may benefit from it. 3 –5 Additionally, concerns and ambivalence regarding PrEP have been identified and the likelihood of prescribing PrEP has been strongly associated with PrEP-related knowledge. 6,7 Knowledge and support for PrEP is highest among infectious disease (ID) providers and HIV physicians already familiar with the prescription of antiretroviral medications for HIV-infected patients but who may not routinely serve HIV-negative individuals at risk. 5,8 –10 In South Florida, a number of federally qualified health centers (FQHCs) function as HIV treatment clinics and also provide primary care for HIV-negative individuals. These centers, with provider and institutional knowledge of HIV care and also a primary care function, may be well positioned to provide PrEP in South Florida. Lack of insurance is a significant identified barrier to PrEP care in other studies and is particularly relevant to regions such as South Florida with large numbers of undocumented immigrants, uninsured and underinsured patients, lack of Medicaid expansion, and lack of safety net services and publicly funded sites for PrEP. 3,5 –8,11 –13 FQHCs provide medical care on a sliding-scale payment basis, 14 facilitating access for patients who are uninsured and may otherwise have difficulty paying for office visits.
While FQHCs are reasonable and appropriate locations to consider PrEP delivery, the potential to implement PrEP recommendations in FQHCs in South Florida has not been examined and may be limited by challenges associated with PrEP-related knowledge among healthcare providers, insurance reimbursement systems, and healthcare access.
This study investigated the acceptability and feasibility of the provision of PrEP in South Florida, with an emphasis on FQHCs as a potential implementation sites. We focused on health centers serving a diverse clientele and located in neighborhoods of particularly high HIV incidence in Southeastern Florida. We explored barriers and facilitators to implementation of PrEP among providers, administrators, and care coordinators, theorizing that decision-making regarding provision of services would require a team approach and considerations beyond the realm of the individual provider, for example, insurance reimbursement systems and health-care access.
Methods
Sampling and Recruitment
This study was part of a larger project designed to develop an educational program on PrEP. From October to December 2014, focus groups were convened at 4 community health centers in Southeastern Florida, 3 of which were designated FQHCs. Clinics were located in Broward, Miami-Dade, and Monroe Counties. Clinic directors were contacted by telephone or e-mail by the investigator regarding the study; those agreeing to participate were asked to invite up to 6 staff members to participate in a focus group including at least 1 prescribing provider (physician, physician assistant, or nurse practitioner), 1 administrator, and 1 case manager or care coordinator, totaling 4 to 6 participants per group. Seven centers were contacted. All expressed interest in participation, and 4 were selected based on locations within different neighborhoods with high HIV incidence and to maximize diversity (including centers serving gay men, transgender women, African Americans, Caribbean Americans, and Hispanics). Clinics averaged 800 to 7500 annual patient/client visits, with 18% to 58% of clients HIV positive, 22% to 64% Hispanic, and 6% to 72% black (African American and Caribbean American). 15 Three sites had HIV prevalence data available by zip code for the center; rates ranged from 2341 to 5352 people living with HIV or AIDS per 100 000 residents. 16 Prior to study onset, the study protocol and focus group guide were reviewed and approved by the institutional review board of University of Miami. Written informed consent was obtained from all study participants prior to data collection.
Data Collection
Brief demographic information, including professional background and role at the center, was obtained from each participant. Focus group discussions were moderated by one of the study investigators using a semistructured guide. Stem questions and frames in the interview guide were selected based on existing literature, 4,8 informal interviews with medical directors conducted by the investigator at 6 local health centers (including 2 centers also included in the focus group study), and discussion among study team members. Stem questions focused on the following topics: (1) current and anticipated practice regarding PrEP at the health center, (2) provider and community perception of PrEP, (3) facilitators and barriers to providing PrEP at the health center, and (4) access to PrEP in the community. Clinician providers who participated in each focus group were individually queried regarding their PrEP prior knowledge and prescribing experience. Each focus group discussion was audio-recorded.
Data Analysis
Audio recordings were transcribed verbatim. Transcripts were uploaded to Dedoose version 5.0.11 (SocioCultural Research Consultants, LLC, Los Angeles, California) for analysis. Open coding of the transcripts allowed further development of themes across frames based on the elicited content. Coded transcripts were reviewed by 2 additional team members, 3 team members in total, for coding accuracy, and identified differences were resolved by discussion and mutual agreement.
Results
Participant Characteristics
Focus groups consisted of between 4 and 6 participants each, for a total of 22 participants. Six (27%) participants were medical providers (physicians or nurse practitioners), 7 (32%) were administrators, and 9 (41%) were care coordinators. Twelve (55%) participants identified as non-Hispanic black (African or Caribbean American), 5 (23%) as non-Hispanic white, and 5 (23%) as Hispanic. Care coordinators included case managers, HIV counselors, and patient support group facilitators. All participants had at least 2 years of experience working in health centers with patient populations that include HIV-negative and HIV-positive individuals. None were ID specialists by training. Two centers were predominately, but not exclusively, serving an ethnically diverse lesbian, gay, bisexual, and transgender (LGBT) community; these were centers with PrEP experience. Two centers served a predominately heterosexual urban African and Caribbean American population, although both indicated they served a significant LGBT population as well; these were not currently prescribing PrEP. All centers were community based and not affiliated with academic institutions.
Knowledge and Practices Regarding PrEP among Providers
All medical providers indicated that they had heard of PrEP and were able to describe the recommended populations to receive PrEP. Three providers at 2 centers (both with LGBT health focus) had written at least 1 prescription for PrEP at the time of the focus group, whereas the remaining 3 had not. Among nonmedical providers, some confusion between PrEP and nonoccupational postexposure prophylaxis was apparent. Medical providers at all sites indicated that they were comfortable with the use of Truvada as they frequently prescribed it for HIV-infected individuals but felt that providers in the larger community would be less willing to prescribe this medication.
Perception of Low PrEP Demand among Patients
All providers had at least 1 patient who had asked for PrEP but did not perceive that there was a large demand for PrEP in their patient population. Although one provider indicated that he had received frequent inquiries from patients regarding PrEP, most providers had none to very few patients who initiated discussions about PrEP. Those at LGBT-specializing clinics indicated a higher frequency of inquiry regarding PrEP from their patients. At clinics not specializing in LGBT care, requests for PrEP were rare and when they occurred were frequently related to preconception use. Many believed that the lack of prior information about PrEP limited patient demand for PrEP. At all centers, regardless of client demographics, it was suggested that providers or health centers should bear some responsibility for education of clients and the community to increase demand, particularly given the current incidence of new HIV infection in South Florida and the need to respond with additional prevention options. Because I’m not sure if our clients is really aware or educated enough to go and ask for that …. (Case Manager) … The only one, for example, in my practice is the people who want to have babies. They come with a question, “Can I have PrEP? What can I do?” (MD Provider) In 6 months, I have, I could say like 25 newly diagnosed and it’s too much. And most of them are young. And then that’s why I think we should work faster on all of that and give to the community, to try … (to) stop that. (MD Provider)
Cost as a Perceived Barrier to PrEP Provision
Many participants targeted the cost of medication as a barrier to widespread PrEP uptake. Some providers had experience with private insurance plans that provided coverage for PrEP, although some included cost-prohibitive copayments. Experiences with pharmaceutical company patient assistance programs were generally positive, however, limitations to these plans included requirements for low income and documentation that was frequently unavailable to undocumented immigrants. Universally, the complexity of the process of obtaining medication was identified as a barrier to PrEP implementation. Patients with no insurance were anticipated to be more complicated cases, given the need for multiple visits to ensure continuous coverage and appropriate adherence. You have to be insured in order to get it or else you have to be completely destitute. You have to be willing to do the paperwork; you have to be willing to go find a doctor who’s willing to do that with you, so it’s not completely possible here. There’s a lot of young people here who are working the bars; service people have no insurance and don’t have a lot … this takes more than one visit, so there’s a lot more to it than just to say, “Okay, I’ll take PrEP. and be done with it.” (MD Provider) I am not sure if there has been a study on it but I think that because of the cost, they will not be adherent to it because well, who is going to get it, who is going to provide it? How do we know that, because we know that everything is grant funded, then how do we know that the grant is not going to stop? (ARNP Provider) We have a lot of patients that … work jobs that don’t offer insurance but are relatively low income also if somebody is not a legal resident that’s going to be a barrier to PrEP because the PrEP program does not provide free drug to nonlegal resident. (MD Provider) I think it’ll be part of the flow because every time we start, or I start a patient on medication I take the time to discuss all the things related with the medication from how to take it, the side effects, what we expect, the adherence to treatment, all of that and in that case for me would be one more patient with the same. (MD Provider)
Concerns about Adherence
Preexposure prophylaxis adherence was a commonly expressed concern. Most providers who had prescribed PrEP had done so at the patients’ request and assumed that patients’ proactively soliciting medication would be adherent. … I think where we are at now, these people have sought it out so these people are inclined to be adherent. I don’t think we are at a place right now where we are thinking about it any other way because they’re asking for it. (MD Provider) These are younger people from my experience, these are younger people who may have partners who are HIV positive and they are negative …. These people, just from my personal experience, just do not seem like they are actually going to follow-up to be repeatedly tested to make sure that they are negative. That is my concern. (Physician Assistant Provider) And you also need to know who would benefit, because there is really no benefit if you’re doing the PrEP with someone who is really high risk (for nonadherence) and you feel like it’s not going to benefit them. It’s better when you know it’s someone who’s going to have a really good result. (MD Provider) I think it would require some sort of screening tool that let’s say assesses whether someone will be compliant. Even if they say they are, you can’t really ensure that. So you have to have those kinds of tools in place to know whether this person will be compliant, who’s likely to be compliant, who would be a good candidate? (Case Manager) I would say their past history is important. If you look at some of our patients, if you look at their history, how many no-show appointments have you had? What has their overall medical compliance been like? Because that is clearly an indicator of moving forward—if I reschedule an appointment, then that would be someone who has a history of no-shows or rescheduling appointments—that would be something I would add to a screening. (MD Provider) “Are you taking medication are you taking it every day? Have you taken medication in the past?” So it would be a combination of all of those. And you would also need to assess the social aspect because there’s a lot of homeless people who want to take their medication but they don’t have a place to store it, or they don’t have food to eat so you also have to look at the social aspect. (MD Provider) It does require a team effort … where I work, there is a program where they follow the patient, you know, they provide counseling, you know like testing for other STDs when they’re on PrEP … Not only prescribe it, take it and go home and next thing you know, you don’t know what’s going on. We have to follow those patients … it requires a lot. (Administrator)
Concerns about Risk Compensation
Several providers expressed concerns about risk compensation and increased unprotected sex among PrEP users, primarily focused on the acquisition of other sexually transmitted diseases (STDs) due to decreased condom use and the potential for increased sexual activity. For several participants, this discussion took on a moralistic tone. Some felt that PrEP would give patients “permission” to not use condoms and provide tacit endorsement for this behavior. Those more experienced with PrEP were less concerned and indicated that thus far they had not observed this outcome. Several participants emphasized the importance of offering PrEP as part of a comprehensive prevention package. Let’s talk briefly about the gay community, we know that they’re very promiscuous and, the word that they use is that they’re having fun. So it sounds like PrEP is a license for well, having fun.…And you know, you also need to inform them of the risk, the risk that’s out there even when they are on PrEP. (Case Manager) So then it is a matter of, how do we make sure, even if they are going to do PrEP and still do so combined with other prevention methods? It should not be an individualized prevention practice. It should be something that they should be doing with other prevention methods talking about their responsibility still to protect themselves from other things. (Nurse Practitioner Provider) I think that I have a different viewpoint than let’s say, for a couple who are monogamous and let’s say, they are a partner who is positive and another who is negative, and then using it for the purposes of wanting to get pregnant than I do for someone who’s younger and they’re having multiple partners and they’re using it for that purpose. And I think that has to do with my perception of other behaviors that those clients might be engaged in …. (MD Provider)
Risk Assessment as a Barrier to PrEP
Universally, the need to discuss sexual activity to assess risk and determine whether PrEP was appropriate was perceived as a major barrier to PrEP. Providers, case managers, and counselors indicated that bringing up sexual topics was difficult and asserted that many providers, case managers, and staff would not obtain the relevant sexual history to identify those who would benefit from PrEP. Inaccurate risk perception and lack of partners’ HIV status disclosure were also perceived to be barriers to PrEP consideration. … another thing I would add is the perception of risk. You know, we will identify them at being at risk, but do they think that what they’re doing will put them at risk? I think sometimes we skip those questions …. (Case Manager) I think that people can be in a relationship with someone who’s positive and not know. I would say that would be a big way that it [HIV disclosure] could play a role in it [PrEP]. You could have someone who is at risk because they’re in a relationship with a positive person and they benefit from PrEP but they don’t know that they benefit from it. (Case Manager) I’m from Haiti when, you know … when the HIV epidemic started; I remember … when Haitians was one of the 4H’s and … [HIV] is something they don’t want to discuss. They don’t feel comfortable. (Case Manager) … There’s a lot of judgments about you shouldn’t be doing this [risky sex] in the first place so why are we going to give you a tool that lets you do it more. (MD Provider) There is still stigma in the community and amongst people and, you know, his concern was everybody was going to think he was already positive including his insurance. And you know that was a concern that he had. “Is that going to be an issue as far as insurance and rates? What’s going to go on my medical history?” and “Is that going to follow me along? Here I am trying to protect myself but is that going to be something that trails behind me for the rest of my life?” (Administrator) People will say, “If people see me going in there, people will think that I have HIV.” (Administrator)
Discussion
This study presents provider and health center administrator attitudes toward PrEP in a high-incidence metropolitan area in the Southeastern United States. Focus group participants generally felt PrEP implementation was feasible at their sites, although demand for PrEP was reported to be low and several barriers to implementation were identified including stigma, concern about risk compensation, and difficulty of obtaining accurate risk assessment to identify PrEP candidates. Even though centers participating in the focus groups provide care at no or low cost on a sliding scale, lack of insurance was still identified as a significant barrier to PrEP care in that care for uninsured patients was more complex. Further, participants approached PrEP as a scarce resource, worried about social issues that may interfere with adherence, and were concerned about “wasting” this resource on patients who were unlikely to take the medication.
To achieve the potential for PrEP implementation in sites such as these FQHCs, a broad-based training plan for PrEP provision is needed. Discussions on the HIV serostatus of sexual partners, sexual behavior, and sexual risk may depend on the provider’s or counselor’s comfort level for implementation and may be a barrier to prescribing PrEP. Consistent with other studies, some providers expressed concerns about risk compensation and increased unprotected sexual activity by PrEP users, asserting that PrEP would give permission for condomless sex leading to an increase in STDs. For a smaller number of participants, moral concerns regarding the perception that the provider may be encouraging promiscuity were also raised. This provider discomfort may lead to conscious or subconscious bias against PrEP as a prevention strategy and limit availability to patients who may benefit. As previously reported, 17 some providers were most comfortable with PrEP provision to discordant couples, particularly heterosexual couples considering pregnancy, expressing less concern about risk compensation and treatment adherence in the use of time-limited PrEP during the periconception period. For some participants, particularly at centers not specializing in LGBT health, this preference may also reflect more comfort with heterosexual couples with a perceived commitment to monogamy compared with same-gender couples or those with multiple partners.
Training may be required to identify PrEP candidates in communities with increased HIV incidence to prepare clinic staff to engage in sensitive conversations. Similarly, community or cultural stigma associated with HIV and medication is also a barrier to opening the dialogue regarding HIV prevention. To promote uptake of PrEP and avoid reinjuring high HIV-incidence communities, consideration is needed of historical stigmatization associated with HIV. Routinization of screening for PrEP candidates and introduction of PrEP information to patients, perhaps through task shifting of risk assessment away from medical providers, may also ensure that PrEP is offered regardless of individual subconscious preferences or biases in prescribing.
Previous surveys in Miami and Washington, DC indicated that fewer than 5% of providers responding would prescribe PrEP to patients who demonstrated nonadherence to medication and medical appointments. 17 The potential for inadequate adherence was voiced as a major barrier to PrEP provision, exacerbated by a potential lack of insurance or income to ensure multiple visits to ensure continuous coverage and supervision. Concerns discussed included offering PrEP with inadequate patient education, lack of patient follow-up, and the potential for harm arising from suboptimal adherence. However, previous studies in HIV-infected populations have not found provider assessment to accurately identify potentially adherent or currently adherent patients when compared with viral load, 18,19 and physician predictions of nonadherence among HIV-infected patients have been associated with failure to initiate antiretroviral therapy when medically indicated. 20 This suggests that decisions to offer PrEP may be based on subjective assessments of adherence that could lead to arbitrary or inequitable PrEP prescribing. Making tools available for adherence assessment and expanding the availability of evidence-based interventions to increase PrEP adherence may increase provider comfort with prescribing PrEP. 21 –24 Additionally, some providers viewed PrEP as a limited resource to be provided only to those most likely to use it appropriately. Such views may arise from delays in HIV care associated with the AIDS Drug Assistance Plan waiting lists that have occurred in recent years in Florida 25 and highlight the importance of ensuing an adequate supply of medication for those both infected and at risk.
This study examined PrEP implementation in a diverse and highly affected area of the United States. As previously noted in studies of PrEP providers in disparate geographical and cultural settings, local concerns, health economics, and social programs greatly influence considerations for PrEP implementation. 26 –29 Despite the limitations of a small sample size associated with a feasibility study, replication of this study in other communities that are severely impacted by HIV and without governmental programs supporting implementation is merited. The variety of factors positively and negatively impacting PrEP implementation and adherence underscore the importance of a coordinated treatment support system that is inclusive of all individuals at risk for HIV infection regardless of legal status or ability to pay.
Footnotes
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) received no financial support for the research, authorship, and/or publication of this article.