Logistical facilitators and barriers to PrEP implementation in methadone clinic settings: provider and staff perspectives

Abstract

Objectives:

The purpose of this study was to examine the feasibility of implementing pre-exposure prophylaxis (PrEP), a daily oral medication for HIV prevention, in methadone clinics.

Methods:

Medical and non-medical staff (n=30) at two methadone clinics in Northern New Jersey were qualitatively interviewed about various aspects of substance use treatment, clinical operations, and HIV risk and prevention among their patient populations. Audio-recorded interviews were professionally transcribed, then coded and analyzed by the research team.

Results:

Themes surrounding the viability of PrEP implementation emerged for both logistical facilitators and barriers. Facilitators included availability of prescribing clinicians, ability to conduct lab testing on-site, and availability of existing Hepatitis C programs as a blueprint for PrEP management. Barriers included increased provider burden, financial concerns, and perceptions that PrEP provision is outside the clinic’s treatment scope.

Conclusions:

While staff expressed willingness and potential ability to provide PrEP, they identified barriers regarding insurance reimbursement, limited funding, and concerns that PrEP would extend the clinic’s treatment scope. However, given the enabling factors such as availability of providers and existing clinical infrastructure, providing PrEP could increase clinic revenue through insurance reimbursement and federal funding for PrEP-related services. Clinic-level education is needed for clinical and non-clinical staff to better understand the logistics of implementing PrEP, particularly regarding prescribing practices, billing and insurance concerns, and the essential nature of HIV prevention as a critical component of substance use treatment.

Introduction

Despite its proven efficacy at preventing HIV, pre-exposure prophylaxis (PrEP) uptake among people who use drugs (PWUD) remains disproportionately low.¹ Identifying potential community-based points of entry for PrEP care is paramount for addressing disparities among this population.^2,3 Social and structural factors, such as poverty, housing insecurity, stigma and racism, place PWUD at increased risk for HIV acquisition due to drug-related or sexual behaviors.⁴ Outbreaks of HIV associated with injection drug use demonstrate the need for comprehensive HIV preventions efforts for people who inject drugs (PWID),⁵ in addition to the documented need for HIV prevention services among all PWUD. While recommendations have called for the integration of PrEP into HIV prevention services for PWUD, these guidelines have yet to be fully actualized in clinical practice.⁶

One point of intervention is methadone treatment settings that serve people with opioid use disorders (OUD).⁷ Researchers have found that patients on medication for OUD (MOUD, e.g., methadone) engage in behaviors associated with HIV risk, including injection drug use and sexual behaviors, yet PrEP awareness in this population of PWUD remained relatively low.^8,9 Studies have demonstrated that patients in methadone treatment programs perceive PrEP as a valuable and acceptable tool for HIV prevention.^7,10 Shrestha and colleagues (2018) found that participants enrolled in a methadone program would prefer PrEP to be administered through the program rather than an HIV clinic. Additionally, medical providers in outpatient substance use programs have expressed interest in introducing PrEP into existing treatment programs.¹¹

While acceptability and interest in PrEP among both patients and staff in methadone treatment clinics may be relatively high, uptake among PWUD remains low.¹² There are likely logistical barriers that complicate rollout in these settings. One study found that providers anticipate difficulties in educating and monitoring patients, as well prescribing to or referring patients elsewhere.¹¹ However, few studies have focused on the logistics of PrEP implementation in substance use treatment programs. Thus, the purpose of this analysis is to examine PrEP implementation feasibility from the perspectives of medical and non-medical staff working in methadone clinics.

METHODS

Sample, study population, and recruitment

Details on the sample and study methodology are available in a previous publication.³ Briefly, research staff compiled a list of methadone clinics in two urban, northern New Jersey counties, and contacted these fifteen clinics in January–April 2019 via telephone, email, and in-person visits. Four clinics initially expressed interest, with two withdrawing, resulting in a final sample of 30 staff participants across two clinics. Participants included both medical providers (e.g., nurses, physicians, physician assistants) and non-medical staff (e.g., front desk staff, administrators, lab technicians, security guards). All participants provided written informed consent, and all materials and activities were previously approved by the New York University Institutional Review Board.

Data collection

Thirty qualitative interviews were conducted that ranged between 15 to 35 minutes, with an average interview time of approximately 25 minutes. Interviewers first administered a five-to-eight-minute questionnaire to collect sociodemographic information. Two interviewers with training and experience in qualitative data collection conducted semi-structured interviews using a guide exploring clinic logistics, substance use treatment models, and HIV-related topics. Examples of questions related to logistics of PrEP implementation included the following: Do you think your patient population is at risk for HIV? Do you think it be possible for patients to receive PrEP care here? What would have to change to make HIV prevention/PrEP possible here?

Data analysis

The audio recordings of the interviews were transcribed by a professional transcription service. The team employed a multi-step method of identifying, contextualizing, and examining themes. The team then developed a tier-leveled coding scheme that was applied to the data to determine patterns, major themes, and subcategories. The coding process, including development, was conducted by three of the authors. All authors assessed the analyses to reconcile differences in themes or interpretation. Atlas.ti was used to organize the qualitative data. Pseudonyms were used to protect the identity of the participants.

RESULTS

The 30 participants interviewed were fairly evenly divided between medical staff (n = 16, 53.3%) and non-medical staff (n = 14, 46.7%). A majority of interviewees were women (n = 19, 63.3%) and nearly all were non-Hispanic Black (n = 26, 86.7%) or Latinx (n = 3, 10.0%).

The following themes emerged: 1) logistical facilitators, including considerations regarding prescriber availability, lab work capability, and previous Hepatitis C programming serving as a blueprint for offering PrEP services, and 2) logistical barriers, including financial constraints and treatment scope concerns.

Theme 1: Logistical facilitators

Providers and staff identified and addressed potential logistical concerns in implementing PrEP in their clinic setting. In particular, most staff were under the impression that PrEP prescribing could only be done by an infectious disease physician. When learning that any prescribing clinician can prescribe PrEP, participants viewed this issue as a facilitator. The following issues were raised: 1) having an appropriate clinician to prescribe PrEP, 2) being able to do PrEP-related lab work on-site, and 3) the possibility of using the Hepatitis C programs as a blue print for offering PrEP services.

Subtheme 1: availability of prescribing clinicians

Many participants were under the impression that PrEP could only be prescribed by an infectious disease or other type of specialist. Once informed that any prescribing clinician could prescribe PrEP, participants were optimistic about the possibility of offering PrEP to patients:

Interviewer: So, with all of those barriers, what would have to happen, logistically, financially, training wise, etc., what would have to happen for this clinic to be able to offer PrEP?

Carol: Very little. We just have to extend it. As long as our doctor, and she’s ASAM [American Society of Addiction Medicine] certified.

Interviewer: Any prescribing clinician can prescribe PrEP. So, a DNP, a PA could prescribe PrEP. An MD or DO.

Carol: We have them here. We still have them here. I wouldn’t have a problem with it. [Carol, non-medical staff]

When asked if PrEP could be prescribed in the clinic, Tamara answered:

Tamara: Could it be done? Yes, but the kinks would have to be worked out because we would have to have a prescribing infectious disease here to write for that.

Interviewer: So, if any NP, or PA, or doctor could do the prescription…

Tamara: Well, if that’s the case, then yeah. My medical director is all for harm reduction, and so I don’t think that would be a problem… [Tamara, medical staff]

Subtheme 2: lab work

Participants were optimistic about the potential feasibility of doing PrEP-related lab work on-site, as both clinics had lab technicians. Below, Marques highlighted how the existing infrastructure of regular visits and lab work required for methadone care would allow for PrEP management to be easily integrated:

…As far as the clinician and medical side of it, I think it’d be great because we already have proper healthcare here. We have nurses on – or if we have a doctor that comes in….[We have a] lab tech. So, we have that and we work with labs, so we could just draw the bloodwork. The person comes, picks it up, sends it, come back with the test results, boom, and that’s like nothing. We have the clients here. They come here daily anyway because, for methadone, at least the ones are on phase one. And the ones that don’t come daily, they come in whenever they are due to come back in for their treatment. [Marques, medical staff]

Subtheme 3: Hepatitis C programs provides a blueprint for offering PrEP

When asked how the clinics might be able to begin offering PrEP, several participants mentioned that their hepatitis C programming could provide a template for implementing PrEP services. Participants largely considered hepatitis C as more prevalent than HIV among their patient population, and viewed their success with addressing hepatitis C as a potential facilitator to increasing HIV prevention efforts. Phyllis, a physician, described how hepatitis diagnosis and treatment is managed at the clinic:

Yes, I think so. I think [HIV is] part of what this population is at-risk for. And so, it’s a part of need, just like smoking cessation. We tried to incorporate that into our treatment here…and hep C. We tried to have a nice little pipeline of okay, we test you. We document that you’re positive with a PCR positive. Now, we’re gonna refer you to a center so that you can now be treated. [Phyllis, medical staff]

Similarly, Tamara spoke about how PrEP could be provided at the clinic in a similar way to how hepatitis C care is delivered to patients:

[Providing PrEP here] is possible. I think it wouldn’t be probably dispensed in the back with the methadone, but to schedule everybody, how we probably would go about this is the same thing as we did with hepatitis… Sometimes, the thing with our clients here is they really, I wanna say, are embarrassed maybe about their status. Or the Hep C, a lot of them didn’t want everybody to know they had Hep C, so we kinda offered a meeting to come and gain information. We gave them breakfast. So, I’m looking at this the same way. [Tamara, medical staff]

Theme 2: Logistical barriers

Although many staff were interested in offering PrEP, there were a few main concerns that were frequently raised in regard to providing HIV-related education and PrEP services. First, participants had financial concerns about being able to offer PrEP, in terms of Medicaid coverage, training staff, and providing HIV education. Second, some participants expressed concern around expanding the treatment scope of the clinic, suggesting that PrEP was too far outside the scope and that offering it would not be possible.

Subtheme 1: Financial concerns around billing

Participants raised concerns about financial constraints in regard to potentially implementing biomedical HIV prevention services on-site. In particular, staff expressed uncertainty about how to bill for time spent with patients discussing PrEP, in addition to general concerns about the resources required to train staff and to provide educational programming. Below, Jada expressed financial concerns regarding insurance and billing, particularly regarding patients on Medicaid:

I feel as though if they have somebody in here like once a week that is gonna do that HIV group, [patients would] be willing to do it.

Interviewer: Yeah. What’s stopping them from having an HIV group?...

Jada: It’s not the staffing. It’s I guess the way how the Medicaid system is switching over now so they can only have certain stuff on certain days. And we have to figure out who is seeing a counselor before they do groups because sometimes you can’t bill everything together. [Jada, non-medical staff]

Leroy was similarly uncertain about the logistics of billing and reimbursement:

My problem will be the billing part of it… And how it’s gonna benefit my practice basically. Because as much as I am doing some clinical work, I’m using my time and I’m using my skills. And I believe there should be some level of reimbursement on my part. Because if it was a visit, that will be 15 minutes. It takes that to 30 minutes or 40 that I’m spending talking about this. It takes away from me. So, it will be time when I was supposed to talk about something else I didn’t get to talk…So, I know I can bill for counseling. If they have insurance, I can bill for screening. The PrEP I can’t bill. I’m not that sure there is a CPT code for that. [Leroy, medical staff]

When asked about concerns related to offering PrEP, Phyllis explained that “time is money”:

It’s timewise. And money is time. So, if you’re talking about more educational programs, you’re talking about instituting more time giving patients that necessary information. It may be more time with the physician to sit down with the patient to discuss the treatment, discuss the benefits and the risks and the possible side effects of treatment, so the patient can make an informed decision about whether they want to proceed with that treatment or not. So, it’s definitely gonna be more time, which is more money. Time is money. [Phyllis, medical staff]

In addition to what other participants expressed about the logistics of billing and ensuring reimbursement for clinicians’ time, Aliyah noted the unique financial difficulties related to serving a low-income population as a clinic with limited funding and resources and no grants:

That’s the biggest change, like what you can and cannot do based off your billing practices and procedures. Well, really what ends up happing the last three to four years, we changed to a [fee for] service- based suite…meaning that the only services that we are paid for is the services that we provide, where it is limited grant, and there’s limited funding. Persons have to have insurance. And that does impact the community that you serve because a lot of them…they’re not insured. And if they’re not insured, how do we still provide the services or what resources are available for them to continue with the services even when they don’t have the insurance… there’s some initiatives in this state that provide free services for clients that is under the poverty guideline and/or do not have insurance and/or maybe have immigration status, but can’t get insured…Unfortunately, our agency doesn’t have any of those grant funding. [Aliyah, non-medical staff]

Subtheme 2: Concerns that offering PrEP would be considered treatment and thus too far outside of the clinic’s substance use scope

Although the staff were in agreement that their patient populations were in need of HIV prevention, some expressed concern that PrEP may be considered non-substance use related treatment and thus outside the scope of the clinic’s services. In addition to having financial concerns, Donna appeared to view PrEP as a “treatment”, which was in the category of services that were referred out of the clinic. It appeared that many staff viewed PrEP in the same category as HIV care. When asked if PrEP could be offered at the clinic, Donna explained:

Donna: Not financially. And we don’t do treatment services. So, having that would be something that we’re not engaged in now. So, for example, if we have a patient who has some medical care needs, we have to case manage that and send that out.

Interviewer: Can the doc write scripts for other things that aren’t related to –

Donna: Can, but again, we’re not following [up]. It’s not treatment. So, if you’re giving something, you gotta have ongoing. That’s considered treatment. So, if we start something, like if somebody is seeing extreme hypertension, or we have our psychs who are gonna prescribe meds. …We treat the addiction, but we’re not treating medical issues. So, we’re case managing and we’re referring out.… [It’s restrictions]in terms of treatment services and what we may be licensed to do. So, every program has to be licensed to do certain things. And we’re not licensed to provide that level of care. [Donna, non-medical staff]

Discussion

Injection drug use accounts for 6% of all new HIV infections,¹³ and beyond injection use, mixing sex and drugs also places people at increased risk for HIV acquisition.₄ (Indeed there have been numerous outbreaks attributed to injection drug use throughout the US.^14–16 Given the recent increase in injection drug use and overdoses, there may be additional increases in HIV incidence¹⁷ without specific and widespread efforts to address the structural underpinnings that shape people’s HIV risk. Methadone clinic settings can contribute to Ending the Epidemic by seeking HIV prevention education for staff and patients and harnessing existing infrastructure to offer PrEP services on-site. While this may require a reframing of ‘methadone clinics’ to ‘substance use services’ clinics, the resulting framework provides a more comprehensive and prevention-focused approach to patient’s health.

Many of the clinic staff expressed concerns about the ability of medical providers to prescribe PrEP citing special licensing requirements as the primary barrier. This persistent misconception regarding special licensing requirements to prescribe PrEP likely stem from the additional credentialing requirements to prescribe Buprenorphine,¹⁸ certifications of opioid use treatment programs ¹⁹ and additional DEA approvals.¹⁹ Within the United States, there are no additional licensing requirements for prescribing clinicians to prescribe PrEP. Lack of provider education around PrEP is common across many clinical settings and specialties.^20–22 This is potentially remedied by expanding educational programs that specifically reach out to non-traditional healthcare settings such as substance use treatment clinics.

Clinic staff also expressed concerns around the financial aspects of offering PrEP. Financial constraints are related to Medicaid and private insurance reimbursement for PrEP services, particularly for the patient.²³ These concerns are shared by medical providers in other treatment settings;²² however, both Medicaid and private insurance reimburse for PrEP services under the International Classification of Diseases 10^th Edition (ICD-10) code Z20.6 (Contact with and (suspected) exposure to HIV) is acceptable for PrEP visits.²⁴ In methadone clinics, the additional code F19.20 (injection drug use exposure risk) may offer additional justification for PrEP services.²⁴ Moreover, the Health and Human Services Ready, Set, PrEP program expands access to PrEP for uninsured and underinsured Americans thereby reducing patient costs;^25,26 additionally, several PrEP co-pay assistance and PrEP assistance programs exist.^25,26 Extant research indicates that PrEP awareness among clinicians and patient populations is still relatively low,^27–29 and perceived cost is a significant barrier.^30,31 Notably, previous research has found high interest in PrEP among PWID,²⁹ suggesting that efforts to reach people who use drugs may be effective. Increasing education and awareness around PrEP as an extremely effective form of HIV prevention is necessary to begin normalizing PrEP as preventative healthcare and to take full advantage of the existing programs that facilitate low-cost or free PrEP.

Some clinical staff also expressed concerns about expanding the treatment scope to include PrEP services, which staff largely perceived as “treatment” and thus necessitating a referral. While the addition of PrEP services to the methadone services does expand the clinic offerings, it should be noted that PrEP is a preventative service and not a treatment. While these concerns are common²² and valid, many existing features of methadone treatment programs can help incorporate PrEP services both efficiently and effectively. Methadone programs already require eight random drug screening tests per year,³² and the required PrEP bloodwork must be completed on a similar timeframe and only requires STI and kidney function labs.³³ Clinically required follow-up for PrEP includes blood work and HIV testing every three months and STI and kidney function tests every six months.³³ Should a patient seroconvert while using PrEP, methadone clinic staff would follow the pre-existing referral protocols each clinic has established for other patient health concerns.

Although expanding services is inherently challenging, PrEP has been effectively introduced in primary care, sexual and gender minority healthcare settings, STI clinics, federally qualified health centers, and HMO clinics; lessons learned from these initiatives provide guidance for a similar expansion of services in methadone clinics.^22,34 For example, the ‘no wrong doors’ model that has been used to improve access and initiation of complementary services. The no wrong doors model is predicated on establishing a hub of complementary services for patients on the edge of care.³⁵ Using this model would mean that patients in the methadone clinic would be offered PrEP services through whatever ‘door’ they arrived through. This model has been used to advocate for the co-location of substance use services and mental health counseling.³⁶ Applying the no wrong doors model to methadone clinic settings can also help alleviate barriers related to NIMBYism (Not In My Back Yard) that has been used to justify the geographical distance to methadone clinics.³⁷ This geographic isolation means that methadone clinic patients may need to travel long distance between substance use services and other related healthcare services (e.g., HIV prevention). These additional barriers to accessing care that can be alleviated by co-locating services³⁷ and offering PrEP alongside HCV screening and treatment, both of which are directly related to injection drug use and/or mixing sex and drugs.

Limitations

This study has limitations that should be considered. Although generalizability may be limited to dissimilar settings, Northern New Jersey was intentionally selected as an area with low substance use treatment and HIV prevention resources. Thus, data collection in this area allowed researchers to reveal the experiences of people that more closely resemble those of the rest of the county, where resources are often limited. The brevity of staff interviews is a second potential limitation. Although staff participants spent as much time as possible before having to resume work, interviews ranged from 15 to 30 minutes, and were on average were about 20–25 minutes. Consequently, several topics were covered and with more time, additional probing would have been helpful.

Conclusion

Integration of PrEP-related services in methadone clinics was tentatively supported by clinic staff, with many explaining how current services and programs provided by the clinic could facilitate PrEP implementation. Staff concerns about potential barriers can be addressed by harnessing existing resources and programming in methadone clinic settings and educating staff on PrEP, particularly around prescribing practices and issues related to co-pay assistance and reimbursement. By incorporating PrEP-related services, methadone treatment settings will contribute to the Ending the Epidemic.