Promising approaches to improving PrEP access

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For pre-exposure prophylaxis (PrEP) to have a substantial public health impact, access to PrEP needs to be improved so that more people who would benefit from it receive PrEP. Services need to adapt and innovate. A series of recent articles outline a range of promising approaches.

Nurse-led services: PrEP provision may challenge sexual health services because of the large influx of new patients who will need to attend quarterly. These services may need to be reconfigured to create more appointment slots.

“Task shifting” involves delegating tasks from health workers who are in short supply – such as doctors – to other staff members, such as nurses. It has been instrumental in expanding access to HIV treatment in African countries and Dr Heather-Marie Schmidt of the New South Wales Ministry of Health says that it has played a crucial role in the massive scale-up of PrEP there. A nurse-led model has increased the capacity of clinics to rapidly expand PrEP, without calling on extra resources.

Within the EPIC-NSW trial, registered nurses can screen, educate, clinically assess, order tests and manage results. Extensive planning and consultation with stakeholders was needed to create an acceptable and legally valid procedure that would allow nurses to provide PrEP medication. The nurses are delegated responsibility by a senior physician at their clinic to dispense PrEP medication at the clinic, within clearly set parameters and with each patient’s records being regularly reviewed by a doctor. People with kidney problems, suspected HIV seroconversion, abnormal test results or side-effects are referred to a doctor.

Registered nurses are authorised to initiate people on PrEP, but most clinics have chosen to have this handled by a doctor, with nurses conducting follow-up appointments. These may take place at community-based testing sites, which may be more convenient for the person taking PrEP.

Providing PrEP in community pharmacies: Existing PrEP services are often at a significant geographic distance from many people. In the US, people living outside of cities and in southern states are especially unlikely to have local access to PrEP. However, most people live close to a community pharmacy and pharmacists already provide screening for a range of health issues as well as helping to manage long-term conditions like cardiovascular disease.

In Seattle, the Kelley-Ross Pharmacy created a PrEP service. It set up a Collaborative Drug Therapy Agreement with an HIV specialist physician, which allows trained pharmacists to perform specific functions, including initiating and monitoring PrEP in line with national guidelines. As with the nurse-led service in New South Wales, complex cases are referred to the physician.

The service is called One-Step PrEP and marketing emphasises that all steps for PrEP initiation (including testing, getting results and picking up medication) are done at the pharmacy, usually in one visit. In addition, pharmacists have experience in helping people navigate health insurance requirements, authorisations and applications for co-payment cards.

Success of the service is facilitated by the state of Washington’s supportive policies. It has expanded Medicaid and there is a PrEP drug assistance programme. Moreover, legislation gives pharmacists a wide scope of practice and requires commercial insurers to recognise pharmacists as healthcare providers.

Digital health services: Digital health services (also known as telehealth services) use communication technologies to exchange data between an individual at home and a clinical team, allowing health care to be provided at a distance. In San Francisco, the PrEPTECH programme was marketed to young gay and bisexual men of colour. They could access a mobile-optimised website to get information about the service and to be screened for PrEP.

Eligible participants were mailed a self-sampling kit for sexually transmitted infections and were referred to a local laboratory for HIV and kidney blood tests. Phone appointments with a doctor were used for both PrEP initiation and regular follow-up, with medication sent by post. Users could choose to receive mobile phone reminders for medication adherence and appointments.

The programme has some similarities with PrEP@Home, reported on a few months ago. PrEP@Home has the advantage of using self-sampling for all necessary tests (thereby dispensing with the need for laboratory visits). However, users were required to attend a face-to-face appointment once a year, whereas all PrEPTECH appointments were by phone.

In a small pilot study, most PrEPTECH users said that it was more convenient, faster and easier to use than other ways of accessing PrEP.

Digital mentoring for local PrEP providers: Healthcare providers who currently have limited experience of PrEP may need training and mentoring to support them to deliver PrEP. If this support can be delivered across wide geographic areas, a more comprehensive network of PrEP providers can be developed.

Project ECHO faciliates knowledge-sharing networks in medicine, using video-conferencing to conduct virtual clinics with community healthcare providers. In the US, one such network educates and mentors community HIV practitioners in the states of Washington, Oregon, Montana, Idaho, Utah and Alaska.

In 2015 it added regular content on PrEP – quarterly talks by experts plus monthly case discussions, based on situations that had arisen in the participants’ own practice. Most cases focused on identifying appropriate individuals to receive PrEP, considerations for serodiscordant couples (including conception) and transitioning from post-exposure prophylaxis (PEP) to PrEP.

Participants reported that taking part improved their knowledge and confidence in prescribing PrEP, helping them manage individual patients. Dr Brian Wood of the University of Washington says the programme served as a catalyst for them to be PrEP champions and become a resource for other healthcare providers in their communities.

Key population-led services: In Thailand, around 85% of the country’s estimated 6,600 PrEP users are obtaining PrEP from a service which is led by community health workers drawn from the key populations affected by HIV.

One of these is the Princess PrEP programme, which works with organisations such as Adam’s Love, the Rainbow Sky Association and Swing that have strong links with communities of men who have sex with men and transgender women. PrEP was added into existing services, which offer cash incentives to peer mobilisers who bring people in for HIV testing provided by community health workers. If the test result is reactive, HIV treatment is offered. If the result is negative, a prevention package is offered, including condoms, lubricant, PEP and PrEP.

The individual taking the test and the peer health worker decide together whether PrEP would be appropriate. Around one in ten decide to take PrEP and the medication is dispensed the same day by the community worker. One challenge is retention, which drops to around 50% after one year, with poorer results seen in younger and less educated individuals.

Engagement with PrEP has been much better in key population-led services than in Thailand’s public hospitals (less than 5% of the country’s PrEP users). Dr Nittaya Phanuphak of the Thai Red Cross says this shows that “PrEP needs to be urgently demedicalised” to facilitate uptake. But the World Health Organisation does not currently recommend this model of care. “To scale-up and sustain key population-led PrEP programmes, strong endorsement from international and national guidelines is necessary,” she says.

Holistic services for transgender women: Many transgender women do not feel comfortable using mainstream health services. In Detroit, 54% said that they had felt disrespected at health facilities, 59% had postponed getting services because clinics were not trans-inclusive and 81% said they would prefer to use a clinic that specialises in transgender care.

The city’s Ruth Ellis Health and Wellness Centre has been able to engage transgender women with PrEP by offering it alongside gender-affirming hormone therapy. Blood samples for the laboratory tests needed for both PrEP and hormone therapy are drawn at the same time. Similarly, adherence support for the two interventions is integrated. Prescriptions can be delivered onsite, avoiding the need to visit a pharmacy where a person may encounter discrimination.

The Ruth Ellis Centre is trusted as a safe and supportive space in Detroit’s transgender community. It provides a wide range of physical, behavioural and psychosocial health services; provides support to people selling sex; has a drop-in centre that provides access to food, showers and computers; provides case management services; and has expertise in navigating health insurance requirements.

Specialist and holistic services like these may be needed to reach marginalised transgender women.

Abstract 1
Pre-exposure prophylaxis (PrEP) with antiretrovirals could prevent millions of infections, yet effective strategies to get PrEP delivered are just being defined. This editorial introduces a series of 17 articles which form a special issue of Sexual Health focused on the opportunities and challenges for health service providers engaged in PrEP prescribing. All pieces presented here share useful lessons from PrEP pioneers; more than that, they should serve as catalysts to accelerate PrEP implementation around the world.

Authors
Iryna B Zablotska, Jared M Baeten, Nittaya Phanuphak, Sheena McCormack, Jason Ong

Abstract 2
Pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) is now accepted as an efficacious approach to preventing HIV acquisition among people at high risk of HIV infection but, in most places, PrEP uptake to date has not been sufficient to have a large effect on HIV incidence. In this paper we consider several key elements of the effort to expand PrEP uptake for at-risk populations who would benefit most, such as increasing access to PrEP, integrating PrEP programs with other services, promoting PrEP persistence and developing systems for monitoring PrEP use. We used a PrEP Continuum framework to describe barriers to equitable uptake of PrEP, and to illustrate possible solutions to barriers. Access to PrEP includes regulatory issues and geographic proximity to PrEP providers. Integrating PrEP programs with other comprehensive sexual health services, through clinic-based programs or technology-based approaches, offers opportunities to identify PrEP candidates and improve linkages to PrEP care. Once at-risk people are prescribed PrEP, lowering barriers to persistence on PrEP is critical to realising the most population benefits. To understand progress and identify underserved groups and communities, systems to monitor the uptake of PrEP are needed. Making the most of a new biomedical intervention tool requires ongoing research about implementation, scale-up through multiple channels, including community-based organisations, and high-quality monitoring of uptake. We must turn to questions of PrEP implementation and continue to seek innovative approaches to reduce barriers to PrEP uptake and persistence on PrEP.

Authors
Patrick S Sullivan, Aaron J Siegler

Abstract 3
There is little evidence and no standardised model for nurse-led HIV pre-exposure prophylaxis (PrEP). In 2016, public sexual health clinics in the state of New South Wales (NSW), Australia, participating in the population-scale PrEP access trial Expanded PrEP Implementation In Communities in New South Wales (EPIC-NSW) were authorised to adopt a nurse-led model of PrEP provision in order to facilitate the rapid expansion of PrEP access to more than 8000 participants in under 2 years without additional resources. The model has been implemented successfully in public clinics in 10 of 14 local health districts, with widespread support and no serious safety events reported. With the increasing importance of PrEP as an HIV prevention tool, non-traditional models of care, including nurse-led PrEP, are needed.

Authors
Heather-Marie A Schmidt, Ruthy McIver, Rebecca Houghton, Christine Selvey, Anna McNulty, Rick Varma, Andrew E Grulich, Joanne Holden

Abstract 4
Background: In the United States, young men who have sex with men (YMSM) of color represent a high number of new HIV diagnoses annually. HIV pre-exposure prophylaxis (PrEP) is effective and acceptable to YMSM of color; yet, PrEP uptake is low in those communities because of barriers including stigma, cost, adherence concerns, and medical distrust. A telehealth-based approach to PrEP initiation may be a solution to those barriers. This pilot study investigates one such intervention called PrEPTECH.
Methods: We enrolled 25 HIV-uninfected YMSM, aged 18–25 years, from the San Francisco Bay Area into a 180-day longitudinal study between November 2016 and May 2017. Participants received cost-free PrEP services through telehealth [eg, telemedicine visits, home delivery of Truvada, and sexually transmitted infection testing kits], except for 2 laboratory visits. Online survey assessments querying PrEPTECH features and experiences were administered to participants at 90 and 180 days.
Results: Eighty-four percent of participants were YMSM of color. Among the 21 who completed the study, 11 of the 16 who wanted to continue PrEP were transitioned to sustainable PrEP providers. At least 75% felt that PrEPTECH was confidential, fast, convenient, and easy to use. Less than 15% personally experienced PrEP stigma during the study. The median time to PrEP initiation was 46 days. Sexually transmitted infection positivity was 20% and 19% at baseline and 90 days, respectively. No HIV infections were detected.
Conclusions: Telehealth programs such as PrEPTECH increase PrEP access for YMSM of color by eliminating barriers inherent in traditional clinic-based models.

Authors
Refugio, Oliver N; Kimble, Mabel M; Silva, Cara L; Lykens, James E; Bannister, Christian; Klausner, Jeffrey D

Abstract 5
Background: National guidelines for the provision of HIV pre-exposure prophylaxis (PrEP) to reduce a person’s risk of acquiring HIV were made available in 2014. We created a pharmacist-managed HIV PrEP clinic in a community pharmacy setting at Kelley-Ross Pharmacy in Seattle, WA, USA.
Methods: The clinic operates under a collaborative drug therapy agreement based on these guidelines. This allows pharmacists to initiate and manage tenofovir disoproxil fumarate/emtricitabine under the supervision of a physician medical director.
Results: Between March 2015 and February 2018, 714 patients were evaluated and 695 (97.3%) initiated PrEP. Five hundred and thirteen (74%) patients began medication the same day as their initial appointment. Of the prescriptions filled in our pharmacy, 90% of patients had a mean proportion of days covered (PDC) greater than 80%, and 98% had a zero-dollar patient responsibility per month, including uninsured individuals. 19% of patients were lost to follow up, with an effective drop-out rate of 25%. Two hundred and seven diagnoses of sexually transmissible infections were made. There were no HIV seroconversions in the service.
Conclusion: The pharmacist-managed PrEP clinic proved to be a successful alternative model of PrEP care, with high initiation rates and low drop-out and lost-to-follow-up rates. This may benefit individuals who do not access PrEP in traditional health care settings or where PrEP access is scarce. Financial sustainability of the model was dependent on the ability of pharmacists in the clinic to bill insurance plans for their services in accordance with Washington State legislative changes requiring commercial insurances to recognise pharmacists as providers.

Authors
Elyse L Tung, Annalisa Thomas, Allyson Eichner, Peter Shalit

Abstract 6
Background: No data are available on the feasibility of pre-exposure prophylaxis (PrEP) delivered by trained key population (KP) community health workers. Herein we report data from the KP-led Princess PrEP program serving men who have sex with men (MSM) and transgender women (TGW) in Thailand.
Methods: From January 2016 to December 2017, trained MSM and TGW community health workers delivered same-day PrEP service in community health centres, allowing clients to receive one PrEP bottle to start on the day of HIV-negative testing. Visits were scheduled at Months 1 and 3, and every 3 months thereafter. Uptake, retention and adherence to PrEP services and changes in risk behaviours over time are reported.
Results: Of 1467 MSM and 230 TGW who started PrEP, 44.1% had had condomless sex in the past 3 months. At Months 1, 3, 6, 9 and 12, retention was 74.2%, 64.0%, 56.2%, 46.7% and 43.9% respectively (lower in TGW than MSM at all visits; P < 0.001), with adherence to at least four PrEP pills per week self-reported by 97.4%, 96.8%, 96.5%, 97.5% and 99.5% of respondents respectively (no difference between MSM and TGW). Logistic regression analysis identified age >25 years, being MSM and having at least a Bachelors degree significantly increased retention. Condomless sex did not change over the 12-month period (from 47.2% to 45.2%; P = 0.20). New syphilis was diagnosed in 4.9% and 3.0% of PrEP clients at Months 6 and 12 (cf. 7.0% at baseline; P = 0.007). Among PrEP adherers and non-adherers, there were one and six HIV cases of seroconversion respectively, which resulted in corresponding HIV incidence rates (95% confidence interval) of 0.27 (0.04–1.90) and 1.36 (0.61–3.02) per 100 person-years.
Conclusion: Our KP-led PrEP program successfully delivered PrEP to MSM and TGW. Innovative retention supports are needed, especially for TGW and those who are young or with lower education levels. To scale-up and sustain KP-led PrEP programs, strong endorsement from international and national guidelines is necessary.

Authors
Nittaya Phanuphak, Thanthip Sungsing, Jureeporn Jantarapakde, Supabhorn Pengnonyang, Deondara Trachunthong, Pravit Mingkwanrungruang, Waraporn Sirisakyot, Pattareeya Phiayura, Pich Seekaew, Phubet Panpet, Phathranis Meekrua, Nanthika Praweprai, Fonthip Suwan, Supakarn Sangtong, Pornpichit Brutrat, Tashada Wongsri, Panus Rattakittvijun Na Nakorn, Stephen Mills, Matthew Avery, Ravipa Vannakit, Praphan Phanuphak

Abstract 7
Background: Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention strategy, but it is unclear how best to deliver PrEP to key populations. Drawing upon a cross-sectional survey of transgender women (TW) in Detroit, USA, and experience of a PrEP clinic that serves this population, this manuscript describes the following: (1) the risk profile of Detroit TW; (2) the proportion of TW with at least one PrEP indication; and (3) perceptions of and experiences with PrEP among TW in Detroit.
Methods: Between August 2017 and March 2018, 126 TW completed an online PrEP survey. Survey responses were summarised using descriptive statistics and multivariable relative risk regression.
Results: Among participants who reported a negative or unknown HIV status (76% of all participants), 56% reported risk behaviour(s) consistent with PrEP indication guidelines, 17% reported currently taking PrEP and another 4% reported discontinued PrEP use. Among participants who met an indication for PrEP but were not currently taking PrEP, 64% indicated that they were not interested in taking PrEP. Approximately 60% of participants who were not currently taking PrEP reported that they would be more likely to take PrEP if it were provided at a clinic that also provided hormone replacement therapy.
Conclusions: Although a substantial proportion of TW in our survey were on PrEP, interest in PrEP among high-risk TW who were not taking it was low. Specialised clinical infrastructure that is responsive to the specific needs of TW may be needed to expand PrEP to this oftentimes marginalised and high-risk population.

Authors
Julia E Hood, Tony Eljallad, Julisa Abad, Maureen Connolly, Christine Heumann, Jonathan Fritz, Mary Roach, Dawn Lukomski, Matthew R Golden

Aidsmap material
Sexual Health abstract 1
Sexual Health abstract 2
Sexual Health abstract 3
Journal of Immune Deficiency Syndromes abstract
Sexual Health abstract 4
Sexual Health abstract 5
Sexual Health abstract 6


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