Interest in Switching to On-Demand HIV Pre-Exposure Prophylaxis PrEP Among Australian Users of Daily PrEP: An Online Survey

The PrEPX team will be working on a number of important research questions related to the uptake and ongoing use of PrEP by GBM at risk of HIV. Preceding the anticipated public subsidisation of PrEP through Medicare, the Victorian government has funded a program (PrEPX) to rapidly scale-up PrEP access to GBM through high-caseload clinics.

Apr 22 PPP048 – HIV Pre-exposure Prophylaxis

• Pharmacological studies in cis-gender women suggest that on-demand† PrEP does not provide adequate tissue levels of PrEP to provide high levels of HIV protection and on-demand† PrEP should not be recommended for cis-gender women.
• Whereas on-demand PrEP was previously contraindicated in people living with chronic hepatitis B infection, on-demand PrEP may now be considered for this patient group (see section on hepatitis B and PrEP).
• 79, 80 Now, PrEP is a key pillar of the National HIV Strategy.
• General practitioners and nurses should be aware of people not currently benefiting from PrEP who might do so (younger men and people born overseas without access to Medicare – see Background to this chapter) and assess their barriers to, and options for, access.

Cisgender men, regardless of the sex of their sexual partners. Nurses can and ought to have a pivotal role in exploring and providing innovative methods of PrEP medication adherence support in marginalised, vulnerable populations, which could include DOT, other forms of highly supported therapy and the provision of financial incentives. Key components of medication adherence counselling (from the national PrEP guidelines 76). Expanded PrEP implementation in Australia started with two population-based implementation trials, EPIC-NSW in New South Wales 77, 78 and PrEPX in Victoria. 79, 80 Now, PrEP is a key pillar of the National HIV Strategy.

Providing PrEP

However, all participants who responded to this question with any answer other than “very satisfied” were asked to list their reasons for dissatisfaction. We were so fortunate to have Edwina – who ran the pivotal Australian trials and was so kind in sharing her knowledge with us. † The Therapeutic Goods Administration (TGA) has not approved this regimen in Australia. Whereas on-demand PrEP was previously contraindicated in people living with chronic hepatitis B infection, on-demand PrEP may now be considered for this patient group (see section on hepatitis B and PrEP). We pay our respects to the Aboriginal and Torres Strait Islander peoples of the past, present, and future, including the Gadigal peoples (Sydney office), the Turrbal and Jagera/Yuggera peoples (Brisbane office), and all First Nations people of the nations where we live and work.

Table 1.

• However, all participants who responded to this question with any answer other than “very satisfied” were asked to list their reasons for dissatisfaction.
• Future Australian studies of on-demand PrEP will need to be accompanied by education on its relative efficacy and by adherence supports that are specifically tailored to this method.
• The HIV Prevention group is playing a crucial role in monitoring the outcomes of the PrEPX trial in Victoria.
• Data collection, including through the ACCESS surveillance system, is monitoring crucial implementation outcomes such as the effectiveness of PrEP and its impact on sexual behaviours and sexually transmitted infections.

When assessing people for PrEP eligibility and suitability, it is important for general practitioners and nurses to understand pin up online casino a shift in the national PrEP prescribing guidance, from targeted to broader access to PrEP. 76 Targeted PrEP prescribing (focused on high risk MSM) was the key feature of Australian PrEP implementation guidelines up to now, due to the limited PrEP availability prior to the PBS listing of PrEP. The goal of the current 8th National HIV strategy is fast PrEP uptake and broad coverage of people who are at medium or high risk of being infected with HIV.

Apr 22 PPP048 – HIV Pre-exposure Prophylaxis

Very few transgender women have been evaluated in randomised controlled trials of on-demand† PrEP (9-11); nor have such trials been undertaken in cis-gender women or cis-or transgender men, or in people whose principal HIV exposure risk is injecting drug use. Pharmacological studies in cis-gender women suggest that on-demand† PrEP does not provide adequate tissue levels of PrEP to provide high levels of HIV protection and on-demand† PrEP should not be recommended for cis-gender women. To emphasise, these recommendations apply only to scenarios in which the risk of HIV transmission arises from sexual exposure, not exposure through intravenous drug use. The ASHM PrEP guidelines panel recommends that caution be used in recommending on-demand PrEP to adolescent MSM because there have been no trials of on-demand PrEP in adolescent MSM and because adherence rates to daily PrEP have been consistently low in studies of adolescent MSM (7, 8). One limitation of our study is that only 20% of former PrEPX participants provided complete responses to our survey. However, participants who provided complete responses had similar characteristics to the overall PrEPX cohort and hence were likely to have formed a representative sample.

The email explained the concept of on-demand PrEP, in accordance with the IPERGAY protocol, and contained a link to an online survey. The 15-question survey covered demographics, previous and current PrEP use, satisfaction with daily PrEP use, knowledge of on-demand PrEP, interest in starting on-demand PrEP, and reasons for having or not having interest in on-demand PrEP (Supplementary Appendix). Most questions had multiple answer options, and participants could select more than one answer. The prescription and provision of PrEP is straightforward for many medical practitioners. Initiatives such as telementoring 87 and innovative Information and Communication Technology (ICT) solutions offered by eHealth NSW 88 are good examples of how communication technologies can support new PrEP prescribers in remote areas where traditional sexual health services may be limited.

All authors reviewed the paper for intellectual content. Supplementary materials are available at Open Forum Infectious Diseases online. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author. The survey received 1008 unique responses, of which 22 were incomplete and 16 were not from PrEPX participants; therefore, 970 responses were analyzed, producing a response rate of approximately 20%. Key components of medication adherence counselling are presented in Table 9. O    For vulnerable groups, intensive support, case management, directly administered or observed therapy (DOT), partial-DOT, financial incentives.

The PrEPX study was supported by funding from the Victorian Department of Health and Human Services and the Victorian AIDS Council. V.J.C. received a stipend from the Research Training Program of the Australian Government’s Department of Education and Training. This survey was approved by the Alfred Health Ethics Committee, Melbourne, Australia (project 516/18). A“Satisfaction with daily PrEP” was rated by participants on a Likert scale, from which we created a binary variable “satisfied vs dissatisfied” for analysis.

Small studies have indicated that the use of gender-affirming oestrogen may reduce the concentrations of TDF and FTC among transgender women by 12–27%,3, 4 potentially undermining the effectiveness of on-demand PrEP. The authors wish to acknowledge PrEPX participants, the participating study clinics and pharmacies, the HIV-affected community of Victoria, and all human and animal participants of previous pre-exposure prophylaxis (PrEP) studies. The authors wish to acknowledge the excellent work of other researchers that we have not been able to cite in this publication. The newly updated ASHM 2019 PrEP guidelines 76 recommend daily PrEP for all people at risk of HIV infection. In addition, they also recommend that on-demand PrEP should be offered as an alternative option to cis-gender MSM.

In Australia, more than three quarters of new HIV diagnoses are made among gay and bisexual men (GBM). Annual diagnoses of HIV in Australia continue to increase. HIV pre-exposure prophylaxis (PrEP), the use of HIV treatment medication by people at risk of HIV to reduce their risk of acquisition, has emerged over recent years as a highly-effective HIV prevention tool. They will play a key role in assessing people for clinical and behavioural eligibility for PrEP; provide PrEP prescriptions and regular follow-up and support services. Among Australian users of daily PrEP, interest in switching to on-demand PrEP was high but tempered by concerns around its efficacy and the relative complexity of this strategy when compared to daily PrEP. Future Australian studies of on-demand PrEP will need to be accompanied by education on its relative efficacy and by adherence supports that are specifically tailored to this method.

A further limitation of our study is that we did not ask the participants whether they were currently taking on-demand PrEP. At the time of the survey, the only approved PrEP regimen in Australia was daily PrEP, and the PrEPX study intended to provide daily PrEP, but it is possible that some participants were using their PrEP in an on-demand fashion. We did, however, ask participants whether they had prior knowledge of on-demand PrEP. On November 23, 2018, a single email invitation was sent to all former PrEPX participants. This email explained that the PrEPX team was assessing the feasibility of a new study that would offer on-demand PrEP and that we wished to measure the interest of previous PrEPX study participants in participating in an on-demand PrEP study.

Biomedical prevention

The PrEPX study was an Australian demonstration study of daily PrEP conducted in Victoria, South Australia, and Tasmania, which enrolled over 5000 participants between July 2016 and March 2018, consisting mainly of MSM. We plan to conduct a study to determine the benefits of switching from daily to on-demand PrEP among users of daily PrEP. Trans and gender diverse people who were assigned the male sex at birth, who are not taking exogenous oestradiol-based hormones.

Providing PrEP

For many general practitioners and nurses new to PrEP, prescribing may be unfamiliar but is described in detail in the updated ASHM 2019 PrEP guidelines. 76 PrEP training and resources are also available on the ASHM website to assist clinicians. PrEP can be taken on a daily basis (daily PrEP) or around the time of exposure as event-driven PrEP, also known as event-based PrEP (EB-PrEP) and on-demand PrEP. Behavioural data collected at baseline and three-monthly clinic visits will help explore the potential prevention impact of PrEP. PrEP has been approved in several jurisdictions around the world for use by high-risk populations and was recently approved for HIV prevention in Australia by the Australian Government Department of Health Therapeutic Goods Administration.

In 2019, the US Food and Drug Administration approved emtricitabine + tenofovir alafenamide (FTC/TAF or F/TAF, Descovy®) as another drug that can be used for PrEP. We will also monitor the background incidence of HIV among gay men attending PrEP implementation clinics, undertaking world-leading research to measure the impact of rapid PrEP scale-up on background rates of HIV transmission. V.J.C. wrote the survey questionnaire, and E.J.W. and L.L. V.J.C. curated and analyzed the survey data and wrote the first draft of the paper.