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Process description of developing HIV prevention monitoring indicators for a province-wide pre-exposure prophylaxis (PrEP) program in British Columbia, Canada

  • Lalani L. Munasinghe,

    Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Writing – original draft, Writing – review & editing

    Affiliation British Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada

  • Junine Toy,

    Roles Data curation, Formal analysis, Investigation, Writing – review & editing

    Affiliations British Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada, St. Paul’s Hospital Ambulatory Pharmacy, St. Paul’s Hospital, Vancouver, British Columbia, Canada

  • Katherine J. Lepik,

    Roles Formal analysis, Writing – review & editing

    Affiliations British Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada, St. Paul’s Hospital Ambulatory Pharmacy, St. Paul’s Hospital, Vancouver, British Columbia, Canada

  • David M. Moore,

    Roles Formal analysis, Writing – review & editing

    Affiliations British Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada, Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada

  • Mark Hull,

    Roles Formal analysis, Writing – review & editing

    Affiliations British Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada, Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada

  • Nic Bacani,

    Roles Data curation, Formal analysis, Investigation, Writing – review & editing

    Affiliation British Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada

  • Paul Sereda,

    Roles Data curation, Formal analysis, Investigation, Writing – review & editing

    Affiliation British Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada

  • Rolando Barrios,

    Roles Writing – review & editing

    Affiliation British Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada

  • Julio S. G. Montaner,

    Roles Writing – review & editing

    Affiliations British Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada, Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada

  • Viviane D. Lima

    Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Supervision, Writing – original draft, Writing – review & editing

    vlima@bccfe.ca

    Affiliations British Columbia Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, Canada, Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada

Abstract

In 2018, the pre-exposure prophylaxis (PrEP) program was initiated in British Columbia (BC), Canada, providing PrEP at no cost to qualifying residents. This observational study discussed the steps to develop key evidence-based monitoring indicators and their calculation using real-time data. The indicators were conceptualized, developed, assessed and approved by the Technical Monitoring Committee of representatives from five health authority regions in BC, the BC Ministry of Health, the BC Centre for Disease Control, and the BC Centre for Excellence in HIV/AIDS. Indicator development followed the steps adopted from the United States Centers for Disease Control and Prevention framework for program evaluation in public health. The assessment involved eight selection criteria: data quality, indicator validity, existing scientific evidence, indicator informativeness, indicator computing feasibility, clients’ confidentiality maintenance capacity, indicator accuracy, and administrative considerations. Clients’ data from the provincial-wide PrEP program (January 2018—December 2020) shows the indicators’ calculation. The finalized 14 indicators included gender, age, health authority, new clients enrolled by provider type and by the health authority, new clients dispensed PrEP, clients per provider, key qualifying HIV risk factor(s), client status, PrEP usage type, PrEP quantity dispensed, syphilis and HIV testing and incident cases, and adverse drug reaction events. Cumulative clients’ data (n = 6966; 99% cis-gender males) identified an increased new client enrollment and an unexpected drop during the COVID-19 pandemic. About 80% dispensed PrEP from the Vancouver Coastal health authority. The HIV incidence risk index for men who have sex with men score ≥10 was the most common qualifying risk factor. The framework we developed integrating indicators was applied to monitor our PrEP program, which could help reduce the public health impact of HIV.

Introduction

Despite numerous ongoing interventions to help prevent the spread of the human immunodeficiency virus (HIV), the global burden of HIV is still substantial. In 2019, an estimated 1.7 million individuals became infected worldwide [1]. In the same year, Canada recorded 2122 HIV incident cases [2], with the highest proportion of cases (39.7%) being among gay, bisexual and other men who have sex with men (gbMSM), while heterosexual contacts and people who inject drugs accounted for 28% and 22%, respectively [2]. Pre-exposure prophylaxis (PrEP), the use of daily oral antiretroviral therapy, is protective against HIV infection [37], as it reduces the risk of HIV acquisition among gbMSM by as much as 97% [58]. In 2015, the World Health Organization strongly recommended PrEP for adults with a substantial risk of HIV [4]. In response, several countries, including Canada, approved the use of tenofovir disoproxil fumarate and emtricitabine for PrEP, and many provinces subsequently initiated PrEP programs [3, 9, 10]. In January 2018, a publicly funded PrEP program was implemented in British Columbia (BC), Canada, as a supplementary initiative to the existing broad BC HIV prevention strategies such as Treatment as Prevention and harm-reduction programs [1113]. The BC Centre for Excellence in HIV/AIDS (BC-CfE) provides PrEP free of charge to BC residents who fulfil the risk-based eligibility criteria according to its PrEP guidelines [11]. These criteria are primarily focused on gbMSM as the current HIV epidemic in BC is concentrated on this population [14], with more limited criteria for individuals who may be exposed to HIV through injection drug use or heterosexual contact. However, access to the program has been potentially limited in some cultural and ethnoracial communities due to PrEP-related stigma and unawareness [15, 16], and in remote rural areas due to topography, physical barriers, and out-of-pocket travel expenses [17, 18]. The program website provides more details: http://bccfe.ca/hiv-pre-exposure-prophylaxis-prep.

PrEP is a biomedical prevention option that requires high adherence, thus making proper routine monitoring an essential task to assess uptake, effective use and safety [19]. Unlike other HIV prevention strategies, most potential beneficiaries from PrEP are key population groups facing legal and social challenges in accessing health services [19]. Therefore, multiple factors can influence the success of PrEP program retention and adherence, including HIV-related stigma and discrimination, perceived and actual side-effect concerns, poor understanding of treatment benefits, personal choices and lifestyle [4, 1922]. Therefore, early development and examination of robust reporting, surveillance and monitoring systems are crucial [4, 19]. In addition, timely monitoring of PrEP program outcomes helps highlight the successes and drawbacks of its performance to guide the continued optimization of the delivery of this prevention strategy. Several monitoring frameworks and indicators for examining the effective delivery of PrEP programs have been proposed [19, 23]. However, the lack of standard monitoring frameworks to assess the safe and effective delivery of PrEP, focusing on those who would benefit most, poses a challenge with indicator interpretation due to varying indicator definitions and terminologies [24]. Additionally, the inconsistent definitions and choice of indicators make evaluating PrEP programs’ performance difficult across jurisdictions [24, 25].

Over four years since the BC-CfE PrEP program implementation, actionable data have been generated to monitor the program’s progress, which is a crucial step towards its long-term success. Here, we aim to describe the steps used for the development of program monitoring indicators that can be adopted by other jurisdictions and the calculation of those indicators using live PrEP program data. We have now standardized this approach by creating a province-wide PrEP Monitoring Report (available at https://bccfe.ca/hiv-pre-exposure-prophylaxis-prep/prep-reports) that address program goals through the monitoring of key indicators to inform HIV prevention efforts across the province.

Materials and methods

Subjects and data sources

Data to illustrate indicators of this study were acquired from the secure and computerized BC-CfE PrEP program real-time database of clients’ data available from 1 January 2018 to 31 December 2020. The dataset was linked to a centralized province-wide population-based registry that holds data from various sources, including the BC-CfE HIV Drug Treatment Program (e.g., demographic, clinical, antiretroviral medication dispensation data) [26], the BC-CfE Pharmacovigilance Initiative (e.g., clinician-reported antiretroviral adverse drug reaction data) [27], BC Vital Statistics mortality data [28], Providence Health Care Laboratory Interface (e.g., testing data from laboratory sites, including the BC Centre for Disease Control Public Health Laboratory) [29], and the College of Physicians and Surgeons of BC (e.g., physician-related data to determine specialty type [family versus specialist physician]) [30]. Unfortunately, data were not captured for those accessing PrEP outside the program, i.e., third-party private insurers, cash-paying clients or direct online purchases [11].

Process of developing and selecting monitoring indicators

The study adopted the Centers for Disease Control and Prevention (CDC) Framework for Program Evaluation in Public Health recommended by the United States CDC to guide the development of monitoring indicators [31]. The steps involved were: (a) engaging stakeholders, (b) describing the program, (c) focusing on the monitoring design, (d) gathering credible evidence, (e) justifying conclusions, and (f) ensuring knowledge translation and implementation. This framework was previously applied when we developed the province-wide BC-CfE Seek and Treat for Optimal Prevention HIV/AIDS Quarterly Monitoring Report Indicators [32, 33].

An interdisciplinary Technical Monitoring Committee was established, composed of representatives responsible for the healthcare delivery across BC’s five geographic health authority (HA) regions (Interior, Fraser, Vancouver Coastal, Vancouver Island, and Northern), the BC Ministry of Health, the BC Centre for Disease Control, and the BC-CfE to conceptualize, develop, review and approve the indicators. This Committee included stakeholders such as HIV specialists, epidemiologists, clinicians, data analysts, statisticians, clinical researchers, community members, and other health professionals.

Regular in-person meetings were held throughout the development process of the PrEP monitoring indicators to review and provide feedback. The Committee created a list of potential goals and objectives to develop the PrEP program monitoring indicators and described them in detail. They prioritized the objectives to identify the most relevant indicators in a feasible and timely manner. Each Committee member recognized their roles and responsibilities. The development of the monitoring indicators also focused on the availability, quality and interpretability of the PrEP program data that required monitoring.

To develop a list of indicators that define the PrEP program attributes, selected members of the Technical Monitoring Committee conducted a comprehensive literature review on existing monitoring and evaluation indicators used in HIV/AIDS surveillance, prevention and PrEP. After an extensive literature search for relevant indicators based on published material and grey literature, the whole Committee assessed the proposed indicators against eight selection criteria to minimize systematic error in decision-making, including: 1) the quality of the data source(s), 2) the validity of the indicator, 3) existing scientific evidence-based value of the indicator, 4) whether the indicator is informative, 5) feasibility of computing the indicator, 6) capacity to maintain clients’ confidentiality, 7) accuracy of estimated indicators, and 8) administrative considerations. Uniformity and consistency in making the decision were maintained using a tabulated guide provided by Lourenço et al. [32] that was slightly modified based on the consensus of the Technical Monitoring Committee (Table 1). The Committee created this list of selection criteria as informed by the CDC Framework for Program Evaluation in Public Health [31], the BC-CfE Seek and Treat for Optimal Prevention HIV/AIDS [33], the World Health Organization Implementation Tool for Pre-exposure Prophylaxis of HIV Infection [19], and the Optimizing Prevention Technology Introduction on Schedule Review and Documentation of Monitoring and Evaluation of Indicators for Oral PrEP [34].

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Table 1. Eight-selection criteria guide for choosing indicators for decision-making.

https://doi.org/10.1371/journal.pone.0283025.t001

All Committee members reviewed and commented on the shortlist, which consisted of the monitoring indicators that best satisfied the selection criteria or were administratively required by the BC-CfE PrEP program. Their feedback was incorporated and sent back to the Committee for re-evaluation. This process was repeated until an agreement was reached on the most relevant indicators and the best presentation method. The BC-CfE PrEP program webpage [11] provides more details on each indicator’s rationale, description, definition, calculation, use and interpretation.

Ethics statement

The BC-CfE PrEP program is under the aegis of the BC-CfE Drug Treatment Program (DTP). The DTP is a provincially-funded clinical program mandated to i) deliver health care to individuals living with HIV and related diseases or at risk of HIV infection, ii) implement and support public health initiatives to curb HIV/AIDS, iii) monitor and evaluate these health care programs, iv) support continued quality improvement initiatives, and v) support related knowledge translation and education programs. As a result, the University of British Columbia/Providence Health Care Research Ethics Board has agreed that as a clinical registry, the DTP is able to carry out the activities mentioned above under the existing contractual agreement, known as the Shared Cost Agreement (SCA), with the BC-Ministry of Health (PharmaCare), in place since 1992 and renewed and updated regularly. Therefore, specific Research Ethics Board approval is not required for the present analysis as it falls under the mandate of the DTP. All analyses were conducted on anonymized datasets.

Results

PrEP monitoring indicators

A total of 14 PrEP monitoring indicators were finalized after considering the eight selection criteria shown in Table 1. Table 2 summarizes these indicators and their calculation procedure. These indicators integrate demographic, clinical characteristic risk factors of PrEP clients, health service indicators, PrEP dispensing information, and adverse drug reaction reporting. Notably, the PrEP monitoring indicators selected were client gender identity, age, regional HA, new clients enrolled by provider type and by the HA, new clients dispensed PrEP, clients per provider, key qualifying HIV risk factor(s) reported at program enrolment, client status (active or inactive), PrEP usage type, PrEP quantity dispensed, syphilis testing and incident cases, HIV testing and incident cases, and adverse drug reaction events.

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Table 2. Finalized PrEP monitoring indicators, their definitions and their calculation procedurea.

https://doi.org/10.1371/journal.pone.0283025.t002

Examples illustrating these monitoring indicators over time using live PrEP program data are depicted in Fig 1. Additionally, results obtained after calculating the indicators are explained below. We did not create a plot showing the trend of HIV incident cases to avoid the potential breaches of confidentiality in data, as very few seroconversions were identified.

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Fig 1. Selected monitoring indicator outputs for BC-CfE in HIV/AIDS pre-exposure prophylaxis program client database.

(A) Cisgender male program clients dispensed PrEP by calendar quarters (count). (B) Program clients dispensed PrEP by gender identity except cisgender males (count). (C) New program clients enrolled by provider type (percentage). *Expansion of the nurse practitioner role to prescribe PrEP was started at the beginning of Q4 2018. (D) Providers by the number of program clients (count). (E) New program clients by non-mutually exclusive qualifying HIV risk factors reported at the enrolment (percentage).

https://doi.org/10.1371/journal.pone.0283025.g001

Client enrollment into the program database is ongoing, and indicator values are updated as new data becomes available. Therefore, as an example, if we use program data to calculate the indicators only to the last quarter of 2020, 3139 clients received PrEP dispensation, of whom 45% were between the ages of 29 and 40 years, 98% self-identified as cisgender males, and 66% resided in our most urban HA (i.e., Vancouver Coastal). Of 315 new clients (10% of the total), 61% were enrolled by a family physician. In the same quarter, there were 554 PrEP providers, 65% of whom only had one client enrolled in the program, while 48% of clients (n = 1502) were seen by providers with ≥50 clients. There were 3387 PrEP prescriptions during this quarter, including initial prescriptions and refills. Of them, 75% had a record of syphilis testing done, and 88% had a record of HIV testing done. Fifty syphilis incident cases were identified, and two did not have any HIV testing done in that quarter. A total of 15 HIV incident cases were found from 1 January 2018 to 31 December 2020, and two of them were syphilis incident cases that were active in the program, while another two syphilis incident cases were inactive in the program.

A total of 6966 cumulative clients’ data were available in the BC-PrEP program from 1 January 2018 to 31 December 2020. In each quarter, 98–99% of the clients were identified as cisgender males, and 40–45% were aged 29–40 years. Most clients were dispensed PrEP from the Vancouver Coastal HA (67–71%) and 8–10% from Vancouver Island HA. Of 6727 clients who picked up at least one prescription, the majority (72% [n = 4829]) had only HIV Incidence Risk Index for Men who have Sex with Men [HIRI-MSM] score of ≥10 as a qualifying risk factor. The second-largest group was among those who reported having two qualifying risk factors (16% [n = 1066]): (HIRI-MSM ≥10 and previous/current infectious syphilis or rectal bacterial sexually transmitted infection). Of the 86 clients who reported having three qualifying risk factors, 51 had HIRI-MSM ≥10, prior/present infectious syphilis or rectal bacterial sexually transmitted infection, and recurrently used non-occupational post-exposure prophylaxis. Over 95% of active clients in each quarter were prescribed PrEP daily. A total of 112 adverse drug reaction events that included PrEP-related side effects or intolerance were reported, and 106 were among distinct PrEP users. The PrEP interruption was not well-defined in our cohort to identify whether these adverse drug reaction events have resulted from it; however, 84% (n = 94) of adverse drug reaction events resulted from PrEP discontinuation.

Knowledge translation

The developed monitoring indicators can monitor regular and up-to-date information regarding the BC-PrEP program. The findings are disseminated to clinicians, medical practitioners, epidemiologists, public health personnel, funders and other stakeholders across BC to inform the best clinical and public health practice in relation to PrEP. Ultimately, the provincial HAs are responsible for designing and implementing strategies and interventions to improve PrEP delivery and outcomes for their clients.

Discussion

We described developing an indicator framework for monitoring a province-wide PrEP program in BC, Canada. Our study summarizes several aspects of the program, including demographic, programmatic and clinical characteristics. The proposed monitoring indicators could also be stratified by geographic HA region (possibly combining the regions with low population densities) to identify people who access PrEP at the health region level, which enables prioritizing such regions for additional preventive measures. Although our data did not allow for further stratification by gender, age and clinic type due to small counts, this information would also highlight subgroups for targeted interventions to improve access and outcomes related to the BC-PrEP program across the province.

The monitoring indicators should focus on reducing HIV infections and maintaining the program’s safety and effective use [19]. Due to successful HIV management through our PrEP program, the live data we used to calculate the indicators had very few HIV seroconversions and could not create a time trend. However, it is also possible that HIV seroconversion occurs after receiving PrEP due to pre-existing HIV, no or inconsistent use of PrEP, PrEP failure, or discontinued PrEP use [19, 37]. The actionable indicators such as PrEP usage, the quantity of PrEP dispensed, the number of new PrEP users, and active vs inactive PrEP users allowed direct monitoring of effective use of the program. These indicators can help ensure a sufficient and uninterrupted supply of PrEP, forecast potential demand for PrEP and identify gaps in PrEP needs and access. Active syphilis infection is a potent risk factor for HIV incidence and consequently benefits from PrEP use [38]. However, studies have identified high syphilis incidence and some adverse drug reactions among PrEP users [19, 39]. The observed associations of PrEP use and syphilis risk in those studies were potentially mediated by their behavioural change after PrEP initiation [39] and having a history of syphilis infection. Thus, routine monitoring of syphilis incidence and adverse drug reactions could help understand PrEP discontinuation and interruptions and decide on actions to take for safety measures.

Even though the global awareness of the role of PrEP in preventing HIV infection is well-established, recent literature regarding the implementation, monitoring and evaluation of PrEP strategies is limited [19]. We proposed monitoring indicators that have clear definitions and are easy to interpret, thereby demonstrating the feasibility of standardizing indicators to monitor any PrEP program and facilitate communication across settings. However, adequate monitoring would require access to quality and reliable data. We calculated the proposed indicators from routinely generating linked de-identified population-level administrative live data maintained by the BC-CfE that facilitates the production of periodic PrEP monitoring reports. Real-time data further informs and underpins more rapid, relevant and timely decision-making and responses [40]. For example, the numerous indicators we calculated using our ongoing PrEP program data are likely affected by the COVID-19 pandemic due to interrupted PrEP service delivery. The sudden drop in the number of clients in our program from 2020 Q1 to 2020 Q2 explains the unexpected decrease in PrEP access due to the pandemic. The number of new clients enrolled by the family physician and nurse practitioner decreased during the pandemic, while those enrolled by the physician specialists increased. Pandemic-related government restrictions and regulations may have changed the client’s HA, enrolment, or PrEP dispensation. The indicators such as general characteristics, HIV risk factors of the clients, healthcare providers and their trends over time help us to identify such unexpected situations as well as clients and health authorities that need prioritization to improve the effective use of the program. Further studies on the effects of the pandemic on program delivery could be beneficial for more pertinent revision of the indicators.

We acknowledge and highlight the limitations. The proposed indicators were assessed against eight selection criteria; however, the involvement of subjective judgement of the Technical Monitoring Committee when making decisions may affect the reproducibility of the finalized indicators. Therefore, selecting a committee consisting of relevant expertise is critical. We did not consider race/ethnicity as a possible stratification factor for our monitoring indicators since this information was not asked in the PrEP Enrolment and Prescription Request Form from January 2018 to December 2020. However, collecting this information is imperative to assess any bias in accessing the PrEP program, and therefore, the PrEP Enrolment and Prescription Request Form was revised at the end of 2022, and it now collects information on race/ethnicity. Further, some data limitations are associated when calculating the indicators. We list the applicable limitations here to avoid defining indicators incorrectly, enable proper interpretation of the results for program monitoring, and enhance clarity when these indicators are used in other settings. The eligible people and the proportion of clients offered or declined PrEP could not capture and thus considered only those prescribed when creating indicators. There could be under-reporting of key qualifying HIV risk factors and other variables since they were based on provider-reported information, which we could not validate. Program discontinuations and PrEP usage types must be better captured due to information lag and provider underreporting. We address these issues by changing the reporting system to include discontinuation and usage information on PrEP refill prescription forms. Data on adverse drug reactions in our PrEP program is based on voluntary reports of clinicians, patients, and caregivers. Therefore, the data to populate these indicators are constantly being revised. Complete data collection would help calculate adverse drug reaction events as an indicator of monitoring the safe use of PrEP. The study findings should be interpreted with caution since reductions in the availability of non-essential medical services due to the COVID-19 pandemic since March 2020 could have impacted the available data for indicators such as reduced access to testing. Also, the proposed indicators only capture some PrEP-associated domains due to data unavailability. Therefore, the developed indicators ideally include potential barriers to access care, such as social support, stigma, ongoing risk behaviour, PrEP awareness, personal perception, and willingness to use PrEP, as indicated in other studies [4143]. In addition, as put forward by the WHO, PrEP is expected to supplement existing harm-reduction initiatives [19]. Thus, information from outlets that give harm-reduction support to high-risk groups will likely improve indicators’ reliability and validity, providing impending changes in such attributes before they occur. Our online report that uses these indicators for monitoring the PrEP program describes data limitations in detail [11].

We explained the process of developing a comprehensive PrEP monitoring framework using evidence-based indicators, and we calculated the indicators using an administrative database with real-time information. Stratification of the indicators exposed variability in the proper use of PrEP among subpopulations, thus providing approaches to address subpopulation considerations in continuing the PrEP program and identifying potential HIV prevention choices. In addition, these indicators can be adapted to other settings to guide strategically targeted interventions and facilitate collaboration across jurisdictions.

Acknowledgments

We thank all the members of the BC-CfE PrEP program Technical Monitoring Committee and all clients in the program.

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