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REVIEW PROTOCOL

Strategies for access and adherence to HIV preexposure prophylaxis: a scoping review protocol*

Pedro Henrique Paiva Bernardo1, Lucas Vinícius de Lima1, Gabriel Pavinati1, Isadora Gabriella Silva Palmieri1, André Estevam Jaques1, Marcelle Paiano1, Vitória Maytana Alves dos Santos1, Gabriela Tavares Magnabosco1

1Universidade Estadual de Maringá, Maringá, PR, Brazil

ABSTRACT

Objective: To map evidence on strategies used globally to prevent HIV infection through preexposure prophylaxis (PrEP). Additionally, to identify actions that strengthen the connection between users and health care services, aiming to understand vulnerabilities related to access and nonadherence. Method: This scoping review will follow the methodology proposed by the Joanna Briggs Institute (JBI). The review will include primary quantitative and qualitative studies, systematic reviews, meta-analyses, and gray literature. Selected databases will include Medline via PubMed, LILACS, BDENF, and SciELO. For gray literature, Google Scholar will be utilized. Studies published from 2012 onward will be considered as this marks the year PrEP was first approved by a regulatory health agency, the U.S. Food and Drug Administration (FDA). The results will be presented in full and structured according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses – Extension for Scoping Reviews (PRISMA-ScR) checklist.

Descriptors: Preexposure Prophylaxis; Sexual Health; Effective Access to Health Services.

INTRODUCTION

In the current context of public policies related to HIV/AIDS, prevention strategies predominantly based on condom use have undergone significant reformulations. This shift is driven by advancements in new prophylactic biotechnologies, which have generated increased optimism about controlling the global HIV epidemic(1).

In this context, combination prevention stands out as a set of actions aimed at reducing or minimizing HIV transmission. This approach allows for the selection of one or more prevention methods, depending on the needs and the social, cultural, and behavioral context of individuals at a given time. It seeks to adopt a broader prevention framework. However, the primary focus remains on the so-called “key and priority populations,” given the higher prevalence of HIV infection within these groups in the country(2).

Among the components of combination prevention, pre-exposure prophylaxis (PrEP) stands out. In Brazil, it is presented as part of a mandala illustrating various options and possibilities. PrEP has proven to be highly effective, preventing up to 99% of HIV infections before sexual activity. This strategy involves the daily or on-demand use of two combined antiretrovirals: tenofovir and emtricitabine, which provide protection rates between 96% and 99%, according to the World Health Organization. Additionally, injectable PrEP, using the long-acting antiretroviral cabotegravir, has recently been approved internationally, further expanding the available prevention options(3-4).

PrEP is characterized as a biomedical tool that, to be consolidated as a right, faces various political, economic, and social challenges. It is, therefore, an ongoing political process that can even become part of the agenda for social movements. Reducing these options to a mere “biomedical approach” oversimplifies what is, in reality, a deeply political and social issue(5).

In the context of the response to HIV/AIDS, aligned with the third Sustainable Development Goal (SDG) proposed by the United Nations (UN), the importance of ensuring the right to access and adhere to the most advanced prevention technologies, particularly PrEP, is highlighted. This approach considers the significant impact PrEP can have on reducing the incidence of new HIV cases. As such, it currently represents one of the central policies in the fight against HIV within Brazil’s Unified Health System (SUS)(6).

However, it is crucial to recognize that simply making new prevention methods available is unlikely to significantly change the reality of virus transmission. Adherence and the proper use of recommended strategies are essential for the success of such policies. Assigning sole responsibility to individuals for daily adherence to medications, without considering their contextual realities, is unsustainable. This is widely acknowledged, as living conditions directly influence behavior, decision-making, and self-care practices in health(7).

In this context, the concept of adherence can often be viewed as a moral responsibility placed on the user, particularly when considering the primary target audience of PrEP: predominantly stigmatized and marginalized groups, such as sex workers, transgender individuals, and/or homosexuals(8).

Furthermore, access to PrEP among these specific populations remains unequal. While there is a high rate of access among men who have sex with men (MSM), transgender individuals at high risk of HIV infection experience significantly reduced access. This disparity highlights a failure in the policy for access and adherence to prophylaxis, undermining the principles of universality and equity that should guide the actions and services provided by the SUS(9).

Thus, this review aims to map evidence on the strategies used globally for HIV prevention through PrEP and to identify actions that strengthen the connection between individuals and healthcare services. The goal is to contribute to the expansion of policies related to PrEP, enhancing access to this strategy and providing a foundation for the necessary support to ensure proper medication use.

This review is expected to contribute, on a broader scale, to achieving internationally agreed-upon goals and proposals aimed at eliminating HIV/AIDS as a public health issue by 2035. Additionally, it seeks to foster the development of policies that expand access to PrEP and promote greater adherence to this strategy.

The findings will also be analyzed through the lens of nursing practice, given the essential role of nurses in health promotion. Their importance is particularly evident in implementing prophylactic measures and supporting individuals to strengthen their connection to care, especially in the context of PrEP.

This proposal is unprecedented, as no similar studies were identified in prior searches conducted in academic databases. This highlights the importance of understanding strategies for access and adherence to PrEP.

METHOD

This review will follow the scoping review methodology proposed by the Joanna Briggs Institute (JBI), known for its rigor and reliability in conducting reviews. The process will be carried out in stages, including: identifying a guiding research question; searching for and identifying relevant findings; grouping the selected studies; analyzing the studies; and, finally, synthesizing and presenting the results(10).

The study will be written in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses – Extension for Scoping Reviews (PRISMA-ScR) guidelines(11).

Lastly, the protocol has been registered on Open Science Framework (OSF) under DOI 10.17605/OSF.IO/G2B8T.

Review question

To formulate the guiding question, the PCC acronym (Population, Concept, and Context) will be used, with the following elements: 1) population (P): PrEP users; 2) concept (C): access and adherence to PrEP; 3) context (C): combination prevention(12).

Based on this framework, the guiding question for the review will be:

“What strategies are being used to expand access to and adherence to PrEP as part of combination prevention globally?”.

Eligibility criteria

Primary studies conducted using quantitative or qualitative approaches will be included. These will encompass randomized and non-randomized clinical trials, as well as case-control studies and prospective or retrospective cohorts. Additionally, systematic reviews, meta-analyses, manuals, government reports, and clinical practice guidelines related to the concept of this scoping review will be considered, including grey literature.

The timeframe will include studies published from 2012 onward, marking the year PrEP was first approved by a regulatory health agency, the United States Food and Drug Administration (FDA). Studies will be accepted in Portuguese, English, or Spanish, depending on the language skills of the authors.

Exclusions include conference abstracts, editorials, opinion articles, animal studies, and in vitro research, as these are unlikely to provide information relevant to the objectives of this review.

Search strategy and study identification

Initially, controlled and uncontrolled descriptors will be selected through a preliminary search limited to the Medline database via PubMed and SciELO. This search aims to identify commonly used terms in studies related to the central theme of this review.

Subsequently, uncontrolled terms will be matched with the Medical Subject Headings (MeSH), which provides English descriptors for database searches. For Portuguese and Spanish descriptors, equivalences will be identified using the Descritores em Ciências da Saúde (DeCS).

With the controlled and uncontrolled descriptors identified and combined using the Boolean operators AND and OR, a search strategy will be developed for the following databases: Medline via PubMed, LILACS, BDENF, and SciELO. Additionally, a specific search strategy will be designed for grey literature by using Google Scholar, as illustrated in Figure 1.

Figure 1 - Search strategies used to systematize the collection of publications in the databases. Maringá, PR, Brazil, 2023

Selection of evidence sources

In the second stage, the study search will be conducted in the selected databases, independently by two researchers, between September 2023 and April 2024. To ensure greater methodological rigor and access to relevant content, the search will be carried out via the Comunidade Acadêmica Federada (CAFe), enabling broad access to indexed journal publications.

After the search, the titles and abstracts of the studies will be analyzed to identify those that align with the review’s objectives. Selected studies will be imported into the software EndNote Web (Clarivate Analytics), where duplicates will be identified and removed. Subsequently, for detailed selection and evaluation, the included articles will be read in full. Studies meeting the proposed objectives will be analyzed using the Rayyan® software.

In the third stage, all studies selected after the full-text review will have their references explored. This step aims to identify additional documents that may be relevant and included in the scoping review.

Data analysis and presentation

For the articles included in the final sample of the review, a tool adapted from the Joanna Briggs Institute (JBI) will be used to extract and characterize the studies. This tool will cover the following: title, authors, language, country of origin, publication venue, journal, and year; methodological aspects: study design, approach, theme, and target audience; key findings: the main results identified in the studies.

Additionally, a flowchart will be developed to detail the material selection process. This will include the identification of duplicates and excluded materials, along with the reasons for exclusion and the stage at which they were excluded. The chart will also present the total number of materials deemed relevant for this review.

Finally, the results will be presented in full, following the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses – Extension for Scoping Reviews (PRISMA-ScR) checklist.

*Paper extracted from the Master's Dissertation entitled “Preexposure prophylaxis for HIV: adherence and associated factors”, presented to the Graduate Program in Nursing at the State University of Maringá, Maringá, Paraná, Brazil, in 2024.

CONFLICT OF INTERESTS

The authors have declared that there is no conflict of interests.

FUNDING

This paper was carried out with the support of the Coordination for the Improvement of Higher Education Personnel–Brazil (CAPES) – Finance Code 001

REFERENCES

1. Bavinton BR, Grulich AE. HIV pre-exposure prophylaxis: scaling up for impact now and in the future. Lancet Public Health. 2021;6(7):e528-e533. https://doi.org/10.1016/s2468-2667(21)00112-2

2. Ministério da Saúde (BR). Agenda Estratégica para ampliação do acesso e cuidado integral das populações-chave em HIV, hepatites virais e outras infecções sexualmente transmissíveis [Internet].  Brasília, DF: Ministério da Saúde; 2018 [cited 24 Jul 2023]. Available from: https://www.gov.br/aids/pt-br/central-de conteudo/publicacoes/2018/agenda-estrategica-para-ampliacao-do-acesso-e-cuidado-integral-das-populacoes-chaves-em-hiv-hepatites-virais-e-outras-infeccoes-sexualmente-transmissiveis/view

3. World Health Organization (WHO). Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV [Internet]. Geneva: WHO; 2015 [cited 24 Jul 2023]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK327115/

4. U.S. Food and Drug Administration. FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention [Internet]. 2012 [cited 12 nov 2023]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-treatment-hiv-pre-exposure-prevention

5. Polidoro M, Kauss B, Miskolci R, Oliveira DC. O panorama atual da estratégia da profilaxia pré-exposição (PrEP) no Brasil e os caminhos possíveis para busca da equidade em saúde [Internet]. Saúde Transf Soc. 2020 [cited 2023 jul 24];11(1):1–11. Available from: https://incubadora.periodicos.ufsc.br/index.php/saudeetransformacao/article/view/5797

6. Lucas MCV, Böschemeier AGE, Souza ECF de. Sobre o presente e o futuro da epidemia HIV/Aids: a prevenção combinada em questão. Physis. 2023;33:e33053. https://doi.org/10.1590/S0103-7331202333053

7. Grangeiro A, Ferraz D, Magno L, Zucchi EM, Couto MT, Dourado I. Epidemia de HIV, tecnologias de prevenção e as novas gerações: tendências e oportunidades para a resposta à epidemia. Cad Saúde Pública. 2023;39:e00144223. https://doi.org/10.1590/0102-311XPT144223

8. Dourado I, Magno L, Greco DB, Grangeiro A. Prevenção combinada do HIV para homens adolescentes que fazem sexo com homens e mulheres adolescentes transexuais no Brasil: vulnerabilidades, acesso à saúde e expansão da PrEP. Cad Saude Publica. 2023;39:e00228122. https://doi.org/10.1590/0102-311xpt228122

9. Blair KJ, Torres TS, Hoagland B, Bezerra DR, Veloso VG, Grinsztejn B. et al. Pre-exposure prophylaxis use, HIV knowledge, and internalized homonegativity among men who have sex with men in Brazil: A cross-sectional study. Lancet Reg Health Am. Fev 2022; 6:100152. https://doi.org/10.1016/j.lana.2021.100152

10. Joanna Briggs Institute. Methodology for JBI scoping reviews. Joanna Briggs Institute Reviewer’s Manual: 2015 edition/Supplement [Internet]. South Australia: 2015 [cited 24 Jul 2023]. Available from: http://joannabriggs.org/assets/docs/sumari/Reviewers-Manual_Methodology-for-JBI-Scoping-Reviews_2015_v2.pdf

11. Tricco AC, Lillie E, Zarin W, O’Brien KK, Colquhoun H, Levac D, et al.  PRISMA ex-tension for scoping reviews (PRISMA-ScR): checklist an dex planation. Ann Med Intern Fenn. 2018. https://doi.org/10.7326/M18-0850

12. Peters MDJ, Godfrey C, Mc Inerney P, Munn Z, Tricco AC, Khalil H. Scoping reviews (2020 version). In: Aromataris E, Munn Z, editors. JBI manual for evidence synthesis. Adelaide: JBI; 2020. chap. 11. https://doi.org/10.46658/JBIMES-20-12

Submission: 04-Dec-2023

Approved: 30-Nov-2024

Editors:

Ana Carla Dantas Cavalcanti (ORCID: 0000-0003-3531-4694)

Paula Vanessa Peclat Flores (ORCID: 0000-0002-9726-5229)

Corresponding author: Pedro Henrique Paiva Bernardo (E-mail: pedro.henrique.hpb@gmail.com)