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Do we Still Need Eligibility Criteria to Recommend PrEP? Impact of National Prescribing Requirements on Retention in Care and Sexually Transmitted Infections Acquisition

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Abstract

Italian guidelines recommend HIV pre-exposure prophylaxis (PrEP) only upon satisfying strict eligibility criteria. The objective of this study is to evaluate if PrEP candidates attending a community-based service comply with these criteria and whether these prescribing conditions affect retention in care and sexually transmitted infections (STIs) acquisition. A retrospective analysis was performed on PrEP candidates evaluated from January 2019 to June 2022. Data were collected from self-administered questionnaires and clinical files. The population was divided in subjects with 0/1 (0/1 C) and ≥ 2 (≥ 2 C) criteria. Descriptive statistics and non-parametric tests were employed to describe study population. Incidence of PrEP discontinuation and of STIs was estimated per 100 persons-year of follow up (PYFU), and incidence rate ratio (IRR) was calculated. Univariate and multivariable Cox regression analyses were used to evaluate the association strength between PrEP drop out and other variables. The analyses enrolled 659 individuals: 422 individuals were included in 0/1 C, 237 in ≥ 2 C group, respectively. Inconsistent condom use was the most reported prescribing criteria (399 individuals, 60.6%), followed by a previous STI (186 individuals, 28.2%). 0/1 C exhibited lower STIs incidence. PrEP discontinuation was 29% in 0/1 C and 38% in ≥ 2 C (p = 0.031). Cox model revealed that inconsistent condom use was the only prescribing criteria associated to PrEP persistence. The majority of PrEP candidate did not comply with prescribing conditions. Eligibility criteria failed to identify individuals with better retention in care. Our results suggest that Italian guidelines should be updated removing barriers to prescription.

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Data Availability

The data that support findings of this study are available from the corresponding author upon reasonable request.

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Acknowledgements

The authors wish to thank all subjects who agreed to participate to this study. Preliminary results have been presented at the 14th Italian Conference on AIDS and antiviral Research (ICAR), June 14–16, 2022, Bergamo, Italy (Abstract #OC01).

Funding

No specific funding support was planned for study design, data collection and analysis, and manuscript writing of this paper.

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Authors and Affiliations

  1. Department of Infectious Diseases, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, Milan, 20162, Italy

    Roberto Rossotti

  2. Milano Checkpoint ETS, Milan, Italy

    Roberto Rossotti, Alessandro Tavelli, Daniele Calzavara, Anna De Bona, Camilla Muccini, Davide Moschese, Enrico Caruso, Alessandro Soria, Simona Bossolasco, Giuseppe Lapadula, Massimo Cernuschi & Antonella d’Arminio Monforte

  3. ICONA Foundation, Milan, Italy

    Alessandro Tavelli & Antonella d’Arminio Monforte

  4. Department of Infectious Diseases, ASST Santi Paolo e Carlo, Milan, Italy

    Anna De Bona

  5. Unit of Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy

    Camilla Muccini, Simona Bossolasco & Massimo Cernuschi

  6. Division of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy

    Davide Moschese

  7. Department of Infectious Diseases, IRCCS San Gerardo dei Tintori, Monza, Italy

    Alessandro Soria & Giuseppe Lapadula

  8. School of Medicine, University of Milano, Milan, Italy

    Antonella d’Arminio Monforte

Authors
  1. Roberto Rossotti
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  2. Alessandro Tavelli
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  3. Daniele Calzavara
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  11. Massimo Cernuschi
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  12. Antonella d’Arminio Monforte
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Contributions

RR did the literature search and data analysis, conceived the study, and wrote the original draft of the manuscript. AT collected and performed data statistical analyses. DC and EC supervised data collection and analysis and regulatory procedures. RR, ADB, CM, DM, AS, SB, GL, and MC were treating physicians. AdAM made intellectual contributions to the concept of the study, supervised the study, validated, and edited the first draft. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication. All authors attest they meet the ICMJE criteria for authorship.

Corresponding author

Correspondence to Roberto Rossotti.

Ethics declarations

Ethics Approval

The study was conducted in accordance with the ethical standards of the current revision of the Helsinki Declaration. All subjects starting PrEP at Milano Checkpoint ETS provided written informed consent allowing the analysis of their anonymized aggregated data for scientific purposes. Approval by Ethics Committee was deemed unnecessary according to the Italian law (art. 6 and art. 9, leg. decree 211/2003).

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none of the Authors has conflicts of interests to declare.

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Rossotti, R., Tavelli, A., Calzavara, D. et al. Do we Still Need Eligibility Criteria to Recommend PrEP? Impact of National Prescribing Requirements on Retention in Care and Sexually Transmitted Infections Acquisition. AIDS Behav (2024). https://doi.org/10.1007/s10461-024-04320-3

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