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Different guidelines for pre-exposure prophylaxis (PrEP) eligibility estimate HIV risk differently: an incidence study in a cohort of HIV-negative men who have sex with men, Portugal, 2014-2018.

ABSTRACT: IntroductionGuidelines for pre-exposure prophylaxis (PrEP) provide criteria to identify individuals at higher risk of HIV infection. We compared the ability to predict HIV seroconversion of four guidelines: the World Health Organization (WHO), the United States Public Health Service and Centers for Disease Control and Prevention (US CDC), the European AIDS Clinical Society (EACS) and the Portuguese National Health Service (PNHS).AimWe aimed to measure the association between guideline-specific eligibility and HIV seroconversion.MethodsWe studied 1,254 participants from the Lisbon Cohort of men who have sex with men with at least two evaluations between March 2014 and March 2018, corresponding to 1,724.54 person-years (PY) of follow-up. We calculated incidence rates (IR) according to each guideline eligibility definition and incident rate ratios (IRR) to test the association between eligibility at baseline and HIV seroconversion.ResultsWe found 28 incident cases (IR: 1.62/100 PY; 95% confidence interval (CI) 1.12-2.35). Guidelines' sensitivity varied from 60.7% (EACS) to 85.7% (PNHS) and specificity varied from 31.8% (US CDC) to 51.5% (EACS). IR was highest among those defined as eligible by the PNHS guideline (2.46/100 PY; IRR?=?4.61; 95% CI: 1.60-13.27) and lowest for the WHO guideline (1.89/100 PY; IRR?=?1.52; 95% CI: 0.69-3.35).ConclusionsBeing identified as eligible for PrEP was associated with a higher risk of infection. The magnitude of risk varied according to the guideline used. However, the number of HIV infections identified among ineligible participants highlights the potential for missing people who need PrEP.

SUBMITTER: Meireles P

PROVIDER: S-EPMC7376846 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Different guidelines for pre-exposure prophylaxis (PrEP) eligibility estimate HIV risk differently: an incidence study in a cohort of HIV-negative men who have sex with men, Portugal, 2014-2018.

Meireles Paula P Plankey Michael M Rocha Miguel M Brito João J Mendão Luís L Barros Henrique H

Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin 20200701 28

IntroductionGuidelines for pre-exposure prophylaxis (PrEP) provide criteria to identify individuals at higher risk of HIV infection. We compared the ability to predict HIV seroconversion of four guidelines: the World Health Organization (WHO), the United States Public Health Service and Centers for Disease Control and Prevention (US CDC), the European AIDS Clinical Society (EACS) and the Portuguese National Health Service (PNHS).AimWe aimed to measure the association between guideline-specific e ...[more]

PMID: 32700673

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Project description:BACKGROUND:Pre-exposure prophylaxis (PrEP) is a promising and effective tool to prevent HIV. With the approval of Truvada as daily PrEP by the European Commission in August 2016, individual European Member states prepare themselves for PrEP implementation following the examples of France and Norway. However, context-specific data to guide optimal implementation is currently lacking. OBJECTIVE:With this demonstration project we evaluate whether daily and event-driven PrEP, provided within a comprehensive prevention package, is a feasible and acceptable additional prevention tool for men who have sex with men (MSM) at high risk of acquiring HIV in Belgium. The study's primary objective is to document the uptake, acceptability, and adherence to both daily and event-driven PrEP, while several secondary objectives have been formulated including impact of PrEP use on sexual behavior. METHODS:The Be-PrEP-ared study is a phase 3, single-site, open-label prospective cohort study with a large social science component embedded in the trial. A total of 200 participants choose between daily or event-driven PrEP use and may switch, discontinue, or restart their regimen at the 3-monthly visits for a duration of 18 months. Data are collected on several platforms: an electronic case report form, a Web-based tool where participants register their sexual behavior and pill use, a more detailed electronic self-administered questionnaire completed during study visits on a tablet computer, and in-depth interviews among a selected sample of participants. To answer the primary objective, the recruitment rate, (un)safe sex behavior during the last 6 months, percentage of reported intention to use PrEP in the future, retention rates in different regimens, and attitudes towards PrEP use will be analyzed. Adherence will be monitored using self-reported adherence, pill count, tenofovir drug levels in blood samples, and the perceived skills to adhere. RESULTS:All participants are currently enrolled, and the last study visit is planned to take place around Q3 2018. CONCLUSIONS:As PrEP is not yet available in Belgium for use, this study will provide insights into how to optimally implement PrEP within the current health care provision and will shape national and European guidelines with regard to the place of PrEP in HIV prevention strategies. CLINICALTRIAL:EU Clinical Trial 2015-000054-37; https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-000054-37/BE (Archived by WebCite at http://www.webcitation.org/6nacjSdmM).

Project description:BackgroundOptimising HIV pre-exposure prophylaxis (PrEP) provision requires insight into preferences of PrEP regimens and PrEP discontinuation. We assessed regimen switching and discontinuation and their determinants among men who have sex with men (MSM) participating in the Amsterdam PrEP demonstration project.MethodsBetween 3-August-2015 and 31-May-2016, we enrolled MSM (n = 374) and TGP (n = 2) in a prospective, longitudinal study. Participants could choose between daily or event-driven PrEP regimens at enrolment and every 3 months. We assessed transition intensities (TI) and determinants of switching (i) between regimens, and (ii) from either regimen to discontinuing PrEP using a multi-state Markov model. PrEP discontinuation was defined as formally stopping study participation or having no study visit for ≥6 months.FindingsOf 367 analysed participants, 73·3% chose daily and 26·7% event-driven PrEP at enrolment. Median follow-up was 3·1 years (IQR 2·9-3·2). 121 participants switched their PrEP regimen at least once (cumulative probability 34·2%, 95% CI 29·4-39·6), with 90 switches from event-driven to daily PrEP (TI 0·35/PY, 95% CI 0·29-0·44) and 113 switches from daily to event-driven PrEP (TI 0·16/PY, 95% CI 0·13-0·20). Switching from event-driven to daily PrEP was associated with younger age, not reporting sex with HIV-positive partners, chemsex, and sexual compulsivity. Switching from daily to event-driven PrEP were associated with younger age and lower sexual satisfaction. 67 participants discontinued PrEP (cumulative probability 17·7%, 95% CI 14·1-22·2), with no difference between regimens: event-driven (n = 23, TI 0·08/PY, 95% CI 0·05-0·13) and daily PrEP (n = 44, TI 0·06/PY, 95% CI 0·04-0·08). Discontinuing daily PrEP was associated with younger age, fewer casual partners, and higher number of condomless anal sex acts with casual partners.InterpretationSwitching between PrEP regimens was common, while going from event-driven to daily PrEP use was associated with certain sexual-related determinants (i.e. chemsex, sexual compulsivity, no known HIV-positive partners). PrEP discontinuation rates were low and independent of regimens. PrEP care should consider the reasons for choice and switch of regimen and involve education on safely switching or discontinuing PrEP, especially among younger MSM.FundingZonMw, H-TEAM, RIVM, GGD research funds, Aidsfonds, Amsterdam Diner Foundation, Gilead Sciences, Gilead Sciences Europe Ltd, Janssen Pharmaceuticals, MAC AIDS Fund, ViiV Healthcare.

Dataset Information

Different guidelines for pre-exposure prophylaxis (PrEP) eligibility estimate HIV risk differently: an incidence study in a cohort of HIV-negative men who have sex with men, Portugal, 2014-2018.

Publications

Different guidelines for pre-exposure prophylaxis (PrEP) eligibility estimate HIV risk differently: an incidence study in a cohort of HIV-negative men who have sex with men, Portugal, 2014-2018.

Similar Datasets

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