PrEPararsi alla PrEP: indagine sulla propensione dei medici di malattie infettive

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1 UOC Infezioni emergenti e Centro di riferimento AIDS Dipartimento di Epidemiologia Istituto Nazionale per le Malattie Infettive L. Spallanzani - IRCCS, Rome, Italy Profilassi con antiretrovirali pre- e post-esposizione gennaio 2013 PrEPararsi alla PrEP: indagine sulla propensione dei medici di malattie infettive Dott. Antonio Palummieri

2 Studies exploring physicians' perspective on PrEP are largely lacking. July 2012 Volume 7 Issue 7 e40603

3 HIV specialists were more knowledgeable about PrEP than generalists Physicians indicated that they would prefer to prescribe topical PrEP (75%) as compared to oral PrEP (25%) before iprex 178 participants 56% female 75% HIV specialist CDC guidelines would have the greatest impact on willingness to prescribe PrEP (96%) after iprex 115 participants 63% female 59% HIV specialist

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5 75% of respondents were concerned: increased high-risk behavior, non-adherence and viral resistance Majority of respondents were aware of the iprex study results and the CDC s interim guidance 189 participants AAHIVM 55.9% male 47.1% 50 years old 85.2% > 20 HIV+ patients monthly

6 The majority of the providers were concerned: The safety, efficacy, and cost of PrEP. 360 participants 71% nonphysician 78% female The willingness to prescribe PrEP increased with greater knowledge about PrEP, older age, and belief that PrEP would empower women and/or that it would be effective in preventing new HIV transmission

7 Understanding physicians perspective on PrEP would facilitate planning for future implementation.

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9 Sexual partner HIV-positive; High risk sexual behavior without a condom; People treated recently for a STDs; People used PEP more than once within the past year; People or partner has been in prison; People or sexual partner use drugs and alcohol heavily; People or sexual partner have to exchange sex for money, housing or other needs; Violent partner; In case of conception.

10 Don t know their HIV status; Are HIV-positive; Recently engaged in high risk HIV behaviors ; Symptoms of acute HIV infection (similar to the flu); Can t locate a health care provider to provide regular HIV and STD testing; Don t think they are adherence; Don t know whether they have hepatitis B; Want to disco dose their PrEP; Have existing kidney disease or kidney dysfunction.

11 Ann Intern Med. 2012;157:

12 To investigate knowledge, attitudes and beliefs among Italian physicians in order to: prescribe and monitor PrEP use identify factors predictive of a positive attitude towards PrEP prescription.

13 Survey Instrument 1. To develop the questionnaire, an initial focus group discussing PrEP potential impact on HIV prevention was conducted at Spallanzani Institute involving 10 HIV specialists. 2. We contacted the Fenway group (Mayer et al.), and part of their survey tools were incorporated in the questionnaire after adaptation to current knowledge and Italian setting 3. A first version of the questionnaire was administered in a pilot session in Tuscany during the Regional HIV education course in February After further revision, the final survey was administered in Latium and in Tuscany during Regional HIV education and to 500 physicians through Limesurvey an online web survey tool between March 2012 and May Participation was voluntary and no financial incentive was offered.

14 Regioni Pre-ICAR 11 Post-ICAR 11 N % N % Abruzzo 3 1,0 Calabria 2 0,6 Campania 6 1,9 Emilia-Romagna 12 3,9 12*** 50,0 Friuli-Venezia Giulia 2 0,6 Lazio 144* 46,3 1 4,2 Liguria 10 3,2 Lombardia 16 5,1 4 16,7 Marche 1 0,3 1 4,2 Molise 1 0,3 1 4,2 Piemonte 7 2,3 1 4,2 Puglia 7 2,3 Sardegna 1 0,3 Sicilia 8 2,6 2 8,3 Toscana 82** 26,4 2 8,3 Trentino-Alto Adige 2 0,6 Umbria 3 1,0 Veneto 4 1,3 Totale , ,0 *116 Corso regionale ex 135/90 **71 Corso regionale ex 135/90 ***9 Corso regionale ex 135/90

15 Based on the available evidence, do you think PrEP should be offered? Never 95; 30,5% Yes 216; 69,5%

16 Demographic characteristics and work history Attitude towards PrEP prescription Positive Negative Total (N=216) (N=95) (N=311) N (%) N (%) N (%) Gender Male 122 (56.5) 52 (54.7) 174 (55.9) Female 94 (43.5) 43 (45.3) 137 (44.1) <40 33 (15.3) 18 (18.9) 51 (16.4) Age Class (23.6) 26 (27.4) 77 (24.8) > (61.1) 51 (53.7) 183 (58.8) Length of service (years) Workplace Prevailing Activity Survey <10 35 (16.2) 20 (21.1) 55 (17.7) (32.9) 35 (36.8) 106 (34.1) >= (50.9) 40 (42.1) 150 (48.2) Non teaching hospital 129 (59.7) 58 (61.1) 187 (60.1) University/Research institute 87 (40.3) 37 (38.9) 124 (39.9) Ward/Inpatients 116 (53.7) 53 (55.8) 169 (54.3) Outpatient clinic/day hospital 100 (46.3) 42 (44.2) 142 (45.7) Online Survey 69 (31.9) 55 (57.9) 124 (39.9) Regional HIV education 147 (68.1) 40 (42.1) 187 (60.1)

17 Onset of activity with HIV patients HIV-infected persons currently followed HIV tests prescribed in the last month Attitude towards PrEP prescription Positive Negative Total (N=216) (N=95) (N=311) N (%) N (%) N (%) HAART era 57 (26.4) 34 (35.8) 91 (29.3) Pre-HAART era 159 (73.6) 61 (64.2) 220 (70.7) <=5 45 (20.8) 19 (20.0) 64 (20.6) (28.2) 28 (29.5) 89 (28.6) > (50.9) 48 (50.5) 158 (50.8) <=5 109 (50.5) 46 (48.4) 155 (49.8) (35.6) 33 (34.7) 110 (35.4) >20 30 (13.9) 16 (16.8) 46 (14.8)

18 Practice ARV prescription to HIV-- individuals A positive attitude was more frequent Attitude towards among those who participated in the HIV PrEP educational prescription courses, had prescribed ARV to negative individuals Positive to prevent Negative HIV infection, Total and used to inform their patients previously on PEP. Pre-emptive information on PEP Knowledge Self-evaluation of PrEP knowledge (N=216) (N=95) (N=311) N (%) N (%) N (%) No 26 (12.0) 30 (31.6) 56 (18.0) Yes 190 (88.0) 65 (68.4) 255 (82.0)* No 65 (30.1) 44 (46.3) 109 (35,0) Yes 151 (69.9) 51 (53.7) 202 (65,0) Poor 73 (33.8) 27 (28.4) 100 (32.1) Sufficient 72 (33.3) 42 (44.2) 114 (36.7) Good 71 (32.9) 26 (27.4) 97 (31.2) *4 prescribed PrEP

19 Physicians Attitudes Offer PrEP at some groups of people at higher risk: (N=216) Injection drug users (IDU) 20,8% NO condoms Always Men who have sex with men (MSM) 54,6% 15,7% Persons with sexually transmitted infections 41,7% 16,2% Persons with multiple partners 42,1% 18,5% Sex workers/transactional sex 38,8% 21,8% Offer PrEP in serodiscordant couples : Viremic partner Always Men in heterosexual couples 39,8% 28,7% Women in heterosexual couples 45,4% 33,8% Men in MSM couples 44,9% 33,8% Women for conception 32,8% 38,0% Men for conception 33,3% 27,8%

20 * this question was not included in the first session of the survey administration Physicians Attitudes In the case of HIV positive patients in discordant couples who do not meet the criteria for starting treatment, which of the following options would you choose to protect the negative partner? (N=271)* Only safe sex counseling 55% ARV to the positive partner 27% PrEP to the uninfected partner 8% ARV to both partners 10%

21 Physicians Beliefs Do you think the costs of PrEP should be sustained by the NHS? (N=216)* No, entirely sustained by the patient 21% Yes, always 38% Partially: shared with the patient on an income basis 41%

22 I am concerned that PrEP will not be 100% effective (N=295) I am concerned about the potential side effects of PrEP (N=297) I feel uncomfortable prescribing drugs for new indications unless there are clear evidences (N=293) I am concerned about a low adherence to PrEP* (N=159) I do not have time to engage in prevention counseling and PrEP monitoring (N=290) The use of PrEP will cause patients to engage in riskier behaviors (N=297) The provision of PrEP will result in an increase in sexually transmitted disease incidence among patients (N=296) Encourage access to testing and care for HIV infection are more effective measures* (N=160) Non-biomedical HIV prevention interventions (behavioral) are more effective than PrEP (N=290) Non-biomedical HIV prevention interventions (behavioral) are safer than PrEP (N=301) The use of PrEP will result in less frequent HIV testing among patients (N=299) PrEP is too costly (N=295) The use of antiretrovirals for prevention will select for, and disseminate, antiretroviral drug resistance (N=294) Positive Negative Total OR (95% CI) All Agree 161 (78.9) 77 (84.6) Disagree 43 (21.1) 14 (15.4) ( ) Agree 133 (64.9) 75 (81.5) Disagree 72 (35.1) 17 (18.5) ( ) Agree 132 (65.0) 71 (78.9) Disagree 71 (35.0) 19 (21.1) ( ) Agree 55 (59.8) 44 (65.7) 99 1 Disagree 37 (40.2) 23 (34.3) ( ) Agree 22 (11.0) 7 (7.8) 29 1 Disagree 178 (89.0) 83 (92.2) ( ) Agree 145 (70.4) 73 (80.2) Disagree 61 (29.6) 18 (19.8) ( ) Agree 136 (66.7) 67 (72.8) Disagree 68 (33.3) 25 (27.2) ( ) Agree 81 (87.1) 64 (95.5) Disagree 12 (12.9) 3 (4.5) ( ) Agree 136 (67.7) 79 (88.8) Disagree 65 (32.3) 10 (11.2) ( ) Agree 183 (88.0) 84 (90.3) Disagree 25 (12.0) 9 (9.7) ( ) Agree 90 (43.7) 52 (55.9) Disagree 116 (56.3) 41 (44.1) ( ) Agree 159 (77.6) 78 (86.7) Disagree 46 (22.4) 12 (13.3) ( ) Agree 135 (66.5) 68 (74.7) Disagree 68 (33.5) 23 (25.3) ( )

23 I am concerned that PrEP will not be 100% effective (N=295) I am concerned about the potential side effects of PrEP (N=297) I feel uncomfortable prescribing drugs for new indications unless there are clear evidences (N=293) Non-biomedical HIV prevention interventions (behavioral) are more effective than PrEP (N=290) Non-biomedical HIV prevention interventions (behavioral) are safer than PrEP (N=301) The use of PrEP will result in less frequent HIV testing among patients (N=299) PrEP is too costly (N=295) The use of antiretrovirals for prevention will select for, and disseminate, antiretroviral drug resistance (N=294) Positive Negative Total OR (95% CI) All Agree 161 (78.9) 77 (84.6) Disagree 43 (21.1) 14 (15.4) ( ) Agree 133 (64.9) 75 (81.5) Disagree 72 (35.1) 17 (18.5) ( ) Agree 132 (65.0) 71 (78.9) Disagree 71 (35.0) 19 (21.1) ( ) Agree 55 (59.8) 44 (65.7) 99 1 Disagree 37 (40.2) 23 (34.3) ( ) Agree 22 (11.0) 7 (7.8) 29 1 Disagree 178 (89.0) 83 (92.2) ( ) Agree 145 (70.4) 73 (80.2) Disagree 61 (29.6) 18 (19.8) ( ) Agree 136 (66.7) 67 (72.8) Concerns about efficacy and safety positive negative I am concerned about a low adherence to PrEP* I Increased am (N=159) concerned risks of that HIV PrEP and will other not STI Agree 161 positive (78.9) negative 77 (84.6) be The 100% effective (N=295) I do not have time to engage in prevention Disagree 43 (21.1) 14 (15.4) ( ) Costs use of PrEP will result in less Agree 90 counseling and PrEP monitoring (N=290) positive (43.7) negative 52 (55.9) I frequent am concerned HIV testing about among the Agree 133 (64.9) 75 (81.5) 208 potential patients The use (N=299) of side PrEP effects will cause of patients PrEP Disagree Agree (56.3) (77.6) (86.7) (44.1) ( ) 1 to engage in (N=297) PrEP is too costly (N=295) The riskier provision behaviors of (N=297) PrEP will result in Disagree Agree (35.1) (22.4) (66.7) (18.5) (13.3) (72.8) ( ) ( ) 1 The an increase The use provision of antiretrovirals in of sexually PrEP will transmitted result for in increase in prevention disease sexually incidence transmitted disease incidence among Agree 135 (66.5) 68 (74.7) patients (N=296) will select among for, patients and Disagree Disagree 68 (33.3) 68 (33.3) 25 (27.2) 25 (27.2) ( ) disseminate, (N=296) antiretroviral drug resistance Encourage (N=294) access to testing and care for HIV Disagree 68 (33.5) 23 (25.3) ( ) The infection use of are PrEP more will effective cause measures* patients (N=160) Agree 145 (70.4) 73 (80.2) I to am engage concerned in riskier about behaviors a low Agree 55 (59.8) 44 (65.7) 99 1 adherence (N=297) to PrEP* (N=159) Disagree Disagree (29.6) (40.2) (34.3) (19.8) ( ) ( ) Agree 81 (87.1) 64 (95.5) Disagree 12 (12.9) 3 (4.5) ( ) Agree 136 (67.7) 79 (88.8) Disagree 65 (32.3) 10 (11.2) ( ) Agree 183 (88.0) 84 (90.3) Disagree 25 (12.0) 9 (9.7) ( ) Agree 90 (43.7) 52 (55.9) Disagree 116 (56.3) 41 (44.1) ( ) Agree 159 (77.6) 78 (86.7) Disagree 46 (22.4) 12 (13.3) ( ) Agree 135 (66.5) 68 (74.7) Disagree 68 (33.5) 23 (25.3) ( )

24 Recommended NOT Recommended ND Participation in a multicenter trial International/national PrEP guidelines 60% 22% 18% 79% 11% 10% The vast majority of respondents require policymakers and planners to develop and provide them with guidelines on PrEP use.

25 Most specialists seem to be willing, with guidance from normative bodies, to promote PrEP within multiple prevention strategies among vulnerable populations.

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27 The Questions about PrEP 1. Why do we need new HIV prevention tools, like PrEP? 2. Aren t condoms enough? 3. What about side effects from the PrEP drugs? 4. Who will pay for PrEP? 5. Is PrEP available right now? 6. Will PrEP take away people s motivation to maintain safer sex practices? 7. What about HIV developing drug resistance to PrEP drugs? 8. Why is daily dosing of PrEP recommended? 9. Discordance dilemma: My partner is HIV positive and I am HIV negative, could I take PrEP to protect myself? 10. Who is really talking about PrEP? 11. How do you talk to your provider about PrEP? Until now, adopting safer behaviors including condom use has been the only option available for people who wished to protect themselves from becoming infected.

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32 Based on the available evidence, do you think PrEP should be offered? Yes; 14; 42% Never; 19; 58%

33 Demographic characteristics and work history Attitude towards PrEP prescription Positive Negative Total (N=14) (N=19) (N=33) N (%) N (%) N (%) Gender Male 6 (42.9) 8 (42.1) 14 (42.4) Female 7 (50.0) 11 (57.9) 18 (54.5) Age Class Length of service (years) Workplace Prevailing Activity Unknown 1 (7.1) 1 (3.1) <40 2 (14.2) 5 (26.3) 7 (21.1) (21.4) 1 (5.3) 4 (12.2) >50 8 (57.2) 13 (68.4) 21 (63.6) Unknown 1 (7.1) 1 (3.1) <10 2 (14.2) 5 (26.3) 7 (21.1) (35.7) 3 (15.8) 8 (24.5) >=20 7 (50.0) 11 (57.9) 18 (54.4) Non teaching hospital 2 (14.2) 3 (15.8) 28 (84.8) University/Research institute 12 (85.8) 16 (84.2) 5 (15.2) Ward/Inpatients 8 (57.2) 9 (47.3) 17 (51.5) Outpatient clinic/day hospital 2 (14.2) 8 (42.1) 10 (30.3) Other 4 (28.6) 2 (10.6) 6 (18.2)

34 Onset of activity with HIV patients HIV-infected persons currently followed HIV tests prescribed in the last month Attitude towards PrEP prescription Positive Negative Total (N=14) (N=19) (N=33) N (%) N (%) N (%) HAART era 4 (28.6) 5 (26.3) 9 (27.3) Pre-HAART era 10 (71.4) 14 (73.7) 24 (72.7) <=5 0 (0.0) 1 (5.3) 1 (3.0) (28.6) 2 (10.6) 6 (18.2) >50 10 (71.4) 16 (84.1) 26 (78.8) <=5 8 (57.2) 8 (42.1) 16 (48.5) (28.6) 10 (52.6) 14 (42.4) >20 1 (7.1) 1 (5.3) 2 (6.1) Unknown 1 (7.1) 1 (3.0)

35 Physicians Beliefs Do you think the costs of PrEP should be sustained by the NHS? Yes, in Yes, some in some case; 2; case; 14% 3; 9% Partially; 8; 25% Yes, always; 8; Yes, 25% always; 5; 36% Partially; 4; 29% No, entirely sustained No, entirely sustained by the by th patient; 3; 41% 21%

36 Physicians Attitudes In the case of HIV positive patients in discordant couples who do not meet the criteria for starting treatment, which of the following options would you choose to protect the negative partner? Arv to the positive partner; 12; 36% Only safe sex counselling; 19; 58% Arv to both partner; 1; 3% PrEP to the uninfected partner; 1; 3%

37 Qualcuno dei tuoi pazienti ti ha chiesto informazioni sulla PrEP? Sì; 19; 58% No ; 14; 42% Qualcuno dei tuoi pazienti ha mai assunto la PrEP?

38 Cover a larger sample of HIV specialists Progetto IRAPEP Studio PrEP (new) Questionario Medici Infettivologi e dei Centri IST Survey on: Physicians working in STI clinics Target populations (in hospitals and the community) Acknowledgements We are grateful to the focus group participants at Spallanzani Institute, all respondent physicians and to Dr. Mayer and the Fenway group Funding: Grant ISS 40H32 and Ricerca Corrente IRCCS

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