N - inmi spallanzani

ROMA, 25-27 MAGGIO 2014
Awareness and Use of HIV PreExposure Prophylaxis in Italy:
a nationwide cross-sectional study
Palummieri A, De Carli G, Ladisa N, Borghi V, Maggiolo F, Rizzi M, Mezzaroma I,
Zaccarelli M, Schiaroli E, Pinzone MR, Chessa L, d’Ettorre G, Ambu S, Rosenthal E,
Cacoub P, Mussini C, Puro V and the PrEPventivHIV Italy Study Group
All authors: no relevant conflicts of interest to declare
Background
Although trials showed that pre-exposure prophylaxis
(PrEP) with antiretrovirals (ARV) lowers HIV transmission
to HIV-negative, at-risk individuals, in Europe PrEP is not
routinely recommended and prescribed.
Data from other countries (i.e. U.S., Australia and France)
suggest an informal use of ARV for PrEP among HIVnegative individuals, as identified through survey of gay
and bisexual men, and patients living with HIV/AIDS
(PLWHA) (Voetsch, et al., 2007; Zablotska, et al., 2013;
Rosenthal, et al., 2013).
This study aims to:
1. Assess whether PLWHA share ARV for PrEP with
uninfected people in Italy;
2. Describe awareness and discussion on PrEP in this
population.
Methodology
1.
The French questionnaires and study protocol were translated
and adopted, after approval of the Ethical Committee (EC) at
the Coordinating centre*;
2. Italian HIV specialists were contacted by e-mail from 2 mailing
lists and through retrieval of Infectious Diseases (ID) centres;
3. Participant HIV specialists filled a form describing their activity
and knowledge/attitude on PrEP.
4. During the study week (9-14/12/2013 or 13-18/01/2014) they
proposed to all PLWHA on ARV since at least 3 months an
anonymous standardized questionnaire including items on:
a. PrEP (awareness; discussion with their close circle,
physician or patients’ association; experience: share ARV)
b. personal socio-demographic characteristics, risk behaviors
and HIV status of the participants.
*Almost all centres had to resubmit the study protocol to their local EC
Results: HIV specialists
(83 from 32 ID centres)
N (%)
Gender
Female
44 (53.0)
Age
>50
45 (54.2)
ID centre located in
University/Research institute
46 (55.4)
Weekly activity on HIV (visit)
Median 23 (range 2-92)
Member of HIV associations Yes
7 (8.4)
PrEP awareness (before study) Yes
81 (97.6)
PrEP experience (last 6 mos) Yes
12 (14.4)
(if yes) -Type of experience
Suggest
9 (75.0)
Prescribe
3 (25.0)
-Drugs for PrEP
TDF-FTC
11 (91.6)
-Suggested schedule Intermittent OR single dose
5 (41.6)
-Indication
Conception OR SD couple
9 (75.0)
Nonconsistent condom use
2 (16.6)
Multiple partners
1 (8.3)
Results: Patients (N=1415)
Total
(N=1415)
N (%)
73 (5.2)
-30
1212 (85.7)
Age
30-60
130 (9.2)
>60
679 (48.0)
Metropolitan area
Place of residence Urban area
458 (32.4)
278 (19.6)
Other/NR
Research institute
422 (29.8)
Enrolling centre University institute
548 (38.7)
General hospital
445 (31.5)
268 (18.9)
Without occupation
Socio-economic Farmers/Intermediary workers 506 (35.8)
category
Employee/Intellectual workers 429 (30.3)
212 (15.0)
Retired
Member of HIV
241 (17.0)
Yes
associations
Female
(N=379)
%
6.6
87.6
5.8
46.7
30.1
23.2
28.2
40.4
31.4
29.8
29.6
28.2
12.4
Male
(N=1009)
%
4.5
85.0
10.5
48.5
33.3
18.2
30.4
38.4
31.2
14.1
38.3
31.4
16.3
Transgender
(N=17)
%
11.8
88.2
58.8
35.3
5.9
41.2
23.5
35.3
58.8
23.5
17.6
-
15.3
17.3
41.2
Results: Patients (N=1415)
Heterosexual
Homo/bisexual
HIV group of transmission
IDU
Other/unknown
Change ARV (last 12 mos) Yes
Undetectable HIV RNA Yes
<200
200-499
3
CD4 count/mm
500+
NR/ND
Hospitalization (last 12 mos) Yes
Total
(N=1415)
N (%)
470 (33.2)
467 (33.0)
231 (16.3)
247 (17.5)
315 (22.3)
1128 (79.7)
117 (8.3)
379 (26.8)
677 (47.8)
Female
(N=379)
%
58.8
5.8
15.3
20.1
24.0
81.8
9.5
25.3
51.5
Male
Transgender
(N=1009)
(N=17)
%
%
24.4
5.9
42.5
94.1
16.9
16.2
21.9
5.9
79.0
76.5
7.9
5.9
27.5
11.8
46.5
47.1
242 (17.1)
13.7
18.1
35.3
102 (7.2)
6.1
7.7
-
HIV/HCV
HIV/HBV
Yes
Yes
336 (23.7)
120 (8.5)
24.3
3.4
23.8
10.3
5.9
11.8
STI (last 12 mos)
Yes
107 (7.6)
2.4
9.2
29.4
Results: Patients (N=1415)
Single
Living with.. An HIV- partner
An HIV+ partner
No partner
Sexual partner
Single partner, condom
and condom use
Single partner, no condom
during
Multiple partners, condom
last 3 mos
Multiple partners, no condom
Total
(N=1415)
N
593 (41.9)
523 (37.0)
299 (21.1)
450 (31.8)
546 (38.6)
192 (13.6)
157 (11.1)
70 (4.9)
Female
(N=379)
%
39.1
37.2
23.7
40.4
34.8
21.9
1.6
1.3
Male
(N=1009)
%
42.6
37.1
20.3
28.8
40.4
10.8
14.2
5.7
Transgender
(N=17)
%
52.9
29.4
17.6
17.6
41.2
41.2
Results: Patients (N=1415)
1. PrEP awareness
2. Awareness of PrEP studies
3. PrEP discussion with their close
circle
4. PrEP discussion with members of
patients’ associations
5. PrEP discussion with their
physician
6. PrEP use in their close circle
7. Asked to share their ARV for PrEP
8. Sharing personal ARV for PrEP
Yes
Yes
Total
(N=1415)
N (%)
397(28.1)
338(23.9)
Female
(N=379)
%
24.3
21.6
Male
(N=1009)
%
29.4
24.6
Transgender
(N=17)
%
35.3
41.2
Yes
144(10.2)
9.5
10.3
23.5
Yes
82(5.8)
5.8
5.7
5.9
Yes
214(15.1)
15.0
15.3
17.6
Yes
Yes
Yes
132(9.3)
13(0.9)
14(1.0)
5.8
0.8
1.1
10.3
1.0
1.0
29.4
-
Discussion on PrEP (3+4)
PrEP Experience (6+8)
Yes 167(11.8) 43(11.3) 119(11.8)
Yes 141(10.0) 24(6.3) 111(11.0)
4(23.5)
5(29.4)
Results: PrEP Discussion (n=167)
Gender
Age
Socio-economic
category
Member of HIV
associations
Discussion
N (%)
OR (95% CI)
MLR-OR (95% CI)
Female
Male
Transgender
-30
30-60
>60
Without occupation
Farmers/Intermediary workers
Employee/Intellectual workers
Retired
43 (11.3)
119 (11.8)
4 (23.5)
12 (16.7)
148 (12.3)
6 (4.7)
30 (11.3)
47 (9.4)
72 (16.9)
17 (8.1)
1
1.0 (0.7-1.5)
2.4 (0.7-7.7)
4.1 (1.4-11.4)
2.8 (1.2-6.6)
1
1
0.8 (0.5-1.3)
1.6 (1.0-2.5)
0.7 (0.4-1.3)
2.7 (0.9-8.2)
2.2 (0.9-5.4)
1
1
0.8 (0.5-1.4)
1.6 (0.9-2.6)
0.9 (0.4-1.7)
Yes
51 (21.3)
2.5 (1.7-3.5)
2.4 (1.6-3.4)
41 (8.7)
74 (15.8)
32 (14.0)
19 (7.9)
21 (17.9)
45 (12)
75 (11.2)
25 (10.4)
18 (16.8)
39 (8.8)
65 (12.0)
21 (10.9)
27 (17.3)
14 (20.0)
1
1.9 (1.3-2.9)
1.7 (1.0-2.8)
0.9 (0.5-1.6)
1.7 (1.0-2.9)
1.1 (0.7-1.7)
1
0.9 (0.6-1.5)
1.6 (0.9-2.7)
1
1.4 (0.9-2.1)
1.3 (0.7-2.2)
2.2 (1.3-3.7)
2.6 (1.3-5.1)
1
1.7 (1.1-2.6)
1.8 (1.1-2.9)
0.9 (0.5-1.7)
2.0 (1.2-3.6)
1.2 (0.8-1.8)
1
1.2 (0.7-1.9)
Heterosexual
Homo/bisexual
HIV group of
IDU
transmission
Other/unknown
<200
200-499
CD4 count/mm3
500+
NR/ND
STI (last 12 mos) Yes
No partner
Sexual partner and Single partner, condom
condom use during Single partner, no condom
Multiple partners, condom
last 3 mos
Multiple partners, no condom
1
1.2 (0.8-1.9)
1.1 (0.6-1.9)
1.7 (0.9-3.0)
2.0 (1.0-4.2)
Boldface = p<0.05; Italic boldface = p<0.10
Results: PrEP Experience (n=141)
(sharing personal ARV and/or PrEP use in close circle)
Gender
Age
Enrolling centre
Member of HIV
associations
Female
Male
Transgender
-30
30-60
>60
General hospital
Research Institute
University Institute
Yes
Heterosexual
Homo/bisexual
HIV group of
transmission
IDU
Other/unknown
Undetectable HIV RNA Yes
No partner
Sexual partner and Single partner, condom
condom use during Single partner, no condom
last 3 mos
Multiple partners, condom
Multiple partners, no condom
Experience
N (%)
24 (6.3)
111 (11.0)
5 (29.4)
12 (16.7)
118 (9.8)
10 (7.8)
32 (7.3)
57 (13.5)
51 (9.4)
OR (95% CI)
MLR-OR (95% CI)
1
1.8 (1.1-2.9)
6.2 (2.0-18.9)
2.4 (0.9-5.8)
1.3 (0.6-2.5)
1
1
1.9 (1.3-3.1)
1.3 (0.8-2.1)
1
1.8 (1.1-2.9)
1.3 (0.8-2.1)
42 (17.5)
2.3 (1.6-3.4)
2.3 (1.5-3.4)
27 (5.7)
57 (12.2)
34 (14.8)
22 (9.2)
101 (9.0)
36 (8.1)
56 (10.3)
14 (7.3)
20 (12.8)
14 (20.0)
1
2.3 (1.4-3.7)
2.9 (1.7-4.9)
1.7 (0.9-2.9)
0.6 (0.4-0.9)
1
1.3 (0.8-2.0)
0.9 (0.5-1.7)
1.7 (0.9-2.9)
2.8 (1.4-5.6)
1
1.8 (1.1-3.0)
2.6 (1.5-4.5)
1.6 (0.9-2.8)
0.6 (0.4-0.9)
1
1.3 (0.8-1.9)
0.9 (0.5-1.7)
1.5 (0.8-2.7)
2.7 (1.3-5.5)
Boldface = p<0.05; Italic boldface = p<0.10
Conclusions
In spite of the limits of a survey and the possible
selection bias, these results suggest that a number
of PLWHA are aware of and discuss PrEP, and
informal ARV use for PrEP starts to be practiced in
Italy though PrEP is not officially provided.
However, PLWHA do not seem to widely share their
ARV with uninfected people.
In the absence of recommendations, these findings
alert towards the risks deriving from uncontrolled
PrEP procurement and self-administration
practices.
PrEPventivHIV Italy Study Group
• AO Policlinico - Bari: Ladisa N.
• Giovanni XXIII - Bergamo: Rizzi M.
• Malattie Infettive S. Orsola Malpighi - Bologna: Calza L,
Colangeli V, Girometti N.
• AO Spedali Civili - Università degli Studi di Brescia - Brescia:
Ferraresi A, Focà E, Giorgetti PF, Pezzoli MC.
• AO Garibaldi Nesima - Catania: Celesia BM, Pinzone MR.
• AOS Croce e Carle - SC Malattie Infettive e Tropicali - Cuneo:
Vitullo D.
• AOU Ferrara - Ferrara: Guardigni V, Sighinolfi L.
• AOU Careggi - Firenze: Ambu S., Bartolozzi D, Campolmi I,
Meli M, Pozzi M, Sterrantino K.
• ASL LATINA - UOSD Malattie Infettive - Formia: Matarazzo F,
Purificato F.
• Ospedale «F. Spaziani» - Div. Malattie Infettive - Frosinone:
Anzalone E, Sarracino L.
• Ospedale Santa Maria Goretti Università Sapienza Polo
Pontino - Latina: Lichtner M, Marocco R, Mercurio VS.
• Ospedale di Macerata ASUR Marche zt9 - Macerata: Castelli
P.
• Ospedale Madonna delle Grazie, UO Malattie Infettive Matera: Linzalone A.
• Ospedale dell’Angelo - Mestre (VE): Franklyn Esoka E.
• Ospedale San Raffaele - IRCCS - Milano: Bossolasco S,
Castagna A, Cernuschi M, Cinque P, Fumagalli L, Gaiera G,
Gianotti N, Guffanti M, Maillard M, Nozza S, Spagnuolo V,
Uberti-Foppa C.
• AOU Modena - Malattie Infettive - Modena: Borghi V.
• AOU di Cagliari - Monserrato (Cagliari): Chessa L.
• AORN «Ospedali dei Colli» - Napoli: Franco A, Izzo CM,
Manzillo E, Marocco A, Pizzella T.
• Seconda Università degli studi di Napoli - UOC Diagnosi e
Terapia AIDS e Patologie Infettive Correlate - Napoli: Martini
S.
• Ospedale Santa Maria della Misericordia - Perugia: Schiaroli
E.
• Ospedale San Jacopo - AUSL 3 Pistoia - U.O. Malattie Infettive
- Pistoia: Trezzi M.
• AO - O.C. Ompa - UO di Malattie Infettive - Ragusa: Migliore
S.
• AUSL Ravenna - UO Malattie Infettive - Ravenna: Ballardini G.
• Arcispedale Santa Maria Nuova - IRCCS - Reggio Emilia:
Barchi E, Garlassi E, Magnani G, Prati F, Testa L, Ursitti MA,
Zoboli G.
• AOU Sant'Andrea - Roma: Teti E.
• Policlinico Tor Vergata - Roma: Buonomini AR, Cerva C,
Sarmati L.
• INMI «L. Spallanzani» - IRCCS - Roma: Ammassari A,
Bellagamba R, Boumis E, Cicalini S, Liuzzi G, Loiacono L,
Migliorisi P, Nicastri E, Pinnetti C, Sampaolesi A, Tommasi C,
Zaccarelli M.
• Policlinico Umberto I - Roma: d'Ettorre G, Iaiani G,
Mezzaroma I, Paoletti F.
• AOU Senese, UOC Malattie Infettive Universitarie - Siena: De
Luca A, Carnicelli N, Gonnelli A, Marri D, Rossetti B, Toscano
L.
• Ospedale Belcolle - Viterbo: Armignacco O, Caterini A,
Ialungo AM, Rastrelli E.
Funding: Ricerca Corrente IRCCS