PrEP uptake and associated factors
among MSM and TGW in the PrEP Brasil
demonstration project
Brenda Hoagland, Valdilea G. Veloso, Raquel B. De Boni, José Valdez
Madruga, Esper G. Kallas, Nilo Martinez Fernandes, Ronaldo I. Moreira,
Albert Y. Liu and Beatriz Grinsztejn for the PrEP Brasil Study Team
IAS 2015- Vancouver
Disclosures
• Research recipient from Gillead, BMS, GSK/ViiV, Merck
• Current or recent participation in clinical trials sponsored by
GSK/ViiV, Merck, BMS, Gillead, Janssen
Funding
• Gilead Sciences. Inc. donated Truvada®
WHO recommends PrEP to prevent
HIV
HIV prevalence in Brasil
16
14.2
14
12
10
8
5.9
6
5
4.9
4
2
0.6
0.7
0.4
0
Total 15-49 Male 15-49 Female 15- PWUD 18+ PU crack Gay/other FCSW 18+
(2013)
(2013)
49 (2013)
(2011) 18+ (2013) MSM 18+
(2009)
(2010)
Kerr et al. AIDS. 2013
Veras et al. AIDS and Behavior. 2014
PrEP Brasil
• Demonstration project
– Clinicaltrials.gov NCT01989611
• Main Objectives
– Assess uptake, safety and feasibility of
PrEP implementation provided at no cost
for hjgh risk MSM and TGW in the context
of the Brazilian public health system
• Secondary objectives
–
–
–
–
–
PrEP awareness
Adherence pattern TDF levels in DBS
Social harm
Risk compensation
Adherence patterns
Method
• Sites
• Fiocruz
• Referral Center for HIV treatment (CRT/SP)
• University of São Paulo (USP)
• Inclusion criteria
– MSM and TGW, ≥ 18 years, presenting sexual risk for HIV infection
(reported ≥ 2 male condomless anal sex partners OR ≥ 2 anal sex
episodes with HIV positive partner OR STD diagnosis in last 12 months)
• Exclusion criteria
– HIV positive result, HIV acute infection, HBsAG positive, urine protein,
creatinine clearence <60, using ARV, using interferon, severe medical
comorbidity, unable to return within 45 days
Method
• Social and other media used for advertising
the project
• This presentation aims to describe PrEP Brasil
uptake and associated factors
Pre-screening visit
Method
• Individuals assessed at FIOCRUZ-RJ. CRT-SP and USP-SP
• Fiocruz and CRT: self-referred or assessed for participation during HIV-testing or PEP
Approach • USP: participants were self-referred
• Reported Sexual Risk ( ≥ 2 male condomless anal sex partners OR ≥ 2 anal sex
episodes with HIV positive partner OR STD in last 12 months)
Potentially • HIV rapid test = negative
Elegible
Screen
visit
Enrollment
visit
• Behavior assessment
• HIV RNA pool
• Clinical assessment
• Renal function
• HBV testing +HIV testing
• Within 45 days after screening
• Behavior+ clinical assessment + STD testing+ HIV testing
• HIV RNA pool
Method
• Statistical Analysis
– PrEP uptake = proportion of enrolled
individuals/potentially eligible
– Chi-square tests were used to test the difference of
PrEP uptake
– Poisson regression model with robust estimate of
variance was performed to evaluate PrEP uptake
associated factors
– R was used for analysis
– Individuals who had used PrEP before (iPrEX and
iPrEX OLE) were excluded
Reason for refusal
N=
21
Dont have time
6
Fear side effects
6
Prefer other
Refused=21
prevention
methods
4
Worry
withshow
my up
Did not
privacy N=287
2
Dont
want take
2
Refused
N=19
medication
Unable
18N=1
Refusedto return
Refused
Dont
to answer 12 N=12
withinwant
45 days
Did not show up
Unknown
Reason
forN=36
refusal 1
Reason for refusal
Not interested in
7
Not
interested in study
7
study
Dont
Donthave
havetime
time
33
Dont
Dontwant
wanttotoanswer
answer
11
Other
Other
11
Results
Approached
N=986
Potentially elegible
N=798
Screen visit
N=490
Enrollment visit
N=422
Enrolled
N=409
Ineligible (n=188)
•N=106 w/out sexual risk
•N=82 HIV positive
Ineligible
N=13
HIV positive result
3
Severe medical
comorbidity
4
Creatinine clearence
<60mL/min
1
Unable to provide
contact
1
HBsAG positive
1
Ineligible
Urine protein
Severe medical
comorbidity
N=1
3
1
Uptake
Approached
N=986
Potentially elegible
N=798
Screened
N=490
Enrolled
N=409
% uptake=
# Enrolled
*100
# Potentially eligible
51.25%
Characteristics and PrEP uptake
Overall
Site location
FIOCRUZ
CRT-SP
USP-SP
Age
18-25 years
26-35 years
36-45 years
>45 years
Gender
Male
TGW
Color/Race
White
Non-white
Schooling
<12 years
≥12 years
Steady partner
Yes
No
Approached
N(%)
Potentially
Eligible N(%)
Enrolled
N(%)
Declined
N(%)
PrEP
uptake
986
798
409
365
51.25
pvalue*
<0.001
622 (63.1)
225 (22.8)
139 (14.1)
455 (57.0)
216 (27.1)
127 (15.9)
175 (42.8)
135 (33.0)
99 (24.2)
282 (77.3)
57 (15.6)
26 (7.1)
38.5
62.5
78.0
0.26
335 (34.0)
435 (44.1)
160 (16.2)
56 (5.7)
266 (33.3)
358 (44.9)
124 (15.5)
50 (6.3)
127 (31.0)
189 (46.2)
62 (15.2)
31 (7.6)
128 (35.1)
165 (45.2)
57 (15.6)
15 (4.1)
47.7
52.8
50
62
0.06
942 (95.5)
44 (4.5)
762 (95.5)
36 (4.5)
385(94.1)
24 (5.9)
351(96.2)
14 (3.8)
50.5
66.7
0.05
455 (46.1)
531 (53.9)
399 (50)
399 (50)
219 (53.6)
190 (46.4)
161 (44.1)
204 (55.9)
54.9
47.6
0.06
89 (9.0)
897 (91.0)
66 (8.3)
732 (91.7)
26 (6.4)
383 (93.6)
42 (11.5)
323 (88.5)
39.4
52.3
<0.001
472 (47.9)
514 (52.1)
385 (48.3)
413 (51.7)
223 (54.5)
186 (45.5)
149 (40.8)
216 (59.2)
57.9
45.0
*chi-square for bivariate analyses
Characteristics and PrEP uptake(cont.)
Approached
N(%)
Perceived likelihood of getting
HIV in the next year
0-25%
50-100%
Previous HIV test (12 months)
Potentially
Eligible N(%)
Enrolled
N(%)
Declined
N(%)
PrEP
uptake
p-value
<0.001
569 (57.7)
437 (54.8)
189 (46.2)
237 (64.9)
43.2
417 (42.3)
361 (45.2)
220 (53.8)
128 (35.1)
60.9
<0.001
Yes
No
Prior PrEP awareness
Yes
No
# Male condomless anal sex
partners (last 12 months)
<2
2 or more
Anal sex with HIV-positive
partners(12 months)
Yes
No
I do not know
History of STD diagnosis (12
months)
Yes
No
657 (66.6)
329 (33.4)
575 (72.1)
223 (27.9)
334 (81.7)
75 (18.3)
219 (60)
146 (40)
58.1
33.6
<0.001
594 (60.4)
389 (39.6)
498 (62.6)
297 (37.4)
296 (72.5)
112 (27.5)
183 (50.4)
180 (49.6)
59.4
37.7
<0.001
512 (51.9)
474 (48.1)
370 (46.4)
428 (53.6)
143 (35)
266 (65)
222 (60.8)
143 (39.2)
38.6
62.1
<0.001
346 (35.1)
211 (21.4)
429 (43.5)
324 (40.6)
87 (10.9)
387 (48.5)
208 (50.9)
41 (10.0)
160 (39.1)
104 (28.5)
44 (12.0)
217 (59.5)
64.2
47.1
41.3
0.01
138 (14)
848 (86)
128 (16)
670 (84)
79 (19.3)
330 (80.7)
39 (10.7)
61.7
326 (89.3)
49.2
*chi-square for bivariate analyses
Predictors of uptake
aOR
Age (per year increase)
Schooling
<12 years vs. > 12 years
Site
CRT-SP vs. FIOCRUZ
USP-SP vs. FIOCRUZ
Steady partner
Yes vs. No
Gender
TGW vs. Male
Perceived likelihood of getting HIV on the next year
50-100% vs. 0-25%
Previous HIV test (last 12 months)
Yes vs. No
Prior PrEP awareness
Yes vs. No
# Male condomless anal sex partners (last 12
months)
2 or more vs. < 2
Anal sex with HIV-positive partners(12 months)
Yes vs. No
I do not know vs. No
95%CI
p-value
1.01
1.00
1.01
0.11
0.95
0.70
1.29
0.74
1.22
1.69
1.04
1.45
1.44
1.98
0.02
<0.01
1.21
1.05
1.39
0.01
1.64
1.30
2.08
<0.01
1.17
1.03
1.33
0.01
1.23
1.02
1.49
0.03
1.30
1.11
1.52
<0.01
1.77
1.53
2.04
<0.01
1.40
1.10
1.78
0.01
0.89
0.70
1.12
0.31
Conclusions
• In this first PrEP demonstration project for MSM and TGW without
prior PrEP experience in a middle-income country, PrEP uptake was
high.
• Interest on PrEP was high in the MSM community.
• Targeted Trans community education activities and a Trans friendly
environment can play a major role in getting Trans people to access
PrEP services.
• The higher uptake among those at higher risk and prior PrEP
awareness emphasizes the importance of establishing strategies to
improve HIV risk perception and PrEP awareness in the MSM and
TGW communities in Brasil.
Acknowlegdments
•
•
•
•
•
•
•
All study participants
Sponsors
Gilead
Study team
Sites personell
Arco Íris
Rio de Janeiro and Sao Paulo States AIDS
Programs
• Stephanie Cohen -UCSF