2. Integrating Diagnostic Services at Point of Care
Early diagnosis of HIV and use of the GeneXpert System as part of a comprehensive strategy to end HIV transmission
Michael Meulbroek
Projecte dels NOMS-Hispanosida
Integrating Diagnostic Services at Point of Care
Cepheid
Paris, 24 July 2017

3. Introduction BCN Checkpoint opened in January 2006
BCN Checkpoint introduced the use of HIV rapid tests in community-based centers in Europe in 2006
BCN Checkpoint serves clients per day
“ .. Community-based projects providing professional services and peer support (by gay men for gay men) have had success in achieving high client satisfaction, thereby ensuring better uptake, follow-up and compliance. “”

4. Services BCN Checkpoint
POCT
HIV / Syphilis / HCV
Hepatitis A and B vaccination
Linkage to Care
Chlamydia and Gonorrhea
Peer counseling and psychological Support
Community Research

5. Number of tests and clients in BCN Checkpoint (2006 - 2016)
7,737 tests represents 2.8% of all HIV tests performed in the country
7,737
5,542
3,837
3,198

6. Impact of BCN Checkpoint
BCN Checkpoint detects around 35% of all reported cases in Catalonia
Source: Actualizació a 06/10/2016. Vigilància epidemiològica de la infecció pel VIH i la SIDA a Catalunya. Ceeiscat. Departament de Salut. Generalitat de Catalunya

7. Same-day confirmation of reactive HIV rapid test
with Point Of Care PCR test
Period of evaluation:
March 2015 – September 2016
GeneXpert: Xpert® HIV-1 Qual test
(Lower limit of detection: 278cp/ml, 95%IC: cp/ml)
Rapid HIV test
Reducing time for confirmation to 90 minutes has been possible in 91.2% (197/216) of cases with positive PCR result
Standard Western Blot test

8. Difference between detection and transmission
HIV detection reflects only the moment a person is tested for HIV, but not when the transmission occurred
late detection if CD4 is less than 350
more detection does NOT mean stopping the transmissions
HIV transmission is the moment a person is infected (virus is transmitted from one person to another)
the only information comes from cohort studies (HIV incidence)
MSM have a faster transmission rate and more detections is not enough
Earlier HIV detection (as close as possible to the transmission moment) may help to reduce the HIV incidence

9. Acute infections Viral load over 10 million copies
Virus dissemination:
HIV infection is at least 9 times
more transmittable than in the chronic phase
A. McMichael, P. Borrow, G. Tomaras et al. The immune response during acute HIV-1 infection: clues for vaccine development. Nature Reviews Immunology 10, (January 2010) doi: /nri2674

10. Detection of acute infections
The Xpert HIV-1 Qual kit probit LOD on WHO standards is 278cp/ml (95%IC cp/ml) from 100µl of whole blood

11. Detection of acute infections
When Rapid HIV Test result is negative, the Xpert HIV-1 Qual test was offered to clients who comply selection criteria
analysis criteria 2015
2015
2016
2015 Q4 Q2 Q3 Q4 Q2 Q3 Q4
2016
Today
20/04/2015
Period I
17/05/2016
52 wks
Criteria period I:
No consistent condom use during last 3 months
Partner with a recent HIV diagnosis
Symptoms of acute infection
45 wks
23.8 wks
Phase III

12. Results period I Period I Period II Total rapid HIV tests 8,018
Period I
Period II
Total rapid HIV tests
8,018
Total persons tested
5,718
Total positive results
152
Total Viral Load tests
1,178
993
Total acute infections 7
Prevalencia
0.70%
+4.6%

13. Results period I
Reason for testing
Frequency
Positive results %
Odds ratio
No consistent condom use last 3 months
1,098 2
0.18 1
Partner with a recent HIV diagnosis 32
3.13
17.4
Symptoms of acute infection 30 4
13.33
74.1
No data 18 NA
Total
1,178 7
Confirmation test will be performed with Xpert® HIV-1 Viral Load

14. Detection of acute infections
When Rapid HIV Test result is negative, the Xpert HIV-1 Qual test was offered to clients who comply selection criteria
analysis criteria 2015
2015
2016
2015 Q4 Q2 Q3 Q4 Q2 Q3 Q4
2016
Today
20/04/2015
Period I
17/05/2016
52 wks
18/05/2016
Period II
31/12/2016
Criteria period I:
No consistent condom use during last 3 months
Partner with a recent HIV diagnosis
Symptoms of acute infection
Criteria period II:
More than 2 partners with penetration in last month without condom
Partner with a recent HIV diagnosis
Symptoms of acute infection
ChemSex during last month
Diagnosed rectal STI
45 wks
23.8 wks
Phase III

15. Results period II Period I Period II Total rapid HIV tests 8,018 4,784
Period I
Period II
Total rapid HIV tests
8,018
4,784
Total persons tested
5,718
3,920
Total positive results
152 92
Total Viral Load tests
1,178
482
993
404
Total acute infections 7 6
Prevalence
0.70%
1.49%
+4.6%
+6.5%

16. Results period II Reasons for testing Frequency Positive results N %N %
ChemSex 30
7.0
0.0
ChemSex + Diagnosed rectal STI 1
0.2
Diagnosed rectal STI 24
5.6
Partner with a recent HIV diagnosis 51
11.9
16.7
More than 2 partners without condom
174
40.5
More than 2 partners w/o condom + ChemSex 65
15.1 3
50.0
More than 2 partners w/o condom + ChemSex + Rectal STI
More than 2 partners without condom + Rectal STI 4
0.9
Symptoms of acute infection 80
18.6
Total
430
100.0 6

17. Results period II Multivariate logistic regression analysis
Reason for testing
Odds Ratio
CI 95%
P-value
Lower limit
Upper limit
More than 2 partners without condom in last month
1.78
0.29
10.76
0.532
Partner with a recent HIV diagnosis
6.05
0.48
76.35
0.164
Symptoms of acute infection
2.14
0.40
12.43
0.398
GHB/GBL
10.36
1.25
85.75
0.030
Mephedrone
0.33
0.03
4.00
0.380
Crystal methamphetamine
1.54
0.20
11.70
0.675

18. Time to start treatment
Early detection + start treatment = reduction transmissions
Cases
Age
Time to hospital
Time to start treatment VL
(millions)
CD4
% CD4
# 1 37 3
> 10
265
19%
# 2 38 1
117
17%
# 3 25 2
261
33%
# 4 35
928
46%
# 5 26
489
48%
# 6 32
916
39%
# 7 49
308
24%
# 8
1,700
470
31%
# 9 23
0,730
1,097
35%
# 10 22
0,411
495
23%
# 11 19
0,242
1,061
38%
# 12 33
0,095
174
13%
# 13 31
0,003
439
58% had > 10 million copies of viral load

19. Summary
Using Point of Care PCR testing in a community center is feasible and permitted to detect a 5% additional number of HIV cases.
The prevalence of acute infections in the first period was 0.7% and after adjusting selection criteria prevalence doubled to 1.5%. Based on these results a cost-effectiveness study is in progress.
Diagnosis in the acute phase with immediate start of treatment will favor a new generation of people living with HIV with potential benefits in the prognosis of their infection and, at the same time, will avoid a disproportionate number of new HIV transmissions.
The general time for a hospital visit has been 1 day and almost all persons started treatment the same day.
Detection of acute infections should be an essential part of a strategic plan to end transmission of HIV in MSM and transgender women.

20. Acknowledgements