Journey Towards Bridging the Gap in Monitoring HIV Viral Load in Resource Limited Settings:

The Third 90 Experiences in Kenya, Nigeria & Zambia.

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Speaker: Hadiza Khamofu

Country: Nigeria

Venue: Kempinski Hotel, Accra Ghana

Date: 16 May 2019

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Outline

❖ Evolution of treatment monitoring recommendations in Nigeria

❖ Challenges to VL monitoring

❖ Implementing veritable solutions

❖ Promising innovations

❖ Clinical management of patients on ART using VL

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• Prevalence of HIV: 1.4% with an estimated

burden of 1.9 million people – NAIIS 2018

• Nigeria adopted the WHO recommendation

to scale up viral load (VL) testing as the

standard for antiretroviral therapy (ART)

monitoring in 2015

• Guidelines for the WHO test and start

recommended in 2016.

The Nigerian HIV Epidemic: NAIIS 2018

29.20%

88.40% 83.10%

0.00%

20.00%

40.00%

60.00%

80.00%

100.00%

120.00%

Diagnosed On treatment Virally suppressed

90-90-90 cascade - Nigeria

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Why Viral Load Monitoring?

❖ With an increasing number of patients on ART worldwide with the “Treat all policy”, the risk for HIV drug resistance (HIVDR) is increasing. There is also increasing risk for transmission of resistant HIV strains.

❖ Viral load monitoring provides the most veritable method for assessing response to ART and can help determine adherence and drug resistance issues.

❖ Early detection of treatment failure and initiation of remedial interventions such as adherence support and ART regimen switches can push programs towards the 3rd

90/95.

Source: WHO HIVDR report 2017

Switch to CD4: 500 ART initiation criteria Switch to “treat all” policy

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Evolution of Art & Art Monitoring Policies

Inzaule SC et al; Lancet Infect Dis 2016; e267-275

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Evolution of VL Monitoring in Nigeria

58,864 50,971 21,233

150,968

448,012

1,120,000

0%

10%

20%

30%

40%

50%

60%

70%

-

200,000

400,000

600,000

800,000

1,000,000

1,200,000

2013 2014 2015 2016 2017

VIRAL LOAD ASSAYS CARRIED IN NIGERIA FROM 2013-2018

% inc scal up No. of VL Tests

FY18

❖ 2013 – 2015: No concerted efforts to implement VL monitoring. Only 5 states with PCR labs country-wide had the capacity to perform VL assays which were requested on a clinical needs basis. Heavy reliance on CD4 assays.

❖ In 2016, through PEPFAR support, a pooled system for PCR lab equipment and reagents was set up nationwide.

❖ 2017: NISRN set up to improve efficiency in sample collection and referral across a network of 26 PCR labs nationwide. This is run by GHSC-PSM through 3rd party logistics agencies.

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VL Scale Up - Challenges

Post analytic: clinical use of results:• Inefficient use of VL results for clinical

decision making by physicians.• Suboptimal documentation of results.

Reference Laboratory Factors:• Reagent stock outs.• Equipment downtime.• Power outages.• Inadequate storage capacity for referred samples.• Short duration of lab uptime.

Health Facility Factors:• Inadequate capacity for sample preparation,

storage and transfer; unavailable or dysfunctional high capacity centrifuges and -80 °C freezers.

• Power outages and equipment downtime.• Suboptimal sample transfer mechanisms and

challenges in maintaining sample integrity through the transfer process.

Health Facility Factors:• Suboptimal awareness and motivation for

VL prescription among care providers.• Inefficient triage systems for coordinated client

VL eligibility determination/sample collection.• Inadequate HRH for VL sample collection.• Incessant health worker strikes.• Restricted sample collection days.

Client Related Factors:• Poor VL literacy among patients and care givers for

children and adolescents.• Religious/cultural biases and poor adherence to ART.• Poor retention post VL assessment.• Poor outcomes for tracking efforts due to inaccurate

contact details provided.

54321

21

3

4

5

Suboptimal Viral load coverage/suppression

Demand Related

Analytics Related Post-analytics Related

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WHAT WERE THE INTERVENTIONS?

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Monitoring and Evaluation - For all 3 steps

PRE-ANALYTIC ANALYTIC POST-ANALYTIC

❖ Health worker capacity building

❖ Client focused literacy

❖ Demand creation through optimized clinic triage systems – “client folder color coding”, clinic VL ticketing, case management and line listing

❖ Sample collection drives and client level clinical audits

❖ Integrated sample transfer

❖ mHealth interventions and remote sample logging

❖ Financing expansion of referral labs

❖ POC machines

❖ Super (mega) labs

❖ Extended working hours

❖ HR support at high burden/high capacity labs

❖ Supply chain management

❖ Power supply support at referral labs (inverters, solar power and fossil fuel supply)

❖ mHealth and web-based results delivery through Laboratory information management systems (LIMS)

❖ Linking lab reporting systems to EMRs

❖ Job aides to support clinical decision making

❖ Clinic organization and systems to trigger action if VL > 1,000

❖ Support for viraemiaclinics targeted at virally unsuppressed patients

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VL Uptake

❖ The interventions have yielded some successes. However, viral load coverage was still 53 % in 2018.

❖ Progress needs to be made across the continuum of care -demand and supple sides of the cascade have required significant interventions to improve effectiveness and efficiencies.

❖ Promising innovations have been proposed and are currently being implemented to address specific issues across the continuum of care from the pre-analytic to post analytic phases of VL services.

70%

71%

72%

73%

74%

75%

76%

77%

0

20000

40000

60000

80000

100000

120000

140000

160000

180000

FY16 FY17 FY18 FY19 (Oct 18 - Mar19)

SIDHAS VL UPTAKE AND SUPPRESSION

Suppressed Nonsuppressed Suppression rate

<1Age 1-

9Age

10-14Age

15-19Age

20-24Age

25-29Age

30-34Age

35-39Age

40-49Age50+

Male 85% 43% 51% 60% 48% 60% 40% 42% 46% 51%

Female 85% 43% 55% 61% 43% 50% 44% 48% 50% 53%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

PE

RC

EN

T

FY18 VL COVERAGE Male

Female

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VL Suppression

❖ Children and adolescents lag behind other patient categories in terms of VL suppression

❖ Reports of increased levels of pre-treatment HIVDR may be one of the factors driving the poor VL suppression.

<1 Age 1-9 Age 10-14 Age 15-19 Age 20-24 Age 25-29 Age 30-34 Age 35-39 Age 40-49 Age 50+

Male 55% 55% 55% 60% 77% 75% 81% 81% 82% 85%

Female 55% 55% 60% 70% 78% 78% 81% 82% 85% 87%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

PE

RC

EN

T S

UP

PR

ES

SIO

N

Male Female

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Promising Innovations - NISRN

❖ Prior to NISRN, the ad-hoc system for sample referral by IPs relied heavily on facility staff to transport specimen from collection sites to hubs and PCR Labs

❖ This resulted in:

• Inefficient use of human and financial resources / inconsistent cost

• PCR Lab and Referral Network not optimized for distance or capacity

• Inability to track lab specimen transport performance indicators

❖ NISRN was rolled out in phases at the states from Mar - Sept 2018 and leverages on pooled resources from PEPFAR, GoNand GFATM to improve efficiencies in sample referral reducing TAT and increasing VL uptake

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Promising Innovations - Mega Labs & DBS For VL

Megalabs

❖ To improve efficiency, support for PCR labs has been reduced from 22 to 11.

❖ The labs have been installed with high throughput PCR machines that can potentially increase the capacity for VL sample processing within the country.

❖ These sites to be provided with enhanced site monitoring services to optimize their output

DBS for VL

❖ Rolled out it FY 18 to mitigate challenges with facility power supply and need for sophisticated and timely sample transfer mechanisms especially from remotely located health facilities.

❖ Obviates the need for centrifuges, freezers and other sample preparation equipment.

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Promising Innovations - Others

Color coding and VL ticketing

❖ Color coded tags placed on client foldersto guide care givers on the appropriate services to be rendered to the patients including VL services.

❖ Ticketing avoids missed opportunities ensuring that each clinical contact with the patient allows the patient access all the relevant services.

Use of EMRs to optimize VL services

❖ The national data repository (NDR) has been fully onboarded in-country.

❖ The system has the potential to help monitor the early warning indicators for HIVDR including ART regimen optimization, adherence, retention and VL monitoring.

❖ EMR reminders also help optimize coverage

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VL For Clinical Decision Making - Refresher

http://www.aslm.org/resource-centre/hiv-viral-load-testing/hiv-viral-load-scale-tools/

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Treatment Failure Algorithm

VL>1000copies/ml

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Structured Processes For Tracking VL

❖ Adoption of structured clinical support for virally unsuppressed patients through viraemia clinics.

❖ Introduction of OTZ to optimize VL suppression for adolescents LWHA

❖ Joint clinic and lab performance review supported at high volume facilities.

❖ Performance tracking for unsuppressed patients introduced into the routine performance reporting indicators on a program level.

Source: PEPFAR Nigeria, 2019

Number with unsuppressed VL

result

Number of patients that have

had 1st EAC

Number of patients that have

completed the 3rd

EAC

Number of patients with repeat VL after 3

sessions Of EAC

Number of patients that remained virally

unsuppressed After Repeat VL

Number of patients switched

to 2nd Line

Switch Rate (%)

Total 4,449 4,206 3,256 2,793 885 377 43%

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Impact of VL on Switch To 2nd Line ART

0.00%

0.50%

1.00%

1.50%

2.00%

2.50%

3.00%

3.50%

4.00%

4.50%

94.00%

94.50%

95.00%

95.50%

96.00%

96.50%

97.00%

97.50%

98.00%

98.50%

99.00%

99.50%

FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19

Impact of Routine VL monitoring on population of patients moving to 2nd line ART

Proportion of patients on first line ART Proportion of patients on second line ART

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Conclusion

❖ Progress has been made through investments in infrastructure for viral load monitoring, innovation and dogged determination of stakeholders in ensuring optimal VL suppression for PLHIV, however the challenges are quite substantial.

❖ Further implementation of innovative ideas must focus on efficiency, efficiency, efficiency.

❖ Through the use of DBS for VL, integrated sample referral and high throughput “Superlabs”, the potential to achieve 95 % VL coverage by 2020 is feasible.

❖ However, programs should prioritize:

• Health care provider education to improve the knowledge and motivation for VL services – including support for unsuppressed patients.

• Patient sub-populations especially children and adolescents – ART regimen optimization, VL coverage support and adherence support.

• Data for decision making at all program levels to optimize program viral load performance.

AbbVie (Pty) Ltd, Reg. 2012/068113/07. Address: Abbott Place, 219 Golf Club Terrace, Constantia Kloof, 1709, South Africa. Tel: 011 831 3200. Fax: 011 831 3292. Date of Publication of this Material: May 2019.