Rapid HIV Testing & Scaling Up Testing

Rapid HIV Testing&

Scaling Up Testing

Phillip [email protected] 2012

Overview

• Why rapid HIV testing?

• Where to now on rapid HIV testing

• National HIV Testing Policy Review

• Scaling up testing

UNPD Targets• Need to scale up testing coverage and

frequency: New technologies (eg. rapid HIV testing) Reorienting existing testing services New models for marketing & providing

testing Community/peer-based Outreach (Home?)

Testing Coverage among MSM

• There is still scope for benefit from increased testing coverage and frequency

o Testing coverage low in broad-based MSM samples:

• e-Male Survey (2008)

– 23.8% never tested

– Among men who had tested, 31% had not tested in previous year

• PASH Survey (2009)

– 15.2% never tested

• Adam (2012), NCHSR

– 28.3% of young MSM (16-26) had never tested

Testing Frequency

• Real testing frequency v’s self-report data

o Guy et al (2010):

• Less than 40% of MSM retested after I year

• Less than 20% of highly sexually active men retested after six months

• Late HIV diagnoses

o Approximately 14% of diagnoses among MSM are late diagnoses

• Most have never previously tested, others have not tested for a long time.

Rapid HIV Testing in other Settings

• Pedrana (2011): Rapid HIV Testing & Community-Based Testing services:

o High proportion of never previously tested

o High positive yields

o High consumer satisfaction with rapid HIV testing

o High workforce satisfaction with rapid HIV testing

o Staffing models incorporating non-clinical staff in community based testing services

Rapid Testing at NZAF

HIV Testing Policy Review•Support for rapid HIV testing for use at point of care:

• Limited to use as screening tests

• Confirmatory testing required for reactive rapid test results

• May be considered for:

• High risk populations (eg. gay men)

• Hard to reach populations and individuals (who are resistant to conventional testing) and

• People who might be otherwise reticent to access conventional testing and/or return for results

False Positives to True Positives

Test Specificity

Positive Yield 99.5% 99.8%

1.5%(MSM in VPCNSS)

1:3

(5 FP per 1000 tests)

1:7.5

(2 FP per 1000 tests)

1.0%(Males @MSHC, 2009) 1:2 1:5

0.1%(Females @MSHC, 2009) 5:1 2:1

0.025%(All females tested in Victoria,

2004)20:1 8:1

Community based testing

• Scope for non-clinical staff to administer rapid tests:

• If State/Territory health department endorses organisation

• Staff must attend accredited training and achieve certification

• Service must have access to clinical support and venepuncture, and a relationship with a laboratory approved by the National Association of Testing Authorities (NATA)

• Service must be able to be indemnified and compliant with NATA and Medicare arrangements

What Now?

• Policy support for rapid testing at POC, but:

• No TGA licensed tests

• No Medicare funding for rapid test kits or procedures

• What planning is needed to prepare?

Community Organisations• What models for rapid testing make sense locally?

• Establish a new community based testing service?

• What planning needed?

• Partner with other services to offer rapid testing?

• Incorporate peer-based workers to some parts of testing services?

• Identify services well-placed to introduce rapid HIV testing and start talking to them

• Liaison with funders and other stakeholders to plan for the introduction of rapid testing

• Working with rapid HIV test manufacturers?

HIV Educators & Counsellors

• Peer Educators & TreatAware Officers:• Community Awareness about rapid HIV testing

• Limitations and benefits of rapid testing

• Participate in rapid testing service delivery

• Very different role for most

• What selection & training?

• Counsellors:

• Different issues in context of rapid HIV testing – e.g. anxiety while awaiting a confirmatory test if rapid HIV test is reactive

Reorienting Services

• Opening hours

• Location

• One-stop testing Providing results by phone/email

Marketing

• Increasing HIV testing rates will be needed to reach new HIV Prevention and Targets

• Introducing rapid HIV testing represents an opportunity to re-frame HIV testing

Home Testing

• Home testing was not supported in the recent Australian HIV Testing Policy review

• UK: House of Lords Select Committee on HIV in the UK recommendations:o Legalise home testing

o Establish a quality control system

o THT supports the above

Home Testing

• USA: Orasure application to FDA for home sales Study of home users found 93% sensitivity

v's 99.3% when used by trained testers Expert panel unanimously supported

approving home sales FDA decision expected soon

Outreach Testing

• Was not considered in detail in policy review

• Outreach testing trial may start soon in Sydney

• Community HIV sector doesn't have a well-developed position on outreach testing.

Thanks

Clinical Staff

• Should rapid testing be introduced?

• New procedures

• Training & staffing – clinicians or nurses?

• Relationship with NATA-approved laboratory

• GPs

Policymakers

• Planning• How and where should rapid testing be introduced to complement

existing testing services?

• NSW Health Model - Point of Care Testing Working Group:

• ASHM

• Clinical & social research

• Community orgs

• Sexual health clinic director

• Counsellor

• GP

• Nurse

• Policymakers

• Local health workforce

Policymakers II

• Funding

• Public sexual health clinics and specialist community based testing services may be best placed to offer rapid HIV testing - but State/Territory funding covers most costs of public sexual health clinics and would need to for new community based testing services

• Cost barriers to introducing rapid testing in all settings until there is Medicare funding

• Public clinics: Currently some HIV testing costs recouped from Medicare

• Private GPs: Lab testing funded; no funding for rapid tests

• Will community based testing services be eligible to charge some costs back to Medicare?

Policymakers III

• Funding support for trials of rapid HIV testing

• Trials are underway in public sexual health settings

• Test performance (sensitivity, specificity, NPV & PPV)

• Acceptability to clients

• Feasibility issues in clinics

• Any impact on testing frequency?

• Community based testing?

• Rapid testing in GP settings?

Researchers

• Tracking changes in testing patterns in the context of rapid testing

• Understanding the impact of rapid HIV testing on gay men’s sexual cultures

CD4 at start of cART (closest CD4 with 6 months prior)

Prior to 1 Jan

20061 Jan 2006 onwards Overall

Total 1882 427 2309Mean 327.9 324.0 327.1SD 242.4 193.5 234.1Median 288.5 294 29025th 150 200 16075th 450 422 445

n (%) n (%) n (%)250-349 347 (18.4) 101 (23.6) 448 (19.4)<250 787 (41.8) 161 (37.7) 948 (41.1)>=350 748 (39.7) 165 (38.6) 913 (39.5)

CD4 Decline Following Seroconversion

• CASCADE Study (Europe n. = 18,495)

CD4 Level Median time following Seroconversion

500 1.19 years

350 4.19 years

200 7.93 years

Treatments Uptake Needed

• Rapid increases in treatments uptake occurred 1996-1998 (20% > 70%)

Year Estimated Population

Proportion on ARVs

Population not on ARVs

Additional needed if

90%

2010 21,391 70% 6,417 4,278

2011 22,391 70% 6,717 4,478

Challenges

• Costs of access

• Costs of multiple medications / management interventions

• Complexity of access to prescriber / dispensing arrangements

• Dr concerns re adherence

• Dr concerns re lifelong treatment commitments

• Concern re impact of side effects

• Other Patient barriers

Increased cost sharing• 1. Lower rates of drug treatment / selective Rx

• 2. Diminished adherence among existing pts

• 3. More frequent discontinuation of therapy

• 4. Affect likelihood of pt to seek care

• Summary point

• For each 10% increase in cost sharing, prescription drug spending decreases by 2 – 6%. (Subject to class of drug and condition).(Rand 2010)

Issues – Pt involvement

• 35% started treatment within a year of diagnosis

• Majority waiting more than a year btwn diagnosis and initiating

• Reasons

• 47% - Dr’s decision to wait*

• 27% - Pt Unsure about starting

• *Age split: Under 50 – 52% / Over 50 - 18%

Issues - Access

• Access has costs

• PBS drugs have pt contributions $35.40 / $5.80 per script

• Safety net $1281.30 / $324.00

• Pt experience survey – PCR (ABS) 2009

• 9.7 % delay or reject filling a script (general pop)

HIV population

• 30% live below poverty line

• 40% rely on a govt benefit

• Chronic disease management increasingly complex within the ageing population

• Medicare not covering cost of most non medical treatments, or increasingly newer procedures

• Spending up to an average of 30% of income on medications

Issues - Access

• Chronic Illness

• - regardless of income levels spending up to 30% of household income on medications

• Plhiv (Futures 6) (n = 1100)

• - 42% report major source of income as Govt support

• 31% report living below poverty line levels

Issues - Access• BGF Survey (2010)

• PLHIV respondents struggling to access treatment

• 46% - HIV medications

• 60% - Other prescribed medications

• Hardship requires people to make decisions between care and basic living expenses

Patient Concerns

• Concern about side effects

• Lifelong treatment

• Lack of readiness

• Pt perception ARV are bad for you

• Dislike of taking (Reminder)

• Commencing Rx means health has declined

• Impact on lifestyle

Issues – Pt Attitudes

• 70%(ATLIS) to 80% (Futures) of treating population believe that ARVs mean better prospects for themselves

• 39% (ATLIS) & 30% (Futures)- Negative beliefs such as “harmful” and impacts outweighing benefit to QOL.

• Reminder of status / fear of disclosure (includes access issues to care / drugs)

Psychological barriers

“Commencing was terrifying. I was scared and the night before I started I was a mess. Initial physical reaction was minimal so that was a relief. Changing meds is also a scary thought which I am trying to avoid” (ARCSHS Tracking Changes, 2011)

“I had thought it would be difficult for me to commence meds since this would be an acknowledgment of the progression of my HIV. However since starting my meds I have found that a lot of small irritating conditions have cleared up and my overall health is significantly improved. I'm just grateful every day that the meds exist!” (ARCSHS Tracking Changes, 2011)

What are the outcomes

• Therapeutic Treatment coverage and maintenance will improve individual health

• Secondary prevention impacts will follow

• Dynamics across other Strategies and within the BBVSS framework benefits shared

• As fast as knowledge is acquired it must be applied (NHMRC Research Translation goal)

ROI

• Base policy options on evidence base of current data + the value of treatments to community

• Environment of community acceptability with drive to resolve barriers or disincentives for individuals

• National Strategy could be adapted to this expansive vision

Economic analysis

• NSW – 50% Gay + men initiated Treatment at diagnosis then minimum 10 % - up to 22% of new infections would be averted

• $14,000 annually on HIV therapy

• One infection over a lifetime costs Govt $700,000

• Data build to show nationally if a program targets people who would otherwise have not received therapy, it would be cost effective, but also over a lifetime become cost saving to Govt.

Minimum, Most Recent, Maximum CVL and Newly Diagnosed and Reported HIV cases

Success of Test and Treat in San Francisco? Reduced Time to Virologic Suppression, Decreased Community Viral Load,

and Fewer New HIV Infections, 2004-2009M Das, P Chu, G-M Santos, S Scheer, W McFarland, E Vittinghoff, G Colfax

Where can we do more?

TestingTreatments uptake

Community Mobilisation

PrEP + PEP

Targeting Primary Infection

Targeting Late HIV DiagnosesSpecific actions to reduce heterosexual transmissions

HIV diagnoses, 2006 -- 2010, by HIV exposure

category

Source: State and Territory health authorities

Newly diagnosed HIV among men who report an exposure other than sex with men, 2001 – 2010, by year and HIV

exposure category

0

20

40

60

80

Year

Number


Newly diagnosed HIV among women, 2001 – 2010, by year and HIV exposure category


Reducing Heterosexual Transmissions

• Diagnosingo Expand ASHM mentoring project

o Clinical markers (eg oral candidiasis)

o Populations focus – people from high prevalence countries & partners

o Clusters (swingers)

• Serodiscordant coupleso Offer treatment

o PrEP for partners if detectable

Peer base

• Community information

• Informed by community

• Drivers / influence

• Nuances

• Sophisticated (Persistence/ Resilience)

• Strength of peer ownership / partnership

• Acceptability / thresholds of tolerance & support

Community Mobilisation

• Gay community

o High profile social marketing initiatives to suggest a period of concerted community action

o Seek support from gay community leadership

• Disproportionate contributions to new diagnoses from:

o Men in serodicordant relationships

o Sexually adventurous men

o Highly sexually active men

o Target community mobilisation to address these areas

Targeting Late HIV Diagnoses

• NAPWA believes there is scope to reduce late HIV diagnoses among MSM, heterosexuals and CALD.

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CD4+ cell count at HIV diagnosis, 2001 – 2010, by year


What proportion of ‘late’ HIV diagnoses are MSM?

Late HIV Diagnoses Actions

• Reduce structural and psychological barriers to testing

• Encourage primary health services to offer testing to populations at increased risk. o Low caseload GPs in areas of high HIV prevalence

– offer testing to MSM

o GPs and community health services working with CALD populations at increased risk

Need data for targets

• Variable treatment patterns across sub groups

• Attitudes and beliefs are wide ranging and complex

• Motivations and drivers critical

• Campaigns need to be diverse and different mediums – websites, blogs and social media


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Should we expect an initial increase in HIV Diagnoses?

PopulationSize

Undiagnosed(10%)

Undiagnosed (20%)

22,391 (1) 2,239 4,478

• (1) Estimate of the number of people living with HIV in Australia as at 31/12/2010 plus 1,000 (estimated number of new diagnoses in 2011)

• The estimates of the proportion of the PLHIV population that are undiagnosed are from Mapping HIV Outcomes: Geographical and clinical forecasts of numbers of people living with HIV in Australia (NCHECR/NAPWA, 2010)

• If testing coverage and frequency increase, there may be an initial spike in new HIV diagnoses

A package

• Targets disease prevention

• Targets access inequities

• Targets continuity of care

Targets are a package

• They bring other dynamics and roll on effects

• National HIV strategy links

• The momentum brings energy and focus

• Forward to future yrs and see results

• Health and well being of a population is what fosters other secondary benefits, such as prevention and broader BBVSS health maintenance

Setting Targets

• Set targets based on the number of people it will positively affect.

• Planning should be optimistic and lead with positive frameworks for what you can do and what potentials there are to truly transform


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Targets and Reduced Diagnoses

Exposure Category 2010 Diagnoses 50% Reduction 80% Reduction

MSM + MSM & IDU 621 (311) 124

Heterosexual 289 145

IDU 25 13

All Categories 1,043

• An 80% reduction in MSM diagnoses and a 50% reduction in heterosexual, IDU and other categories would result in approximately 335 annual diagnoses, which is a 68% reduction overall on the 1,043 diagnoses in 2010.

Opportunities

• Emerging combination prevention options offer the best chance in thirty years to drive infections down

• We have to seize the moment – ‘wait and see’ isn’t an option

• Signing up to ambitious (but not unrealistic) 2015 targets will provide the galvanising factor

Thanks

End here?

• End?

• Jo, following slides are in case you want to keep them and move them back up into the presentation

Implications

• Targeted sub groups may require varied interventions

• Health maintenance not just understood as clinical benefits

• Must be peer driven and focused

• Need to measure national against state analysis

Treatments Uptake

• Reducing barriers to treatment

o Dispensing arrangements

o Co-payments

• Difficulties obtaining medication and co-payments associated with stopping ARVs (ARCSHS Tracking Changes, 2011)

• ATRAS and other Medicare Ineligibles

• Addressing Psychological barriers to initiating treatment

o Recommend doctors commence discussing treatments at or soon after diagnosis & assess psychological supports needed

Self reporting

• Actual utilisation vs self reported levels

• - Both testing – but also treating, and maintenance

Health & Medicine

Rapid HIV Testing & Scaling Up Testing