Vincent Wong, MSc Dr. Charlene Brown, MD MPH Global Health Mini-U HIV Testing and Counseling...

Vincent Wong, MSc Dr. Charlene Brown, MD MPH Global Health Mini-U HIV Testing and Counseling Roundtable Discussion

HIV Testing and Counseling Context and History Minimum standards 5Cs etc. Testing technologies Programmatic Approaches Issues (Quality, Linkage to care, etc) New directions (self-testing, etc) Where weve been and where were going

Access to HIV Testing is Increasing +33% growth in 4 years 21 million more tests Source: WHO Global Reporting 2014, WHO Global Reporting 2014

Nearly Half of All PLHIV Aware of Status ~16 million in 2013 Source: UNAIDS, Gap Report 2014 PLHIV aware of HIV status 35 million Weve come a long way

Estimated Percentage of PLHIV Know Their Status in Top 30 Countries* in 2014 Estimated awareness of status among PLHIV varies significantly, but for 2/3s of countries it is within the 40%-60% range. * By size of the epidemic Sources: Courtesy of CHAI, UNAIDS Aidsinfo; DHS StatcompilerUNAIDS AidsinfoDHS Statcompiler Likely Aware Likely Unaware Total: ~35 million South Africa Nigeria India Uganda Malawi Zimbabwe Kenya Tanzania Zambia Average PLHIV aware = ~48% Remaining Countries Grouped by Region 3.2 M 6.3 M

Source: DHS data (Staveig, 2013; WHO 2014 progress report) Percentage of men ages 15-49 yrs ever tested for HIV & received results of most recent test Percentage of women ages 15-49 yrs ever tested for HIV & received results of most recent test Trends in Reported Uptake of HIV Testing in Sub- Saharan Africa Malawi Zimbabwe Mozambique Congo Ghana Nigeria Ghana

Evolution of HTC Approaches 2015 1985 2005 1995 1985 Clinical diagnostic testing; Blood donors 1990 VCT sites, e.g. AIC Uganda 1999 Social marketing, e.g. New Start 2013 Community-based HTC (WHO) 2007 PITC (WHO) HIV self-testing? 2000 Campaigns

Evolution of HIV Diagnostics 2015 1985 2005 1995 2015 Smartphone testing 1985 1st HIV Antibody test licensed 1988 Rapid test (WHO eval) Numerous RTDs developed 1999 EIAs for Ag/Ab detection 2001 Rapid test, oral fluid 2008 Rapid HIV test for Ag/Ab detection 2010 HIV / syphilis multiplex rapid test 2012 Self-test approved by US FDA

Source: 1. Shanks PLoS One 2013; 2. Klarkowski PLoS One 2009; WHO 2015 forthcoming Studies (N=44) Identified in a Literature Review, Reporting Factors Related to Misclassification #% Improper practices around supplies 19 43% Clerical / technical errors 14 32% Incorrect / suboptimal testing strategy 13 30% User error 11 25% Weak positive 9 20% Cross-reactivity 7 16% HTC Quality / Misclassification Reports of misclassification range from 2.6% to 10.3% 1,2 Implications: For public health Undermines credibility of health system Emotional & legal False positive Unnecessary life long ART False negative Ongoing transmission risk to partners & infants

12 SCMS HRDT Product Diversity (2007-2013)

Health Service Utilization Model, from Ulett et al. The therapeutic implications of timely linkage and early retention in HIV care. AIDS Patient Care STDs. 2009: 23(1)41-49.

Determinants of Linkage & Retention Psycho-social factors Structural factors Health care delivery factors Related to knowledge, beliefs and motivations within a given social context (herbal medicine, lack of disclosure, stigma) Qualities of health care delivery at the point of contact with the patients (waiting time, conflict with staff, coordination of care) Underlying economic conditions of daily life (accessibility of care, transportation, work responsibilities, food insecurity) NEED ELVINS PERMISSION TO USE

Source: UNAIDS Graphic of Recent DHS Data, 2012

EXTRA SLIDESET for DISCUSSION

Where we are with HTC? Where are the gaps? HTC approaches Concerns and issues Next steps Overview Toward the UNAIDS 90-90- 90 Right people? Right places? The good, the bad, and the ugly Quality, prioritisation For programmes and research

Source: Frits van Griensven, 2014 Thailand Treatment Linked / Retained in Care Linked / Retained in HTC & Prevention HTC at Core of Prevention and Care Cascades

Nearly Half of All PLHIV Aware of Status ~16 million in 2013 Source: UNAIDS, Gap Report 2014 PLHIV aware of HIV status 35 million Weve come a long way

Estimated Percentage of PLHIV Know Their Status in Top 30 Countries* in 2014 Estimated awareness of status among PLHIV varies significantly, but for 2/3s of countries it is within the 40%-60% range. * By size of the epidemic Sources: Courtesy of CHAI, UNAIDS Aidsinfo; DHS StatcompilerUNAIDS AidsinfoDHS Statcompiler Likely Aware Likely Unaware Total: ~35 million South Africa Nigeria India Uganda Malawi Zimbabwe Kenya Tanzania Zambia Average PLHIV aware = ~48% Remaining Countries Grouped by Region 3.2 M 6.3 M

Access to HIV Testing is Increasing +33% growth in 4 years 21 million more tests Source: WHO Global Reporting 2014, WHO Global Reporting 2014

Countries HTC Scale-up and Diagnosis of PLHIV of Over Time Averaged evolution over time for the percent identification of PLHIV, Top 30 countries* by burden On current trajectory, projection suggests, it will take ~25 years for countries to identify 90% of PLHIV * By size of the epidemic Source: CHAI Input data via UNAIDS Aidsinfo; DHS Statcompiler projections via CHAI NMOT modelingUNAIDS AidsinfoDHS Statcompiler Slow start: Initial VCT efforts (Voluntary Testing) Steep increase: Ramping up the number of facilities and introduction of Provider-Initiated testing Decelerated increase: High hanging fruits are more difficult to reach via traditional strategies

Evolution of HTC Approaches 2015 1985 2005 1995 1985 Clinical diagnostic testing; Blood donors 1990 VCT sites, e.g. AIC Uganda 1999 Social marketing, e.g. New Start 2013 Community-based HTC (WHO) 2007 PITC (WHO) HIV self-testing? 2000 Campaigns

Evolution of HIV Diagnostics 2015 1985 2005 1995 2015 Smartphone testing 1985 1st HIV Antibody test licensed 1988 Rapid test (WHO eval) Numerous RTDs developed 1999 EIAs for Ag/Ab detection 2001 Rapid test, oral fluid 2008 Rapid HIV test for Ag/Ab detection 2010 HIV / syphilis multiplex rapid test 2012 Self-test approved by US FDA

Source: DHS data (Staveig, 2013; WHO 2014 progress report) Percentage of men ages 15-49 yrs ever tested for HIV & received results of most recent test Percentage of women ages 15-49 yrs ever tested for HIV & received results of most recent test Trends in Reported Uptake of HIV Testing in Sub- Saharan Africa Malawi Zimbabwe Mozambique Congo Ghana Nigeria Ghana

Make Up Approximately 63% of Those Tested in 2013 Much testing in ANC, even in low and concentrated epidemics Women Source: WHO global reporting 2014 AFROSEARO EMROAMRO WPRO EURO

Source UNAIDS, 2014; UN Human Development Report 2014 Percentage of Pregnant Women Tested for HIV in Africa ANC Coverage 90-100% 60-89% 0-58% In 2013, 54% of pregnant women in low- & middle-income countries did not receive HTC.

Cohabiting relationships are common

Positivity Rate Facilities Home based Campaigns KP outreach Index partner ? Community Based HTC Unit Cost But cost effectiveness may be acceptable especially for KP Linkage to Care Highly variable and problematic ?? Earlier Diagnosis 11 studies (3190 participants) CD4 >350 cells- pooled 59%. Missing Populations Men Key Populations Young women (not pregnant) Highly Acceptable Home based 82% (#18) Index partner 93% (#6) Mobile/outreach 93% (#9) Workplace 59% (#4) Source : Suthar 2914; WHO 2014

Malawi National HTC programme outputs 2008- 14 Source: Ade Fakoya GFATM 2015

High uptake of those reached Low positivity rate cf background prevalence Lower than hoped access by men Poor linkage to care Source: Labhardt et al 2014. PLoS Med; UN Development Report 2014; AIDSinfo 2013 prevalence Home-based vs. Mobile HTC in Lesotho Not always what we expect

Source: Unpublished literature review based on 88 country studies, 2007-2013 Average HIV Prevalence in Key Population Surveys and General Population Key Populations are Disproportionally Affected by HIV in All Regions

Source: Mathews R et al forthcoming, WHO forthcoming 2015; *Data not shown Uptake, Positivity and Linkage from Community- based HTC PWID and Transgender People, 16 studies, mean and range HTC Uptake (n= 4 TG; n=4 PWID) Positivity Rate (n=8 TG; n=7 PWID) Linkage (n=1 TG; n=5 PWID) Transgender People Who Inject Drugs Studies primarily mobile or venue-based approaches. Generally good uptake, lower than expected positivity rates, and suboptimal linkage Highest uptake of mobile HTC, but with lower positivity rate, compared to venue-based or peer- recruitment*

Already happening in many settings, (formally & informally) March 2014 Supplement to ARV Guidelines & UNAIDS technical update Individual performs a HIV test and interprets his or her results Many models, priorities and policy issues, and evidence gaps WHO Evidence Map of HIVST (www.hivst.org) HIV Self-Testing (HIVST)

Generally acceptable Studies mostly among MSM in high- income settings Desire HIVST over-the-counter & via Internet Report they would link to care (80- 100%) More research on other KP groups & in resource-limited settings needed! Source: Figueroa et al. forthcoming, WHO 2015 ModerateLow High Acceptability of HIVST Among Key Populations

Implementation-research partnership tackling market barriers by: Demonstrating approaches in multiple sites, models, & among populations Normalising HIVST in Southern Africa Providing evidence for scale-up Developing WHO Guidelines Influencing policy change Enabling the regulatory environment Encouraging market entry of low-cost HIVST products Countries Malawi South Africa Zambia Zimbabwe STAR Project Catalyzing HIVST in southern Africa

Source: Jhpiego/CDC/PEPFAR program in support of the Ministry of Health of Mozambiques HIV prevention efforts HTC for Men and Linkage to VMMC Mozambique: Tracking VMMC Referrals from Home-based HTC

Source: 1. Shanks PLoS One 2013; 2. Klarkowski PLoS One 2009; WHO 2015 forthcoming Studies (N=44) Identified in a Literature Review, Reporting Factors Related to Misclassification #% Improper practices around supplies 19 43% Clerical / technical errors 14 32% Incorrect / suboptimal testing strategy 13 30% User error 11 25% Weak positive 9 20% Cross-reactivity 7 16% #1. HTC Quality / Misclassification Reports of misclassification range from 2.6% to 10.3% 1,2 Implications: For public health Undermines credibility of health system Emotional & legal False positive Unnecessary life long ART False negative Ongoing transmission risk to partners & infants

Sources: Flynn et al forthcoming, WHO information note - 22 October 2014 http://www.who.int/hiv/pub/vct/retest-newly-diagnosed-plhiv- full/en/ #2. Poor Choice of HIV Testing Strategies National Testing Policies in Line with WHO Recommendations, 49 Countries Review of national HTC guidelines - Poor uptake of WHO recommended testing strategies Important to: Implement QA, sufficient training, SOPs, & strategies to reduce workload/stress; Ensure use of WHO testing strategy, correct algorithm, re-testing +ves before ART initiation; Improve inventory management & reducing stock-outs Adapt instructions, e.g. job aides to improve interpretation of weak positives. WHO reminds national programmes to retest all newly diagnosed people with HIV

Source: Flynn et al forthcoming #3. Legitimise Lay Provider HTC WHO considering recommendation for lay provider rapid HIV testing, July 2015 Country policies, trained lay providers can perform HTC tasks Total Policies, 49 Countries WHO African Region, 25 Countries

Concerned complex testing algorithms may lead to errors Proposed policy for community-based sites A single rapid diagnostic test in community- based HIV testing Not a definitive test result Emphasis on HIV diagnosis at health facility (start at A1) Triage prioritize HTC where care most needed Community based tester to focus on linkage for re-test and clinical assessment HIV Test for Triage An Alternative Community-based HTC Approach A0 + Perform HIV test for triage A0 Perform HIV test for triage A0 A0 report HIV- Recommend repeat testing as needed A0 report HIV- Recommend repeat testing as needed Link to HIV testing for diagnosis, care & treatment

#4. Rationalising Testing Strategic use of PITC in low and concentrated epidemics Where to stop testing and re-prioritize Focusing on diagnosing the undiagnosed, underserved & those with ongoing risk Strategies to reach men Overcome reluctance to provide partner testing /index partner testing Legitimize lay provider/peer testing for outreach, esp. for KP Couples and Partner Testing Generalized epidemics - offer to all Low and Conc epidemics - offer to partners of +ves Effective Focused PITC Generalized epidemics PITC in every health contact Low and Conc epidemics PITC in select services (TB, STI, Key pops) Community Approaches Generalized epidemics - outreach for key pops, consider door to door, workplace, schools augmented by campaigns Low and Conc epidemics - outreach to key pops

Forthcoming WHO Consolidated Guidelines on HTC July 2015 Next Steps: Programmes Rationalising Approaches How & where to focus HTC approaches Quality Issues Immediate issues: WHO information note WHO Quality Handbook Long term issue: Quantifying, the magnitude, identifying cause & mitigating misdiagnosis Task Sharing Lay HTC Providers Test for triage

Vincent Wong, MSc Dr. Charlene Brown, MD MPH Global Health Mini-U HIV Testing and Counseling...

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