Population-based HIV Impact Assessments (PHIA): An Introduction Focusing on Malawi and Zimbabwe Elizabeth Radin, PhD Technical Specialist – Population-based Surveys Project Director, Malawi & Zimbabwe PHIAs November 6, 2014 Presentation Objectives 1. Explain what ICAP’s PHIAs are 2. Explain why ICAP is doing PHIAs from both a SCIENTIFIC and POLICY perspective 3. Present how we are approaching the first two PHIAs in Malawi and Zimbabwe 4. Share information on the future of PHIAs at ICAP What are ICAP’s PHIAs Population-based HIV Impact Assessment A survey that is: • Nationally-led (MOH, NSO) • In collaboration with CDC • Cross-sectional • Household-based • Nationally and Sub-nationally Representative • Focused on impact-level indicators of the HIV epidemic through biomarkers and self report What we mean by ‘Impact Assessment’ A Description of Impacts . . . IMPACT: long term, high-level result (reduced transmission, reduced mortality) IMPACTS OUTCOMES OUTPUTS OUTCOME: medium-term result (# tested, # on ART) OUTPUT: product of activities (# of health staff trained) What does a PHIA Assess? • The currents status of the epidemic in a country • The access to and uptake of HIV care and treatment services Scientific Rationale for PHIAs Health facilities, and health facility access exists in a spectrum . . . ART Site VCT/ANC Health Center Pharmacy Limited/No Access Summary: Scientific Rationale Current data is largely facility-based Facility-based data describes a subset of the population It is difficult to infer population measures– such as prevalence or incidence – from facility based data Population-based surveys are the gold standard for these indicators Policy Rationale for PHIAs Adults and children with HIV infection receiving ART with PEPFAR support, 2004-2011 Number on ART 4 million 2004 2011 El-Sadr WM et al 2012 Policy Rationale for PHIAs After more than a decade of PEPFAR what is that status of the epidemic? For Example: • What is the rate of new infection following prevention efforts? • What is the proportion of Viral Load Suppression following expanded ART coverage? Sampling for the PHIAs A Two-stage Cluster-based Sampling Strategy: An example: What is the prevalence of coffee drinking at ICAP? Background: ICAP has 1000 staff, 20 Offices, 50 Staff/Office A Census: Ask all 1000 ICAP staff if they drink coffee A Simple Random Sample: Select 10, 100 or 500 ICAP staff and ask if they drink coffee A Cluster-based Sample: Select 5 ICAP country offices, ask all staff in those offices if they drink coffee A Two-stage Cluster-based Sample: Select 10 ICAP country offices, randomly select 25 people from each country office Sampling for the PHIAs Sampling Strategy: • Using two-stage cluster-based sampling strategy – Sample ~500 Enumeration Areas (EA),stratified by health zone – Sample ~30 Households per EA • Sample size includes ~15,000 HH; ~30,000 individuals • Adults from every HH ~20,000, all children every other HH ~10,000 The DHS: A Pop Survey Celebrity Similarities between DHS/PHIA • • • • Population-based household survey Cross-sectional, nationally representative Household and individual questionnaires National and subnational HIV prevalence estimates • Household and individual sample size similar Differences between DHS & PHIA • Biomarkers for CD4 counts, viral load, recency, drug resistance, ARV metabolites, peds • Point-of-Care HIV testing and CD4 testing with return of results • Opportunity to assess global HIV outcomes of interest that are outside domain of DHS – PMTCT – Potential for Treatment as Prevention ICAP Experience with Pop Surveys • Swaziland HIV Incidence Measurement Survey • Sinazongwe Combination Prevention Evaluation [SCOPE], in partnership with the Zambia MOH • Bukoba without New Infections, “Bukoba Bila Maambukizi Mapya,” [BBM2] in Tanzania Presentation Objective MOH, CDC & ICAP’s Approach to Two PHIAs: Malawi and Zimbabwe First Two PHIAs: Malawi and Zimbabwe • In collaboration with CDC • Work with Ministries of Health to develop, implement and disseminate findings from PHIA Pilots in Malawi in Zimbabwe • From April 2014-March 2016 • Currently in protocol development and preimplementation stage Malawi • 16. 3 Million People • Life expectancy: 54 Years • Causes of Premature Mortality (YLL): HIV/AIDS (23.7%), Malaria (10%), Lower Respiratory Infection (9.7%)1 • HIV Prevalence (age 15-49) • National: 10.3% 2 • HIV Care and Treatment: Malawi 2010 DHS. • 675 ART sites, 470,000 patients on ART (83% of need)3 1 Malawi Global Burden of Disease Study 2010; Institute for Health Metrics and Evaluation (IHME); 2 UNAIDS HIV and AIDS Estimates 3 UNGASS 2013 Malawi Country Progress Report Zimbabwe • 13 Million People • Life expectancy: 58 Years • Causes of Premature Mortality (YLL): HIV/AIDS (29.0%), Lower respiratory infection (11.7%), Diarrheal disease (6.0%)1 Duri Kerina et al. HIV/AIDS: The Zimbabwean Situation and Trends. American Journal of Clinical Medicine Research, 2013, Vol. 1, No. 1. • HIV Care and Treatment: 665,000 patients on ART (77% of need)2 1 Zimbabwe Global Burden of Disease Study 2010; Institute for Health Metrics and Evaluation (IHME); 2 UNGASS 2013 Zimbabwe Country Progress Report Objectives for Malawi & Zimbabwe PHIAs Primary Objectives: • To estimate HIV incidence (i.e., prevalence of recent HIV infection) in a household-based, nationally representative sample of HIVinfected adults • To estimate the sub-national prevalence of suppressed HIV viral load (<1000 cells/ml3) in a household-based, nationally representative sample of HIV-infected adults Measuring Incidence Longitudinally Incidence: new infections in a population January 1, 2014 - January 1, 2015 - = + - = 1 41 = .25 cases per person year Measuring Incidence Cross-Sectionally 1 2 Objective 1: Incidence Recent infection (4-6 months) is identified by: 1) Low avidity - weak bonding strength between host antibody and virus. 2) An elevated level of HIV virus in the body . . . And converted into an annualized rate US HIV Incidence (06-09) = .02% Expected Zimbabwe/Malawi Incidence= ~1% Objective 2: Viral Load Suppression (VLS) 100 HIV Treatment Cascade % of all people with HIV 90 80 70 60 50 40 30 20 10 0 Diagnosed Linked to Care Retained in Care Prescribed ART Virally Surpressed Adapted from: aids.gov/federal-resources/policies/care-continuum/ Objectives for Malawi & Zimbabwe PHIAs • To estimate HIV incidence (i.e., prevalence of recent HIV infection) in a household-based, nationally representative sample of HIVinfected adults • To estimate the sub-national prevalence of suppressed HIV viral load (<1000 cells/ml3) in a household-based, nationally representative sample of HIV-infected adults Objectives for Malawi & Zimbabwe PHIAs Secondary Objectives: • • • • • • • • HIV prevalence in adults and children CD4 T-Cell counts Transmitted drug resistance ARV metabolites Nutrition in HIV positive children HIV-related risk behaviors Use of HIV-related services HIV knowledge and attitudes Similarities in Malawi and Zimbabwe PHIAs Objectives: • Incidence (national), Viral Load Suppression (zonal) Eligibility Criteria: • Must be a HH member – resides or slept night before in HH • Must give informed consent • All adults in every household • All children (ages 0-14) in every other household Similarities in Malawi and Zimbabwe PHIAs Survey Procedures: • Collect questionnaire data and blood samples • Carry out POC HIV and CD4 testing • Provide counseling and return results • Refer HIV positives to care • Transport blood samples to central lab for additional testing Similarities in Malawi and Zimbabwe PHIAs Questionnaires: • Household Questionnaire • Adult Individual Questionnaire – Demographics including marriage – HIV knowledge and attitudes – Reproduction – Sexual history – HIV testing, care and treatment history Similarities in Malawi and Zimbabwe PHIAs Data Management: • Tablets Cloud server in-country server Laboratory Management: • Central level testing at a national lab (VL, EID, recency) Country Oversight Mechanism: • TWG chaired by MOH • Sub-committees on Management, Protocol, Data, Communications Unique to Malawi PHIA • Oversampling of high prevalence health zones – for greater precision around cascade analysis – interest in making programmatic assessments/comparisons in future rounds • Sample will include adults aged 15-64 Unique to ZIMPHIA Secondary Objectives: • Prevalence of Syphilis • Describing the extent of stigma Sampling: • Sample will include all adults over 15 Questionnaire: • Module for adolescents aged 10-14 Presentation Objective The Future of PHIAs: The PHIA Project On the Horizon: ‘the next 20’ In collaboration with CDC and MOHs , ICAP will conduct PHIAs in ~20 sub-Saharan African countries over the next 5 years • No country list yet Focus on building capacity for population-based surveys • Strengthen capacity in epidemiology, surveillance, statistics and national reference laboratory services to collect, analyze, and use morbidity and mortality data On the Horizon: ‘the next 20’ • Partnerships with experienced groups: – UCSF (KAIS), ICF (DHS), Westat (NHANES), SCHARP (e.g., HPTN/MTN/VTN and SHIMS) and ASLM • Approach for high prevalence countries may differ for low prevalence countries • Use results to assess impact of PEPFAR and guide policies and future programs Key Messages • ICAP’s PHIAs are Population-based HIV Impact Assessments • Rigorously measure key indicators of the epidemic such as • Incidence • Viral Load Suppression Key Messages • They will provide information on HIV program effectiveness that can be used to inform future programs and policies • The first two PHIAs will be in Malawi and Zimbabwe • ICAP will work on ~20 PHIAs over the next 5 years Acknowledgements • The Governments of Malawi & Zimbabwe • United States Centers for Disease Control and Prevention • The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) • Padmaja Patnaik, Suzue Saito, Jessica Justman • The PHIA Team Zikomo, Tatenda, Thank you!