Summary* of Track D presentations Operational Research

1. Summary* of Track D presentationsOperational Research • Carla MakhloufObermeyer**, World Health Organization • Rachel Baggaley, World Health Organization • Peter Godfrey-Faussett, London School of Hygiene and Tropical Medicine • Melissa Neuman, Harvard School of Public Health • George Schmid, Centers for Disease Control and Prevention, USA • Reuben Granich, World Health Organization • Chika Hayashi, World Health Organization • Yves Souteyrand, World Health Organization • *Not exhaustive, thanks to presenters whose slides we freely used • **Lead rapporteur

2. Promotingoperationalresearch on HIV GUIDE TO OPERATIONAL RESEARCH IN PROGRAMS SUPPORTED BY THE GLOBAL FUND Since 3x5 at WHO, collaborations with multiple partners 2008 Consensus statement (WHO, World Bank, Global Fund, IAS) 2009 Track D

3. Operational research: definition, scope, and questions • Many definitions, different flavors…some agreed upon elements: • Analysis, problems /programsdecisions, improvements • NOT: basic science, theoretical, pure clinical, hard core social science • Pragmatic combination of approaches • Exact scope may not matter • Middle ground: between lab and field, pure science and common sense • Multi-disciplinary—core disciplines? • ?Just right? • Consensus statement of 2009: delivering treatment and care • Current scope for IAS: • Improving efficiency of service delivery • Impact evaluation • Human resources • Integration • Financing • Using operational research Definitions and scope Goldilocks research Evolving field

4. Major themes from Track D and outline of presentation • How technologies and tools perform in settings where they are applied • Testing and diagnostics • Tools to increase injection safety, reduce harm (eg IDUs) • How elements and linkages within the system influence outcomes • Improving health information, reporting, indicators • Human resources, task shifting • Decentralization • Integration • Focus on testing as the starting point • What happens after entering ‘the gateway’ 1. Public health approach 2. Systems perspective 3. Cascades and retention 4. Reflections on the track • Is OR a distinctive approach to research? • Gaps and missing elements • How IAS defines and supports OR—Track D

5. 1. The Public Health Approach: subthemes • Evaluating new and old tools and technologies, with special attention to their performance in field conditions • Major focus on Point Of Care (POC) technologies and rapid tests • Progress in several diagnostic technologies for CD4, TB testing, • meningitis, resistance • Other technologies: safe injections and harm reduction • Potential for further OR: male circumcision, biomedical prevention, and how they operate in field conditions • Feasibility, cost-effectiveness • Modelling—belongs in OR? • Intervention evaluation in field conditions—do presentations live up to this? Methods/ approaches

6. 1. The public health approach: illustrative presentations on point of care (POC) • Evaluation of mobile HCT program for CD4 testing (ACCESS VCT) by Larson et al. • Pilot shows POC CD4 testing can be integrated into routine HCT mobile program. • More patients receiving POC CD4 test at HCT completed a referral visit within 8 weeks of testing. Referral up from 39% to 65%

7. 1. The public health approach: comments • Evaluating new and old tools and technologies, with special attention to their performance in field conditions • Major focus on Point Of Care (POC) technologies and rapid tests • Progress in several diagnostic technologies for CD4, TB testing, • meningitis, resistance • Other technologies: Safe injections, and harm reduction • Feasibility, cost-effectiveness • Modelling—belongs in OR? • Intervention evaluation in field conditions—do presentations live up to this? Methods/ approaches

8. Major themes from Track D and outline of presentation • How technologies and tools perform in settings where they are applied • Testing and diagnostics • Tools to increase safety, reduce harm • Elements and linkages within the system and their effects on outcomes • Improving information, reporting, indicators • Human resources, task shifting • Decentralization • Integration • Focus on testing as the starting point • What happens after entering ‘the gateway’ 1. Public Health Approach 2. Systems perspective 3. Cascades and losses • Is OR a distinctive approach to research? • Missing elements • How IAS defines and supports OR—Track D 4. Reflections on the track

9. 2. Systems: subthemes, part 1 • Efforts to evaluate changes in HR, special attention to task shifting • Initiation of treatment/ viral load suppression/ mortality Malawi, South Africa • Circumcision in Kenya and Swaziland • Integrated testing, Ethiopia • Using information, developing indicators, triangulating data • Decentralization of information, reviewing program indicators, Lesotho • Early warning indicators of drug resistance Central America • Triangulating data for priority setting in India Human Resources Information, M & E

10. 2. Systems: subthemes, part 2 • Growing evidence • Decentralize lab testing in 6 African countries • Enrollment and referral of patients on ARV at lower level facilities, S Africa • Services around HIV • Continuum of care, Cameroon • Retention and attrition, Mozambique • Integrating FP and HIV, Tanzania • Integrate HIV prevention into care services, Uganda • Integrating HIV services with those of other diseases • TB-HIV in SA and Uganda • HIV diabetes in Ethiopia • Malaria and HIV in Uganda Decentralization Integration • Dynamic area of research • Definitions issues, especially for integration • Centralization impact tends to be better documented, but not uniform • Impact of integration more difficult to demonstrate • Assessing full packages or their individual contents?

11. 2. Human resources: illustrative presentations • Task shifting: evaluation of the STRETCH trial through a pragmatic, cluster randomised design, Fairall et al. Primary care clinics, South Africa, randomly allocated (intervention/control) 2 cohorts: already on ART (6K patients), waiting list, CD<350, (9K patients) Outcomes: viral suppression@12 months, mortality@12-18 months No worse outcomes in nurse-led management No overall difference in mortality

12. 2. Decentralization: illustrative presentation Decentralization of HIV pediatric services (Fayorsey et al.) •  Kenya, Lesotho, Mozambique, Rwanda and Tanzania. • Pediatric enrolment, ART initiation, LFU and mortality between primary and secondary/tertiary facilities. • Primary care facilities outcomes are more favorable than secondary Indicators of mortality and loss to follow-up

13. 2. Integration: illustrative presentation Integration of HIV Treatment in Primary Health Care Centers and Attrition from HIV Treatment Programs in Central Mozambique, Lambdin et al. 2004: National program 2006: ART integrated in PHC Whileintegrationwas essential for scaling up ART, retention maybe higher in thoseclinicsthat are still « vertical »

14. 2. Integration of diabetes care in HIV services: illustrative presentation Integration of non-communicable disease care in Ethiopia, Rabkin et al. • Six-month outcomes • Marked increase in documented service delivery with no added staff; • Expansion of services: peer education, point-of-service diabetes screening for family members; • Rapid improvement in standards of care. •  Possible to leverage HIV services to expand coverage of other pathologies

15. 2. Systems: Comments • Efforts to evaluate changes in HR, special attention to task shifting • Using information, developing indicators, triangulating data • Services around HIV • Integrating HIV services with those of other diseases Human Resources Information, M & E Decentralization Integration Dynamic area of research • Definitions issues, especially for integration • Centralization impact tends to be better documented, but not uniformly so • Impact of integration more difficult to demonstrate • Assessing full packages or their individual contents?

16. Major themes from Track D and outline of presentation • How technologies and tools perform in settings where they are applied • Testing and diagnostics • Tools to increase safety, reduce harm • Architecture and linkages among different components of the system • Information, reporting, indicators • Human resources, task shifting • Decentralization • Integration • Focus on testing as the starting point • What happens after entering ‘the gateway’ 1. Public Health Approach 2. Systems perspective 3. Cascades and losses • Is OR a distinctive approach to research? • Missing elements • How IAS defines and supports OR—Track D 4. Reflections on the track

17. 3. Cascades and retention • Assessing impact of different approaches to testing: PITC in clinics, in US Emergency Departments, in China • Uptake, knowledge of HIV status, factors that influence testing • Outreach: home-based in Kenya • Loss-to-follow-up (LTFU) after PMTCT testing in Malawi, in 7 countries of Sub-Saharan Africa, in Thailand • Intervening in the cascade: involving communities, referral of people who use drugs US, information sharing, cell phones, etc., to reduce LTFU Testing as the gateway What happens afterwards Key questions on testing: • Yield (percent positive), cost-effectiveness of different modes of testing • Factors that hinder or facilitate testing—stigma, motivations, attitudes, context • How different modes perform: access, quality testing and 3-Cs, linkage to care • After the test: "Know your cascade"? • Simplify indicators • Learn from interventions

18. 3. Testing as gateway: Illustrative presentation Assessing opt-in and opt-out in a Los Angeles study, Majahan et al. Factors that predict test acceptance (N=3,664) • Odds of acceptance of opt-out/MD 6 times more likely than RN • Sociodemographic characteristics affect acceptance • Those not tested recently more likely to accept * p<0.0001, Model also adjusted for clinical site

19. 3. Retention, illustrative presentation Retention in care : patient advocates (Greenwood et al.) Patient advocates (PAs) assigned to children on ART with PAs Retention in care logrank P = 0.027 without PAs Adjusted hazard of attrition of patients with PAs: 0.57 (CI: 0.35–0.94) logrank P = 0.027 Note: uncertainties about confounding and clustering in statistical analyses

20. 3. Retention, illustrative presentation • 3 Big Pediatric Challenges for HIV in Malawi • 100K children with HIV (majority unidentified) • Poor PMTCT coverage (35%) high loss to follow-up > 50% • 30,000 babies contract HIV each year THE TINGATHE PROGRAM: Community Health Workers Improving PMTCT, EID, and Pediatric HIV services, Hamed et al. Community Health Workers can improve case finding and patient enrollment into care, retention and linkages among HIV services

21. 3. Cascades and losses: Comments • Assessing impact of different approaches to testing: PITC in clinics, in US Emergency departments, in China: uptake, knowledge of HIV status, factors that influence testing • Outreach: home-based in Kenya • Loss-to-follow-up (LTFU) after PMTCT testing in Malawi, in 7 countries of SubSaharan Africa, and Thailand • Intervening in the cascade: referral of people who use drugs US, providing information, cell phones, etc, to reduce LTFU Testing as the gateway What happens afterwards Key questions on testing: • Yield (percent positive), cost-effectiveness of different modes of testing • Factors that hinder or facilitate testing—stigma, motivations, attitudes, context • How different modes perform: access, quality testing and 3-Cs, linkage to care • After the test: "Know your cascade"? • Simplify indicators • Identify key points to intervene • Promote systematic assessment of interventions

22. 4. Reflections on OR in Track D • Field of OR reflects broader changes in response to HIV epidemic • OR limited potential for scientific breakthroughs, but important nitty-gritty elements: how new technologies perform, how to implement/ scale-up in equitable ways • Is OR on HIV a residual category, is it similar to monitoring or is it a field of inquiry? • What are the building blocks of OR on HIV? • Intervention assessment: need a Goldilocks approach • ‘Technologies’, ‘interventions’ are not a given, providers and clients re-appropriate them • What would enrich and strengthen OR on HIV? • Re-think the notion of ‘what works’ and the criteria (economic, time perspective) • Problematize centralization, integration, ‘cascades’ develop better definitions and designs • Broaden the definition of ‘system’ • Avoid reductionism, include more context, local adaptations communities, actors • Truly multi-disciplinary approaches to research are possible