Implementation Science: Evidence to Action. Wafaa El-Sadr, MD, MPH, MPA ICAP at Columbia University
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1 Implementation Science: Evidence to Action Wafaa El-Sadr, MD, MPH, MPA ICAP at Columbia University
2 Outline Achievements and challenges in HIV response Knowledge-impact gap (Know-do gap) Research pathway Implementation science ICAP and implementation science Summary and conclusions
3 HIV Treatment Coverage and AIDS-related Deaths, global, Reaching the Third 90: Implementing High Quality VL Monitoring at Scale Ezulwini, Swaziland, June 27-30,
4 New WHO Treatment Guidelines New WHO guidelines recommend HIV treatment for all 4
5 HIV Treatment: Global Targets By % of all people living with HIV will know their HIV status 90% of all people diagnosed with HIV will receive sustained antiretroviral therapy 90% of all people receiving antiretroviral therapy will have durable suppression UNAIDS
6 HIV Continuum
7 Continuum of HIV Care US SubSaharan Africa NA HIV Positive Diagnosed Linked to Care Retained/ Initiated Retained on ART Virus Suppressed
8 Challenges in HIV Care Continuum
9 Critical Issues How to define the target population? How to reach and engage the target population? How to adapt intervention(s) to specific contexts? How to deliver and package the intervention(s)? Why did intervention(s) work/not work? What is acceptability, feasibility and costeffectiveness of intervention(s)? Etc. etc.
10 Initial research often involves populations, procedures and settings that differ substantially from the context of implementation
11 Knowledge to Impact Gap Knowledge Implementation Efficacious interventions Often demonstrated through randomized clinical trials High level of internal validity Engaged communities and target populations Infrastructure Equipment & Supplies Staff Policies Processes Sanders et al, PLoS Medicine, 2006
12 Explanatory versus Pragmatic Research Explanatory Research Descriptive and epidemiologic research What, why, where, who? Intervention research What? Pragmatic Research How to translate knowledge into practice within health and social systems Eccles et al. Implementation Science, 2012 Sanders et al, PLoS Medicine, 2006 El-Sadr et al. NEJM 2014
13 Research Pathway
14 What is Implementation Science? Research to promote the uptake & successful implementation of evidence-based interventions and policies (Sanders) Evidence that informs effective, sustained & embedded adoption of interventions by health systems & communities (Allottey) All aspects of research relevant to the scientific study of methods to promote the uptake of research findings into routine settings in clinical, community and policy contexts Research to significantly improve access to efficacious interventions by developing practical solutions to common implementation problems (WHO) Study of how to accelerate the translation of research-tested interventions into policy and practice (Best) 'Implementation Research is the scientific study of methods to promote the systematic uptake of clinical research findings and other evidence-based practices into routine practice, and hence to improve the quality (effectiveness, reliability, safety, appropriateness, equity, efficiency) of health care. It includes the study of influences on healthcare professional and organizational behaviour.' Sanders et al, PLOS Med, 3:e186; Allottey et al, BMC Pub Health 8:343, WHO;, Best Am J Health Promot 2011 Adapted: accessed 10 February 2009
15 Factors affecting Implementation of health innovations Chaudoir et al. Implementation Science 2013
16 Characteristics of Implementation Science Systematic Multi/interdisciplinary Contextual Complex
17 Characteristics of Implementation Research Systematic Adheres to norms of scientific inquiry Specific intervention, specific setting Balances relevance with rigor Multi/Interdisciplinary Considers biological, social, economic, political, system and environmental factors that impact implementation Collaborations between behavioral and social scientists, clinicians, epidemiologists, statisticians, policy makers, stakeholders
18 Characteristics of Implementation Research (continued) Contextual Relevant to local circumstances and need Generates generalizable knowledge that can be applied across contexts Complex Dynamic and adaptive Occurs at multiple levels of health care system, community Analyzes multi-component programs
19 ICAP and Implementation Science
20 Where ICAP Works
21
22 Implementation Science Studies
23 CIS Components Cascade Step 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Link4Health: Intervention Combination Intervention Strategy (CIS) HIV infected Diagnosed HIV Linked to Care Retained Assessed in Initiated ART Retained Retained Viral Load in in for ART care for Care ART ART Suppression Care eligibility Eligibility 1. Point-of-care CD4 at HIV testing X X X 2. Accelerated ART for CD4 < 350 X X 3. SMS appointment reminders X X 4. Basic care and prevention package X X 5. Non-cash financial incentive X X 23
24 Link4Health: Study Design Cluster-randomized controlled trial 10 study units randomized to CIS versus Standard of Care Study unit included 1 secondary and 1 affiliated primary-level health clinic Study population: > 18 years identified as HIV+ Primary outcome: Linkage: HIV clinic visit within 1 month after HIV testing at assigned study unit and Retention: HIV clinic visit within 12 months (+/- 3 months) after HIV testing at assigned study unit 24
25 Pragmatic Design (PRECIS-2) * * * Loudon et al. BMJ 2015
26 Mapping of Studies Thorpe et al. J of Clin Epi, 2009
27 Link4Health Study * * * Loudon et al. BMJ 2015
28 Approach to the Research Conduct of feasibility assessments with the target population and consultation with program managers and policy makers Interdisciplinary engagement Research done by facility staff rather research staff Selection of standard program outcomes as research outcomes
29 Approach to the Research- 2 Measuring the research outcome through routinely-collected data Adaptation of intervention(s) without loosing fidelity to the core of the efficacious interventions being studied Capturing why and how interventions work/don t work rather than solely focusing on if they work/don t work
30 Summary Many implementation gaps that stand in the way of achieving impact of efficacious interventions Implementation science critical to advancing population health Rigorous and pragmatic research designs are needed that adhere to the principles and framework of implementation science Need for focus on why interventions work/don t work in addition to if they work Partnership between researchers, implementation experts and other stakeholders is critical to the success of research
31 Thank you Asante Sana
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