Good Participatory Practice: An Investigator s Perspective on Evaluating Engagement Strategies

Transcription

1 Good Participatory Practice: An Investigator s Perspective on Evaluating Engagement Strategies Kathleen M. MacQueen, PhD, MPH CPTR 2014 Workshop Panel on EVALUATING THE IMPACT OF ENGAGEMENT ON TB DRUG DEVELOPMENT September 25, 2014 Washington, DC

2 Background October 2012: CPTR SCE-WG issues Good Participatory Practice Guidelines for TB Drug Trials (GPP-TB) Based on similar guidelines for HIV Indicative of the importance of community engagement and participatory strategies But empirical assessment of the benefits and burdens has languished We proposed using a Theory of Change approach to develop an evaluation process for GPP-TB

3 Developing a Theory of Change for Evaluating Good Participatory Practices in TB Drug Trials 2 year project with NIAID/NIH funding (5R21AI108519) Funded July 2013 FHI 360 lead organization Kate MacQueen, PI Carol Dukes Hamilton, Co-Investigator Natalie Eley, study coordinator Treatment Action Group (TAG) partner organization Mike Frick, TAG project lead

4 Objectives AIM 1: Bring TB drug trials stakeholders together to map a GPP-TB Theory of Change (TOC) Develop an evaluation strategy that is plausible, doable and testable AIM 2: Work with global TB trials to conduct formative research Develop and pilot priority outcome measures suitable for an ethical analysis of risks, benefits and social value in TB trials

5 AIM 1: Stakeholder engagement Advisory Board established Laia Ruiz Mingote, Nomampondo Barnabas, Stephanie Seidel, Stefan Goldberg, Jerome Singh, Stacey Hannah, Udom Likhitwonnawut, Natalie Nelson Skipper, Jim Lavery Full-day stakeholder meeting held in Decatur, GA in October 2013 with Advisory Board & others Stakeholder and Community Engagement Workgroup (SCE-WG) Critical Path to TB Drug Regimens (CPTR) Community Research Advisory Group (CRAG) AVAC TB Trials Consortium (TBTC)

6 TOC: what is the GPP-TB ethical goal? GPP-TB does not provide an explicit ethical goal, but notes that the principles and benchmarks described serve as the ethical framework underlying the GPP-TB (p. 16) Evaluation of the effectiveness of GPP-TB for enhancing ethical outcomes requires a clearly defined ethical goal Consensus statement on GPP-TB ethical goal: TB clinical trials demonstrate social value, achieve increased access across stakeholders, and meet standards of acceptability

7 TOC ethical goal: definitions SOCIAL VALUE: a trial is responsive to global and local needs and equitably alleviating the burden of TB disease, where equitably refers to the fair distribution of benefits from the research. INCREASED ACCESS: a trial is responsive to all TB stakeholders (end users, communities, researchers, drug companies, policy makers, providers) with regard to access to the drug/product, to trial results regardless of the outcome, to communities where trials can be conducted, and to markets for drug/product. STANDARDS OF ACCEPTABILITY: a trial includes consideration of whether the drug/product is one that end users, decision makers, policy makers, providers and funders will use and support.

8 TOC: identify powerful strategies to achieve goal Core GPP-TB programmatic strategies intended to address the ethical goal Each strategy reflects practices to be enacted by multiple groups of stakeholders Reflects overall participatory approach of GPP-TB Identified 5 powerful strategies that overlap with and cross-cut practices outlined in GPP-TB

9 TOC: GPP-TB practices & powerful strategies Good Participatory Practices Powerful Strategies Accountability mechanisms Community mapping Shared learning Responsible advocacy Deliberation

10 TOC: identify short term outcomes If the powerful strategies are being implemented, what immediate outcomes should we anticipate? POWERFUL STRATEGY Accountability mechanisms Community mapping Shared learning Responsible advocacy Deliberation SHORT-TERM OUTCOME INCREASED transparency & integrity in representing interests and expectations, and in maintaining scientific standards INCREASED identification of needs & understanding of context (local / research / global public health) INCREASED shared stakeholder knowledge (literacy on community context, research context & TB) INCREASED awareness, political will, & resources for TB clinical trials & community engagement INCREASED use of formal discussion & negotiation to ensure options for mutual gain are pursued when trade-offs in principles or benchmarks are needed

11 TOC: short-term outcomes Provide the foundation for GPP-TB principles to be realized Lead to GPP-TB benchmarks demonstrating that the principles are realized

12 Intermediate & long-term outcomes Document the results of the enactment of GPP-TB principles Three broad cross-cutting outcomes identified through consensus process Stakeholders are empowered to decide together if a given trial is appropriate in a given community Investigational products demonstrated to be effective are made available to trial participants & local community stakeholders Stakeholders are clear about what a trial can accomplish in a particular community

13 GPP-TB theory of change model POWERFUL STRATEGIES SHORT-TERM OUTCOMES GPP-TB PRINCIPLES GPP-TB BENCHMARKS INTERMEDIATE & LONG-TERM OUTCOMES ETHICAL GOAL Accountability mechanisms Community mapping Shared learning Responsible advocacy Deliberation Mutual understanding Complementarity Efficiency Respect Fairness Integrity Transparency Accountability Autonomy Increased transparency & integrity Increased understanding Increased shared knowledge Increased awareness, political will & resources Increased options for mutual gain Effective products made available Potential trial outcomes clear Shared decision making about site involvement TB clinical trials demonstrate social value, achieve increased access across stakeholders, and meet standards of acceptability

14 GPP-TB Evaluation Framework

15 AIM 2: Conduct formative research TOC Framework is being used to develop data collection instruments On-line survey In-depth interview guide Instruments will be piloted at 3 TBTC sites Baseline data collection GPP-TB implementation training (web-based) 6-month follow-up data collection Pilot focus is on research site implementation

16 Interview guide Collect descriptive baseline information from sites about The kinds of stakeholders they recognize The extent to which they are using each of the powerful strategies identified in the TOC framework The extent to which the ethical goal identified in the TOC framework is shared Their familiarity with and perceived usefulness of GPP-TB Similar/related questions will be asked 6 months after the GPP-TB implementation training

17 Survey design Collect indicator data from sites showing Actions taken by sites that are aligned with each of the powerful strategies Short term outcome indicators Evidence that GPP-TB principles are being realized Benchmark outcome indicators Results of GPP-TB principles being realized Long term outcome indicators Similar/related questions will be asked at follow-up

18 Survey design: example Powerful strategy = Accountability mechanisms Does your site have an active community advisory board (CAB), community advisory group (CAG) or similar mechanism in place for TB-related research? Short-term outcome = increased transparency Thinking about all the different community members and stakeholders that your site has interacted with in the last 12 months, how often was your site able to provide updates to them in their preferred language and format (e.g., face-to-face meetings, newsletters, )?

19 Survey design: example GPP-TB benchmark = mutual understanding Thinking about all the TB trials research staff at your site, how many could speak knowledgeably about the following topics? Cultural norms, practices and beliefs of your site's research participants Social, political and economic circumstances of your site's research participants The diversity of viewpoints held by TB research stakeholders in the local community The diversity of viewpoints held by TB research stakeholders in your country The scientific research process that guides TB clinical trials The kinds of considerations included in the design of a TB clinical trial How to collect TB trial data How to analyze TB trial data How to explain the findings from a TB clinical trial

20 Survey design: example Ethical goal = social value, access, & acceptability Thinking about the most recent clinical trial that your site implemented, which of the following are true for that trial? Please check all that apply. Our site was not able to recruit the target number of participants Our site was not able to retain and follow up with the target number of participants Our site was closed early due to recruitment or retention problems but the trial continued at other sites The trial was closed early The trial was successfully completed The trial demonstrated efficacy in one or more treatment arms The trial ultimately led to new TB treatment or prevention guidelines The experimental drug tested in the trial is not suitable for use in the local context The experimental drug tested in the trial is now available and affordable in our local community The experimental drug tested in the trial is available but many providers refuse to use it The experimental drug tested in the trial is available but many patients refuse or fail to use it as directed The experimental drug tested in the trial is available and successfully used by providers and patients The trial results have contributed to lower TB morbidity and mortality in our country

21 Summary TB trials stakeholders engaged Theory of change evaluation framework developed Evaluation tools being finalized Planning for pilot data collection underway

22 THANK YOU!