MEASURING THE IMPACT OF

COMMUNITY ENGAGEMENT

ON TB CLINICAL TRIALS

A Case Study from the Tuberculosis Trials

Consortium

Mike Frick, MSc

Project Officer, TB/HIV

Treatment Action Group

Erica Lessem

Lindsay McKenna

Lakshmy Menon

Laia Ruiz Mingote

Dorothy Namutamba

Carol Dukes Hamilton

Growing consensus that community engagement is an

essential part of ethical TB trials…

“According to a growing consensus among biomedical researchers, community engagement can improve the ethics and outcomes of clinical trials….To build momentum, lessons need to be shared, and formal assessment strategies for community

engagement initiatives need to be developed.”

…little information on the impact of community

engagement on the overall success of trials

• Many researchers believe that community engagement

means increasing recruitment, enrollment and retention of participants into trials

• Questions persist re. autonomy of community advisory boards and their role in post-trial access issues, including results dissemination and access to investigational products

• Lack of consensus on the ethical outcomes of community engagement: what can sponsors expect from their investments in community engagement programs?

To help answer these questions, the CRAG embarked

on a monitoring and evaluation project

Community Research Advisors Group (CRAG)

• an international, community-based advisory body

• ensures the meaningful engagement of TB-affected communities in research conducted by the U.S. CDC’s TB Trials Consortium (TBTC)

• supports a TBTC research agenda that is responsive to community needs and scientific priorities.”

Approach

• Partnered with CDC Department of TB Elimination Field Services & Evaluation Branch to develop a system to monitor and evaluate CRAG activities

• Trained CRAG members in M&E concepts • Worked with CRAG members to define strategic goals • Used these goals to anchor “logic models” that could

a) demonstrate the cause-and-effect of CRAG members’ work b) function as simple planning and evaluation tools used by CRAG members when developing annual community engagement and advocacy work plans c) provide an M&E template for other community engagement groups working on TB clinical trials

Results Strategic goals identified at several levels of engagement

TB Trials Consortium

TB-affected Communities

Policymakers and Donors

Clinical Trials Sites

Social,

Political,

Economic

Context

Community

Context

Research

Context

TB Trials Consortium • Ensure community priorities reflected in TBTC research priorities

• Ensure CRAG members involved in protocol development

• Contribute to increased recruitment, enrollment and retention

Community • Increase local community knowledge of TB and TB research

• Ensure participants in TBTC research understand potential risks

• Ensure communities understand results of TBTC studies

• Ensure communities have access to the benefits of TB/TBTC research

TBTC Sites • Ensure that TBTC researchers understand their local communities

• Promote communication between communities and TBTC sites

Policymakers

• Increase support for TB and TBTC research

• Influence local and national policy impacting TB

Example: should bedaquiline be studied in new,

experimental regimens for drug-sensitive TB?

CRAG Member Advocacy and Community Engagement Work Plan

Individual project Process indicators Outcome indicators

Related Terms of Reference

(TOR) Activities

Related

Expenses Objectives Quantitative / Qualitative

Quantitative / Qualitative

Read FDA

briefing document

to understand

bedaquiline safety

issues

Ask community

members for their

opinions

Read publicly

available materials

$0.00

Meeting space for

community forum–

$100.00

Transportation

vouches for

participants $50.00

Decide if

bedaquiline should

be studied for DS-

TB and provide

guidance to TBTC

and other TB

researchers

# of sources consulted (guidelines,

articles, experts, package insert)

# of teleconferences held to discuss

issues

Narrative recount of teleconference

discussion

Narrative description of

community forum discussions

# articles written

# abstracts written

# conversations with CABs

# conversations with researchers

and primary investigators

Long-term follow-up of

bedaquiline’s inclusion into

experimental DS-TB reigmens

CRAG members continually build TB and

research literacy skills.

Ensure community priorities reflected in

TBTC research priorities.

Lessons learned

• Community engagement is a professional space

• This professional space unites the different constituencies of a clinical trial, from funders to researchers to study participants

• The issues impacted by community engagement extend well beyond informed consent among study participants • Research agenda setting

• Results dissemination

• Post-trial access to medicines

• Funding for TB research

• Mobilization of political will

… all stages of the research lifecycle

Access (early access, price, registration)

Before research begins

Program implementation

and policy change

During research

When research ends

Framing research question

Engagement of site communities

Results dissemination

Uptake of evidence-based policies

Support for recruitment, informed consent, retention

Practical implications of research

Communication of priorities, concerns, information

Protocol review

Ethics consultation

Thank you Acknowledgments

Members of the CRAG,

Awal Khan, TBTC leadership

Questions?

mike.frick@treatmentactiongroup.org