The role and value of a community and stakeholder engagement strategy for the establishment of a Controlled Human Malaria Infection Study (CHMIS) for P. vivax in Bangkok, Thailand. Public

Abstract

South East Asia carries 83% of the global burden of Plasmodium Vivax (P.vivax) malaria[1], and has increasing development of multi-drug resistant P.vivax ¹,[2]. Standard control measures have proven unsuccessful at combating P.vivax, leading the Mahidol Oxford Tropical Medicine Research Unit (MORU) in conjunction with Mahidol University to propose and receive funding to conduct a Controlled Human Malaria Infection Study (CHMIS) to test vaccines, identify correlates of protection and test novel drugs for P.vivax malaria. Due to its study design CHIMS creates a multitude of ethical and regulatory challenges [3],[4].

This thesis was a qualitative case study to examine the role and potential value of a community and stakeholder engagement strategy for the establishment of a P.vivax CHMIS by the Mahidol Oxford Tropical Medicine Research Unit (MORU) in Bangkok Thailand. The aim of the study was to examine: 1.) the unique challenges that arose during the planning and creation of a CSE strategy for a P.vivax CHIMS, 2.) how CSE was used to address these challenge; and 3.) the value of utilizing CSE in the development of CHIMS for P.vivax. Seven in-depth interviews and nine informal interviews were conducted with MORU and Mahidol staff, along with a focus group discussion with global ethical researchers and Thai ethics committee members. Additional data were collected through field observations and literature reviews. Data analysis was conducted using grounded theory and qualitative analysis methods of memo writing, analytic code creation, clustering, and freewriting. Findings showed that a P.vivax CHIMS had unique societal, social and ethical challenges compared to other clinical trial studies and that community and stakeholder engagement functioned as a “de –risking” mechanism for the P.vivax CHIMS in Bangkok, Thailand.

[1] World Health Organization. (2018). “World malaria report 2018.” Retrieved February, 2018 from https://apps.who.int/iris/bitstream/handle/10665/275867/9789241565653-eng.pdf?ua=1

[2] CDC (2018) “Malaria: Frequently Asked Questions” Retrieved from: https://www.cdc.gov/malaria/about/faqs.html

[3] Gordon, S. B., Chinula, L., Chilima, B., Mwapasa, V., Dadabhai, S., Mlombe, Y., & Malawi Research Ethics Workshop 2018 Participants (2018). A Malawi guideline for research study participant remuneration. Wellcome open research, 3, 141. doi:10.12688/wellcomeopenres.14668.2

⁴ Lavery, J. V. (2018). Building an evidence base for stakeholder engagement. Science, 361(6402), 554-556.

 

 

Table of Contents

Contents

Purpose: 1

Objectives: 3

Context: 3

Section 1: Malaria. 3

Malaria infection: 4

Malaria Transmission. 5

Malaria globally. 6

Section 2: P. vivax Malaria. 7

Asymptomatic infection. 8

Evading detection. 9

Relapse. 10

Vector lifecycle: 11

Insecticide and drug resistance. 12

Background and Significance: 14

Section 1: Considerations for the feasibility of large scale vaccine trials for the development of a vaccine for P. vivax 14

Genetic and geographic responses. 14

Insufficient animal models and correlates of protection: 15

Time. 16

Where P.vivax vaccine development is now.. 16

Section 2: Utilizing A Controlled Human Malaria Infection Study (CHMIS) Design in Bangkok, Thailand. 17

Section 3: Considerations for CHIMS. 20

Origins of Human infection studies: 20

Malaria infection studies: 21

Infrastructure- and capacity of medical and scientific communities. 22

Ethical complexities: 23

Ethics and regulatory framework/ considerations. 24

Public perception of Human infection with malaria. 26

The need for Community engagement to address concerns. 26

Methods: 27

Study Design: 28

Data Collection: 28

Data Analysis: 29

IRB Approval: 30

Findings: 30

Section 1: Challenges for P.vivax CHIMS. 30

“Fear of “infection” or participation in the study. 30

Social acceptance of the study. 32

Agreement within the team on what CSE was. 35

Section 2: How challenges were addressed with CSE. 37

Utilizing a stakeholder analysis to remedy a lack of clarity on the goal of CSE. 38

Limiting fear of infection and increasing social acceptance. 39

Section 3: Using CSE to De-Risk the Project. 40

Limitations: 42

Discussion: 42

What is de-risking?. 42

Challenges with the terminology of “de-risking.”. 44

The relational component of CSE. 45

Moving Forward. 46

References: 48

 

About this Master's Thesis

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School	Rollins School of Public Health
Department	Hubert Department of Global Health
Degree	M.P.H.
Submission	Master's Thesis
Language	English
Research Field	Health Sciences, Public Health
Mot-clé	Controlled Human Malaria Infection Studies P. vivax Challenge studies Community engagement Malaria Human infection studies Community and Stakeholder Engagement
Committee Chair / Thesis Advisor	Lavery, James, Emory University

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