Volunteers’ Perceptions and Experiences of Clinical Research Participation in Kenya: Case study of KAVI Emily Nyariki PhD Student KAVI, Department of Medical Microbiology University of Nairobi
Dec 23, 2015
Volunteers’ Perceptions and Experiences of Clinical Research Participation in Kenya:
Case study of KAVI
Emily Nyariki PhD StudentKAVI, Department of Medical Microbiology
University of Nairobi
Presentation Outline
BackgroundProblem statementObjective (s)Research question (s) and hypothesisMethodologyStudy Population Data Collection and analysisExpected Outcomes
2
Background
• Increased number of people living with HIV
Global: An estimated 34.0 million Sub Saharan Africa : An estimated
23.4 million Kenya: An estimated1. 6 million Decline in HIV prevalence for Kenya
observed– at 6.3% (KDHS 2008/9 ) to 6.2% (NACC 2012)
In Kenya (2011)approx. 91,000 adults and 12,894 children under age 15 became newly infected with HIV
3 (UNAlDS , 2012).
Problem Statement
• Conduct of clinical research faces unique challenges that hinder optimal recruitment of volunteers
• Some eligible volunteers fail to turn up for the actual enrolment
• Lau and colleagues (2011) have argued that clinical research occurs within a context where biomedical science and social issues are interwoven
• Limited studies have attempted to assess the quality and efficacy of the entire clinical research process from the subject's perspective.
4
Objectives
Broadly, this study aims at exploring volunteers’ perceptions and experiences of clinical research participation and their potential on decision making to participate in clinical research.
Specific objectives will be to: • Establish the characteristics of individuals who
participate in clinical research studies• Establish volunteers’ perceptions towards clinical
research• Establish volunteers’ experiences at various
stages of clinical research • Identify factors that enhance/constrain volunteers’
clinical research participation experience5
Study Scope and Justification
• Scope: Study will be conducted in Nairobi and will draw participants from KAVI Clinical sites
• Justification: A number of challenges still face the conduct of clinical research and study will inform the design and recruitment processes of future studies lead to increased understanding of the barriers that hinder volunteer participation
6
Research Question and Hypothesis
• Question: How are volunteers’ perceptions and experiences of participation in clinical research likely to affect their decision making and willingness to participate in clinical research?
• Hypothesis: Volunteers’ perceptions and experiences of clinical research participation are likely to impact on their decision making and willingness to participate in clinical research.
7
Theoretical Framework
• This study is grounded on the phenomenological approach advanced by Husserl (2001)
• An approach that seeks to understand phenomena through the actors in the situation.
• It looks at the meaning or significance of individuals’ lived experience
• It studies structure of various types of experience that range from perception, thought, memory, imagination, emotion, desire , social activity
8
Conceptual Framework
9
Study Methodology
10
• A mixed method design (Creswell 2003)• Qualitative methods will be applied as they
lay greater emphasis on understanding and description of phenomenon and of decision making processes.
• Quantitative method will be used to capture social and demographic data and data relating to experiences
• Allows for inferences to be drawn using both qualitative and quantitative approaches
Study Population
11
Data will collected in 2 phases• 233 Survey Questionnaires• 35 IDIs and 8 KIIs
• Quantitative data will be cleaned, coded and analysed using SPSS
• Qualitative data will be cleaned, coded and analysed using Atlas ti.
12
Data collection and analysis
Expected Outcomes
• An understanding of the characteristics of volunteers likely to participate in clinical research
• Increased understanding of volunteers experiences of clinical research participation
• Increased understanding of enhancers and barriers to volunteer participation in clinical research
13
Acknowledgements
1. Prof Joyce Olenja
School of Public Heath
University of Nairobi
2. Dr. Robert Read Lorway
Department of Community Health
University of Manitoba
3. Prof. Omu Anzala
Department of Medical Microbiology
University of Nairobi
14