4.0 INTRODUCTION
This chapter highlights the main study aim and specific objectives of the study. The chapter also presents the study questions that the study sought to answer, as well as the hypotheses that were tested as part of the study.
4.1 MAIN STUDY AIM
The primary aim of the study was to assess microbicide trial research participants’
understanding of randomisation, double-blinding and the use of placebo in the microbicide trial. The main aim was sub-divided into specific objectives.
4.2 SPECIFIC OBJECTIVES
The specific secondary objectives of the study were as follows:
Cluster 1
- To assess and describe the processes and methods that research staff engage in to explain double-blinding, randomisation and the use of a placebo in a microbicide trial.
- To explore the attitudes of research staff regarding full disclosure of information regarding double-blinding, randomisation and placebo to research participants.
Cluster 2:
- To understand whether research participants understand the trial procedures as well as the personal implications of these concepts on themselves.
- To assess research participants’ attitudes towards randomisation, double-blinding and use of placebos.
Cluster 3:
If indicated by cluster 2 above,
- to develop and test an intervention for improving trial participants’ understanding of the above three key concepts and their implications and, if it is successful, to recommend it to researchers for use in future as a way of promoting better informed consent
processes.
4.3 RESEARCH QUESTIONS
The empirical study focused on two main areas; (1) how research staff and study information sheets explain the concepts of double-blinding, randomisation and the use of the placebo and what prominence they give them; and (2) research participants’ understanding and attitudes towards the concepts and whether they considered these three key concepts in making decisions on participation in the microbicide trial.
The main research question for the study was therefore as follows:
• Are trial participants aware that they are participating in a trial which employs randomisation, double-blinding and placebo use and are they aware of the purposes and personal implications of these procedures?
In attempting to address the main research question, the main research question was broken down into various manageable sub-research questions as follows:
1. How do trial related documents explain the concepts of randomisation, double-blinding and placebo use?
2. How do study staff explain the concepts of randomisation, double-blinding and placebo use to prospective trial participants?
3. Are participants aware of the purpose of the study?
4. Are participants aware that they are participating in a trial to test a product whose efficacy is not known?
5. Are participants aware that they are still exposed to HIV infection while they are using the experimental product they have been issued with?
6. Are trial participants aware that randomisation, double-blinding and placebo use are part of the study?
7. Are trial participants aware of the reasons why randomisation, double-blinding and placebos are used in the study?
8. Are participants aware of the various study arms in the microbicide study?
9. Are participants aware that they have been randomised into different groups?
10.Are participants aware that they may be receiving a placebo?
11.Are participants aware that neither themselves nor the trial nurses and doctors (i.e., research personnel) are aware of the arms they are in?
12.Are trial participants aware of the personal implications of randomisation, double- blinding and placebo use?
13.Are participants aware of the implications of their participation, regarding protection from infection by the product under test?
14.What are the attitudes of the trial participants regarding randomisation, double-blinding and placebo use?
15.Can an intervention improve trial participants’ understanding of research, randomisation, double-blinding and placebo use?
4.4 STUDY HYPOTHESES
The hypotheses for the current study were formulated on the basis of the aims, specific objectives and research questions that were generated for the study. Hypotheses were only generated for the most important research questions as follows:
A. Informed consent forms and materials provide adequate information on randomisation, double-blinding and placebo use. This hypothesis was tested using data from document review and indepth interview with study staff responsible for obtaining informed consent.
B. Research staff have a positive attitude regarding full disclosure of information on blinding, randomisation and placebos to research participants. This hypothesis was tested using data from structured interviews and focus group discussions with participants from the microbicide study.
C. Trial participants are aware that the procedures of double-blinding, randomisation and placebo use are being used in the trial. This hypothesis was tested using quantitative and qualitative data from the structured interviews and focus group discussions with
selected microbicide trial participants.
D. Trial participants are aware of the purpose of double-blinding, randomisation and placebo use in research. This hypothesis was tested using quantitative and qualitative data from the structured interviews and focus group discussions with selected
microbicide trial participants.
E. Trial participants understand the personal implications of the trial procedures under study. This hypothesis was tested using quantitative and qualitative data from the structured interviews and focus group discussions with selected microbicide trial participants.
F. Trial participants do not believe that they are completely protected from HIV infection by the microbicide under study. This hypothesis was tested using quantitative and qualitative data from the structured interviews and focus group discussions with selected microbicide trial participants.
G. Trial participants have a positive attitude towards double-blinding, randomisation, and use of placebos. This hypothesis was tested using quantitative and qualitative data from the structured interviews and focus group discussions with selected microbicide trial participants.
H. Research staff provide adequate information on double-blinding, randomisation and placebo use to trial participants. This hypothesis was tested using qualitative data from the indepth interviews with four study staff members responsible for obtaining informed consent. Data from the focus group discussions with selected microbicide trial
participants was also used in considering whether to support or reject this hypothesis.
I. An intervention using common language and examples can assist in improving
understanding about randomisation, double blinding and placebo use. Quantitative and qualitative data from the implementation phase of the current study was used in
considering whether to accept or reject this hypothesis.
4.5 SCOPING THE BOUNDARIES OF THE STUDY
It is important to clearly demarcate the boundaries of this study in line with the main research question, sub-research questions, main aim, specific objectives and hypotheses of the study. In this section, the boundaries of the study are clearly laid out.
• The study which forms the subject of this thesis was conducted in Blantyre and Lilongwe in Malawi. The findings may therefore not be generalisable to participants from any other sites or clinical trials beside the two study sites.
• The study specifically sought to assess the understanding of trial procedures by participants from a specific microbicide trial (HPTN035).
• The study is not aimed at focusing on the making of decisions to participate in research broadly, but seeks to find out if participants had understood the procedures of randomisation, double-blinding and placebo use as these are important in making their decisions to participate.
• The study population for the study consisted of 780 women from 2 sites in Malawi who were on the 3 gel-arms of the 4-arm microbicide study, and study staff who were involved in obtaining informed consent for participation in HPTN035. The participants from the microbicide study formed the main units of analysis.
• The study attempted to interpret why trial participants understand or do not understand by focusing on the information that was provided to them (looking at trial documents and interviewing study staff) and by assessing a sample of the microbicide trial participants.
• The main purpose of the study was to assess understanding using a tool that was developed specifically for the study and thereafter to test an intervention that was also specifically designed for the study. The main purpose was not to test the usefulness of an existing test of understanding.
• The main aim of the study was not to improve informed consent. While the study is aimed at improving informed consent, the focus was on understanding of the three concepts under study. In this way the current study contributes in an indirect way towards the improvement of informed consent as informed consent is much broader than an understanding of the three concepts.
4.6 SUMMARY
The main aim of this chapter was to clearly lay down the main aim of the study, followed by the specific objectives, study questions, study hypothesis and boundaries of the study. The main aim of the study as the topic suggests was to assess microbicide trial participants’
understanding of randomisation, double blinding and placebo use. Based on the review of literature and anecdotal evidence from the field, the researcher believed that research participants with low levels of understanding would be identified. This placed on the
investigator an ethical obligation to offer a potential intervention should the study reveal low understanding. The intervention was to be based on the findings from the current study and on previous research identified in the literature review. The answers to the hypotheses and
research questions are presented in Chapter 11.