RESEARCH METHODOLOGY
5.8 RESEARCH QUESTIONS AND METHODS
• Involved in obtaining informed consent for the microbicide trial during past 3 months or more
• Available at the site during the data collection period
• Provided informed consent for the in-depth interview
microbicide trial participants as they were exiting the sites. Upon confirmation of their participation in the microbicide study as well as their microbicide study arm, the eligible women were then briefed about the present study. The study only recruited women from the 3 gel arms of the four arm study. Upon obtaining their verbal consent, the respondents for the present study were then selected using a random procedure. Each potential respondent was requested to pick up a small piece of paper from a box. In the box were small pieces of paper labeled either 1 or 2. All those who picked small pieces of paper labeled with figure 2, were invited to participate in the structured interviews or focus group discussion. In the box there were twice the number of papers labeled 2 as compared to those labeled 1. This was aimed at speeding up the recruitment drive in view of the limited study resources. Using this procedure, 54 women were recruited for structured interviews at the Lilongwe site and 149 at the Blantyre site. For the focus group discussions, women who picked up small papers labeled 2 were invited for the discussions on specified times at the two cites. Using the same procedure, 10 women were invited at each site for the focus group discussion. At the Blantyre site, 8 women responded to the invitation while 10 responded positively at the Lilongwe site. Those who picked up papers labeled number 1 were thanked for their patience, offered refreshments and excused. This procedure was aimed at ensuring the randomness of the samples for both structured interviews and focus group discussions.
5.8.2 Information Disclosure
The study focused on how research staff and study information sheets explained the concepts of double-blinding, randomisation and the use of placebo, and what prominence they gave them.. In order to answer the question about the information disclosure, the following sub- questions were asked:
a. How do trial related documents explain the concepts of randomisation, double- blinding and placebo use, and what level of prominence are the concepts given?
b. How do study staff explain the concepts of randomisation, double-blinding and placebo use to prospective trial participants, and what prominence are they given?
To answer these questions, trial documents were analysed for content and in-depth interviews were conducted with study staff who were involved in the processes of obtaining informed consent. The various methods used are described in greater detail in Section 5.9. In-depth interviews allowed for direct contact with the respondents and the opportunity to use probing questions to obtain pertinent data on the informed consent processes and the disclosure of information to trial participants. To triangulate and verify data on the disclosure of
information, data was collected from various sources: programme documents, staff involved in informed consent, and trial participants. Using the data obtained in response to the above sub- questions, the following hypotheses were tested:
a. Research documents adequately explain the purpose, implementation and personal implications of randomisation, placebo use and double-blinding.
b. Research staff provide adequate information on double-blinding, randomisation and placebo use to trial participants.
c. Research staff have a positive attitude regarding full disclosure of information on double-blinding, randomisation and placebos to research participants
5.8.2 Research Participants’ Understanding
The study focused on how the procedures of randomisation, double-blinding and placebo use were understood by the participants, as well as their attitudes to these procedures. The study also sought to understand whether the participants had considered these three key concepts in making decisions about participation in the microbicide trial. In attempting to
address the question about trial participants’ understanding, the following sub-questions were asked:
a. Are participants aware of the purpose of the study?
b. Are participants aware that they are participating in a trial to test a product whose efficacy is not known?
c. Are participants aware that they are still exposed to HIV infection even as they are using the product that they have been issued with?
d. Are trial participants aware that randomisation, double-blinding and placebo use are part of the study?
e. Are trial participants aware of why randomisation, double-blinding and placebos are used in the study?
f. Are participants aware of the various study arms in the microbicide study?
g. Are participants aware that they have been randomised into different groups?
h. Are participants aware that they may be receiving a placebo?
i. Are participants aware that neither themselves nor the trial nurses and doctors (i.e., research personnel) are aware of the arms they are in?
j. Are trial participants aware of the personal implications of randomisation, double- blinding and placebo use?
k. Are participants aware of the implications of their participation, regarding protection from infection by the product under test?
l. What is the opinion of the trial participants regarding randomisation, double- blinding and placebo use?
m. In making the decision to join the microbicide study, did trial participants consider the fact that the study involves randomisation, double-blinding and placebo use?
To answer these questions, structured interviews and focus group discussions were held with a sample of the women participating in the microbicide trial. To triangulate and verify data on participants’ understanding, data was collected using various methods. Some data from the review of study documents, in-depth interviews with study staff, and field notes were used to verify or support the findings from the structured interviews and focus group discussions.
Using the data collected in response to the above sub-questions, the following hypotheses were tested:
A. Trial participants are aware that the procedures of double-blinding, randomisation and placebo use are being used in the trial.
B. Trial participants are aware of the purpose of double-blinding, randomisation and placebo use in research.
C. Trial participants understand the personal implications of the trial procedures under study.
D. Trial participants consider the three concepts when making a decision to agree or refuse to participate in the microbicide trial.
E. Trial participants do not believe that they are completely protected from HIV infection by the microbicide under study.
F. Trial participants have a positive opinion regarding double-blinding, randomisation, and use of placebos.
5.8.3 Intervention to Improve Understanding
In the event that some microbicide trial participants with low levels of understanding were identified, an intervention aimed at improving understanding was designed, developed, implemented and evaluated. From an ethical point of view, it would have been
inappropriate not to take some action aimed at correcting a situation after a problem has been identified. The idea of an intervention was also stimulated by findings from previous
studies reviewed in Chapter 2 which had identified low levels of understanding among participants from various trials. Following on the findings from these studies, it had been postulated that the likelihood of identifying some participants with low levels of
understanding would be high. Once the intervention had been implemented, the study would proceed to investigate the usefulness of the intervention in improving understanding regarding the procedures under study. The assessment would assist in determining whether the intervention can be recommended for use by other investigators. The following
question was specifically developed for the pilot intervention:
a. Can the designed intervention improve trial participants’ understanding of research, randomisation, double-blinding and placebo use?
The development and implementation of the intervention are reported in greater detail in Chapter 9.