The intervention designed as part of this study was based on the nature of data yielded by our empirical study (under review) conducted in Lilongwe and Blantyre at two sites of a multi-country microbicide trial between 2008 and 2009. The empirical assessment study assessed trial participants’ understanding of randomisation, double-blinding and placebo use and their personal implications. In the empirical study, the majority of respondents (61.1%; n=
124) obtained low scores (lower than 75%) on understanding of all three concepts under study. The intervention reported in this paper used everyday examples in explaining clinical trial procedures and their implications. African cultures are generally well known for story telling as a way of educating individuals [31
]. Stories with some meaning are often told as a way of ensuring that individuals understand a particular issue. The intervention did not make any assumptions about pre-existing knowledge and it was based on the review of existing interventions and studies aimed at testing some related interventions [9
The intervention was mainly based on Faden and Beauchamp’s psychosocial schema, which views informed consent as being made up of three sequential behavioural steps: (a) reception, (b) comprehension and (c) utilisation of the comprehended information in reaching a decision whether or not to participate in a study [33
]. The schema postulates that for consent to be informed, a prospective trial participant has to go through the three steps. The intervention also borrowed from the Meerwein model of information processing [34
]. Meerwein's model defines three main dimensions of the informing process, namely (a) the information itself, (b) the emotional dimension concerned with rapport between the researcher and the participant, and (c) the interactional dimension which is concerned with the capacity and willingness of the research staff to perceive and discuss emotional needs, concerns and complaints of trial participants and to deal with these.
The main components of the intervention consisted of a PowerPoint presentation which included a mix of the following approaches:
•A hierarchical and modular approach to providing information. This entails providing information in manageable sections. The information becomes more complex as the presentation proceeds [16
•Use of vignettes in explaining the trial concepts and research [35
•Colourful pictures were included in the presentation to supplement written information and the discussions about microbicides and the trial [9
]. Purpose, justification and implications of research participation and trial procedures were also included [4
•Asking patients to repeat in their own words or explain to others [35
•Use of other appropriate ways of ensuring personal understanding, including inviting research participants to discuss with other participants [36
•Use of a neutral team of intervention staff distinct from the research team in group discussions with trial participants. These were persons who had been trained to teach potential participants about the key methodologic aspects of research and who had experience in research [38
The intervention was implemented in the form of a narrative which was given in ChiChewa, the local language, with the assistance of a PowerPoint presentation. Figures , , below show some of the slides that were used in the intervention. The intervention was based on a story about a company which intended to test a new fertilizer in an area (Ntcheu) where farmers were experiencing very low potato yields. Ntcheu is well known throughout Malawi for Irish potato production. Using the fertilizer story, the concepts of research, randomisation, double-blinding and placebo use were illustrated including the reasons why research is necessary and why these procedures were employed as well as the personal implications of these procedures to the farmers in Ntcheu. In the narrative, the farmers were given some eligibility criteria (including having one acre plot and willingness to participate). The farmers were randomised by picking small pieces of paper from a hat that were numbered from 1–100. These numbers would determine the “fertiliser bag” that each farmer would take home. There were 100 bags all of the same colour and 50 of them contained the test product (the fertiliser) while 50 contained “some material” which looked exactly like the test fertiliser but did not have any of the chemicals in the test fertiliser (placebo). The farmers and the agriculture extension workers were both not aware of which study arms farmers had been assigned to since the test product and the placebo had been packed in bags which looked similar. The intervention covered the application of the procedures as well as the interpretation of the findings from the fertiliser study. This was aimed at ensuring that the intervention promoted a fuller understanding of research and trial procedures. After narrating the story, the presenter then related the Irish potato fertiliser research narrative and the procedures of the microbicide clinical trial, including the trial concepts under study (as well as their justification and personal implications).
Slide showing the problem of low potato yields in Ntcheu area.
Slide showing results from different potato plots.
Slide linking clinical trials to the medicines that are available in pharmacies, hospitals and stores.
The intervention was implemented on 20th
August 2009 at the Blantyre site only for logistical and budgetary reasons. All follow-up activities of the microbicide trial had already come to an end and participants had been informed about the findings from the microbicide study in March 2009. This therefore meant that the intervention did not in any way impact on the microbicide study since the microbicide study activities had already come to an end. The microbicide study had established that the two products which were being tested were not effective in protecting women against HIV infection [39
]. The intervention was approved by the principal investigator at the Blantyre Site after being briefed about the findings from the empirical study that had tested understanding of the three trial concepts. The principal investigator then informed the study team members about the impending intervention and requested them to support the intervention by providing space and logistical support.
A list of the low scorers from the Blantyre site was provided to the microbicide study staff so that they could assist with the tracing of the women who had participated in the empirical study. From a list of 77 participants who obtained low scores at the Blantyre site, current contact details could only be found for 63 participants who were still based in Blantyre. It was noted that 56 of the 63 participants who were identified were based in Manyowe and Manase areas. A decision was therefore made to follow-up only the 56 participants from Manyowe and Manase areas. Staff who were employed as field tracers at the microbicide trial site were requested to visit the homes of all 56 participants. It is important to note that during the empirical study, the women had given permission to be re-contacted for the purpose of continuing with the intervention. The researcher in the current study offered transport as well as other logistical support to the field tracers. The field tracers found 38 women at their homes and invited them to visit the study site for the intervention study. For the remaining 18 who were not available, the field tracers left messages inviting them to visit the study site at 8:00am on Thursday August 20, 2009.
On Thursday 20th August 2009, by 8:30am there were 39 women present and a decision was made to precede with the study activities. All 39 women had scored less than 75% during the initial assessment. Informed consent was sought from all 39 women after disclosure of information by a study team member. The information which was provided included reminding them about the microbicide study, the empirical study on understanding of procedures, and then requesting their consent for the intervention study. Three women indicated that they could not spend more than one hour at the site as they had to collect their children from school and were accordingly excluded from the study activities and reimbursed for transport expenses. Three women arrived more than 25 minutes after the two sessions had already begun. The three were not invited to join as they would have affected the flow of activities. They were, however, offered some refreshments and reimbursement for transport, and were given the opportunity to meet the microbicide study nurses for any issues that they might want to discuss with them.
The remaining 36 women indicated verbally that they were consenting to continue with their participation in the study and were prepared to go through all the remaining activities of the current study (Note that at this time, the microbicide study had already been terminated). The 36 women were accordingly randomised into two groups using small papers numbered from 1–36. All those who picked odd numbers were assigned to the intervention arm and those who picked even numbers were assigned to the non-intervention arm which was going to receive standard microbicide trial informed consent information.
A trial nurse responsible for obtaining informed consent was requested to present standard informed consent information on the microbicide study to the 18 women in the non-intervention group, in addition to health information on cervical cancer, and was advised to allow the women to ask questions. Our ethical concern here was to make the non-intervention group ‘more than placebo’ by imparting some useful women’s health information unrelated to the information presented in the intervention arm.
The two sessions began at the same time and the non-intervention arm session ended about 30 minutes earlier than the intervention session. The women were then invited for individual structured interviews on a one on one basis. There were two research assistants administering the questionnaire and the two groups were kept in separate rooms and there was one study team member who coordinated the movement of the women from the two sessions to the separate rooms that had been assigned for the post-intervention interviews. Each interview took on average 15 to 20 minutes since the post-intervention questionnaire was shorter than the initial one (it only included questions on the 3 concepts as well as their implications). Figure diagrammatically illustrates the procedures that were followed in the implementation of the pilot intervention including decisions that had to be made at the various stages. All participants were reimbursed for transport and all those who were interviewed during or after lunch hour were provided with refreshments.
Illustration of pilot intervention procedures.
Data from the 36 pre-coded questionnaires was managed using SPSS version 10 after checking by the investigators for completeness and consistency. The quantitative data was cleaned using the appropriate techniques including double-checking and was analysed using frequencies, percentages, means, standard deviations, cross tabulations, group statistics, matched pair analysis and other statistical tests such as independent sample tests, Chi-Square test and Fischer’s exact test. Figures, percentages and tables were used to summarise the data.
The following measures were taken to remove bias:
•Interviewers were blinded regarding the group the individuals they were interviewing had participated in. The 36 women were randomly assigned to the two interviewers.
•Scoring was done by a different individual before unblinding of groups.
•Individuals involved in presenting the intervention and the placebo programme did not participate in the assessment or in the scoring – scoring was thus independent and blinded.
•The intervention and second assessment were done about eight months after the empirical study. This could have assisted in eliminating the effects of history and maturation of instrument.
The intervention was implemented in accordance with the requirements of the Declaration of Helsinki. Permission was sought in writing and granted by the Principal Investigators at the two sites before data collection for this study. The study was reviewed and approved by two Research Ethics Committees (RECs) at the University of KwaZulu-Natal (Approval number HSS/0679/07D) and the College of Medicine, University of Malawi respectively (Approval P/02/08/612). Written informed consent was sought and obtained from all the study participants after purpose of the intervention as well as the procedures to be followed during the intervention. Those who refused to participate in the intervention for various reasons were excluded (n=3). The women who participated in the study were reimbursed for transport using the standard rate applicable at both sites. They were also provided with refreshments in view of the additional time they had to spend at the site.