UNDERSTANDING
2.5 ASSESSING MICROBICIDE TRIAL PARTICIPANTS’
UNDERSTANDING
There is a small volume of literature on studies that have tested trial participants’ understanding of procedures and concepts within the context of microbicide trials. One of the few studies evaluated trial participants from a major multi-site Phase III microbicide study referred to as COL 1492. The COL 1492 study was conducted in Durban (South Africa), Cotonou (Benin) and Hat Yai (Thailand) to evaluate the effectiveness of Nonoxynol-9 in preventing the transmission of HIV. The study was conducted between the years 1998 – 2000. This study which was evaluating trial participants’ understanding, was conducted as a sub study of the main microbicide trial by some of the co-investigators of the main study. The evaluation included trial participants from all the three sites. An evaluation of trial participants’
understanding after three months of enrolment indicated that a greater proportion of women were not able to understand concepts and procedures provided during the initial informed consent process. Women with no education fared worse than those with some formal education and nearly all women believed incorrectly that both products had a protective effect (Kilmarx et al., 2001).
In Thailand, testing of women’s knowledge revealed that informed consent information was not understood. The same study also revealed that 58 percent of the women at the Cotonou site did not remember the name of the gel under study and 30 percent did not fully understand that the gel was being tested for preventing HIV and STDs. About 25 percent of the women could understand what a placebo was and 35 percent understood the importance of remembering their
study and randomisation number, which identified the gel they were receiving. After an
intervention reiterating the informed consent procedure at each visit, 82.8 percent of the women were able to explain the notion of placebo five months later. Re-assessment of trial participants was conducted throughout the trial.
An intervention which included colourful charts with graphic presentations was said to have proven successful, but the rate of success was not quantified. At the Cotonou site, several methods were employed to promote understanding. These included role plays, using different methods to explain randomisation, placebo and double-blinding (Kilmarx et al., 2001).
Unfortunately there was no follow-up to evaluate the effectiveness of these strategies on trial participants’ understanding. However, focus group discussions at the end of the trial suggested that some women still did not understand the blinding process (Kilmarx et al., 2001). At the Cotonou site, several methods were employed to promote understanding, including role play and different methods to explain randomisation, placebo and double-blinding.
At the Durban site of the same microbicide trial, 70 percent of the women did not understand that they were in a trial even after three months. The women thought that the microbicide and the placebo would protect them from sexually transmitted diseases (STDs) and HIV. Asked why they liked the gel, some of the women responded that the gel protected them from STDs and this had an effect in that the women in both arms of the study reported fewer symptoms of STDs since enrolment. They attributed this to the gel rather than to the increased condom use or the syndromic standard treatment they obtained as part of the study (Ramjee et al., 2000).
The authors therefore concluded that some of the women may have believed that the test product they were using had a protective effect and therefore minimised condom negotiation with their partners (Kilmarx et al., 2001; Ramjee, 2007; Ramjee et al., 2000,).
Kilmarx et al. (2001) concluded that it may take several weeks or even months before participants understand the concepts and procedures of clinical trials. They recommend that future trials should have a short run-in period prior to implementation to allow for the understanding of trial procedures. They also recommend that participants should be asked about their knowledge of the study, their reasons for participation and whether their
participation was voluntary or not. Overall, Kilmarx et al. concluded that low education levels were associated with poor understanding
As a result of the debates surrounding the quality of informed consent, the HIV Prevention Trials Network (HPTN) has developed a conceptual framework for an enhanced informed consent process which drew upon the experiences gained during the various trials conducted by HPTN throughout the world (Woodsong & Abdool Karim, 2005). The framework is designed to ensure initial and continued understanding of research information with an emphasis on HIV prevention research. The majority of HIV prevention trials conducted by HPTN involve the testing of new methods of preventing HIV using HIV negative persons. For such trials, it is important for participants to remember that they are participating in a trial aimed at testing a product. That way they may not to adopt some risky behaviours. Attention in information provision is focused on the individual and the community, and the framework focuses on the three study phases: pre-enrolment, enrolment and post-enrolment.
During the pre-enrolment phase, researchers have to identify the best ways to convey research protocol concepts, recognise community concerns about HIV and respect community norms on decision making. During the enrolment phase, focus is on the individual and not on the
community. To ensure that the researchers adequately address the information needs of the individual, this phase is further divided into smaller phases, which include information
disclosure, discussion and decision making. During the post-enrolment phase, focus is on both
the individual and the community. Staff and the community monitor any issues arising in the study and work towards addressing them. During this post enrolment phase, the community advisory board (CAB) takes centre stage as the bridge between the community and the research team. During all three phases, researchers need to continuously provide information, assess understanding, and take positive steps to clarify any misunderstanding or misconception (Woodsong & Abdool Karim, 2005). This initiative by HPTN is very important as it is a clear acknowledgement that the area of informed consent needs concerted effort if informed consent is to be adequately informed.
The current section has highlighted some of the debates in the area of microbicide trials. The section has also highlighted some of the ways in which the microbicide trial community is responding to the ethical challenges. The next section is devoted to studies that have assessed trial participants with limited decision making abilities.