Abstract
BackgroundHIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania.MethodsA total of 1146 women at increased risk of HIV acquisition working as alcohol and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews (IDIs) conducted immediately after their 4, 24 and 52 week follow-up visits.Results99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks (a total of 256 interviews). In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy.ConclusionsProviding information to trial participants in a focussed, locally-appropriate manner, using methods developed in consultation with the community, and within a continuous informed-consent framework resulted in high levels of comprehension and message retention in this setting. This approach may represent a model for researchers conducting HIV prevention trials among other vulnerable populations in resource-poor settings.Trial registrationCurrent Controlled Trials ISRCTN64716212
Highlights
HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas
In this paper we describe how a participatory, multimethod, continuous informed consent process developed by researchers, study participants and community stakeholders during the preliminary feasibility and pilot phases of the program resulted in high levels of comprehension and message retention in the MDP301 vaginal microbicide trial in Mwanza
But that it will benefit all people, even the whole world, the whole of Tanzania' 'They are doing the research because a woman does not have the ability to force a man to use a condom ...this is the reason it has been developed, for a woman to protect herself against HIV' Complex issues such as the research development process, the concept of a placebo gel and the requirement for randomisation and blinding in the experimental trial design appear to have been broadly understood by trial participants, despite low levels of literacy and educational attainment among women in this occupational group [25]: 'The gel has gone through research ...three different researches, starting with a research on animals through to a research on human beings
Summary
HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. In many developed and developing country settings, prevention trials are feasible only among vulnerable sub-populations at increased risk of HIV and sexually transmitted infections (STIs) [11,12]. Innovative approaches to information delivery include the use of an educational video during informed consent for an HIV prevention trial in Port-au-Prince, Haiti, which was associated with high levels of accurate message retention when combined with a face-to-face educational session with a trained study counsellor [18]. The need to consider informed consent as a process (important throughout the period of research participation) rather than a discrete activity (relevant at study entry only) has increasingly been recognised in both developed and developing country settings [14,16,18,22,23]
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