ORAL PRESENTATION Open Access

Exploring meaning of participation in a clinicaltrial in a developing country setting: implicationsfor recruitmentJoanna Reynolds1*, Peter Mangesho2, Lasse S Vestergaard3, Clare Chandler1

From Clinical Trials Methodology Conference 2011Bristol, UK. 4-5 October 2011

ObjectivesThis study aimed to explore the experiences of peopleparticipating in a clinical trial in Tanzania. We soughtto understand the meaning attached to participation andhow experiences of being in the trial related to partici-pants’ original motivations for consenting, in order toexplore appropriate strategies for recruitment in a devel-oping country setting.

MethodsWe designed a qualitative study alongside a clinicalobservational trial of the efficacy and safety of artemisi-nin-based combination therapy (ACT) for malaria inpatients concomitantly receiving antiretroviral therapy(ART) for HIV in Muheza, Tanzania. Focus-group dis-cussions have been held with HIV-positive and HIV-negative people who have participated in the trial, andwith HIV-positive people who were screened but whodid not participate. This data has been triangulated within-depth interviews with staff conducting the trial anddelivering HIV care at the hospital where the trial wasconducted. Data is being analysed using an iterative,line-by-line approach based on the principles ofgrounded theory, to identify units of meaning anddevelop themes and constructs from the data.

ResultsAnalysis to date of eight FGDs and IDIs indicates a dis-connect between the information given to trial partici-pants in the recruitment and consent process and theirunderstanding of the trial and its aims, with a few parti-cipants stating they did not realise they were part of a

research study. This reflects, and may be attributable totrial participants’ frequent conflation of the clinicalencounter - testing for malaria - with the researchencounter - the recruitment process - and an inabilityto distinguish between these as separate events. Whendescribing recruitment, many participants framed theirnarrative around clinical events such as the malaria testand seeking treatment, the latter being considered themost important reason for joining the study. The clini-cal context in which participants were screened andrecruited appeared to influence their ability to interpretinformation about the trial and expectations for whatmay happen to them, raising questions about the natureof ‘informed consent’ in the recruitment process.Participants reported overwhelmingly positive experi-

ences of participating in the trial, largely based aroundtheir access to numerous tests and free treatment, aswell as reimbursement for transport and telephonecosts. Being part of the trial was frequently conceptua-lised as receiving a ‘service’, valued chiefly for enablingparticipants to be observed and to know their healthstatus. The perceived value of this ‘service’ was reflectedin many participants’ reports of encouraging friends andfamily to attend for malaria testing, in order to accessthe service associated with the trial. Although this indi-cates again some confusion between clinical andresearch activities, it appeared that the ‘enactment’ ofthe trial – giving and receiving the service – offered thesocial space in which participants were likely to raiseany concerns about aspects of the trial. Such concernsincluded questioning the ‘true’ aim of the study, andfears over blood taking. This suggests that it is within arelationship of interaction with trial staff and activitiesthat comprehension about the meaning and value ofparticipation can begin to emerge, thus highlighting the

1London School of Hygiene & Tropical Medicine, UKFull list of author information is available at the end of the article

Reynolds et al. Trials 2011, 12(Suppl 1):A114http://www.trialsjournal.com/content/12/S1/A114 TRIALS

© 2011 Reynolds et al; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative CommonsAttribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction inany medium, provided the original work is properly cited.

potential shortcomings of the standard recruitmentprocess.

ConclusionsThe findings from this study raise questions about howinformation is presented and used in the recruitmentand consenting process for a trial, particularly onelocated within an existing clinical context. Recruitmentstrategies should take into consideration when, whereand how information will be conveyed to participants,and explore likely expectations of these contexts whichmay shape how and if information is interpreted andutilised by potential participants. The findings also indi-cate that the meaning participants place on participa-tion, its risks and benefits, develops largely throughenactment of the relationship with trial staff and activ-ities, rather than through the consent process. Toensure better informed consent, researchers could seekto activate this relationship earlier on in the trial pro-cess, for example through meaningful communityengagement activities prior to recruitment.This study has also underscored the value participants

in this low-resource setting place on engaging with a‘service’ of health care provision, wherein they perceivetheir health status and needs to be the focus of trialactivities. This service is an influential motivator forcontinuing to engage with a trial, beyond more materialcompensations such as money for transport. These find-ings also suggest the potential for word-of-mouth strate-gies to aid informed recruitment in contexts where theperceived benefits of participation are highly valuedamongst the local community.Recruitment and continued participation in trials

involve logistical and ethical challenges. Understandingvalues and concerns of participants can pose practicalsolutions.

Author details1London School of Hygiene & Tropical Medicine, UK. 2National Institute forMedical Research, Amani Centre, Tanzania. 3University of Copenhagen,Denmark.

Published: 13 December 2011

doi:10.1186/1745-6215-12-S1-A114Cite this article as: Reynolds et al.: Exploring meaning of participation ina clinical trial in a developing country setting: implications forrecruitment. Trials 2011 12(Suppl 1):A114.

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Reynolds et al. Trials 2011, 12(Suppl 1):A114http://www.trialsjournal.com/content/12/S1/A114

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