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Open Access Research article

How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania

Andrew Vallely12*, Shelley Lees13, Charles Shagi2, Stella Kasindi2, Selephina Soteli2, Natujwa Kavit2, Lisa Vallely3, Sheena McCormack4, Robert Pool5, Richard J Hayes1 and the Microbicides Development Programme (MDP)

Author Affiliations

1 London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, UK

2 African Medical and Research Foundation, PO Box 1482, Mwanza, Tanzania

3 National Institute for Medical Research, PO Box 1462, Mwanza, Tanzania

4 Medical Research Council Clinical Trials Unit, 222 Euston Road, London NW1 2DA, UK

5 Centre for International Health, University of Barcelona, Spain

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BMC Medical Ethics 2010, 11:10  doi:10.1186/1472-6939-11-10

Published: 13 June 2010

Abstract

Background

HIV 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.

Methods

A 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.

Results

99 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.

Conclusions

Providing 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 registration

Current Controlled Trials ISRCTN64716212