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

Vallely, Andrew, Lees, Shelley, Shagi, Charles, Kasindi, Stella, Soteli, Selephina, Kavit, Natujwa, Vallely, Lisa, McCormack, Sheena, Pool, Robert, Hayes, Richard J. and The Microbicides Development Programme (2010) How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania. BMC Medical Ethics, 11 1, Article number 10: . doi:10.1186/1472-6939-11-10


Author Vallely, Andrew
Lees, Shelley
Shagi, Charles
Kasindi, Stella
Soteli, Selephina
Kavit, Natujwa
Vallely, Lisa
McCormack, Sheena
Pool, Robert
Hayes, Richard J.
The Microbicides Development Programme
Title How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania
Journal name BMC Medical Ethics   Check publisher's open access policy
ISSN 1472-6939
Publication date 2010
Sub-type Article (original research)
DOI 10.1186/1472-6939-11-10
Open Access Status DOI
Volume 11
Issue 1, Article number 10
Total pages 11
Place of publication United Kingdom
Publisher BioMed Central Ltd.
Collection year 2011
Language eng
Formatted 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. © 2010 Vallely et al; licensee BioMed Central Ltd.
Keyword Administration
Intravaginal
Adolescent
Adult
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Non HERDC
School of Public Health Publications
 
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Created: Tue, 22 Feb 2011, 10:07:29 EST by Geraldine Fitzgerald on behalf of School of Public Health