Andrew Vallely|Shelley Lees|Charles Shagi|Stella Kasindi|Selephina Soteli|Natujwa Kavit|Lisa M. Vallely|Sheena McCormack|Robert Pool|Richard Hayes
How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania
Amref Health Africa|London School of Hygiene & Tropical Medicine|London School of Hygiene & Tropical Medicine|National Institute for Medical Research|Amref Health Africa|Amref Health Africa|Amref Health Africa|Amref Health Africa|National Institute for Medical Research|Medical Research Council|Barcelona Centre for International Affairs|Universitat de Barcelona|London School of Hygiene & Tropical Medicine
hiv prevention trials conducted among disadvantaged vulnerable atrisk populations developing countries present unique ethical dilemmas key concern bioethics validity informed consent trial participation obtained research subjects settings purpose study investigate effectiveness continuous informed consent process adopted mdp301 phase iii vaginal microbicide trial mwanza tanzaniaa total 1146 women increased risk hiv acquisition working alcohol food vendors bars restaurants hotels guesthouses recruited mdp301 phase iii efficacy safety trial mwanza preparations trial participatory community research methods used develop locallyappropriate pictorial flipchart order convey key messages trial potential participants prerecorded audio tapes also developed facilitate understanding compliance geluse instructions comprehension checklist administered clinical staff participants screening enrolment 12 24 40 50 week followup visits trial investigate womens perceptions experiences trial including well participants internalize retain key messages provided continuous informed consent process random subsample 102 women invited participate indepth interviews idis conducted immediately 4 24 52 week followup visits99 women completed interviews 4weeks 83 24weeks 74 52 weeks total 256 interviews interviews evidence good comprehension retention key trial messages including gel currently know effective hiv key reason conducting trial women stop using gel event pregnancyproviding information trial participants focussed locallyappropriate manner using methods developed consultation community within continuous informedconsent framework resulted high levels comprehension message retention setting approach may represent model researchers conducting hiv prevention trials among vulnerable populations resourcepoor settingscurrent controlled trials isrctn64716212