4th International AIDS Society Conference on HIV Pathogenesis and Treatment Sydney, Australia - July 22 - 25, 2007

HOW INFORMED IS CONSENT? USING A CONTINUOUS CONSENT PROCESS AMONG HIGH-RISK WOMEN WHO ENGAGE IN TRANSACTIONAL SEX IN THE MDP301 VAGINAL MICROBICIDE TRIAL, MWANZA, TANZANIA

IAS Conf HIV Pathog Treat 2007 Jul 22-25;4th: Abstract No. MOAC303

Vallely A.¹, Lees S.¹, Shagi C.², Kasindi S.², Vallely L.³, Soteli S.², Kavit N.², McCormack S.⁴, Pool R.⁵, Hayes R.⁶, Microbicides Development Programme
¹NIMR/LSHTM/AMREF Collaborative Research Projects, Mwanza, Tanzania, United Republic of, ²African Medical and Research Foundation (AMREF), Mwanza, Tanzania, United Republic of, ³National Institute for Medical Research (NIMR), Mwanza, Tanzania, United Republic of, ⁴Medical Research Council, Clinical Trials Unit, London, United Kingdom, ⁵Centre for International Health University of Barcelona, Barcelona, Spain, ⁶London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom

OBJECTIVES: To understand the effectiveness of locally-appropriate procedures for obtaining informed consent from study participants in a phase III vaginal microbicide trial in Mwanza, Tanzania.

METHODS: A total of 1320 women at high-risk of HIV working as alcohol and food vendors or in bars, restaurants, hotels and guesthouses will be recruited into the MDP301 trial in Mwanza. Participatory community research methods have been used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes have been used to facilitate high levels of understanding and compliance with gel use instructions. These approaches were taken due to the high level of illiteracy observed during a feasibility study conducted among 1573 women from this occupational group. During the trial, a comprehension checklist is being administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits. In order to understand how well women internalize and retain key messages provided by this continuous informed consent process, these issues are being explored in a random sample of women through in-depth interviews (IDIs) conducted immediately after their 4, 24 and 52 week follow-up visits.

RESULTS: To date, 24 women have attended a 4-week IDI and 5 a 24-week IDI. In all interviews there was evidence of good comprehension and retention of key 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 the importance of stopping the gel should they become pregnant.

CONCLUSIONS: Providing information to trial participants in a focussed, locally-appropriate manner using methods developed in consultation with the community and consolidating these activities by a continuous informed-consent process has resulted in high levels of retention and comprehension in this setting.

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2007-07-22
MOAC303
Ethics In Biomedical Prevention

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