Research article

Microbicides Development Programme: Engaging the community in the standard of care debate in a vaginal microbicide trial in Mwanza, Tanzania

Andrew Vallely^1,2 , Charles Shagi² , Shelley Lees^1,3 , Katherine Shapiro⁴ , Joseph Masanja² , Lawi Nikolau⁵ , Johari Kazimoto⁶ , Selephina Soteli² , Claire Moffat^1,2 , John Changalucha³ , Sheena McCormack⁷ and Richard J Hayes¹

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

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

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

⁴Consultant, Global Campaign for Microbicides/PATH, Middlesex, Vermont, USA

⁵Stakeholders Advisory Group, Microbicides Development Programme, Mwanza, Tanzania

⁶Community Advisory Committee, Microbicides Development Programme, Mwanza, Tanzania

⁷Medical Research Council Clinical Trials Unit, 222 Euston Road, London NW1 2DA, UK

author email corresponding author email

BMC Medical Ethics 2009, 10:17doi:10.1186/1472-6939-10-17

Published:	9 October 2009

Abstract

Background

HIV prevention research in resource-limited countries is associated with a variety of ethical dilemmas. Key amongst these is the question of what constitutes an appropriate standard of health care (SoC) for participants in HIV prevention trials. This paper describes a community-focused approach to develop a locally-appropriate SoC in the context of a phase III vaginal microbicide trial in Mwanza City, northwest Tanzania.

Methods

A mobile community-based sexual and reproductive health service for women working as informal food vendors or in traditional and modern bars, restaurants, hotels and guesthouses has been established in 10 city wards. Wards were divided into geographical clusters and community representatives elected at cluster and ward level. A city-level Community Advisory Committee (CAC) with representatives from each ward has been established. Workshops and community meetings at ward and city-level have explored project-related concerns using tools adapted from participatory learning and action techniques e.g. chapati diagrams, pair-wise ranking. Secondary stakeholders representing local public-sector and non-governmental health and social care providers have formed a trial Stakeholders' Advisory Group (SAG), which includes two CAC representatives.

Results

Key recommendations from participatory community workshops, CAC and SAG meetings conducted in the first year of the trial relate to the quality and range of clinic services provided at study clinics as well as broader standard of care issues. Recommendations have included streamlining clinic services to reduce waiting times, expanding services to include the children and spouses of participants and providing care for common local conditions such as malaria. Participants, community representatives and stakeholders felt there was an ethical obligation to ensure effective access to antiretroviral drugs and to provide supportive community-based care for women identified as HIV positive during the trial. This obligation includes ensuring sustainable, post-trial access to these services. Post-trial access to an effective vaginal microbicide was also felt to be a moral imperative.

Conclusion

Participatory methodologies enabled effective partnerships between researchers, participant representatives and community stakeholders to be developed and facilitated local dialogue and consensus on what constitutes a locally-appropriate standard of care in the context of a vaginal microbicide trial in this setting.

Trial registration

Current Controlled Trials ISRCTN64716212