Re-framing microbicide acceptability: findings from the MDP301 trial

Abstract

Microbicides are most usually conceptualised within a disease prevention framework and studies usually define acceptability in terms of product characteristics, willingness to use and risk reduction. This starting point has led to assumptions about microbicides which, rather than being challenged by empirical studies, have tended to foreclose the data and subsequent conceptual models. Few studies take an emic (‘insider’) perspective or attempt to understand how microbicides fit into the broader context of women's and men's everyday lives. As part of the integrated social science component of the MDP301 Phase III microbicide trial, in-depth interviews were conducted with female trial participants in South Africa, Zambia, Tanzania and Uganda. Women's experiences of the gel challenge several assumptions that have commonly been reiterated about microbicides. Our analysis suggests that current definitions and conceptual frameworks do not adequately account for the range of meanings that women attribute to gel. Even within the context of a clinical trial, it is possible to obtain a richer, ethnographic and cross-cultural concept of acceptability based on women's practice and emic interpretations. We now need to move beyond limited notions of acceptability and consider how microbicides fit into a more holistic picture of women's and men's sexuality and sexual health.

Les microbicides sont la plupart du temps conceptualisés dans un cadre de prévention d'une maladie et, habituellement, l'acceptabilité se définit dans les études en termes de caractéristiques du produit, de volonté à l'utiliser et de réduction des risques. Ce point de départ a conduit à des hypothèses sur les microbicides qui, plutôt que d'être remises en question par des études empiriques, ont eu tendance à faire obstacle aux données et aux modèles conceptuels à venir. Peu d'études sont lancées dans une perspective «émique» (intérieure) ou tentent de comprendre comment les microbicides s'intègrent dans le contexte le plus large de la vie quotidienne des hommes et des femmes. Planifiés par l'étude en sciences sociales, intégrée à l'essai de Phase III sur le microbicide MDP301, des entretiens en profondeur ont été conduits avec des participantes en Afrique du Sud, en Zambie, en Tanzanie et en Ouganda. L'expérience des femmes avec le gel récusent plusieurs hypothèses sur les microbicides qui sont couramment réitérées. Notre analyse suggère que les définitions et les cadres conceptuels actuels ne reflètent pas correctement la diversité des significations attribuées au gel par les femmes. Même dans le contexte d'un essai clinique, il est possible d'obtenir un concept plus riche, ethnographique et transculturel de l'acceptabilité, basé sur la pratique des femmes et les interprétations «émiques». Nous devons désormais dépasser les notions limitées de l'acceptabilité et analyser comment les microbicides trouvent leur place dans une vision plus holistique de la sexualité et de la santé sexuelle des femmes et des hommes.

En general los microbicidas son conceptualizados dentro de un programa de prevención de enfermedades y normalmente en los estudios la aceptabilidad es definida en términos de las características del producto, la disposición a usarlo y la reducción de riesgos. Este punto de partida ha llevado a suposiciones sobre los microbicidas, y en vez de cuestionar estas suposiciones mediante estudios empíricos, a menudo se dan por sentado los datos y, en consecuencia, los modelos conceptuales posteriores. Hay pocos estudios que adopten una perspectiva emic (‘autóctona’) o que intenten entender cómo encajan los microbicidas en el contexto más amplio de la vida diaria de hombres y mujeres. En el marco de un componente integrado de ciencia social del estudio MDP301 en fase III sobre microbicidas, se llevaron a cabo entrevistas exhaustivas con mujeres de Sudáfrica, Zambia, Tanzania y Uganda que participaron en el estudio. Las experiencias que las mujeres han tenido con el gel ponen en tela de juicio varias suposiciones que normalmente han sido reiteradas con respecto a los microbicidas. Nuestro análisis indica que las definiciones y las estructuras conceptuales actuales no tienen en cuenta suficientemente los diferentes significados que tiene el gel para las mujeres. Incluso en el contexto de un ensayo clínico, es posible obtener un concepto más rico, etnográfico e intercultural de aceptabilidad según la práctica y las interpretaciones emic de las mujeres. Ahora debemos traspasar las nociones limitadas de aceptabilidad y analizar cómo encajan los microbicidas en una imagen más holística de la sexualidad y la salud sexual de hombres y mujeres.

Keywords:

• sub-Saharan Africa
• HIV prevention
• Microbicide acceptability

Acknowledgements

The authors are grateful to the participants who took part in this study. We also acknowledge the committed work of the Microbicides Development Programme staff who contributed to the data collected and analysed for this paper. This study was funded by a grant from the UK Department for International Development, administered through the Medical Research Council's Clinical Trials Unit.

Notes

^1. Coly and Gorbach (2008) even suggest that ‘acceptability, as measured by single or short-term use of a product in a Phase I or Phase II trial, should be measured as adherence in Phase IIb or Phase III trials that require extended product use and as continuation/maintenance in the open market’.

^2. It is pertinent to note that Heise (1997) identified the same phenomenon in contraceptive research: ‘Historically, there has been lack of clarity regarding the very concept of acceptability – how to understand it, how to measure it, and what it means’ (6).

^3. The terms emic and etic were coined by Kenneth Pike in 1967 (Pike 1967) and have since become key concepts in anthropology (for more see Headland, Pike, and Harris [1990]). In this paper, we use the term emic to refer to a perspective that focuses on the conceptual schemes and categories that are meaningful to the people being studied, i.e. the ‘insider view’. We use the term etic to refer to a perspective based on conceptual schemes and categories that are meaningful to the researcher and the scientific community, i.e. the ‘outsider view’.

^4. Although one of the authors’ previous work in Uganda had shown that covert use was neither feasible nor desired (Pool et al. 2000), covert use was still a major topic in the tools used to collect data in the MDP301 trial.

^5. The reference to appetite and sweetness refers to the analogy of sex with consumption. The heat analogy refers to the idea of blood becoming hot before and during sexual intercourse that converts blood into semen and also causes the blood to move more rapidly within the body (for a fuller discussion of these ideas see Bill [1994], Hammond-Tooke [1981] and Niehaus [2002]).

^6. A ‘round’ refers to a sex act.

^7. Ejaculation here refers to female orgasm.