(CNS): It is well understood that both the efficacy and effectiveness of HIV Prevention research trial products (such as microbicides) depends upon their actual use by the clinical trial participants. “Use is a function of human behaviour and action that is affected by an individual, interpersonal, social, and cultural factors that operate interactively in complex, dynamic and varied ways across settings” said Dr Judith D Auerbach, Vice President for Science and Public Policy at the San Francisco AIDS Foundation, USA.
Dr Judith D Auerbach was speaking at the International Microbicides Conference (M2010) in Pittsburgh, USA (23-25 May 2010).
In HIV prevention research, it is the job of social and behavioural scientists sometimes in collaboration with biomedical scientists to unpack these complex, dynamic and interactive factors and the effect they had on promising biomedical tools.
Historically social and behavioural research has been conducted at the level of being adjunct or handmaiden in HIV prevention trials. “Its purpose is to elucidate the likelihood that clinical trial population in the first place and larger population in the second case, will take up a particular prevention tool as prescribed, to help assess the safety and efficacy of that particular prevention tool” said Judith.
In recent years there are a number of thoughtful articles written on the need on how best to integrate social research into the microbicides clinical trials from pre-clinical to safety and efficacy studies of vaginal and rectal products.
The experience of conducting clinical trials themselves has highlighted the key issues that are thought to affect the trial outcome like: acceptability, adherence, control, covert use and pregnancy.
There has been a great deal of research on acceptability in relation to vaginal products and much less in relation to rectal products.
Acceptability research both quantitative and qualitative is driven by a very theoretical model. It also includes questions like what attributes of product matter – like physical characteristics, the way it is used, perceived efficacy of a product, and other such factors.
What have we learnt from the research on acceptability? “We have learnt that acceptability is variable, by product, by population, by cultural belief and norm, by sexual practices, gender and relationship dynamics” said Judith.
“We have learnt that acceptability may change even in the course of the clinical trial. We have learnt that acceptability does have different attributes. We have also learnt that in case of hypothetical products, acceptability is not often the big predictor of actual use” said Judith D Auerbach, who had also received the 2008 Career Award from the Sociologists AIDS Network.
There is no doubt that adherence of clinical trial participants to using the product-being-researched, is of critical value. “If study products are not used by the study participants, in the way called for in the trial protocol, it becomes impossible to assess their true effects, alone or in relation to other products, in order to work. In the context of clinical trials, the adherence is measured by a number of techniques including biomarkers” shares Judith.
What have we learned from the adherence studies? “We have learnt that adherence rates are quite variable. We have also learnt that adherence needs to be measured differently in different settings. We have learnt that adherence is reported inconsistently by study participants” said Judith Auerbach, who had received the 2004 Feminist Activist Award from Sociologists for Women in Society, and the 2005 Mentor Award from the Public Leadership Education Network.
Dr Judith D Auerbach has served as the past Vice President, Public Policy and Programme Development, at American Foundation for AIDS Research (amFAR), and has also served in the past as Director of the Behavioural and Social Science Programme and HIV Prevention Science Coordinator in the Office of AIDS Research at the National Institute of Health (NIH).
Adherence varies within trials by sites, by participants, by partnership types, by sex acts, for instance.
Adherence depends upon study participants’ understanding on how these products are to be used when there are more than one tool like condom and diaphragm, condom and gel. In fact, in a clinical trial (HPTN035), women study participants thought that the gel should only be used when condoms were also used. There were low level of exclusive gel use when condoms were not used. We have learnt that adherence is also affected by participants’ belief about these products. Like in diaphragm study participants believed that diaphragm have already shown protection against HIV and condoms weren’t necessary. Adherence is also affected by sexual and vaginal practices across populations and is affected by gender and relationship dynamics.
“Historically microbicides advocates believed that women need a product under their own control unlike male condom that is not under their control, and may like to use a product without the knowledge of their male partner” said Judith Auerbach. “We have learnt from research in this area that many women may like control and covert use of such products but not all. Desire for control and covert use vary by population, by culture, by setting, by sexual relationship. Control, as framed by many advocates, is an alien concept in many cultures. And covert use is often quite undesirable. In many settings women and their partners want sharing this decision making about using HIV prevention tools and this is a construct of their interpersonal and cultural frame, about gender and relationship dynamics, their sexual practices and their desire and pleasure” said Judith.
In trials involving women, pregnancy or potential pregnancy is problematic. Those who become pregnant are taken out of study.
Less or no data exists between effect of these products on pregnant women or their embryo and is also not helpful in the research trial considering the end point of the study.
Notwithstanding the fact that intending to get pregnant is an exclusion criteria, women in trials are encouraged to use one and increasingly two forms of contraceptions. Like in microbicides trials, pregnancy rates were between 4 to 40 per 100 woman years. This has implication for both the conduct and the interpretation of the trial. If the participants reduce the use of protective products, during pregnancy, it will affect the assessment of maximum detectable effectiveness of the product and also the lower detectable effectiveness of the product.
“Actually there is not that much behavioural or social research on pregnancy and perspectives of women participating in a trial. The notion of ‘intention to get pregnant’ may not be a very meaningful notion in many cultural contexts. We have learnt that fertility and parenthood, desires and expectations of women and their male partners, their values and religion, cultures and other such factors are strong and often override the public health benefits of prevention” said Judith.
“We have also learnt that asking women to use triple or even quadruple protection may be unrealistic and unreasonable in fact” said Judith.
Undoubtedly, social and behavioural research is absolutely critical to understanding these issues around acceptability, adherence, control, covert use and pregnancy, in the context of clinical trials. These issues signify other deeper and social cultural realities, they characterize the context in which these prevention tools are introduced, modified and incorporated by individuals and communities, and will continue to limit the efficacy of products in a clinical research trial. These realities are themselves not addressed generally in a clinical trial.
“It is much more useful to look at practices rather than behaviours. The term practices convey the social dimension of the behaviours” said Judith. Practical and socially induced behaviours are usually organized by culture. Sexual and other behaviours related to HIV prevention are characterised by social norms.
“Sexual practices for example are influenced by prevailing norms and structures related to gender, love, intimacy, sexuality, pleasure, fertility and family” said Judith Auerbach.
“As an example, in a rectal microbicide acceptability study, there were interviews conducted on unprotected anal intercourse with men – HIV seropositive or serostatus unknown. One of the notion was that women must engage in anal sex coerced by their male partner but these interviews show that women weren’t being coerced into having anal sex rather acted on their own behalf or in their own interest. Rather they follow the sexual script that allows the male partner to take the initiative in initiating anal sex, that women actually find enjoyable as it brings pleasure, intimacy, it is in some ways exceptional and therefore exciting sexual practice, and it allows them to please their partner” said Judith.
Where women are involved, sexual practices may get affected by vaginal practices such as washing, douching, drying etc. These practices are quite wide spread in countries in Africa where microbicides clinical trials are also currently occurring. These practices are related to norms, values and hygiene.
In general the expectation is that the woman’s vagina should be dry allowing optimal protection and sensation during sex.
“We also learnt that these practices are linked to social norms, values, beliefs, that challenged the study to assess effectiveness of certain HIV prevention tools” said Judith.
HIV is a relational matter but very little research has been done on dynamics of relationship.
Women usually incorporate gels and other prevention tools during a study, into their own sexual and vaginal practices. Similarly a survey on use of lubricants during anal sex, found that 60% of respondents added another substance in the lubricant they use, often spit or saliva, during anal sex. So people will incorporate these new prevention technologies into their existing practices.
Medical research is socially embedded and is affected by social relation. “Social science can interrogate how the technology has been incorporated by the people and communities and it can elucidate how medical research and participants’ practices are intertwined” said Judith.
“The in-depth interviews conducted with women trial participants, fundamentally challenged some of the normative concepts we have in microbicides clinical trial research around acceptability, covert use, dry sex among others. For example they found that women want to involve their male partners in gel use. Although the women hope that the gel may prevent HIV they are just as interested in a product that may enhance sexual pleasure for themselves and their partners. The binding in the gel increased sexual pleasure and surprised the researchers because of the prevalent norm of dry sex in these communities” said Judith.
Over the gel use enhancing sexual pleasure and sexual gratification, providing a greater level of intimacy for both women and men, it helps enhance and secure women’s relationship. Some women described how their partners no longer went to other women, or how their husbands are paying much more attention.
It is beyond doubt that social science research is not just a handmaiden to biomedical research in HIV prevention. The biomedical research in HIV prevention should be complemented and informed by non-trial focus social science research. (CNS)
Bobby Ramakant – CNS
(The author is the Policy Adviser to Citizen News Service (CNS), a World Health Organization (WHO) Director-General’s WNTD Awardee 2008, and writes extensively on health and development. Website: www.citizen-news.org)