Hidden harms: Women's narratives of intimate partner violence in a microbicide trial, South Africa
Introduction
The high prevalence of violence in intimate partnerships is a critical social and public health issue, particularly for women. According to a World Health Organisation study of 15 countries (Bangladesh, Brazil, Ethiopia, Japan, Peru, Namibia, Samoa, Serbia and Montenegro, Thailand and the United Republic of Tanzania), one in three women experience intimate partner violence (IPV) (World Health Organisation, 2005). Epidemiological research in South Africa underscores gendered vulnerability to violence. A national cross sectional study found that 25% of women had a lifetime prevalence of experiencing IPV (Jewkes et al., 2002). IPV is also strongly associated with increased HIV risk and susceptibility to infection (Dunkle et al., 2004a, Pronyk et al., 2006). Disproportionately higher rates of HIV infection occur in younger women in comparison to their male age mates (Rehle et al., 2010), due in part to biological factors, but also the relative lack of power that younger women have in age disparate relationships (Pettifor et al., 2004) and transactional sex (Dunkle et al., 2004b). HIV risk behaviour amongst some men is also associated with violent behaviour (Dunkle et al., 2006).
Recognizing the gendered and generational dimensions of HIV infection, researchers have sought to find effective ‘female controlled’ technologies to prevent its spread (Malow et al., 2000, Mantell et al., 2005, Minnis and Padian, 2005, Stein et al., 2003). Microbicides are chemical formulations designed to prevent HIV acquisition, delivered in vaginal gels, film, sponge, and rings. As female controlled methods microbicides are designed to reduce women's vulnerability to HIV infection. These are touted as ‘medical technologies intended to empower women’ (Bell, 2000) that ‘put the power to prevent in women's hands' (Global Campaign for Microbicides, 2009) because they may be used with or without the explicit acquiescence of a male partner, especially when women are unable or unwilling to negotiate condom use.
To date, apart from one intervention that demonstrated partial efficacy (Karim et al., 2010), microbicides are experimental and unproven technologies, tested in clinical trials involving thousands of participants who use them in real life settings within intimate relationships. Women are encouraged to inform their male partners about their microbicide use and trial participation but this is not a pre-requisite for participation. Many women choose to involve their partners while others do not. Research findings from microbicide trials have highlighted the role of microbicides in increasing women and men's sexual pleasure as well as feelings of intimacy and that this encourages open discussion between partners (Montgomery et al., 2010, Stadler and Saethre, 2011). However, male partners may react negatively and even violently to the introduction of microbicides (Orner et al., 2006, Robertson et al., 2013). Given the social dynamics of gender relations, women may avoid disclosure for fear of abandonment and abuse. Concealment and non-disclosure can emerge as flash points if men accidentally find out about their partners' involvement (MacPhail et al., 2009, Okal et al., 2008). Non-disclosure to male partners also raises ethical concerns about men's involvement in trials of female controlled HIV prevention technologies (Moodley, 2007). Requirements of clinical trial involvement such as regular and frequent clinic visits may further create suspicions and tensions within relationships, potentially leading to partner conflict (Montgomery et al., 2008, Woodsong et al., 2006). Women's participation in microbicide trials may also provoke familial and social censure and disapproval (Goicochea et al., 2011, Woodsong et al., 2006). Therefore the potential for conflict and violence within intimate relationships due to trial involvement, can result in what are defined in bioethical terms as ‘social harms’.
Participants, especially marginalized and vulnerable populations, in prevention research on stigmatized diseases such as HIV/AIDS can face social and psychological risk (Potts, 2001, Vallely et al., 2009). Social harms are described as: physical, emotional and psychosocial harm (Fuchs et al., 2007), adverse social incidents or consequences (Sheon et al., 1998), trial related discrimination (Allen and Lau, 2008) social reactions and impacts (Milford et al., 2007, Thapinta et al., 1999), psychological risks (South African Medical Research Council, 2003), and psychosocial risks (Lesch et al., 2010). The most frequently reported social harm in the literature is trial related stigma and discrimination, especially in HIV vaccine trials due to participants being mistakenly identified as HIV positive (Lesch et al., 2010).
Although social harms are fairly well documented in vaccine trials, this tends to favour developed world settings. In the South African context, social harms may be shaped by gender inequalities and domestic violence, increasing women's risk of abandonment and violence (Milford et al., 2007). For instance, during the MIRA diaphragm trial, more than half of the women enrolled in the trial reported IPV, especially the fear of violence, emotional abuse, physical assault and forced sex. In this trial, IPV was closely associated with non-adherence to condoms and diaphragms (Kacanek et al., 2013).
Very little work has been undertaken to document and analyse the social harms as consequences of women's participation in microbicide trials. A review undertaken in 2006 of several microbicide trial sites in southern Africa found that although clinical trialists were aware of the social and psychological issues faced by trial participants, most lacked clear policies to deal with their occurrence (Heise et al., 2008), signalling the need for greater attention to be paid to identifying and mitigating social harms. This is a critical gap that needs to be addressed for the ethical management of clinical trials (Milford et al., 2007). The prevalence of violence against women in community based clinical trial settings also raises concerns about the potentially negative social consequences of microbicides in the general population (Roberts and Matthews, 2012).
Seeking to understand the implications of trial involvement and microbicide gel use for IPV, in this paper we present women's narratives of their experiences of participating in the Microbicide Development Program trial (MDP301) in Johannesburg, South Africa. In particular, we reflect on women's accounts of IPV, and how this contributed toward their experiences of their partner's negative responses to gel use and other requirements of trial participation such as clinic visits and reimbursements. We find that, women's experiences of partner relationships mediated their capacity to participate openly and without fear in the trial. Our findings lead us to question how trialists identify, define and assess social harms of this kind, and to consider the social implications thereof for the potential rollout of microbicides into the public health sector.
Section snippets
Study design
MDP301 was a multi-centre, randomized, double blind, placebo controlled trial that aimed to determine the efficacy and safety of PRO-2000/5 gel in preventing vaginally acquired HIV infection. PRO 2000/5 is a polymer gel applied vaginally using a disposable applicator. The gel was investigated to assess its ability to block the entry of sexually transmitted disease, including HIV pathogens into human cells. Women (n = 9385) were randomized to one of three gel arms: 2% PRO-2000/5, 0.5%
Ethical considerations
Women were required to attend monthly clinic visits for which they were reimbursed for travel and other costs related to trial participation (ZAR150, approximately 15 USD, per clinic visit). The clinic staff encouraged participants to inform their partners about their participation in the trial and to use condoms, and occasional male partner events were held at the clinic site and in the community. Informed consent was administered at enrolment and permission was sought from women to
Demographic characteristics
In the Johannesburg site of the MDP, women participants tended to be younger than 24 years of age (51%), unemployed (74%), and had completed secondary education (88%). Almost one fifth (17%) depended on their partners for material support, but more than one third (38%) received no financial support from their partners. The demographic characteristics of women enrolled in the social science sub-study closely resemble those of women in the trial (Table 1).
Description of IPV in MDP301
Of the 150 women interviewed, 60 (40%) reported 63 separate instances of IPV during the study period (52 weeks). This sub-set was, on average, 28 years old, ranging from 18 years to 51 years. Most (62%) were in long term relationships, while fewer (32%) were in casual relationships and the remaining 6 per cent were between relationships. All but three were unemployed; two were school students and one was a factory worker.
On the whole, these study participants (n = 60) most frequently reported
Unspecified accounts of IPV: everyday violence
Half of the IPV events reported (n = 30) were not specified and not linked to the trial (Table 2). Women talked about incidents of physical violence, as well as their fears and concerns about partner violence, independent of the trial, narrating a routinized ‘everyday violence’. Gloria, (22 years old) remarked: ‘I would wake up in the morning with bruises and not even remember what we were fighting about, but we were always fighting’. Similarly, Tebogo (28) recalled: ‘If we had a
Gels
Negative responses to gel use accounted for 17 individual instances of psychological or emotional violence and two accounts of physical violence. Women recounted intimate partners' refusal to have sex while using the gel, and ‘became angry’, ‘talked nonsense [insulted them]’, and ‘threw the gels away’. Of the two women reporting physical violence, 29-year-old Hlanhla said her partner threatened to abandon her, and then beat her: she repeated her partner's words: ‘we are finished – I told you
Trial requirements and participation
Participation and the trial requirements accounted for 16 reports of IPV, two were classified as threats, two concerned actual physical violence, and nine were classified as emotional or psychological abuse.
The majority (129/150) of the women in the social science sub-study reported that they had informed their partners about their involvement in the trial, and that they were using a microbicide gel. They said that this expressed respect for their partners and embodied mutual trust: ‘it is good
Discussion
Our analysis of women's accounts of their experiences of participating in the MDP301 trial reveals the pervasiveness of violence in this community, and its effects on trial participation. Here we follow Bourgois et al. (2004, 254) who, in their research on hepatitis C infections amongst inner city women, use the phrase ‘everyday violence’ to ‘call attention to the ‘institutionalized brutalities that are normalized and rendered invisible because of their routine pervasiveness’. They argue that
Conclusions
The material presented in this paper has highlighted the importance of the context of violence within intimate partnerships. On the one hand, this signals a need for trialists to be better equipped to deal with IPV, for example by providing counselling and social and legal referral throughout the trial (Heise et al., 2008), including offering participants disclosure facilitation and couples counselling and support. Yet, on the other hand, this has significance, not only for the ethical conduct
Acknowledgements
The authors wish to acknowledge the contribution of the MDP301 trial participants from Orange Farm and Soweto; the MDP301 social science researchers, Florence Mathebula, Sello Seoka, Mdu Mntambo and the MDP301 clinic teams in Soweto and Orange Farm. Robert Pool and Catherine Montgomery designed and supervised the implementation of cross-site research and data coding. Mitzy Gaffos commented on an earlier draft of the paper. Harry Moultrie prepared the demographic data tables.
Thank you to the
References (52)
- et al.
Social impact of preventive HIV vaccine clinical trial participation: a model of prevention, assessment and intervention
Social Science & Medicine
(2008) - et al.
Gender-based violence, relationship power, and risk of HIV infection in women attending antenatal clinics in South Africa
The Lancet
(2004) - et al.
Transactional sex among women in Soweto, South Africa: prevalence, risk factors and association with HIV infection
Social Science & Medicine
(2004) - et al.
Risk factors for domestic violence: findings from a South African cross-sectional study
Social Science & Medicine
(2002) - et al.
Microbicide acceptability research: current approaches and future directions
Social Science & Medicine
(2005) - et al.
Pro2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial
Lancet
(2010) - et al.
Challenges to microbicide introduction in South Africa
Social Science & Medicine
(2006) - et al.
HIV and chemoprophylaxis, the importance of considering social structures alongside biomedical and behavioral intervention
Social Science & Medicine
(2012) Empowering technologies: connecting women and science in microbicide research
Sciences Sociales et Sante
(2000)- et al.
The everyday violence of hepatitis C among young women who inject drugs in San Francisco
Human Organization
(2004)
Perpetration of partner violence and HIV risk behaviour among young men in the rural Eastern Cape, South Africa
AIDS
Negative social impacts among volunteers in an HIV vaccine efficacy trial
Journal of Acquired Immune Deficiency Syndromes
“One teabag is better than four”: Participants response to the discontinuation of 2% PRO2000/5 microbicide gel in KwaZulu-Natal, South Africa
PLoS ONE
About Microbicides. Global Campaign For Microbicides
When HIV-prevention messages and gender norms clash: the impact of domestic violence on women's HIV risk in slums of Chennai, India
AIDS and Behavior
Social Adverse Events Experienced by Trans Women and Other Men Who Have Sex with Men (MSM) Participating in a HIV Pre-Exposure Prophylaxis (PrEP) Trial
The Turn To Female-Controlled Safe Sex Technologies
Mapping the Standard of Care at Microbicide Clinical Trial Sites: Preliminary Findings and Summary recommendations
Intimate partner violence and condom and diaphragm nonadherence among women in an HIV prevention trial in Southern Africa
Journal of Acquired Immune Deficiency Syndromes
Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women
Science
Gaining a foothold: tackling poverty, gender inequality, and HIV in Africa
British Medical Journal
Participation in HIV Vaccine Trials
Managing men: women's dilemmas about overt and covert use of barrier methods for HIV prevention
Culture, Health & Sexuality
Use of female controlled microbicidal products for HIV risk reduction
AIDS Care
What should South African HIV vaccine trials do about social harms?
AIDS Care
Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions
Sexually Transmitted Infections
Cited by (33)
The CHARISMA Randomized Controlled Trial: A Relationship-Focused Counseling Intervention Integrated Within Oral PrEP Delivery for HIV Prevention among Women in Johannesburg, South Africa
2022, Journal of Acquired Immune Deficiency Syndromes