South Africa's Experience of the Closure of the Cellulose Sulphate Microbicide Trial

Ramjee, Gita; Govinden, Roshini; Morar, Neetha; Mbewu, Anthony

doi:10.1371/journal.pmed.0040235

Cited by 47 publications

(26 citation statements)

References 11 publications

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“…Now the desperate 23-yearold says she has become HIV-positive' (Daily Sun, 2007). And, similarly, another popular daily newspaper, City Press stated that trials use people as 'human guinea pigs' due to poverty (Hlongwa, 2007;Ramjee, Govinden, Morar & Mbewu, 2007). These sentiments are echoed in some of the academic literature on clinical trials.…”

Section: Discussionmentioning

confidence: 99%

Rumours about blood and reimbursements in a microbicide gel trial

Stadler

Saethre²

2010

African Journal of AIDS Research

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A rumour that emerged during a microbicide gel trial tells the tale of clinic staff purchasing trial participants' blood. This paper documents the rumour and explores its divergent interpretations and meanings in relation to the context of the trial and the social and economic setting at two of the trial sites (Soweto and Orange Farm) in South Africa. The article is based on qualitative research conducted during the Microbicides Development Programme (MDP) 301 trial to evaluate a microbicide vaginal gel for HIV prevention in women. The research incorporated in-depth interviews with female trial participants and their male partners, focus group discussions with male and female community members, and participant observation in the trial clinic and community setting at the two sites. The article analyses the different perspectives among the clinic staff, community and trial participants in terms of which the rumour about the exchange of blood for cash is seen as: 1) the result of ignorance of the clinical trial procedures; 2) the exploitation of poor and vulnerable women; 3) an example of young women's desire for material gain; and 4) a reciprocal exchange of 'clean blood' for cash between women trial participants and the health services. We suggest that the rumours about selling blood verbalise notions of gender and morality while also providing an appraisal of the behaviour of young women and a critique of social relationships between foreign researchers and local participants. Through stories about the clinical trial procedures and its potential reimbursements, the participants were creating and reconfiguring social relationships. Ultimately, rumours are one way in which foreign enterprises such as a clinical trial are rendered local.

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Section: Discussionmentioning

confidence: 99%

Rumours about blood and reimbursements in a microbicide gel trial

Stadler

Saethre²

2010

African Journal of AIDS Research

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“…To date, with the exception of the CAPRISA 004 trial that tested a microbicide containing the antiretroviral tenofovir, clinical trials of microbicides have had disappointing outcomes. In trials such as those of candidate microbicides Nonoxynol-9 and Cellulose Sulphate, HIV infection increased amongst women on the active arm of the trial (Ramjee et al 2007;van Damme et al 2000), while others such as the MDP301 trial simply showed no effect on HIV infection (Chisembele et al 2010).…”

Section: Microbicide Researchmentioning

confidence: 99%

‘The study has taught me to be supportive of her’: empowering women and involving men in microbicide research

Venables

Stadler

2012

Culture, Health & Sexuality

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Recognising that women often have little control over most HIV-prevention methods, including condoms, researchers have made efforts to develop new bio-technological interventions, such as microbicides, that could allow women greater autonomy in HIV-prevention decision making. In many situations, women are unable to negotiate condom use with their partners, meaning that they could be better protected through the use of an effective microbicide. This paper uses qualitative data from the Microbicide Development Programme 301 (MDP301) microbicide trial in Johannesburg, South Africa. Data is taken from in-depth interviews with male partners of female trial participants (n = 28), six focus-group discussions involving male partners of trial participants (n = 4) and female participants (n = 2). Data show that men's involvement in microbicide research ranges from a disinterest in trials to the desire to actively take part in and promote research that affects the health of themselves and their partners. Results showed that some participants were reluctant to disclose trial involvement and product use to their partners, making identifying men as potential research participants problematic. This paper considers how to involve men in microbicide research without undermining women's sense of empowerment and ownership of the trial and the product that is being tested.

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“…Non-vaccine biological interventions designed to prevent infection with HIV-1 after exposure to the virus include topical microbicides. However, multiple first-generation microbicides (nonoxynol-9, cellulose sulphate, and C31G [SAVVY]) have failed to protect in clinical trials (126)(127)(128)(129). Indeed, these early microbicides seemed to increase the risk of infection, perhaps through subclinical irritation of the mucosa.…”

Section: Tablementioning

confidence: 99%

The spread, treatment, and prevention of HIV-1: evolution of a global pandemic

Cohen¹,

Hellmann²,

Levy³

et al. 2008

J. Clin. Invest.

224

141

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The most up-to-date estimates demonstrate very heterogeneous spread of HIV-1, and more than 30 million people are now living with HIV-1 infection, most of them in sub-Saharan Africa. The efficiency of transmission of HIV-1 depends primarily on the concentration of the virus in the infectious host. Although treatment with antiviral agents has proven a very effective way to improve the health and survival of infected individuals, as we discuss here, the epidemic will continue to grow unless greatly improved prevention strategies can be developed and implemented. No prophylactic vaccine is on the horizon. However, several behavioral and structural strategies have made a difference -male circumcision provides substantial protection from sexually transmitted diseases, including HIV-1, and the application of antiretroviral agents for prevention holds great promise.

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South Africa's Experience of the Closure of the Cellulose Sulphate Microbicide Trial

Abstract: The researchers who conducted the cellulose sulphate microbicide trial share the lessons they learned from the trial's early closure.

Cited by 47 publications

References 11 publications

Rumours about blood and reimbursements in a microbicide gel trial

Rumours about blood and reimbursements in a microbicide gel trial

‘The study has taught me to be supportive of her’: empowering women and involving men in microbicide research

The spread, treatment, and prevention of HIV-1: evolution of a global pandemic

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