Two years ago women were found to have lied in a clinical trial in South Africa for a new HIV drug. The VOICE trial was unsuccessful due to low adherence. When the trial was completed it was revealed many women involved had not been honest about their adherence to the drug regime they had signed up to take.
The fact that the trial did not achieve its aim of proving the drugs were effective led to a fierce debate about the morality of clinical trials and the role of women in them.
Many directed blame at the women. They were accused of deliberate deception to remain in the trial to access “stipends” of between US$10 and $15. They were also accused of being responsible for prolonging the spread of HIV.
Our research wanted to find out why the women who participated in the research lied.
It found many women in the trial came from the rural areas of South Africa and neighbouring states. They were young and unmarried, and many faced uncertain futures. They struggled to find work and many were caught in abusive relationships. And frequently they had no choice but to engage in exploitative relationships with men, employers, police and landlords. The trial represented hope for a better future.
Although the money was a motivation, it was not the main reason they participated in the trial. Instead, the trial allowed them to access good quality health screening and care and to be viewed as responsible virtuous women. It gave them a chance to forge a new moral identity, challenging the stereotypes of “loose” single women.
When the clinical trial was introduced to test the effectiveness of drugs on healthy women as a means of prevention, it was thought this would tackle the challenge of new HIV infections.
If they were successful, it would have resulted in a single product containing one or a combination of drugs – administered orally or vaginally – that could protect high risk women simply by it being taken daily.
The Vaginal and Oral Interventions to Control the Epidemic trial, more commonly referred to as VOICE, took place in Zimbabwe, South Africa and Uganda. The drugs were given to women considered most at risk of contracting HIV. These are women between the ages of 15 and 49, who have an incidence rate of more than 2% in South Africa alone.
More than 5000 women were part of the study to test novel ways for women to protect themselves from HIV infection using pre-exposure prophylaxis.
Some of the women took a pill containing two anti-HIV drugs while others took pills containing only one. A third set were given a vaginal gel with one of the drugs while a fourth set were given an inert gel or dummy pills.
Adherence calculations based on pill counts, interviews and audio computer aided self-interviews showed that adherence ranged from 86% to 90%. Just under half of the participants rated their own adherence as “very good”.
But an analysis of the pharmacokinetic (PK) tests to detect the drug in blood samples taken from 647 women, found the drug in less than half of the samples. This directly contradicted participants’ claims and exposed them as “dishonest”.
A rhetoric of blame
The criticisms of the women in the trial echo similar allegations that young women deliberately fall pregnant or even intentionally expose themselves to HIV to receive state welfare grants.
These criticisms also potentially threaten public confidence in clinical trials because they place a question mark over the trust established between trial participants, and the scientific community and donors.
In Hillbrow, where we conducted our research, we found that many women came from rural areas in South Africa and neighbouring states. Only half were employed and even those who had jobs struggled to sustain work.
Many women were migrants. Because of this they experienced the disruption of social networks and frequently had no choice but to engage in exploitative relationships with men, employers, police and landlords.
They also valued the trial, which was reflected in the high retention rates. It helped them get regular health checkups, HIV testing and quality care at clinics.
While they welcomed the US$15 travel stipends, the trial represented more than immediate monetary gain. Participating in the trial was an investment in “a better life”, as 40-year-old Lily put it. The logic was that if the trials worked, their lives would also improve. Being part of a solution to the AIDS epidemic was also extremely meaningful.
The trial also disrupted the monotony of sitting at home unemployed.
Performing perfect participation
Although participants faced considerable difficulties in adhering to taking the study product once a day, many portrayed themselves as “perfect participants”, never missing a dose.
Why did the women feel it necessary to sustain this fiction of perfection? The trial was seen as an opportunity for the women to assert credibility. For them, admitting to being non-adherent threatened their ongoing participation in the trial. This would have affected the benefits as well as their social status.
Trial participants wanted to redefine themselves as virtuous women. They used the trial as a way to do so. Reputations were managed as women crafted an image of themselves as responsible agents looking to a better future. Crucially, this rested on a performance of being the “perfect trial participant”, whether or not this reflected their adherence.