In-depth: Trials and Tribulations of HIV Prevention Research

SOUTH AFRICA: The trials and tribulations of community involvement in research

Photo: Anthony Kaminju/IRIN

Communities need to play a greater role in research efforts

Johannesburg, 27 September 2007 (PlusNews) - Francinah Ndala, pastor and chairperson of the township Ladies Forum, is no ordinary member of the community; she is a statuesque woman with a slightly intimidating air, who proclaims that "when I talk, everybody listens". Altogether an ideal candidate to participate in the community advisory group for microbicide clinical trials in Soshanguve, a township outside South Africa's capital, Pretoria.

A trial of the microbicide gel, Carraguard, is being run by the Population Council, an international non-profit organisation, at three sites in South Africa: the Setshaba Research Centre in Soshanguve, in Cape Town and in KwaZulu-Natal Province.

Microbicides include a range of products - such as gels, films and sponges - that could help prevent the transmission of HIV and other sexually transmitted infections. No microbicide has yet been shown to be effective. There are over 20 microbicide products in various stages of clinical development in countries including India, Botswana, Tanzania and Malawi.

The community advisory board, which represents communities where the microbicide trials are being conducted, is the usual form of local involvement. It acts as a bridge between the community and the research site, provides input into certain components of the trial, and maintains the ethical integrity of the process, according to the Global Campaign for Microbicides.

"There was a lot of myths and false information, especially from the ladies that I'm involved with in the community. Some of them were saying Setshaba is offering gel to kill them, which was not true, so I came here to get more information, so that when we are together I can bring the right thing to them," Ndala explained.

Once a month, usually on Friday mornings, the 10 community members on the board meet with the researchers at the Setshaba site to discuss progress in the trial.

Although anybody can be a member of the group, "It depends on how people value you, and whether you have earned their trust. If I come with the information about the trials, I believe they will take it, even though they may criticise and question it at first. At the ultimate end, they will listen to me. They have serious trust [in me]; they believe I cannot lead them astray," Ndala told IRIN/PlusNews.

It is easy to be cynical about how effective "community involvement" in clinical trials really is. Most research into microbicides is being conducted in resource-poor countries, in communities hard hit by poverty and HIV/AIDS.

Can untrained and overburdened individuals engage meaningfully with researchers in this highly technical terrain? Or is the process a token gesture, carried out to appear accountable and politically correct?

Tokens or effective intermediaries?

For Dr Khatijah Ahmed, principal investigator with the Carraguard trials in Soshanguve, community involvement is more than just a buzzword. "It's absolutely vital, especially in this field of research, where you're working with HIV, sexual behaviours of people, and there are so many controversies about what works and what doesn't."

She admitted that scientists had been "working in silos" for too long, neglecting the role of communities. "Science cannot function without community involvement; you cannot conduct research in your laboratory and bring people in ... You have to communicate with communities, tell them what you're doing, and make them part of the research from the earliest possible onset."

Before the first trial participants were enrolled, the advisory group in Soshanguve was formed to look at the material used to recruit volunteers and translate it appropriately.

Advisory group member Phillip Langa, who is also an HIV/AIDS counsellor, told IRIN PlusNews that most of the board members see themselves as "ambassadors" of the Setshaba research centre, and their role largely that of informing the community about developments in the trial. "We come here to get the information and then we take it back to our communities."

When asked whether the group would challenge the researchers about results or the trial design, ward councillor Josiah Rabalao said, "We are quite sure the research has no side effects, that's why we have no problem. We are willing to be patient and hear from the doctors."

Photo: Antony Kaminju

Researchers are now using community events to educate people about clinical trials

But this top-down, one-way process made a mockery of community participation, warned Ntokozo Madlala, advocacy officer for the Gender AIDS Forum, a gender lobby group based in KwaZulu-Natal Province.

"They feel that they are employed by the researchers, so the interactions are often biased and there is no aggressive questioning; it's just dictation by the researchers. There should be deliberations," the activist commented.

Staff members at research sites recruit and train the advisory board members, and convene meetings, which could make the members feel that they cannot present conflicting views and should offer answers based on what they think the researchers want to hear.
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It does not help that most members have little or no experience in public health, law and ethics or how clinical trials are run, Madlala commented. "The language barrier is a huge problem, and we still have a long way to go in training communities about clinical trials; you can't really engage with these powerful educated people if you don't know enough."

To make matters worse, community advisory boards also tend to get bogged down in the red tape of bureaucracy and the need to reach consensus. In Soshanguve, for example, the Friday meetings can take up the whole morning, and the information about the trials and the training they received has sometimes made them feel that "we were back at school", Ndala said.

Malebo Ratlhagana, community outreach officer at the Soshanguve site, said it has been difficult to get advisory group members to stay the course, as they had had to make a living and were simply volunteers.

Nevertheless, this form of community involvement still has its place. When news broke earlier this year that trials of candidate microbicide cellulose sulphate had been stopped after findings that it could increase the risk of HIV infection, Francinah Ndala was kept very busy during her weekly Ladies Forum meetings and church services.

"People were scared; they were hearing a lot of stories and asking me, 'is this your gel that is giving people AIDS?' Some people even stopped using the free condoms from here [Setshaba research site] because they said they [the condoms] also had AIDS. We worked hard to make sure that people knew the right things," she told IRIN/PlusNews.

More meaningful involvement

It has now become generally recognised that community advisory groups on their own play a very limited role, and there has been a gradual shift towards much broader outreach programmes.

In KwaZulu-Natal, for example, the Medical Research Council's HIV Prevention Unit, which oversees a number of microbicide trial sites in the province, decided not to have community advisory groups in certain politically charged areas where the forum could "get caught up in different political games and agendas", said Dr Roshini Govinden, principal investigator at the MRC.

Instead, the research site works with municipalities and healthcare workers, and conducts regular community feedback meetings, with smaller meetings at local healthcare facilities and community events.

People were scared, they were hearing a lot of stories and they were asking me, 'is this your gel that is giving people AIDS?'

According to Sinead Delany Moretlwe of the Reproductive Health and HIV Research Unit (RHRU) at the University of Witwatersrand, in Johannesburg, which has been involved in several microbicide trials, "the RHRU recognised the importance of wider community engagement some time ago, and has developed a number of strategies to increase community participation in trials".

These include the use of community radio stations and events to make known important health and trial messages, as well as "communicating the results of our own trials to as wide a range as stakeholders as possible ... this approach has helped to build trust within the communities in which we work."

At the end of the year, the results of the Carraguard trial will be announced - the first microbicide trial to complete the final stage of testing on humans. Ahmed, a principal investigator, and other researchers at the Setshaba centre are now working with the community advisory group to decide how the results will be disseminated.

Everyone is becoming impatient to know the outcome. "We have explained to people that this goes in stages," Ndala said. "After the trial, researchers must clean up the data and analyse the statistics, so that's why it's taking such a long time. We encourage them to be patient ... even though they are tired and are losing heart."

She is also preparing herself for the outcome: "It's difficult to say I'm excited. We are waiting with bated breath: one part of me is a little bit excited, but the other part ... there is room for disappointment."

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Trials and Tribulations of HIV Prevention Research

October 2007

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