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HIV prevention trials require sophisticated community preparation
Controversial PrEP trials serve as cautionary tale
HIV biomedical prevention researchers are leading the way in developing successful models or engaging community involvement and education about research.
For example, the AIDS Vaccine Advocacy Coalition (AVAC) and UNAIDS have published a set of guidelines about building rapport and trust with communities. The 10 principles of Good Participatory Practice (GPP) guidelines for biomedical HIV prevention trials could serve as a model for all clinical trial research.1
The guidelines were developed when pre-exposure prophylaxis (PrEP) trials were launched, says Lori Miller, MHS, a senior program manager of AVAC.
"There were many controversies around community engagement with researchers, including controversies around the PrEP trials in Cambodia, Cameroon, and Thailand," Miller says.
Researchers working in biomedical HIV prevention trials also have learned ways to communicate effectively to potential research participants what their trials are about and how they work.
This also has been a trial and error experience.
For example, investigators conducting HIV prevention trials in Africa, Latin America, and other international sites learned through anecdotal reports that community members misunderstood the intention of blood draws.
"People had some interesting ideas about why we would want to collect blood and what would be done with it," says Kathleen MacQueen, PhD, MPH, a senior social scientist and coordinator of interdisciplinary research ethics at Family Health International in Research Triangle Park, NC.
"We heard about rumors of witchcraft and vampirism or using samples to do genetic engineering that would make people in the United States rich, but leave people in the developing world poor," MacQueen adds.
HIV researchers and experts held a special session to discuss these reports. About 80 people from Asia, Latin America, Africa, and the United States met to discuss this situation.
The meeting was fruitful. Researchers and sponsors learned that if researchers do not fully explain what they're doing and why they're doing it in a way that participants can fully understand then people will jump to their own conclusions based on their own life and culture experiences, MacQueen explains.
"If they don't understand what a laboratory is and how you would use blood to understand the disease, and if they only understand the use of blood in the context of witchcraft, then that's the model they'll use," she adds.
Armed with this new understanding of how cultural and experiential differences can lead to huge misunderstandings, researchers began to educate communities and potential participants in new ways.
For instance, HIV biomedical researchers routinely ask community advisory boards (CABs) to help them identify research terminology that could be misconstrued or research practices that might negatively impact a particular cultural belief or practice.
HIV researchers also understand as well as any investigators how important it is to build trust in a community from which people will be recruited for clinical trials.
"Laying the groundwork in the community can be very important to that process," MacQueen says.
For example, HIV prevention researchers learned from community advisors in Africa that potential participants did not understand the term "vial" when they were told that two vials of blood would be taken, she says.
The word "vial" was translated to the word "bottle," and to participants this meant a Coca Cola bottle. So they thought researchers wanted to take enough blood to fill two Coke bottles.
Investigators found a simple solution: they brought in a liter jug and explained that the blood in the human body could fill four or five of these jugs, MacQueen says.
"Then they showed them a vial and said, 'We use this to collect a small amount of your blood,'" she adds. "Then they also explain that their bodies are constantly making more blood."
Occasionally in HIV research, small misunderstandings can escalate and become major problems for the trial site.
The controversy that erupted over the PrEP trials in Cambodia, where the government cancelled the PrEP trial in 2004 is a good example of this.
Researchers began meeting with community members in Cambodia in preparation of enrolling sex workers in the HIV tenofovir trial for PrEP in 2003. At this time, organizations that assisted sex workers were treated like pariahs by many established HIV organizations. This was because the President's Emergency Plan for AIDS Relief (PEPFAR) prohibited funding to any group that did not have a policy explicitly prohibiting prostitution and sex trafficking.2
Some non-governmental organizations (NGOs) thought the PrEP trials were connected to the U.S. Agency for International Development (USAID). And they feared USAID would restrict their funding if they assisted researchers with tenofovir PrEP trials. This fear also made them suspicious of researchers' motives.2
The situation was made worse by communication problems. For instance, the people attending community meetings to discuss the trials did not have basic research literacy, and the information presented was not presented as simply as needed.
Community members were particularly concerned about how future access to care and antiretroviral therapy (ART) would be assured to seroconverters.
As community discussions progressed, the community members representing sex workers decided to ask that participants be given long-term insurance protection to offset the risk of a side effect from tenofovir that would impact their ability to work. They also decided that the clinical trials should pay them more than the study compensation incentive of $3 per month for their participation.
As a result of their concerns and the publicity they sought to express their disagreement with parts of the trial, the Cambodian government cancelled the trial, and in August, 2004, all work stopped.
The experience proved costly and led to setbacks to PrEP research, but HIV investigators learned that community engagement and trust-building were extremely important to the success of their work.
"Our informed consent process can take a half day or more since some HIV trials are so complex with screening, informed consent, and behavioral interviews," MacQueen says.
"If you don't really talk to people and listen to them and understand what they think, then all of your best intentions can go haywire," she says.
And the best way to ensure this level of understanding is to build research literacy in communities that are targeted for HIV research. This is one of the 10 key principles in the GPP guidelines.
"It should be one of the most important principles because you can't expect to work with communities and have conversations with them if you haven't educated them enough so that they can understand how research is done," Miller says.