GPP core principles would work for any clinical trial
GPP core principles would work for any clinical trial
Building health literacy is top priority
Clinical trial professionals who would like guidelines for working with communities during study enrollment might look no further than the 10 fundamental principles created for HIV biomedical prevention research.
The 10 principles of Good Participatory Practice (GPP), were developed by the AIDS Vaccine Advocacy Coalition (AVAC) of New York, NY, and the Joint United Nations Program on HIV/AIDS (UNAIDS). But they could apply to any clinical trial, especially as sponsors and researchers increasingly are seeing the importance of building rapport with communities in order to improve trial participation.
"These guidelines have very specific suggestions on minimum elements of community engagement," says Lori Miller, MHS, a senior program manager of AVAC.
Here is a list of the 10 principles and explanations about these GPP guidelines:
1. Scientific and ethical integrity: The guidelines ask researchers to adhere to universal ethical principles of respect for persons, beneficence, and justice while working toward a study's scientific goals.1
2. Respect: "The GPP document talks about respect and transparency being the foundation of a relationship between researchers and the community," Miller says. "There is an inherent power imbalance between communities where phase III clinical trials for biomedical HIV prevention research are conducted and the researchers who conduct them."
These trials often are conducted in places where there is a high incidence of HIV and higher levels of poverty, she notes.
"In countries where trials are conducted, groups such as sex workers and men who have sex with men (MSM) are often stigmatized or marginalized," Miller explains. "So there's often an inherent power imbalance between those being researched and the researchers."
Without first building mutual respect in a community, misunderstandings can escalate into crises for research projects.
For example, when HIV researchers were planning a pre-exposure prophylaxis (PrEP) trial in Cameroon and Cambodia a few years ago, a controversy erupted between researchers and activists and the local communities being targeted for the study.2
The U.S. National Institutes of Health (NIH) funded a grant for researchers at the University of California at San Francisco to conduct a trial of oral tenofovir as PrEP among sex workers in Cambodia in 2002. Similar PrEP trials were planned for Cameroon, Ghana, and Nigeria. Several years later, PrEP trials were organized for Thailand and Botswana by the Centers of Disease Control (CDC) in Atlanta, GA.
AIDS activists protested the trials in West Africa in 2004 as enrollment was scheduled to begin. A union of sex workers protested the trial in Cambodia. Activists cited ethical concerns and continued access to HIV care and antiretroviral treatment in the event of HIV infection during the prevention trial. They specifically objected to the prevention package being offered to female participants because it did not include female condoms.2
"There was a sense of miscommunication and misunderstanding about respect and objectives on both sides," Miller says.
The controversy eventually resulted in the Cameroon trial being closed and the Cambodian trial never starting.2
"It was a very unfortunate miscommunication even though the intentions on both sides were good," Miller says.
Call for clarity
3. Clarity in roles and responsibilities: This guideline expresses the need for better communication about expectations and greater shared responsibility in clinical trials.
"Previously, researchers came in and did research on 'research subjects,'" Miller explains. "Now there needs to be a more collaborative approach."
Researchers, participants, and their communities have roles and responsibilities and should share responsibility of research, she adds.
4. Towards shared responsibility: Researchers should work jointly with sponsors, research site staff, local authorities, and the community that is impacted by the clinical trial.1
"Researchers can't just think it's their game and exclude the community and, likewise, communities — if they're interested in research being done there — should take responsibility too," Miller says.
And if a community doesn't want research being done, then it shouldn't be done there, she adds.
5. Participatory management: The community should play an active and informed role in the trial.
This means communities should make certain the people who best represent the community's values and concerns serves on the community advisory board. In addition, these representatives need to help inform the community about the research process, share the community's concerns with investigators, share investigators' explanations with the community, and help to find solutions to unexpected problems.
6. Autonomy: Community advisory boards should be independent without individual conflicts of interest. Their goal should be to provide critical input to the clinical trial process as it intersects with the community's interest and well-being.1
7. More transparency: Transparency increasingly is an important issue among research participants/communities and researchers/sponsors.
"The idea with these guidelines is that researchers have a responsibility for more transparency to the whole community," Miller says.
"There have been a lot of controversies, more in HIV trials because of the power dynamic in which phase III trials are being done in areas where people are poorer," Miller says.
Communities often don't receive information about the research in a timely way, so researchers need to work toward that more and have open and honest communication that is so important to good practices," she adds. "Researchers have an obligation to inform communities about what they're planning to do and to be transparent about it."
Risk reduction counseling
8. Standard of prevention: Risk-reduction counseling and access to HIV prevention methods should be provided to all biomedical HIV prevention trial participants throughout the duration of a trial, according to the guidelines.
9. Access to care: Trial participants have the right to access medical care for trial-related injuries and harm and to the experimental product if it proves to be effective, according to the guidelines.1
This principle also promotes the standard of providing HIV antiretroviral treatment, according to negotiations before the trial begins, to participants who become infected during the study.1
10. Building research literacy: "This is an issue that came up consistently in our consultations," Miller notes. "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."
Investigators enter a community with complicated protocols, science, and epidemiology, so it would be difficult to have a conversation about these issues until the community's level of understanding is raised, she says.
"It's the responsibility of researchers, sponsors, and communities to do this," Miller adds. "And this is one of the hardest things to achieve because it costs money to do it."
It requires clinical trial teams to meet with community members to discuss how the science is done, why randomization is necessary, why a blinded study is needed, what the procedures are, and why these procedures have to be done, Miller says.
"It's basic information for researchers, but for communities this is a complicated topic," she adds. "But it's necessary that you do this basic education before you start recruitment for the trial."
References
- Good participatory practice guidelines for biomedical HIV prevention trials. Published by the AIDS Vaccine Advocacy Coalition (AVAC) of New York, NY, and the Joint United Nations Program on HIV/AIDS (UNAIDS);2007:1-68. Available online: http://data.unaids.org/pub
- McGrory E, Irvin A, Heise L. Research Rashomon: Lessons from the Cameroon pre-exposure prophylaxis trial site. Global Campaign for Microbicides. 2007:1-54. Published on-line: www.global-campaign.org/clientfiles.
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