CT sites could learn a lot about community rapport from HIV trials
Community outreach best practices are renowned
Few diseases have anywhere near the clout, exposure, and clinical trial support of HIV/AIDS. Dedicated foundations, advocacy groups, and international organizations have spent more than two decades working to ensure HIV prevention and medication trials are a top priority for governments and private industry.
As a result, many HIV trials have best practices, including in working with local communities that could be a model for the rest of the clinical research.
"The work I'm engaged in sits at the interface between clinical research and the local community and, increasingly, the global community as well," says Kathleen MacQueen, PhD, MPH, a senior social scientist and coordinator of interdisciplinary research ethics at Family Health International in Research Triangle Park, NC.
HIV investigators and research sponsors have developed complicated and novel ways of educating communities about their studies. Their methods of laying the groundwork for clinical trials provide a template that researchers studying other diseases might emulate.
For example, the AIDS Vaccine Advocacy Coalition (AVAC) of New York, NY, and the Joint United Nations Program on HIV/AIDS (UNAIDS) have developed a set of guidelines called Good Participatory Practice (GPP) guidelines for biomedical HIV prevention trials that provide a framework for how HIV investigators should work with communities during HIV biomedical prevention trials, including vaccine trials and microbicide trials.
"The reason for the development of the guidelines came from when pre-exposure prophylaxis (PrEP) trials were being launched and proposed," 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."
The GPP guidelines establish base principles between researchers and communities and include suggestions for how investigators should work with communities from the inception of a trial to the close-out of the trial, Miller says.
AVAC and UNAIDS brought stakeholders and experts from around the globe together to develop the guidelines. Once they were created they were published in draft form on the UNAIDS and AVAC Web sites to invite input and comments. The guidelines were updated and released in November, 2007.
"They were created as a living document and will be revised on a regular basis to reflect the real needs of the field," Miller says. "We want clinical trials conducted in an ethical fashion and to have everyone feel like it's a positive relationship, and the guidelines are one means to that end."
HIV researchers are particularly sensitive to a community's perception of clinical trials because of the complexity of studying this disease.
"It's a challenge explaining this highly complicated disease," MacQueen says.
Community education is an important part of a vaccine trial's recruitment process, as well.
In a phase IIb HIV vaccine trial in the U.S., investigators used a broad marketing approach, relying on community education and a variety of methods, to reach the target minority audience.
"It did return a substantial amount of phone calls and interest from our minority community about the study," says Paula Frew, PhD, MPH, an assistant professor of medicine in infectious disease and in behavioral sciences and health education at Emory University School of Medicine in Atlanta, GA.
"We were satisfied with our recruitment approach because it was community informed," Frew says. "It gave us that necessary volume of interest we needed to far exceed our enrollment goals."
Complex issues explained
Before investigators can engage a community they have to be prepared to explain complex issues of randomization and what it means in an HIV prevention or treatment trial, she says. Remember, this is a community of people who live with the stigma and behavioral issues associated with the epidemic, she adds.
"HIV as a disease is clearly life-threatening, and it's something that's of great concern to people to find out whether they have HIV or to find out if people in their community have the disease," MacQueen says.
"You need to understand the social context within which this disease happens and do the clinical research in a way that would not worsen the social context of the disease," she adds.
About 15 years ago, MacQueen was a project officer at the Centers of Disease Control and Prevention (CDC) in Atlanta, GA, and led one of the first cohort studies to prepare for HIV vaccine trials in the United States.
"We worked with men who have sex with men (MSM) in several cities to try to get a handle on HIV incidence, as well as other issues," she recalls. "And we discovered that the social and ethical challenges would be very big."
In the early 1990s, there were far fewer treatment options for HIV patients, and people thought the only way the world would ever conquer the epidemic would be through a vaccine.
"The AIDS activists wanted a vaccine and wanted us as researchers to do a good job of explaining the vaccine and explaining the trials," MacQueen says.
"They wanted community representatives at the trial for all the discussions," she adds. "So right from the beginning we were engaged in active conversations with advocates in this country, and as we moved into the international arena, we worked the same way."
MacQueen learned from this and subsequent experience how important it is to educate the community in a way that's beneficial to the community, and she learned that it's important for the education to be in both directions so that researchers can learn from the community about how to improve their trial.
"At every single site that has been involved with HIV prevention research now you have something that looks like a community advisory board," MacQueen says.
"In general, you find there are key opinion leaders, gatekeepers, people who are working in their communities on HIV-related issues, and people who want to make it part of their life work to listen to what's going on in their local community," she explains. "These people bring this experience to the table for researchers, and they listen to researchers, and then bring what they've learned back to the community."
Good community advisory boards share that key characteristic of having members who take the role seriously and who listen to all sides, serving as an important bridge between investigators and the community, MacQueen adds.
"Basically, the more people can understand what you're doing and why you're doing it and the precautions you take to protect them, then the more trust you build," she says.
The GPP guidelines are one tool for building community trust.
Although they were written for researchers, community groups have expressed so much interest in these that there might one day be a version written specifically for lay people, Miller says.
"That's an important next step to make these more accessible to everybody," Miller says.
"The nice thing about these guidelines is they talk specifically about how researchers should work with communities, so community advocacy groups can read these guidelines and offer specific suggestions on elements of community engagement," she adds. "An important next step is to make these guidelines, which were written for researchers, more accessible to communities."
For example, the guidelines talk about how communities should be involved in the protocol development process and how a representative from the community should be provided with summaries of the protocol, Miller says.
The summary should be translated into a language community representatives understand, she adds.
"So community representatives can participate in the discussion about how it's done and make recommendations," Miller says.
"A community representative might say, 'We asked investigators to see the protocol, but they're not giving it to us,'" she says.
The community member can then advocate for greater community engagement by referring to the GPP guidelines which indicate that investigators should share protocols or summaries with the community and give specific examples of the way they monitor trial outcomes.
AVAC has a strategic plan around the guidelines and is looking at continuing relationships with people and organizations that want to work with the guidelines, Miller adds.
"We work with community members, and we build relationships on the ground to support biomedical HIV research stakeholders," Miller says.