HIV study uses consumer advisory boards to assist with trial recruitment
Buy-in among population is key
Researchers dealing with a vulnerable population of homeless and mentally ill people found that their recruitment and retention were high, thanks in part to the help of a consumer advisory board (CAB).
The three-year study involved HIV prevention among people who could become infected with the virus because of mental illness and risky behavior. Investigators recruited participants over a nine-month period, says Stephen Brady, PhD, director of mental health and behavioral medicine program and an associate professor of psychiatry and graduate medical sciences at Boston University School of Medicine in Boston, MA.
The participants had a number of demographic characteristics that might have made them both difficult to enroll and difficult to retain in a clinical trial. For example, about 70% were homeless; 86% had abused substances over their lifetimes; and nearly all of them had comorbid psychiatric disorders, including mood disorders, psychosis, post-traumatic stress disorder, and other serious anxiety disorders, Brady says.
Anticipating a high study drop-out rate, investigators enrolled twice the number of participants they expected to follow in the study. To their surprise, the recruitment was relatively quick, and the retention rate was about 70%, Brady says.
"Honestly, we thought recruitment would be a lot harder," Brady says. "And the retention rate is really high for this population."
The study compared two interventions for preventing HIV infection, including one that involved the use of motivational interviewing techniques to bring about change.
There were two factors that helped researchers succeed in recruitment and retention: First, the study was appealing to this population because of their fear of HIV infection, and, secondly, the clinical trial team started a CAB to assist with the research, Brady says.
"We have a consumer board that is fantastic," Brady says.
The CAB helped researchers tweak study instruments, recruit participants, and even to hire study staff, Brady says.
"We haven't hired anyone that our CAB didn't approve of," Brady says.
The CT team found volunteers for the CAB by networking with a state mental health authority and an HIV/AIDS organization.
"It's often very important to tap into existing consumer grass roots organizations because we'd have a hard time if we went out there blindly, trying to find people with mental illness," Brady notes.
CAB members are paid $10 per hour for their help with meetings, recruitment, staff hiring, etc. It's the same fee the study participants are paid.
Consumer board members also were trained in how to participate on such a board, and they were encouraged to discuss their ideas and concerns at meetings.
"Our board is very active," he adds. "These are people who often feel very strongly about the needs of people with mental illness and recovery from mental illness, and they also feel strongly about recovery from HIV because people they love are infected."
CAB members were empowered to participate at monthly meetings, where they discussed recruitment strategies, helped investigators pilot-test assessment instruments, and interviewed prospective direct-care, clinical trial staff, he says.
For example, CAB members played the role of a study volunteer as CT staff gave them an assessment test.
"They'd give us feedback on whether it was too long or too intrusive," Brady says. "Then from there we were able to make adjustments in the protocol and refine it."
One key to helping the board maintain its enthusiasm is to have investigators demonstrate support and leadership.
For example, Brady tries to attend the CAB meetings, personally listening to their discussions and feedback.
"I was very busy this past fall, and I noticed that when I can't make a CAB meeting, it matters a lot to the members," Brady says. "It's important to them that the head scientist in the study cares about them and wants to hear from them."
Also, Brady asks for CAB members' help in a variety of circumstances, including community outreach.
"We had our CAB participate with us in a presentation at the American Psychological Association meeting," Brady says. "We're also talking about including them as authors in the study, giving them credit for publications related to consumer boards."
As the study evolved, so did the role of the CAB.
"When we had preliminary data, we brought it to our CAB and said, 'What do you think? What do you think these results mean?'" Brady says. "We talked about demographics, how many men and women were enrolled in the study, and the CAB members were very interested."
The CAB theorized that the study's higher enrollment of men than women might be related to the issue of trauma faced by many women who are at high risk for HIV infection.
"They thought it meant that women might be more difficult to engage and retain in research," Brady says.
Investigators maintained participant confidentiality, but did have general conversations about the study volunteers.
When the CAB's role in study recruitment was winding down, they spent the monthly meetings discussing the meaning of the data and troubleshooting what might have worked and what might not have worked in the study, Brady says.
While developing a CAB takes time and effort, which time-stressed investigators might feel they can't spare, it has big payoffs, Brady says.
"What's emerging in clinical trial research is that researchers are being asked to demonstrate that they have active and ongoing consumer involvement in their research," Brady says. "There are a number of ways to do that, and we would suggest that the best way is to have an ongoing consumer advisory board throughout the duration of the study."
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