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Researchers must reach out to youth in trials
Address transportation problems, use multimedia
Investigators of HIV among teenagers and young adults need to develop additional and sometimes complex strategies for enrolling trial participants.
It's a duty and moral obligation to enroll youths in trials because so many people with new HIV infections are in the age group that encompasses teenagers and young adults in their 20s, an expert says.
Researchers need to find out what HIV treatment and biological prevention medication combinations and dosages will work best in young people, says Ralph DiClemente, PhD, a professor of public health at the Rollins School of Public Health, Emory University in Atlanta, GA.
"It's pretty important we get it right," DiClemente says. "We don't want to take chances with the health of anyone, and particularly with young folks."
The key is to improve enrollment and retention of youth so the studies will succeed in finding answers.
In DiClemente's research experience with enrolling young people, the participation rate has been about 85% of those eligible.
"In another study we had a retention rate of 91% over two years," DiClemente says.
"I think one of the misnomers is that young people wouldn't want to be engaged in these processes, but that's clearly incorrect," he says. "Young people are curious, and in many respects, a lot of what we are doing provides some value for them, whether it's HIV prevention or nutrition or exercise promotion."
DiClemente offers these strategies and examples of how to engage youth and effectively enroll them in clinical trials:
Find better ways to inform and educate about HIV research: Investigators who are studying new HIV medications should contact HIV-infected youth and their parents to explain what the new drug is and how it is being studied in a clinical trial, DiClemente suggests.
Use language adolescents and their parents will understand while explaining risks and benefits of the trial, he adds.
"You could simultaneously inform the community and individuals," he says. "But irrespective of the adolescents and their parents, it's important to keep the community in the loop."
The goal is to make the community aware of what's going on. For instance, if adolescents bring home consent forms for their parents to sign then parents will know what these are about, he adds.
Use multimedia in informed consent process: Investigators could develop brochures with pictures as part of the informed consent process.
"One thing we do is actually submit our consent forms, as well as our brochures, through a computerized readability assessment, to make sure none of the words exceed a fifth or sixth-grade reading level," DiClemente says.
"We also use color-coding because there might be a number of forms," he adds. "So parents will complete the green informed consent form, and young people will do the blue form."
The informed consent forms are written as simply and clearly as possible with larger fonts.
Give parents someone to contact for more information: DiClemente always includes his direct phone number for people to call with any questions.
"I've had parents call me from all over the country," he says. "They say, 'My son or daughter has been asked to be in this study, so can you tell me more?'"
Investigators should think of how they'd feel if the study subjects were their own children and empathize with parents of these youth, DiClemente says.
"If it were my child, I'd have the same concerns, and that's exactly how I approach it," he adds.
"For example, as the parent of a five-year-old, I want to know about any field trips my daughter takes at school," he says. "If I don't understand the form they sent home for me to sign then I want to call them and speak with a real live person."
Parents' questions might include the following:
- "One of my children has been asked to participate in a study. Can I get my other child in?"
- "My child has been asked to participate in a study, and he'll receive some compensation. Unfortunately, we don't have a checking account. Is there any other way you can compensate him?"
In this latter case, investigators might offer a Visa cash card or gift certificates to the family's favorite stores, DiClemente suggests.
Offer solutions to transportation obstacles: "If Mom doesn't have a car, or Dad's working all day, then how do they get to you?" DiClemente says.
Also, if research visits are scheduled for evening hours, then will parents be comfortable with their children staying out after dark?
"In Georgia, we have 14 to 22-year-olds in HIV studies, and the most difficult challenge for us is accessibility," DiClemente says. "There's poor public transportation, so if they have to come back to us, then it's really challenging."
Researchers give participants bus tokens when this will work. Sometimes for follow-up visits, they'll obtain the parents' permission to send someone to the participant's home to conduct the visit there, he adds.
"They arrive with a picture badge and call ahead to let them know when they're coming," DiClemente says.
Treat study participants as guests in a five-star hotel: "From our perspective, anyone who is participating in a project is performing a community service," DiClemente says. "They're engaged in a process that hopefully will help their community, so we treat everyone as though they are visiting the Ritz Carlton Hotel."
Investigators need to engage parents and participants, showing them respect and telling them exactly what the study's risks and benefits are, answering all of their questions, he adds.
"We bend over backwards to protect [participants], and they understand that," DiClemente says.
Participants typically are paid a nominal amount of $25, and they're asked to spend three to four hours of their day on a study visit, he notes.
"That's why we have to acknowledge that parents and kids are making a specific commitment," DiClemente says.
"Once we recognize that as a research community this is a commitment they've made then we need to ramp up our efforts to make it as easy as possible for them to participate and to extend to them every courtesy in all due respect," he adds. "That's what people want and deserve."