CT site recruits and retains meth group
CT site recruits and retains meth group
Looking for 'after-affect' drug
Methamphetamine ("meth") addicts are one of the more difficult research populations to recruit both for the erratic lifestyles many have and the illicit drug's tendency to make people paranoid.
Despite these challenges, clinical trials staff and investigators at Iowa Lutheran Hospital in Des Moines, IA, have successfully recruited meth addicts for double-blind, placebo-controlled clinical trials, studying investigational drugs, says Pamela Normandin, RN, MSN, CCRC, a clinical nurse specialist in the office of research.
"We've looked at a plethora of drugs," Normandin says.
"Meth addicts have no real withdrawal period, but they're so sleepy that they sleep for days," she explains. "So we're looking for a drug that helps them with the after-effects of their meth use."
The retention rate typically is 70 % or better, Normandin says.
"This is a hard group when they relapse, and they sometimes don't come back," she adds.
One of the reasons why this is a difficult population to recruit for CTs is because meth addicts are very distrustful of health care workers they don't know well, Normandin notes. "Many times they have legal issues," she explains.
So potential CT recruits have expressed fears that if they come back to the clinic to learn more about a study then it will be a sting operation in which law enforcement officers are waiting there to arrest them, Normandin says.
"They think they'll come in and people will swoop down on them and haul them away," she says. "So we have to reassure them that they'll be safe if they come in to see us."
Here are some of the CT site's recruitment and retention strategies:
1. Show potential recruits the government's certificate of confidentiality.
Under section 301(d) of the Public Health Service Act (42 U.S.C. 241(d)) the Secretary of Health and Human Services may authorize persons engaged in biomedical, behavioral, clinical, or other research to protect the privacy of individuals who are the subjects of that research. This authority has been delegated to the Centers for Disease Control and Prevention (CDC), according to the CDC's Web site at www.cdc.gov.
This law says no federal, state, or local civil, criminal, administrative, legislative, or other proceedings may compel researchers to identify research subjects by name or other identifying characteristic, Normandin says.
The certificate gives the CT site the authority to withhold all names of participants and other identifying characteristics, except in the case of mandatory reporting issues, such as child abuse and sexually-transmitted disease (STD) reporting, she adds.
While HIPAA's privacy rule also provides some protection, the certificate goes further, she notes.
"With HIPAA, there are some issues from a legality standpoint where if you're issued a subpoena, the information might not be as protected as you'd want it to be," Normandin says.
"This population is so fragile and vulnerable that they want to make sure that nothing is shared that would put their privacy in jeopardy," Normandin says. "It's such a big deal with them, so the law is a good thing, and it really helps us as researchers, especially if they have legal issues."
Normandin discusses the certificate during the informed consent process.
"We test their urine every time they come in to see us, and this certificate protects those results," Normandin says.
2. Find right venues for marketing recruitment.
The first time the site had a study enrolling meth addicts, the recruitment marketing didn't work well, Normandin says.
But over time the CT specialists and investigators have developed a brochure that lets meth addicts know that there is an experimental treatment for their addiction.
"The brochure has a picture of an addict who looks woeful, and it asks if you're willing to quit," Normandin says. "On the inside of the brochure it gives you a number to call."
The brochure also contains bold letters stating that the CT site is offering experimental research. Only through trial and error did the CT site find the right places to leave the brochure.
"None of these meth addicts go for routine health care, but they do receive emergency care," Normandin says. "So we put the brochures in the emergency room (ER) waiting area and gave them to clinicians who work in the ER."
They also placed brochures in Planned Parenthood clinics, emergency/urgent care clinics, grocery store bulletin boards, and laundry mats, she says.
"Laundry mats are a place they might find because some of these people are homeless, but they still have to do their laundry, or they might hang out there as a place to get out of the cold," Normandin adds.
Another idea was to place the brochures in tattoo parlors, she notes.
"But only 50% of tattoo places would let us put the brochures in there because of the insinuation that tattoos were associated with drug addicts," Normandin says. "And we also put the brochures in highway rest stops about 15 miles from the city because of the truckers who visit these stops."
3. Develop referrals from variety of disciplines.
"We have a sweet relationship in the Midwest where counselors and physicians and law enforcement officials know about us," Normandin says. "And if they think their person would fit, they'll refer them to us."
The referral sources know that there are few options for treating methamphetamine addicts, so they believe that clinical trial participation might be of benefit to this population, she adds.
4. Advertise in publications that are read by potential subjects.
Again, this was a recruitment strategy that required some trial and error.
"We tried to put an ad in the daily newspaper, but we got zero response," Normandin says.
So they bought a full page ad in an alternative weekly newspaper that also advertised strip clubs, she says. The ad was in red ink with black lettering that highlighted the words "treatment" and "free," and it brought in more trial participants, Normandin says.
"We had one guy who went to a hotel and thought about ending his life," she recalls. "Then he picked up that paper and saw the ad and called us."
The CT site also advertised on bus stop banners, although this method proved too expensive and didn't elicit as big of a response as they had hoped, Normandin says.
Radio ads worked well, but only if they used the right kind of radio station and ran the ads in the evening to late night hours, she says. The night time ads have brought in a good response, she adds.
"We've chosen to advertise on oldies radio stations, and we did run an ad on a talk radio station that many [research participants] said they listen to," Normandin explains. "A lot of times the talk radio station will let us do an interview with key people who have a morning talk show."
The best recruitment method has been through word-by-mouth, Normandin says.
"If people have success here and meet us and feel safe here and understand their role as a participant, then they'll tell a friend and the meth community," she explains. "If [our CT participants] see someone they haven't seen in a while, then they'll give them a business card or brochure, and we'll get a call from someone who says, 'My friend so-and-so says you can help me.'"
Methamphetamine ("meth") addicts are one of the more difficult research populations to recruit both for the erratic lifestyles many have and the illicit drug's tendency to make people paranoid.Subscribe Now for Access
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