Program targets drug compliance for HIV/AIDS

New management approach helps patients cope

Powerful combinations of anti-retroviral medications are transforming HIV/AIDS from a terminal illness into a long-term manageable illness - if they are taken correctly, says David Hardy, MD, professor of medicine at the University of California at Los Angeles.

"Medication adherence presents one of the most significant challenges in managing HIV/AIDS today," he says. "When patients do not fully adhere to their drug regimens, it can result in a virus that is resistant to drugs as well as progression of the disease."

A new management program by Glaxo Wellcome in Research Triangle Park, NC, called Tools for Health and Empowerment, or THE Course, is successfully helping patients comply with the complex regimen, which may include as many as 20 pills a day, he says.

The management program, which provides complete materials to facilitate up to 12 weekly two-hour group sessions for patients and their care partners, features interactive learning techniques. Support materials include videos, overheads, handouts, and supplemental reading materials for facilitators and a workbook, medication planner, log book, glossary of HIV/AIDS related terms, and seven-day medication box for patients.

"Each module includes a series of skill- building techniques to prepare patients to better manage their illness," says Valerie Scott, Glaxo's senior manager for HIV Programs, Care Management Division. "The goal is to increase patients' knowledge, help them build coping skills, and empower them to change their behavior," she says.

Yet changing human behavior is never easy, especially when the patients must follow the complex drug regimen for life.

For example, some HIV/AIDS medications must be taken on an empty or full stomach, others require some food restrictions, and still others have side effects. But all must be taken according to a stringent schedule.

"We explain the fact that taking a 'drug holiday' - stopping for a few days or a weekend - can lead to drug resistance and decrease their chance of survival," says Scott. "We emphasize they must adhere on a daily basis because the virus quickly multiplies and can mutate without the presence of an antiretroviral medication."

And unlike managing diabetes, the HIV/AIDS patient doesn't feel the immediate consequences of a medication lapse. "If you forget to take your insulin, you know it very quickly," she says. "But an HIV/AIDS patient may not feel sick if he or she discontinues the medications for a short time."

The consequences of noncompliance is becoming a public health concern, says Maddy M. Rice, RN, BSN, Glaxo's development manager for THE Course. "Without consistent use of antivirals, the HIV/AIDS virus becomes drug resistant. This limits the options of drugs available in the future and can result in the return of the epidemic, eventually driving up health care costs"

A second concern is that newly infected individuals "are being infected with a virus that is already resistant to our current arsenal."

But THE Course is much more than inundating participants with dire warnings, stresses Rice.

"If you want to change behavior on a long-term basis, you must use a whole new way of facilitating learning," says Rice who incorporated principles of other successful behavior modification and self-management groups such as Weight Watchers and diabetes education groups as she developed THE Course.

That's why the program is not available for off-the-shelf purchase. "Potential facilitators, who tend to be nurses, case managers, social workers, or AIDS treatment educators, must first participate in two- to three-days of intensive training," Rice says.

The training is "not at all like an HIV update," she points out. "We concentrate on having candidates actually experience adult learning principles and participant-centered learning. We tell them about the concepts, we model the concepts, and then they have a chance to practice them."

The training program, which won the 1997 Bob Pike Creative Education Trainer of the Year Award from Creative Training Techniques in Minneapolis, costs from $2,000 to $4,000, including costs of all 12 modules.

A spoon full of sugar . . .

That same interactive and lively learning approach - hear, see, do - is then taken back to the group of about 10 HIV/AIDS patients and their support people, who include friends, parents, or companions.

"The facilitators select about six to eight of the modules that are most applicable to their population," Rice says. For example, one site may need to focus more on women while another focuses on injection drug users.

"Every piece of supporting material in each module, as well as the accompanying activity, is designed to reinforce one or two key learning objectives aimed at changing behavior," Rice says.

The course is also especially created to include all types of learners. For example, the group may read the materials, watch the video, and discuss the principles.

Patients also actively participate in the program, stresses Rice. "We use hands-on 'tools' such as log books, medication box, and relaxation tape that are especially designed to foster behavioral change," she says.

THE Course incorporates role play, as well.

"When we discuss taking an active role as a member of their health care team, we ask them to role-play asking their provider for clarification," she says. "The take-home assignment is to develop a list of questions and practice using them during their next visit to their provider."

In addition, the management program focuses on positive reinforcement. "We use verbal praise, we give buttons, we refer to their decreasing viral load - anything to remind them that their behavior is directly connected to staying healthy," Rice says.

She also encourages the other participants to support each other. "In some cases, they develop a buddy system to call one another as a medication reminder or to encourage each other to meet goals," she says.

Early results indicate success

So far, the approach seems to be working. At the 1998 International AIDS conference in Geneva, which focused on medication adherence, Hardy discussed the preliminary results of the pilot study for the program.

"Patients reported a statistically significant improvement in their medication adherence through the six month follow-up period of the study," he says.

It was tested at 11 sites across the United States in five types of treatment settings: managed care organizations, private practices, public health clinics, AIDS service organizations, and hospitals, says Scott.

In addition to measuring adherence, the pilot study measured quality of life at pre-intervention, post-intervention, and three and six months. The study will continue to measure clinical, humanistic and economics indicators during six, nine, and 12-month follow-up, says Scott.

"We have also seen a statistical significant improvement in their knowledge, empowerment and coping skills," she says.

Rice adds that the very nature of THE Course will keep treatment costs down. "One of the major cost drivers in treating HIV/AIDS is managing opportunistic infections. So if patients better understand the early signs and symptoms, they can manage the condition rather than waiting too late and going to the emergency room," she says.

For more information, contact: Valerie Scott, Senior Manager HIV Program, Care Management Division, Glaxo Wellcome, 5 Moore Drive, Research Triangle Park, NC 27709. Telephone: (919) 483-8817.