“Nurses are naturals when it comes to educating patients about taking medicines. Our training strongly emphasizes patient communication and understanding all aspects of the patient.”—Dr. Marcia McDonnell

A simple daily regimen of antivirals might include five tablets of Viracept every 12 hours with food and one tablet of Combivir (AZT and 3TC) every 12 hours. However, for patients who develop resistance to that method, the dosing regimen becomes increasingly complex. A patient on a complicated antiretroviral schedule might take up to 19 antiretroviral pills plus additional antibiotics each day. The following medication schedule is typical: four capsules of Norvir (100mg) every 12 hours and two capsules of Fortovase (200 mg) every 12 hours. Both of these medications must be refrigerated and taken with food. Additionally, the patient would take two tablets of Videx (150mg) and one tablet of Videx (100 mg) every morning. To be effective Videx must be ingested on an empty stomach so it has to be taken two hours before the Norvir and Fortovase. The antiretrovirals that complete the daily dosage are one capsule of Zerit (40 mg) every 12 hours and one capsule of Hydrea (500 mg) every 12 hours.

“The nurse does not try to solve the problem for the patient but can offer suggestions. Our idea is that if the patients come up with the solutions—what will work for them—they are more likely to follow the prescription that leads to adherence.”—Dr. Colleen DiIorio

“People know how to take their medicines and when to take them. But they have to make a decision to do that because the medication regimen changes their lifestyle. It works differently in life than it does in the office.”—Dr. Peter Campos

itting in an Emory psychologist’s office, a patient with AIDS described his fears: “I feel like I’m a cryogenics experiment. They’ve plugged me into a wall to keep one system alive.

I’m in stasis. I’m not cured, but as one system fails, I’m being treated for that. My worry is they’re going to run out of plugs.”

Unfortunately for that patient, his health care team did run out of options––or “plugs.” The antiretroviral drugs that were keeping him alive failed in the end, and he died.

Antiretrovirals are a new beginning for patients who receive the fatal diagnosis of AIDS. In 1996 at the International Conference on AIDS in Vancouver, scientists first reported the sometimes miraculous results of this class of drugs, which had brought some patients from near death back to a vibrancy of life. Since that time, the death rate attributed to AIDS has dropped dramatically, largely because these Lazarus drugs have prevented fewer conversions from HIV-positive status to full-blown AIDS. However, they don’t offer a cure to the fatal disease, and they do have a darker side.

In recognizing the importance of antiretroviral adherence, researchers in the School of Nursing, in collaboration with other schools in Emory’s Health Sciences Center, are pooling their knowledge to find interventions that encourage patients to take the medications as directed.

That in itself is no easy matter. The dosing instructions for antiretrovirals can be very complicated. For those on a simpler HIV medication regimen, they may need to take only five tablets of Viracept and one tablet of Combivir (a combination of AZT and 3TC) twice a day. However, for those who are already resistant to the straightforward regimen, a complex schedule of more than 20 pills a day may be prescribed. Plus, because the various drugs work to smother the AIDS virus at different points in its replication cycle, they must be taken at very specific times; some stay in the bloodstream longer than others; some require food, and some can’t be taken with food; some must be refrigerated.

Even a healthy, educated person might have difficulty adhering to the antiretroviral prescription, but many people with HIV or AIDS have additional complications. For instance, according to Peter Campos, clinical director of Mental Health Services in Grady Hospital’s Infectious Disease Program (IDP), at least 40% to 60% of the program’s more than 4,000 patients have an active substance abuse problem, and 20% to 40% suffer from a major depressive or mood disorder. Those conditions, coupled with the complexity of taking the medicines, lower adherence.

A 1997 study of HIV antiretroviral adherence at the IDP found only 65% of patients who were prescribed a protease inhibitor were adherent despite a generous definition of nonadherence (failing to fill two or more monthly prescriptions within six- to 12-months of follow-up). In the same population a follow-up study found that nonadherence was a major factor in therapy failure. Researchers found poor adherence caused a 52% failure rate in initial antiretroviral regimens and a 47% failure rate in salvage regimens. Among the reasons for skipping doses were forgetfulness, sleeping, being away from home, change in routine, feeling too sick, side effects such as nausea and vomiting, and depression.

When patients are noncompliant, the results are deadly. Missed dosages can enable HIV to form into a mutant strain that can be resistant to not only one drug but a whole class of medicines. Because HIV proliferates so quickly, scientists have a real fear that drug resistance may become the insurmountable problem in controlling the epidemic. Resistance to these antiretrovirals means a greater risk of more rapid HIV disease progression and a more uncertain future.

he Ponce de Leon Center is a familiar sight in Midtown Atlanta. Standing six stories high, this facility is one of the most comprehensive ambulatory outpatient HIV and AIDS care facilities in the nation. It offers interdisciplinary care under one roof, from pharmacy services to mental health to dentistry.

Seven years ago, Marcia McDonnell joined the IDP, and she came on board at the Ponce Center at its opening five years ago. McDonnell was a front-line nurse practitioner who explained to her patients in the women’s clinic the facts about HIV and antiretrovirals. These days, two full-time nurse educators introduce patients at the Ponce Center to the regimen of antiretroviral drugs that may keep them alive but in the process change the way they live their lives. McDonnell, an assistant clinical professor in the Nell Hodgson Woodruff School of Nursing, still works with patients in her clinical practice once a week. Her work as a primary care provider has evolved over time into a dual role of providing both care and education to the women in the clinic. Through this experience, she has developed more insights about HIV and a close rapport with those she serves.

“Nurses are naturals when it comes to educating patients about taking medicines,” McDonnell says. “Our training strongly emphasizes patient communication and understanding all aspects of the patient. When we take a history, we discuss family background, what the patient does for a living, how many children they have, where they live, and their eating patterns. We get very detailed information.”

McDonnell has a 26-year career to back up her nursing perspectives. She has worked with underserved patients in a health clinic, with diabetics at Grady Hospital, for student health services, and even in a doc-in-a-box. In 1992, she returned to school to complete a Doctor of Science in Nursing to enhance her masters degree. “I went back to school to hone my research skills and to learn more about health policy,” she says. “To really make any kind of difference, you have to know both research and policy well.”

McDonnell is making good use of her research skills, particularly in the area of HIV antiretrovirals. For her dissertation, she studied adherence to tuberculosis (TB) medicines, noticing that the number of subjects in her research that were HIV positive in addition to having TB had lower adherence levels to medication regimens. Currently, she is involved in two trials that seek to make a difference in antiretroviral adherence.

The first effort is a descriptive study of at least 120 patients recruited from the Ponce Center and AID Atlanta that explores what variables correlate to adherence. In self-reporting interviews, participants who have taken antiretrovirals for at least four weeks answer questions about their attitudes and perceptions of HIV. They complete sections on self-care behaviors, their commitment and intentions to take their medicines, their perceptions of the support from others, including significant others, and social demographics. The study will also include a component that examines and compares spirituality with adherence practices.

The second study is a collaborative intervention run by a fellow nurse and public health expert Colleen DiIorio. Involving colleagues in public health and medicine, the interdisciplinary research, designed for patients who have not previously taken antiretrovirals, will compare patients who receive a motivational interviewing intervention with those who receive usual care. The goal is to strengthen adherence to one of the lines of defense against AIDS.

Pooling knowledge

AIDS is such a complicated disease, it takes a cadre of professionals from different backgrounds to understand how it works and to develop roadblocks to slow its progress.

In the case of the adherence intervention for antiretroviral regimens, the intervention study draws on a collaborative effort of nurses, physicians, psychologists, and public health educators to design the most effective obstacles to the disease.

Colleen DiIorio, the principal investigator of the intervention, brings the fields of nursing and public health to her role as “the big picture person.” A joint faculty member of the School of Nursing and the School of Public Health, DiIorio comes to her research as a nurse scholar. She has worked extensively on efforts that study adherence to epilepsy medications and in HIV prevention, and she combines nursing with public health perspectives to discover interdisciplinary solutions. Her co-principal investigator, Peter Campos, a faculty member in Emory’s Department of Psychiatry and Behavioral Sciences, will be the project’s coordinator and on-site supervisor.

He provides a psychologist’s perspective, with a concern for how patients make decisions and their self-efficacy. Physician Brita Lumberg and McDonnell lend clinical expertise to the intervention, having close insights into how HIV is affecting their patients’ lives. Ken Resnicow and Claire Sterk, both faculty members at the School of Public Health, round out the team with expertise in interventions for substance abuse and for women with AIDS.

The study developed by DiIorio’s diverse team will randomly assign 240 patients to either a usual care group or a group that combines usual care with an intervention. Those patients in the intervention group will receive written self-help materials, a self-help video based in part on focus group responses, an introductory session where baseline information is collected, and additional motivational interviewing sessions by nurses that take place at three-, six-, and 12-month intervals.

The interviews are based on a theory known as stages of change, which argues that people are at different points in their desire to change or continue a behavior. “Some people are thinking about adopting a behavior, others have adopted it and need to learn to maintain the behavior, and still others have successfully maintained the behavior for a number of years,” says DiIorio. “We will be selecting people for the study who are just beginning the behavior of taking HIV medications. Most will be motivated, and we want to help them maintain that level of motivation. If their motivation begins to diminish––if they stop taking the medications as ordered or they miss doses––then we want to encourage them to reinstitute the behavior.”

During the interviews, nurse educators will collect data on adherence to antiretrovirals, measures of self-efficacy, attitudes, goals, depression, stigma, social support, satisfaction, patient-provider interactions, quality of life, and alcohol and drug use.

To measure adherence, the Emory team is providing patients with prescription bottles topped by MEMS (medications events monitoring system) caps. The MEMS caps, slightly larger than a regular bottle cap, contain a computer chip that records every time the bottle is opened.

In developing the intervention, the interdisciplinary team drew on the success of motivational interviewing in the field of substance abuse. Resnicow has experience in such study designs, having successfully carried out a program for smoking cessation in Harlem churches. He is currently directing another motivational intervention that seeks to improve African American health by increasing the intake of fruits and vegetables.

Theoretically, these same techniques will increase the willingness of HIV patients to take their medications as ordered. In the intervention, the nurse educator will talk with a patient about the reasons for not taking a medication as ordered to get patients to think carefully about why they missed a dose and to pinpoint a specific reason for the decision. “We then encourage the patients to figure out how they can overcome the problem that interfered with their medication taking,” says DiIorio. “For some people, we just need to develop a good reminder system, but we have learned that the reasons people don’t take their meds really cover a variety of areas.”

The nurse counselor’s role in the intervention is to uncover the reasons for the missed medications, reasons for which the patient might even be unaware. “The nurse does not try to solve the problem for the patient but can offer suggestions. Our idea is that if the patients come up with the solutions––what will work for them––they are more likely to follow the prescription that leads to adherence.”

The trick to making the intervention work is understanding how people make decisions, according to Campos. “People know how to take their medicines and when to take them. But they have to make a decision to do that because the medication regimen changes their lifestyle. It works differently in life than it does in the office.”

While they await a cure to offer their patients, these health care providers and researchers are working together for a treatment to prolong life and increase quality of life. Adherence to medications is a critical component to that goal. For now, that treatment takes place one pill at a time.