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8/22/2002

Study Finds Intensive Coaching Improves Antiretroviral Therapy Adherence

Deena A. Said

State University of New York—University at Buffalo (UB) researchers found a dramatic decrease in viral load among newly diagnosed HIV-positive patients who received intensive medication-adherence coaching from pharmacists during the first 16 weeks of therapy. Results of the study were presented during a poster session at the 14th International AIDS Conference (IAC) in Barcelona, Spain, in July.

According to the research team, this study was the first to show that an outpatient program can produce 48 weeks of virological success in 94% of patients new to antiretroviral therapy. Initial antiretroviral therapy, the team reported, typically results in virological failure in as many as half of patients.

The study took place at the HIV Medication Adherence Clinic in the Immunodeficiency Services Clinic at Erie County Medical Center. UB School of Pharmacy and Pharmaceutical Sciences operates the medication-adherence clinic.

Clinic Director Lori Esch said UB practitioners have assisted in setting up HIV therapy adherence clinics around the country that follow a practice similar to UB’s. The UB clinic also hosts pharmacists working in HIV clinical practice around the country through a preceptorship program.

UB pharmacy students, residents, and practicing pharmacists from across the United States participated in the three-session program at the clinic, said Esch, who was a coinvestigator for the study and is a clinical assistant professor at UB.

Either a specialty resident or Esch conducted the educational sessions. When pharmacists in the HIV-specialty preceptorship program worked at the clinic, they also counseled the patients.

Patients who agreed to receive intensive coaching were told about the virus, the human immune system, and the goals of antiretroviral treatment by a pharmacist. A clinical education nurse, a social worker, and a case manager would often participate in this session.

A second session in which the practitioners discussed individual drugs, the adverse effects of these drugs, and how they could fit into each person’s lifestyle followed.

Practitioners then talked with patients to "find out their phobias, their level of interest, their level of commitment," explained Esch, who was unable to attend this year’s IAC. Then the practitioners would propose what they thought would be a good starting regimen for each patient, she said.

The third session stressed to both the patient and his or her family or friends how to take the medications, what adverse effects to expect, and how to monitor for those effects. Patients who believed they would need help remembering to take their medications received pillboxes, beepers, dose cards, and daily administration schedules. This session was followed by a telephone call within the first few days of therapy and routine follow-up for 16 weeks.

Educational sessions and regimens were tailored to each patient based on his or her education level and lifestyle.

"We catered the education to whatever their basic education level was," said Esch. "We did a lot of individual assessment and provided what the individual needed."

Such intensive one-on-one intervention involved a great deal of personnel time. Each session lasted an average of 30 minutes. As Esch explained, it is not yet clear whether all medication-adherence programs need to be this intensive.

"There’s not a lot of controversy over whether or not these kinds of interventions help. Obviously they are useful. I think the question is, how much do we have to do, because this is labor intensive," she stated. "Where can we most effectively use our manpower? That’s the question we need to look at."

All clinic patients new to antiretroviral therapy were eligible to participate in the study. Those refusing to participate or who were not offered the opportunity to participate by their health care provider served as controls and received the clinic’s standard care.

Esch admitted that the selection of patients for intensive coaching could be considered a limitation in her study "because patients who refuse additional help aren’t as motivated or maybe think they can handle more than they can." This possibility may be apparent in the control group’s results: 60% of those patients had an HIV RNA level of <400 copies/mL at week 48, compared with 94% in the intervention group.

Alice Tseng, an HIV pharmacotherapy specialist and assistant professor of pharmacy at the University of Toronto, is a former preceptor of Esch and runs a similar clinic at Toronto General Hospital. Tseng attended this year’s IAC and expressed enthusiasm toward the UB poster.

As she explained, despite the widespread interest in therapy adherence, data are lacking from good clinical studies of interventions to improve patients’ adherence to regimens—something she believes sets the UB study apart from the rest.

Many of the UB patients, however, were lost to follow-up. Only 17 of 25 patients in the intervention group and 20 of 38 patients in the control group were available for viral-load testing at week 48.

Esch said that future collaborations with other medical centers in a similar but larger study would prove valuable to the HIV community.

The International AIDS Society-USA panel recently released its revised treatment recommendations focusing on the timing of initial antiretroviral therapy and treatment options in patients new to antiretroviral therapy and those in whom treatment has failed. Treatment strategies address the toxicities and suboptimal activity of current regimens and the emergence of drug resistance. The recommendations appeared in the July 10 issue of the Journal of the American Medical Association.