Pam Harrison

July 06, 2015

UPDATED July 8, 2015 // A behavioral intervention effectively improved adherence to HIV regimens in routine clinical care and reduced treatment failure, new research indicates.

"We have done a few systematic reviews recently, and I think this intervention is probably one of the first — if not the first — intervention that has replicated effects in different studies on improvements in adherence and viral loads," said Marijn de Bruin, PhD, from the University of Aberdeen, in the United Kingdom.

"The main challenge now is implementation. The healthcare system is very well organized for implementing medical care, but it's not well organized for implementing behavioral intervention, so this might require a bit of a cultural change," he told Medscape Medical News.

The study results were presented at the 10th International Conference on HIV Treatment and Prevention Adherence in Miami.

The Adherence Improving Self-Management Strategy (AIMS) — designed to equip patients to manage their own behavior — was the result of a collaboration between HIV nurses and patients.

The 223 study participants were recruited from seven HIV clinics in the Netherlands. About half the patients were treatment-experienced, and about half were treatment-naive.

The mean age of the 110 patients randomly assigned to the AIMS intervention was about 45 years. For the other 113 patients, who served as the control group, the mean age was about 43 years.

All but 10 participants completed the trial; mean follow-up was 14.5 months.

At all three follow-up time points, the viral load was 28% higher in the control group than in the intervention group (odds ratio, 1.28; 95% confidence interval [CI], 1.04 - 1.52).

And at the same three follow-up time points, the likelihood that the viral load was undetectable was 89% higher in the intervention group than in the control group (hazard ratio, 1.89; 95% CI, 0.98 - 3.65).

Fewer patients in the intervention group than in the control group had two consecutive detectable viral loads during follow-up (7% vs 17%). In addition, "the effect sizes were similar for ethnic groups and in both treatment-experienced and treatment-naive patients," Dr de Bruin reported.

The cost of the AIMS intervention was only about €83 (US$92) per patient per year, and on all cost-effectiveness analyses, the intervention was cheaper and more effective than treatment as usual.

In this study population, "adherence to care was already fairly comprehensive," Dr de Bruin explained. "This makes it considerably more challenging for any intervention to demonstrate an additional effect."

"In settings with less comprehensive adherence support, the intervention effects would be greater," he added.

Motivation Is Key

A vital element of the intervention was motivation, because "patients need to take their medication every day, despite side effects, for the rest of their lives," Dr de Bruin pointed out.

To reach the necessary levels of motivation, patients need to understand what their medications do and what happens over the long term if they skip pills.

At the beginning of the intervention, "a nurse goes through a number of steps with patients during a routine clinical visit to ensure that they have an adequate understanding of what adherence means in terms of treatment outcomes," he explained.

Patients set a goal for how well they would like to do in terms of adherence and are given electronic medication bottles that register the date and the time they open their pill bottles.

During the first few months of the intervention, healthcare providers analyze data from these electronic monitoring devices and identify lapses in patient adherence that typically occur.

"We then ask patients to select from sample reports — ranging from excellent adherence to quite poor adherence — and ask them what they would like to do and why it would be important for them to do so," said Dr de Bruin.

Throughout the intervention, patients continue to receive feedback to identify discrepancies between their desired and actual adherence levels.

A personalized action plan is developed for each patient to help resolve lapses in adherence. The ability of each patient to execute the action plan is assessed; it must not be so challenging that they are bound to fail.

"Patients leave the clinic well-informed, motivated, and with a concrete action plan on how to cope with their adherence issues," Dr de Bruin said.

"The electronic medication monitor has to be paid for by health insurance, but training nurses and new colleagues on the AIMS intervention can probably be done in three half-day sessions," he explained.

"And I think we can get larger gains from improving the quality of adherence than we can from yet another HIV pill," he added.

Fair Degree of Support

The AIMS intervention has accumulated a fair degree of support during the past several years, said Rivet Amico, PhD, from the University of Michigan, in Ann Arbor.

"This intervention approach uses electronic drug monitoring — Medication Event Monitoring System caps — to facilitate discussions between clinic nurses and people living with HIV who are either new to antiretroviral therapy or have a history of difficulty sustaining viral suppression," she told Medscape Medical News in an email.

A "unique contribution" of this study is the inclusion of cost-effectiveness data, she said.

"Often, interventions using electronic monitoring are thought to have limited generalizability because of costs associated with dose monitoring," Dr Amico explained. But Dr de Bruin's team "presented data supporting positive trends in cost-effectiveness."

"Given the critical role of viral suppression in efforts to promote not only individual health but also public health, high-impact interventions such as this one are sorely needed," she said.

Dr Amico cautioned that although one size will not fit all for adherence support, "the AIMS intervention offers a high-value, effective, evidence-based option for individuals new to antiretroviral therapy or with historic difficulties with adherence."

Dr de Bruin and Dr Amico have disclosed no relevant financial relationships.

10th International Conference on HIV Treatment and Prevention Adherence: Abstract 19. Presented June 29, 2015.

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