A nurse-delivered adherence intervention strategy improved markers of HIV, increased quality-adjusted life years (QALYs), a measure of quality and quantity of health, and saved money, a Dutch trial published in The Lancet Infectious Diseases found. Adherence measures whether people take their medications as prescribed. QALYs estimate how much longer someone could live in good health if a specific medical intervention were provided.
Researchers trained 21 nurses at seven HIV clinics across the Netherlands to deliver the Adherence-Improving s elf-Management Strategy (AIMS). They then randomized 221 people living with HIV to receive either standard adherence counseling or the AIMS intervention during routine care. Study participants had either never taken antiretroviral medications or had taken them for at least nine months and were at risk of having their virus levels rise again (viral rebound). QALYs were calculated based on data from more than 7,000 Dutch people living with HIV.
Standard counseling consisted of a patient leaflet, verbal information on the benefits of adherence and when and how to take the medication, a discussion of the patient's daily routine to determine the best adherence strategy and a telephone number to call in case of problems. At follow-up visits, the patient and nurse discussed how well the patient was doing in taking the medication as prescribed, any problems with doing so, side effects and the patient's viral load and CD4+ cell count results.
Related: The Importance of Adherence: Taking Your HIV Meds Regularly
The AIMS intervention included electronic medication bottle caps (Medication Event Monitoring System or MEMS caps) that provided a printable report of when/how often the medication had been taken. The caps record when the medication bottle is opened and assume that the drug was then taken. In addition to information about the benefits of adherence, the nurse discussed the patient's report and any problems it might reveal. During follow-up visits, nurse and patient reviewed the adherence goal that the patient had set for him or herself and explored how to overcome barriers if the goal had not been reached. MEMS caps including a display were offered to help patients self-monitor their adherence.
Participants' viral loads and CD4+ cell counts were recorded 5, 10 and 15 months after the start of the intervention. Over the course of the study period, viral load remained at or returned to detectable levels (more than 50 copies/mL) in 9.6% of those in the AIMS arm and 16.7% in the standard treatment arm. Average CD4+ cell count rose steadily to almost 600 cells/μL at the third follow-up visit (15 months) in the AIMS group. In the standard treatment group, the highest average CD4+ cell count was achieved at 10 months (close to 570 cells/μL) but fell again by the end of the study period.
AIMS dominated in all incremental cost-effectiveness ratio (ICER) calculations, with lifetime costs of about EUR 200-1,100, depending on the scenario selected and the estimated effect of the intervention beyond its end. The same calculations produced lifetime QALYs gained of 0.016 to 0.049. ICERs are used to compare the cost of two medical interventions while considering their respective effect. When these data were extrapolated to 10,000 people over the course of 18 months, almost EUR 6 million could be saved and 340 QALYs gained.
About 60% of those approached for the study refused to participate. The MEMS caps were cited most often as a reason. Potential participants considered them "too big or impractical." The report does not say whether they also expressed privacy concerns about the electronic data gathered by these caps.
Study authors believed that this barrier could be overcome if such caps were included in routine care. They also expected more user-friendly caps to become available soon. Based on study results, "implementation of AIMS in routine HIV clinical care is therefore strongly recommended," the authors wrote. The Netherlands is currently considering inclusion of AIMS in national HIV treatment guidelines, accompanied by insurance reimbursement for electronic adherence monitors and training of health care professionals across the country.