Implementation of an Innovative Adherence Program in a Large Inner-city Outpatient Clinic

Helene Hardy, Pharm.D. ^1,2; Gary Tataronis, MS²; Anela Stanic, Pharm.D. Candidate². Maura Fagan, MD^1,3; Karen Henley, MD^1,3; Jon Hall, BA; Paul Skolnik, MD^1,3

1: Boston Medical Center; 2: Massachusetts College of Pharmacy;3: Boston University School of Medicine

Abstract:

Poor adherence to antiretroviral therapy represents one of the primary reasons for failure to achieve maximum viral suppression in HIV-infected persons and is often associated with the presence of an active psychiatric illness.^1,2 We developed an innovative and structured adherence program to determine if individualized monitoring of adherence to antiretroviral therapy (ARVT) and to psychotropic therapy (PT), when appropriate, improve and sustain virological suppression in HIV-infected persons. Patients initiating or starting a new ARVT are eligible. Those willing to participate in the program will sign a detailed program enrollment agreement. The program will consist of ten adherence clinic visits spread over a twelve month period. The innovative aspects of the program are two fold: 1/ provide patients with a structured adherence program integrating both HIV and mental health related issues, 2/ assess if the use of an online adherence summary report enhance clinicians’ ability to address adherence issues with patients and impact patient care. A series of questionnaires will be administered at baseline, week 24 and week 48 to assess changes in patients’ mental health status, quality of life, level of education on ARVT and PT. Individualized adherence summary reports will be generated by a pharmacist after each clinic visit and entered into the patient’s computerized medical record accessible by all clinic providers. Adherence scores will be generated at each clinic visit and virologic parameters will be measured at baseline, week 24 and week 48. This innovative program should provide useful insights on successful adherence interventions and useful information on clinicians’ confidence in the use of an electronic adherence assessment tool.

Goals:

To assess the impact of an innovative adherence program on the virological outcome of HIV-infected persons.

Objectives:

• Determine if sustain adherence monitoring to antiretroviral therapy (ARVT) and, when appropriate, to antidepressant therapy (ADT) improves viral suppression.
  • % patients with viral load < 400 or 2 log decrease at week 24 & 48.
  • % patients with mean composite adherence score (CAS) ≥ 5 to ARVT or antidepressant therapy.
  • relation between CAS and viral load variations.
• Identify the most successful adherence interventions.

Methods: Study Design

• Prospective, open-label, pilot program.
  • Intervention group (N= 60).
  • Historical control group (chart review, N= 60).
• Duration: 12 month follow-up (10 visits)
• Target population:.
  • ARVT naïve.
  • ARVT experienced but switching to new ARVT.
  • ≥ 18 year.
  • VL > 400 copies/ml.
• Exclusion Criteria:
  • Pregnant.
  • < 18 years.
  • unable to give an informed consent.
  • Residence in Jail or any institution where medications are being dispensed at least daily

Adherence Program Algorithm:

Methods: Baseline data collection

• Demographics: race, age, gender, language spoken, risk factor for HIV, level of education, smoking history, h/o substance abuse, comorbid disease (hepatitis B or C, depression, anxiety, diabetes/mellitus), employment status, housing..
• Virologic parameters: viral load, CD4 count and CD4 percent.
• Mental Health assessment by completing with patients 12 questions. (SF-12) addressing 8 health concepts: physical functioning, limitations due to health problems, body pain, social, general mental health, limitations b/c emotional problems, vitality, general health perception.⇒ 3 T scores generated [mental, physical & global health], changes will be assessed longitudinally.
• Education on HIV disease/treatment and depression/treatment will be assessed using a 5 multiple choice questions per disease state (score of 25 = excellent education level, 20 = good, 15 = average, 10 = limited, 5= poor)

Methods: Follow-up data collection

• Demographics: updates Q 3 months (employment, use of illegal substances, housing, medications).
  • Pharmacy Refill in the past 4 to 12 wks
• Adherence Summary Report: 4 components
  1. Stages of Readiness: importance/confidence (score 0-10)/self-report
  2. Composite adherence score:
     • Self report (in the past 7 days).
     • Pill count (pillbox, in the past 7 days).
     • Pharmacy refills between study visits .
     • Dosing frequency/food restrictions.
  3. Adherence barriers: 23 barriers to adherence will be reviewed in each adherence summary report
  4. Adherence interventions: 47 potential interventions will be reviewed in each adherence summary report
• Virologic parameters: obtained on week 4, 8, 12, 24, 48.
• Mental health questionnaire: completed on week 24 and 48.
• Provider Satisfaction Survey: 5 questions asked on week 24 & 48

Adherence Summary Report

Preliminary Results

Demographics

Baseline Antiretroviral Therapy:

Baseline Education on HIV disease/tx:

• 9/19 patients with a score of 25 (maximal score): 4 experienced, 6 naïve to ARVT; 1/19 with a score of 20: naïve.
• 3/19 with a score of 10: naïve to ARVT; 1/19 with a score of 0: experienced

Baseline education on depression/tx:

• 1/4 patients with a score of 25: 1 naïve, 2/4 with a score of 20: naïve

Stages of Readiness to start ARVT (score: 0-10)

• IMPORTANCE to start ARVT = score of 10 for all patients.
• CONFIDENCE in taking ARVT consistently = 2 patients with a score of 8 (experienced patients) 2 patients with a score of 8 and 9.5, respectively (naïlve to ARVT)

Most Frequent Adherence Interventions:

• Baseline: education, wallet card with viral load & T-cell count, pillbox, written dosing schedule.
• Week 1: supplemental education tailored to patients’ medications, pillbox refill.
• Week 2 through 4: pillbox refill, side-effect management, referral to other clinic providers (psychiatry, social worker, etc)

Virological outcome at week 4 available in 10 patients:

• decrease in viral load > 1 log from baseline 9/10 patients

Future Perspectives

• Complete an interim analysis when half of the patients in the intervention group complete 6 months of the program
• Match historical controls for age, gender, baseline viral load & T-cell count, and diagnosis of depression
• Statistical Analysis:
  • Adherence to ARVT and AD will be categorized into 3 levels: adherence score ≥ 5; 3-4; <5
  • Pearson’s chi-square or Fisher’s exact test will be used to determine if viral suppression is significantly different between the 2 groups
• Logistic regression analysis:
  • dependent variable: composite adherence scores.
  • independent variables: demographics, education, mental health status/QOL, adherence barriers & interventions

References

1. Aids Care 1996; 8 (3): 261-9
2. Arch Intern Med 2000; 160: 2101-210