1. Assessing Your Clients for Adherence: A Real World Approach Sharon Mannheimer, MD Harlem Hospital Center Treatment Adherence Network Meeting February 27, 2001

2. Adherence A complex behavioral process involving progression through various stages working toward the goal of maintaining 100% adherence with all doses all of the time ultimate goal of improved quality of life and survival

3. It is difficult to identify who will and won’t adhere to medications No test available No single patient characteristic 100% predictive Physicians are poor predictors

4. Assessing for adherence complex involves assessing clients’ progression toward full adherence to therapy as well as assessing for a variety of barriers known to be associated with poorer adherence

5. Steps Toward Adherence to Antiretroviral Therapy (ART) 1. Acceptance of ART (Readiness) 2. Ability to take and adhere to ART 3. Maintenance of adherent behavior

6. Adherence Behavior: Theoretical models Theoretical models can provide a framework for assessing for behaviors such as adherence –Health Belief Model –Prochaska’s Transtheoretical Model of Change (TTM or TMC) –Information, Motivation and Behavioral Skills (IMB)

7. Assessing Clients’ Progression Toward Adherence to Antiretroviral Therapy (ART) 1. Acceptance of ART (Readiness) 2. Ability to take ART 3. Maintenance of adherent behavior

8. Assessing for Acceptance of ART 1. Ask the patient –e.g., “Do you feel that you can take HIV medications two times a day, every day?” 2. Assess for barriers to acceptance –recent HIV diagnosis –denial of diagnosis –lack of knowledge –lack of trust in provider –lack of trust in medications –beliefs

9. A O R p value Acceptance TRUST in Physician Scale 0.08 <0.0001 MISTRUST Medications 0.30 <0.001 * There is an 8% increase in adherence for each unit increase in the 11-55 item Trust in Physician Scale Acceptance of and Adherence to ART Importance of Trust Altice, et al. 4th Conf. onRetrovirus and OIs, 1997

10. Assessing Clients’ Progression Toward Adherence to Antiretroviral Therapy (ART) 1. Acceptance of ART (Readiness) 2. Ability to take ART 3. Maintenance of adherent behavior

11. Assessing client’s ability to take & adhere to ART Assess for: 1. Barriers to adherence 2. Motivation for adherence 3. Skills needed for adherence

12. Assessing Barriers to Adherence: Adherence barriers can be classified as being related to: Patient characteristics Provider Treatment regimen Clinic/office characteristics Disease characteristics

13. Patient characteristics associated with lower adherence levels Demographics –African American race Social/environmental: –Lack of insurance or access –Active substance use –Homelessness –Poor social support –Doubt efficacy of medication –Confidentiality concerns

14. Patient characteristics -2 Lack of Knowledge –HIV treatment regimen –CD4 –Resistance Psychological factors beliefs: –Poor self-efficacy –2 aspects of the Health Belief Model [Becker 1974]: 1) having greater perceived benefits from therapy 2) having fewer perceived barriers to treatment

15. Race and Adherence Lower adherence rates noted among African Americans in several studies –Ostrow. 8th CROI 2001; Mannheimer, XIII Int’l AIDS Conf. 2000; Gifford, JAIDS 2000; Kleeberger, XIII Int’l AIDS Conf. 2000; Singh, Clin Infect Dis1999; Wenger, 6th CROI 1999; Muma, AIDS Care 1995; Moore, NEJM 1994; Besch, Int’l AIDS Conf. 1992 independent of education and drug use history in some studies Nonwhite race may be a marker for other factors such as low literacy

16. Substance Use (SU) and Adherence Mannheimer, et al, HATS data 2/01, updated from Durban N= 164 p =.005

17. Substance Use & Adherence - 2 HATS data 2/01 Active substance users were: –less likely to report 100% adherence (p = 0.06) –less likely to report > 90% adherence (p <.04) –less likely to believe that ART was helpful in fighting HIV (fewer perceived benefits) (p =.03) –more likely to report stressful life events (p =.02)

18. Active Substance Use and HIV RNA (HATS data 2/01, N = 164) p <.05

19. Social support and adherence Gifford, et al. JAIDS 2000 N = 133

20. Adherence OR p value SOCIAL ISOLATION 0.08 0.0001 SIDE EFFECTS 0.09 0.0001 COMPLEXITY of Antiretroviral Regimen 0.33 0.01 Barriers to Adherence to ART Altice, et al. 4th Conf. onRetrovirus and OIs, 1997

21. Psychological factors Depression (Singh 1996, Broers 1994, Burack 1993) Active psychiatric illness (Paterson Ann Intern Med 2000) Stress (Gifford 2000, Singh 1996) Poor coping skills (Singh 1996) HIV “burnout” (Ostrow 8th CROI 2001)

22. Provider-related barriers to adherence Mistrust of provider Provider’s interpersonal skills Provider’s experience/expertise

23. (N=886) Predictors of Adherence Montessori, et al (CROI 2000) Variable AOR CI Male 1.96 1.28 - 3.01 Increased age (@10 yr) 1.33 1.2 - 1.57 AIDS at baseline 2.28 1.44 - 3.61 Physician experience 1.45 1.20 - 1.74 (per 100 pts) History IDU 0.50 0.36 - 0.71

24. Medication-related barriers to adherence fit with lifestyle complexity / pill burden dose frequency side effects duration

25. Correlation With How Well Regimen Fits Patients’ Daily Life* (N = 1910) 70 60 50 40 30 20 10 0 % of Patients Adherent to Therapy † *P <.001. † Patients who reported no missed doses in the past week. Wenger et al., 6th Conf. on Retroviruses and OIs; 1999 Not at all well A little bit Somewhat Very well Extremely well Patients responded that regimen fits in:

26. Fit with daily activities and Adherence Gifford, et al. JAIDS 2000 N = 133

27. Perceived fit and HIV RNA Gifford JAIDS 2000 Patients having a good perceived fit of their regimens with their routine and daily activities (“high regimen convenience scores”) had lower viral loads (1.04 log copies/mL lower) than persons having “low regimen convenience scores”

28. Virologic response by pill burden Bartlettt J. XIII IAC, Durban, 2000. Abstract 4998 Number of antiretroviral pills prescribed per day 90 80 70 60 50 40 30 20 10 0 5 1520 Patients with plasma HIV RNA  50 copies/ml at 48 weeks (%) PI NRTI NNRTI (r=–0.57, P=0.0085) Size of symbol is directly proportional to weight of the data point in the analysis.

29. Disease-related barriers to adherence Health Status –AIDS, h/o OI (Samet 1992, Singh 1996) –symptomatic (Eldred 1997a)

30. Clinical setting-related barriers to adherence long waiting times inconvenient clinic hours unfriendly staff lengthy delays between contact and appointments substantial travel costs Cramer 1991; Cuneo, Clin Chest Med 1989; Haynes 1979

31. Motivation Belief in efficacy of pills –greater perceived benefits from treatment (Balestra 1996, Eldred 1997, Ferris 1996, Mossar 1993, Muma 1995, Samet 1992, Smith 1997) Self-efficacy –Gifford JAIDS 2000; Eldred 1997; Muma AIDS Care 1995 Support –Morse 1991

32. Assess for Behavioral skills helpful with adherence Pill taking - difficulty swallowing pills keeping to a schedule forgetfulness use of pillbox

34. Assessing Clients’ Progression Toward Adherence to Antiretroviral Therapy (ART) 1. Acceptance of ART (Readiness) 2. Ability to take ART 3. Maintenance of adherent behavior

35. Adherence Scores Over Time Mannheimer, XIII int’l AIDS conf., 2000 data from 2 large CPCRA clinical trials of ART (N = 732) P <.001 for difference between mos 1 and 4 and mos 1 and 8

36. Consistency of 100% adherence and virologic outcome Mannheimer et al., data from participants in 2 CPCRA ART clinical trials N = 205 Number of follow-up visits with self-reported 100% adherence

37. Assessing for Maintenance of Adherence in the field Self-report –nonjudgmental –give permission to “miss” Important to assess at every follow- up visit/encounter if possible high risk of relapse even if in “maintenance” Frequent follow-up

38. Assessing for consistency of adherence Assess Stage of Behavioral Change (Precontemplation, Contemplation, Preparation, Action, Maintenance) –e.g. for Maintenance: “Have you been taking medications against the HIV/AIDS virus regularly for the last 6 months?”

39. Correlation of Stage of Behavioral Change with HIV RNA N= 1 N=4N=45 N=34 N=76 p<.001

40. Summary Assessing for adherence is complex Adherence should be assessed frequently Involves assessing for: –acceptance of treatment –barriers to adherence –motivation and behavioral skills for adherence –stage of behavioral change

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