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					        INSIGHTS
           in
Patient Behavior Change



Influencing Behavior Change in
    Patients Living with HIV


                                 1
Program Objectives

   Discuss implications of behavior and psychosocial
    aspects of HIV patients and opportunities for
    improvement from the perspective of the patient,
    caregiver, and managed care organization (MCO)
   Define and describe approaches to stimulate
    behavioral change in HIV patients, applying the
    Stages of Change model
   Discuss application of behavioral change
    techniques to HIV patients to improve care results




                                                        2
Behavioral Health
    Change




                    3
 Purchaser’s View of Behavioral
 Health Change
                 Understand and value role of behavior in
                  influencing health
                 Do not believe they have leverage for
                  type and quality of services
                 Limited access to health status and risk
                  information
                 Limited use of clinical and cost-
                  effectiveness information when making
                  coverage decisions
                 Limited use of NCQA and HEDIS data


NCQA = National Committee for Quality Assurance
HEDIS = Health Plan Employer Data and Information Set
                                                             4
    Findings on MCO Behavioral
    Health Focus
   Medical Directors believe behavioral health to be
    an important determinant of health outcomes but
    are unfamiliar with the evidence
   Most health plans offer some behavioral health
    services, but most focus on chronic disease, not
    health risk
   Current offerings are mass market, as opposed to
    patient, focused behavioral health efforts




                                                        5
Behavior Change in HIV




                         6
Behavior Change in HIV: Goals


   Reduce transmission via high risk behaviors


   Improve adherence to therapy, thereby
    preventing resistance and improving survival
Transmission of HIV

 Primary modes of transmission
 • Sexual


 • Parenteral
    • Intravenous drug use, needles


 • Perinatal
    • Mother to newborn/fetus transmission
  Behavioral Challenges in HIV

          Needle-based drug users and sexual practices
           are behaviorally based challenges and
           potential sources of disease transmission for
           HIV
          Poor adherence to treatment regimens
          High rates of comorbid psychiatric disease
          Psychosocial instability
          Poor health literacy
          Significant barriers to medical interventions
          Network of seemingly unsolvable issues
Sylvestre D. Approaching Drug Use and Coinfection CME online: HIV/HCV Coinfection Monthly . Johns
Hopkins University School of Medicine. Available at: www.hopkinscme.org/courses/sept.2003.
Accessed January 13, 2005                                                                           9
    Special Challenges of Caring for
    HIV Patients
                Complex array of medical, psychological, and
                 social challenges require strong provider-
                 patient relationship, multidisciplinary care
                 team, and frequent visits
                Stigma associated with HIV/AIDS is a critical
                 burden on patients requiring special attention
                 to confidentiality
                Providers play key role in public
                 health/prevention
                Establishing trust, particularly with ethnic
                 minorities, is critical and requires
                 understanding of belief structures
                Many patients have inaccurate information and
                 need explicit communication and education
Sheffield JVL et al. In: A Guide to Primary Care of People with HIV/AIDS. Available at:
www.aidsetc.org/aidsetc?page=et-30-25-01. Accessed January 28, 2005.
                                                                                          10
HIV Treatment



                11
      Highly Active AntiRetroviral
      Therapy (HAART)
      Introduced in 1995
        - Combination therapy with multiple-class drugs
        - Generally includes 3 to 4 drugs in 3 categories:
           • Nucleoside reverse transcriptase inhibitors
             (NRTIs)
           • Non-nucleoside reverse transcriptase
             inhibitors (NNRTIs)
           • Protease inhibitors (PIs)
      HAART significantly decreases viral replication and
       allows immune reconstitution to begin



American Public Health Association. Adherence to HIV Treatment Regimens: Recommendations
for Best Practices. Available at: http://www.apha.org/ppp/hiv/Best_Practices_new.pdf. Accessed May 18, 2006   12
HAART Has Reduced HIV-Related
Mortality




                                                                                          Therapy with a Protease Inhibitor
                                   40                                               100
     Deaths per 100 Person-Years




                                                                                    90
                                                                                    80




                                                                                               (% of patient-days)
                                   30
                                           Deaths                                   70
                                                                                    60
                                   20
                                                                                    50
                                                                                    40
                                   10                                               30
                                                                                    20
                                         Use of protease inhibitors                 10
                                   0                                                 0
                                        1994             1995         1996   1997



Palella F et al. N Engl J Med. 1998;338(13):853-860.
HAART Adherence is Critical
      HAART regimens can fail because of lack of viral
       load response or poor treatment adherence
      If doses are missed or taken improperly:
        - The treatment may lose its potency
        - The patient's HIV infection can rapidly become
           resistant to the drugs


           Missing a single dose of HAART medication
                 even twice a week can cause the
               development of drug-resistant HIV!



Carpenter CCJ et al. JAMA. 1998;280:78-86.
 Challenges for Patients
 Undergoing HAART

     The complexity of HAART can pose significant
      adherence hurdles
       - Pill burden
          • Pill characteristics (size, ease of swallowing)
          • Number of total pills
       - Dosing schedules
       - Side effects
       - Meal requirements
       - Poor pharmacokinetics requiring careful
         attention to timing
       - Therapy is a reminder of illness

Carpenter CCJ et al. JAMA. 1998;280:78-86
Adherence in
HIV Treatment




                16
  Adherence to HIV Therapy is an
  Area for Concern

       Nonadherent HIV patients have:
           - Higher mortality rates
           - Lower increases in CD4 cell count
           - Increased hospitalization




Paterson D, et al Ann Intern Med 2000; 133 21-30

                                                   17
Behavioral Change in HIV and
Treatment Success
   Without a commitment to change, a patient is less
    likely to be adherent to therapy


   Without adherence to HAART, likelihood of a
    successful virologic outcome is diminished
      Adherence Rates Predict Viral
      Load Response
                                  Prospective, observational study of 99 HIV-infected patients
                                  prescribed PI therapy
                     100

                                                                                                 78
% Patients with Viral Load




                             80


                             60
<400 copies/mL




                                                                                   45
                             40
                                                       29            33
                                        18
                             20


                             0
                                       < 70           70-79         80-89         90-94          >95

                                                   % Adherence with PI Therapy

PI = protease inhibitor
Paterson Dl et al. Ann Intl Med. 2000; 133:21-30                                                       19
  Successful HIV Therapy Requires
  Incredibly Rigorous Adherence

       High adherence (>95%), at least with PI-based
        HAART, required for optimizing virologic outcome1
        and avoidance of viral resistance

       Mid-range adherence (60–90%) associated with
        greater risk of virologic failure and may increase
        risk of viral resistance

       Low levels of adherence (<60%) leads to virologic
        failure but may not foster the development of viral
        resistance

1Paterson   D, et al Ann Intern Med 2000; 133 21-30
  HIV Treatment Characteristics
  That Influence Adherence
                          Lifelong expensive treatment
                          Treatment may involve disclosure
                          Skepticism about treatment
                          Treatment a constant reminder of infection
                           and illness
                          HIV-related conditions may interfere
                          Treatment failure due to resistance or
                           inadequate dosing



Frank L et al. National AIDS Education and Training Centers Health Care
Provider Adherence Training Curriculum. 1998.                             21
Changing Behavior in
  Patients with HIV




                       22
Common Intervention Themes in
Behavioral Health
   Primary care role is brief but critical
     - Collaborative planning between primary care
       provider and patient is critical
        • Brief, personalized review of health
          status/risk
        • Collaborative decision making/priority
          setting about what to do
        • Mutual development of a treatment plan
        • Arrangements to follow up on progress
   Wide range of behavior change supports should be
    available
   Managing health risk and chronic conditions
    requires a lifelong series of course corrections
                                                       23
Setting Behavior Change Goals
for HIV Patients
   Set patient goals:
     - Assess the patient’s risk-taking behaviors for
       other infections
     - Build motivation to change risk behaviors
     - Set behavior change goals with patient
     - Problem-solve barriers to risk reduction
     - Distribute specific risk-reduction guidelines.
     Assess Risk-Taking Behaviors in
     HIV Patients
          Administer standardized assessment for other
           infections, such as HAV, HBV, and HCV (eg, HIV
           Risk Behaviors Inventory1)
          Present results with copies for the patients


          Ask for patients' reactions to their level of risk and
           reflect and elaborate on their reactions
            - Patient: "I guess I didn't realize how many
              people I had sex with in the past few years
            - You: "What do you make of this?”

HAV = Hepatitis A virus; HBV = Hepatitis B virus; HCV = Hepatitis C virus

1. Metzger DS et al. In: Problems of Drug Dependence 1991: Proceedings of the 53rd Annual Scientific Meeting. National Institute
on Drug Abuse; 1992. pp. 297-298
   Review Risk-Taking Behaviors
                   Sexual practices
                       -   Number and gender of partners
                       -   Specific sexual practices
                       -   Frequency
                       -   Condom use
                       -   HIV status of partners/disclosure
                       -   Anonymous partners
                       -   Associations with drug use
                       -   Prior STDs
                       -   Genital ulcer disease


                   Drugs
                       -   Substances used
                       -   Routes of administration
                       -   Tolerance and withdrawal history
                       -   Drug treatment history


Sheffield JVL et al. In: A Guide to Primary Care of People with HIV/AIDS. Available at:
www.aidsetc.org/aidsetc?page=et-30-25-01. Accessed January 28, 2005.                      26
Build Motivation to Change HIV
Risk Behaviors
   Affirm the patient ("I think its great that you're
    willing to be honest with yourself and take time to
    look at your level of risk")


   Reframe ("You're concerned about your level of
    risk, but you can't see yourself being celibate,
    either")


   Roll with resistance ("You're jumping ahead a bit
    here. Right now, we're just getting a sense of
    where you are regarding drug injection practices
    and unsafe sex behaviors. Later on, we can talk
    about what, if anything, you want to do about it")
Build Motivation to Change HIV
Risk Behaviors
   Explore consequences of action and inaction


   Communicate free choice


   Elicit self-motivational statements ("What do you
    want to do about this," "Tell me why you think
    you might need to make a change")
      Prochaska’s
Transtheoretical Model
  of Behavior change



                         29
Prochaska’s Transtheoretical
Model of Behavior Change
    Stages of readiness to change


    Decisional balance
      - Weighing the advantages and
        disadvantages of behavior change

    Self-efficacy
      - Measure of patient’s confidence in
        their ability to meet their set goal



                                               30
Power of the Stages of Change
Model

     Ability to guide selection of interventions
      and to assist regardless of
      interest/motivation for change


     Overcome mismatch of provider perception
      and patient’s actual stage of change


     Allows pace of intervention to match
      patient’s ability to carry it out

                                                    31
  Prochaska’s Transtheoretical
  Model of Behavior Change Validated
         Smoking cessation                                                         Choosing condoms
         Quitting cocaine use                                                      Reducing sun exposure
         Controlling weight                                                        Reducing radon exposure
         Reducing fat in the diet                                                  Increasing activity and
                                                                                     exercise
         Reducing adolescent
          delinquent behavior                                                       Increasing mammography
                                                                                     screening
         Practicing safer sex
                                                                                    Increasing physician anti-
                                                                                     smoking activity




Andreasen AR. Marketing social change: changing behavior to promote health, social
development and the environment. San Francisco CA: Jossey Bass; 1995: 145,46.
                                                                                                                  32
Decisional Balance
    Disadvantages                Advantages
   Will be less social if      Will be healthier
    sexual practices
    curtailed                   Will begin to feel
                                 better over time
   No time to
    remember all                Less money spent on
    therapies
                                 less frivolous items
   Therapies are
    expensive                   Family will be proud
                                 I’m taking care of
   Everyone will notice         myself


                                                        33
Prochaska’s Stages of
Readiness for Change
              STAGE         CHARACTERISTICS

 T   Pre-Contemplation   Unaware    Unwilling
 I                       Pros? Cons?
M    Contemplation       Open to information, thinking
                         about it
 E
     Preparation         Ready,
                         setting goals
     Action              Taking steps
                         Engaging willpower
     Maintenance         Action > 6 months



                                                         34
 Precontemplation Stage

         Lack of awareness, denial of risks of sexual
          practices and substance abuse as a problem


         Best respond to simple information to help them
          consider making a behavior change
           - Alcohol use makes safe sex harder to achieve
           - Drug use may increase the risk of infection




Sylvestre D. Approaching Drug Use and Coinfection CME online: HIV/HCV Coinfection
Monthly . Johns Hopkins University School of Medicine. Available at:
www.hopkinscme.org/courses/sept.2003. Accessed January 13, 2005                     35
 Discussion Goals for Patient in
 Precontemplation
     Move to Contemplation
                   Don’t lose the patient “up front”
                     - Nonjudgmental acceptance
                     - Emphasize autonomy
                     - Express personal concern
                   Help patient begin to articulate possible
                    consequences of behavior and/or advantage
                    to change



Sylvestre D. Approaching Drug Use and Coinfection CME online: HIV/HCV Coinfection Monthly . Johns
Hopkins University School of Medicine. Available at; www.hopkinscme.org/courses/sept.2003.
Accessed January 13, 2005                                                                           36
   Contemplation Stage
        Aware behavior is problematic but ambivalent
         about making changes


        Vacillate between difficulties created by unsafe
         sex behavior and challenges required to
         practice safe sex


        Not mentally and physically prepared for
         decision
          - Need additional education, encouragement
Sylvestre D. Approaching Drug Use and Coinfection CME online: HIV/HCV Coinfection
Monthly . Johns Hopkins University School of Medicine. Available at;
www.hopkinscme.org/courses/sept.2003. Accessed January 13, 2005
                                                                                    37
 Discussion Goals for Patient in
 Contemplation
         Move to Preparation
            Increase motivation/commitment to change
              - Emphasize that advantages outweigh
                disadvantages
            Foster autonomy/increase self-efficacy
              - Reminder of past success
              - Develop potential plan
              - Develop strategies for dealing with
                roadblocks
            Help patient begin to take small actions that
             may lead to bigger action
Sylvestre D. Approaching Drug Use and Coinfection CME online: HIV/HCV Coinfection
Monthly . Johns Hopkins University School of Medicine. Available at;
www.hopkinscme.org/courses/sept.2003. Accessed January 13, 2005
                                                                                    38
   Preparation Stage

             Decision has been made in favor of change


             Goals established even if drug use continues
               - Quantity or frequency of use typically
                 reduced
             Discuss treatment options


             Establish a “commitment” date


Sylvestre D. Approaching Drug Use and Coinfection CME online: HIV/HCV Coinfection
Monthly . Johns Hopkins University School of Medicine. Available at:
www.hopkinscme.org/courses/sept.2003. Accessed January 13, 2005                     39
  Discussion Goals for Patient in
  Preparation
             Move to Action
                  Reinforce perception of advantages


                  Increase confidence in ability to make change
                    - Develop plan compatible with life situation
                    - Help to predict and plan for difficulties


                  Foster commitment through goal setting
Sylvestre D. Approaching Drug Use and Coinfection CME online: HIV/HCV Coinfection
Monthly . Johns Hopkins University School of Medicine. Available at:
www.hopkinscme.org/courses/sept.2003. Accessed January 13, 2005                     40
Factors Influencing Decisional
Balance
        LISTEN to understand factors
         motivating patient’s behavior
          - Health beliefs
          - Attitudes
          - Social pressures/roles
          - Resources
          - Knowledge/understanding
          - Life circumstances
          - Barriers to alternative behaviors


                                                41
  Action Stage
        Begin actual attempts to stop drug use


        Consider treating withdrawal


        Manage the consequences of sobriety
          - Unrecognized anxiety
          - Panic disorders




Sylvestre D. Approaching Drug Use and Coinfection CME online: HIV/HCV Coinfection
Monthly . Johns Hopkins University School of Medicine. Available at:
www.hopkinscme.org/courses/sept.2003. Accessed January 13, 2005                     42
  Maintenance Stage


         Establish new coping patterns for emotions and
          relationships


         Foundation for lengthy sobriety


         Relapse common and a product of success



Sylvestre D. Approaching Drug Use and Coinfection CME online: HIV/HCV Coinfection
Monthly . Johns Hopkins University School of Medicine. Available at:
www.hopkinscme.org/courses/sept.2003. Accessed January 13, 2005                     43
Goal Setting for Behavior Change
   Set realistic, concrete risk-reduction goals for
    sexual and/or injection drug behavior risk
     - "I want to start using condoms with Jim this
       week”

     - Encourage patients to identify barriers to risk-
       reduction goals

     - "You've come up with good, realistic goals that
       should lower your risk substantially. Now, what
       might get in the way of your meeting those
       goals?"
Problem Solve the Barriers to
Behavior Change
   Barriers can include:
     - Anticipated problems with negotiating condom use
       with a sexual partner
     - Continuing to drink and frequent bars before using
       intravenously
     - Acquiring condoms
   Problem solve barriers
     - Encourage patients to apply some of the skills and
       problem-solving strategies covered in earlier
       sessions to the problems they anticipate in meeting
       risk-reduction goals
Problem Solving Barriers:
Examples
   Provide specific guidelines and strategies
     - Align specific strategies to risk reduction goals
        • Practice assertiveness in the context of negotiating
           condom use
        • Use positive self-talk to counter ambivalence about
           and objections to condom use
        • Use a problem-solving strategy to clarify the
           connection between ongoing cocaine abuse and
           unsafe sexual practices
     - Offer specific information and provide handouts on risk
       reduction
        • Harm reduction vs abstinence
        • Methods of transmission of HIV, other sexually
           transmitted diseases, and tuberculosis
        • Risks associated with sharing injection-drug HIV
           antibody testing
Problem Solving to Maximize HIV
Regimen Adherence
    Ensure appropriate duration of therapy
    Assess extent of behavior change required
    Consider amount life disruption
    Counsel on options to manage cost of regimen
      - Reimbursement, status of ADAP
    HIV therapy regimen complexity requires patient
     education and training
      - Treatment-experienced patients now being
        prescribed injection fusion inhibitor require
        training


                                                        47
Subcutaneous Injection
    HIV Treatment




                         48
Self-injection
    Can be a fusion inhibitor
      - Blocks HIV from entering and infecting healthy CD4
        cells
    In combination with other antiretroviral agents, is
     indicated for the treatment of HIV-1 infection in
     treatment-experienced patients with evidence of HIV-1
     replication despite ongoing antiretroviral therapy


    This indication is based on results from 2 controlled
     studies (TORO 1 and TORO 2) of 48-weeks duration
      - Study participants were treatment-experienced adults;
        many had advanced disease
      - There are no studies in antiretroviral-naïve patients



                                                                49
   Self injection Clinical Trials:
   TORO 1 and TORO 2
     Population
          HIV-infected patients with prior treatment experience with and/or
           resistance to NRTIs, NNRTIs, and PIs
          Viral load ≥5000 copies/mL
          No entry CD4 criteria

     Design
          Randomized, open-label, multi-center, international

     Regimen
          Optimized background (OB) regimen of 3-5 antiretroviral agents
           was constructed based on prior treatment history and baseline
           genotype (GT) and phenotype (PT)
          Then patients were randomized to 2:1 to injection-based regimen
           or non-injection regimen
Lalezari JP et al. NEJM 2003;348:2175-2185
Lazzarin A et al. NEJM 2003;348:2186-2195
HIV Patient Resources to Assist
in Self-Injection
Summary: Goals in Overcoming
Barriers to HIV Behavior Change
  Assess patient’s willingness and readiness to
   change with Prochaska’s Transtheoretical
   Model of behavior change

  Behavioral change in HIV encompasses risk-
   taking behaviors as well as ability to commit
   to treatment

  Recognize the medical importance of HIV
   treatment adherence

  Provide patients with access to HIV expertise
Summary: Goals in Overcoming
Barriers to HIV Behavior Change
 Understand individual patient barriers to
  treatment and address them uniquely

 Treat co-morbid conditions

 Enroll patients in support and adherence programs

 Provide patients with access to HIV expertise
Injection Information
Important Safety Information
Self -Injection Indication:
   Is used with other anti-HIV medicines to treat
    HIV-1 infection in patients who are treatment-
    experienced and have detectable viral loads even
    though they are taking anti-HIV medicines. This
    indication is based on results from 2 studies that
    lasted 48 weeks each. Patients in the studies were
    treatment-experienced adults, and many of them
    had advanced HIV disease.
Important Safety Information
What are the possible side effects of self-injection?
Injection site reactions
   Injection site reactions. Almost all people get injection
    site reactions. Reactions are usually mild to moderate but
    occasionally may be severe. Reactions on the skin included:
    itching, swelling, redness, pain or tenderness, hardened
    skin, bumps. These reactions usually happen within the first
    week of treatment and can happen again as you keep using
    it. A reaction at one skin injection site usually lasts for less
    than 7 days. Injection site reactions may be worse when
    injections are given again in the same place on the body, or
    when the injection is given deeper than it should be (for
    example, into the muscle).If you are worried about the
    reaction you are having, call your healthcare provider to help
    you decide if you need medical care.
Important Safety Information

   If the injection site reaction you are having is
    severe, call your healthcare provider right away. If
    you have an injection site reaction, you can
    discuss with your healthcare provider ways to help
    the symptoms. An injection site can get infected.
    It is important to follow the instructions to lower
    your chances of getting an injection site infection.


   Call your healthcare provider right away if there
    are signs of infection at the injection site such as
    oozing, increasing heat, swelling, redness or pain.
Important Safety Information
   Pneumonia: Patients with HIV get bacterial
    pneumonia more often than patients without HIV.
    Patients taking injection with other HIV medicines
    may get bacterial pneumonia more often than
    patients not receiving injection.
   You should contact your healthcare provider right
    away if you have a cough, fever or trouble
    breathing. Patients are more likely to get bacterial
    pneumonia if they have a low number of CD4
    cells, have a high viral load, use intravenous
    (injected into the vein) drugs, smoke or have had
    lung disease in the past.
Important Safety Information

   Allergic reactions: Injections can cause
    serious allergic reactions. Symptoms of a
    serious allergic reaction can include: trouble
    breathing, fever with vomiting and a skin rash,
    blood in your urine, swelling of your feet


   Call your healthcare provider right away if
    you get any of these symptoms.
Important Safety Information
Other side effects
   The other side effects seen in patients with their
    other anti-HIV medicines: pain and numbness in
    feet or legs, loss of sleep, depression, decreased
    appetite, sinus problems, enlarged lymph nodes,
    weight decrease, weakness or loss of strength,
    muscle pain, constipation, pancreas problems.
   These are not all the side effects. Some studies is
    still being in children. The safety in children under
    6 years of age is not known. The side effects on r
    HIV-positive children aged 6 through 16 years
    were similar to those seen in adult patients.
Important Safety Information

   If you have questions about side effects, ask your
    healthcare provider. Report any new or worsening
    symptoms to your healthcare provider. Your
    healthcare provider will tell you what to do and
    may be able to help you with these side effects.


   Injections are not a cure for HIV infection or AIDS.
    It does not prevent the transmission of HIV.
    People taking it may still get opportunistic
    infections or other conditions that can happen with
    HIV infection. For these reasons it is very
    important that you remain under the care of your
    healthcare provider while under any treatments.
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