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
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 ( 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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