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The State Of The Science:
        Combination Prevention
             Technologies


                  Perry N. Halkitis, PhD, MS
Professor of Applied Psychology, Public Health, and Medicine
                      Director, CHIBPS
                     New York University


              Presentation for HealthHIV SYNChronicty Conference
                                April 20, 2012
Biomedical Approaches to
          HIV Prevention
•   Anti-HIV Microbicides
     – advantage of being receptive-partner controlled
     – vaginally or rectally applied gels, foams, and creams
     – HIV-specific and nonspecific compounds
•   Male Circumcision
     – cost and infrastructure limitations especially in developing
       world
     – operational, religious, political, and logistic factors
•   Vaccines
     – Still under development
•   PEP
     – Long history of use in medical settings
Biomedical Approaches to
        HIV Prevention
• Pre-exposure Prophylaxis (PrEP)

• Treating/HIV Treatment (including after
  Targeting and Testing)
Treating
•   HPTN 052 trials (NIAID, 2011)
     – HIV+ individuals initiating ART decreased transmission rates
       to sexual partners by 96%
•   The Swiss Statement/Swiss Federal Commission for
    HIV/AIDS
     – “An HIV-infected person on antiretroviral therapy with
       completely suppressed viraemia (“effective ART”) is not
       sexually infectious, i.e. cannot transmit HIV through sexual
       contact.”
     – Contingencies
         • the person adheres to antiretroviral therapy, the effects
           of which must be evaluated regularly by the treating
           physician, and
         • the viral load has been suppressed (< 40 copies/ml) for
           at least six months,
         • there are no other sexually transmitted infections.
Treating
• Uganda Couples Study (Quinn, 2000)
  – 415 heterosexual serodicsordant couples in
    Uganda
  – Viral load above 50,000 copies in the HIV-positive
    partner was most strongly associated with the risk
    of transmission: 23 infections per 100 person
    years
  – Viral load between 400 and 3499: 2.2 infections
    per 100 person years
  – Viral load < 1500: 0 infections
State of the science halkitis
PrEP
• CAPRISA 004 trials (Karim et al. 2010)
  – women receiving tenofovir gel were 39%
    less likely to contract HIV than those
    receiving placebo
• Pre-exposure Prophylaxis Initiative
  (iPrEx) trials (Grant et al. 2010)
  – HIV-negative gay men given Truvada had
    44% lower infection rates than men given
    placebo
PrEP
• Partners PrEP Trial (Baeten, 2011 )
      • HIV-negative partners in serodiscordant
        couples
      • HIV-negative partners taking tenofovir had 62%
        less risk for infection
      • those taking, tenofovir plus emtricitabine
        (Truvada) had 73% less chance of infection
          – Tenofovir: 68% in women 58% in men
          – Truvada : 62% in women, 83% in men
Biomedical Approaches to
        Prevention
• Research supports the efficacy of some
  biomedical interventions!!!
Biomedical Interventions
• Research also indicates less than optimal
  results for other biomedical interventions
   – FEM-PrEP study was halted in April 2011
     • Failures related to adherence
     • Among those who were on Truvada and
       seroconverted
     • 26% had detectable levels of tenofovir in their
       blood in the last visit before they tested HIV
       positive
What is Wrong with
   Behavioral Interventions?
• There is questionable effectiveness of
  behavioral interventions
  – Focus on reducing risk for infection
  – Focus on person-level factors such as
    motivation, efficacy, temptation etc.
  – Focus on rational decision making--social
    cognitive frames
     • Rational operators
  – Perhaps unsustainable
But is the solution to HIV prevention a
complete shift from the behavioral to the
biomedical without any consideration to
  psychological or social processes?
NO!
What Do the Biomedical
     Studies Teach Us?
• Biomedical interventions despite their
  high level of effectiveness, involve a
  critical human component
• Biomedical interventions only work
  when uptake and adherence are
  optimized
• We cannot separate the person from
  the intervention
What is the Solution?
• Combining the best of biomedical treatment
  (e.g., PrEP or initiating HIV treatment) with
  behavioral components
• Biomedical interventions would likely yield
  even better outcomes if combined with
  appropriate behavioral and /or social
  interventions
• “Don’t throw out the baby with the bath
  water!”
Why an Integrated Approach
     to HIV Prevention
1. The success of biomedical
interventions is dependent on behavioral
factors affecting medication adherence
and treatment uptake (i.e., treatment
acceptability and use) (Weiss et al. 2008)
2. Treatment adherence “sticking to the
regimen”) plays central role in biomedical
interventions including
  treatment for HIV (U.S., DHHS, 2011)
  PrEP (e.g., Grant et al. 2010)
  PEP (e.g., Chacko et al, 2012)
3. Adherence is influenced by a variety of
  bio-psycho-social factors that may both
  enhance and diminish this behavior
  – Patient based factors
  – Providers based factors
  – Treatment based factor
  – Contextual factors
4. Biomedical interventions without
combined behavioral approaches have
shown suboptimal medication adherence
and treatment uptake
  – only 27 %of drug users in need of the Hepatitis B vaccine
    completed the required three dose regimen (McGregor et al.
    2003)
  – and only 28.2% of young women at a clinic who were
    offered the human papillomavirus vaccine accepted and of
    those who accepted only 55.7% completed all three required
    doses (Moore, et al. 2010)
5. Medication adherence and treatment
uptake of biomedical interventions can be
addressed by behavioral interventions
that enhance knowledge and build skills
6. Behavioral approaches attend to
factors such as age, socioeconomic
status, developmental understanding,
gender, gender identity, sexual
orientation, culture, stigma, mental health,
substance abuse, attitudes, prior
knowledge
7. Policy and recommendations have yet
to be established as to whether some
biomedical interventions (e.g. PrEP) will
be viewed as life-long or as short-term
solutions for high-risk individuals;
SO WHAT IS A BETTER
 APPROACH TO HIV
PREVENTION MOVING
    FORWARD?
The Biopsychosocial
    Framework
Application to HIV Prevention
• Biological factors: the virus (e.g., PrEP
  and treatment)
  – emerging
• Psychological factors: the person
  (behavioral intervention)
  – established
• Social factors: the context (structural
  intervention)
  – only scratching the surface
The Social Factors
• Science clearly shows that HIV disease is
fueled by…
  –Poverty
  –Discrimination
  –Homophobia
  –Victimization
  –Gender bias
  •EXPLAIN THE PATTERNS OF INFECTION IN
 GAY AND BISEXUAL MEN AND AFRICAN
 AMERICANS
• The development of interventions and social
  policies to address these social ills are critical
  to HIV prevention
   – Behavioral interventions: INSUFFICIENT
   – PrEP/Biological interventions: INSUFFICIENT
   – Behavioral + Biological: ALSO LIKELY
     INSUFFICINET
A NEW GENERATION OF
    HIV PREVENTION
    BIOMEDICAL APPROACHES
               +
BEHAVIORAL SUPPORT/PROGRAMS
               +
  SOCIAL POLICIES/STRUCTURAL
        INTERVENTIONS
• PREP OR TREATING to deter infection from
  the virus
• BEHAVIORAL SUPPORT to (1) support
  uptake, adherence and maintenance (2)
  develop and understanding of PREP, and (3)
  to reinforce condom use and safer sex
  strategies
• SOCIAL POLICY to combat social
  inequalities and decrease vulnerability to HIV
  infections
A 3-Pronged
Approach
• biological,
  psychological, social
• just like we approach
  HIV treatment with
  combinations of
  drugs across classes
• The most effective
  HIV prevention
  program and policy
  will marry all 3
  components

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State of the science halkitis

  • 1. The State Of The Science: Combination Prevention Technologies Perry N. Halkitis, PhD, MS Professor of Applied Psychology, Public Health, and Medicine Director, CHIBPS New York University Presentation for HealthHIV SYNChronicty Conference April 20, 2012
  • 2. Biomedical Approaches to HIV Prevention • Anti-HIV Microbicides – advantage of being receptive-partner controlled – vaginally or rectally applied gels, foams, and creams – HIV-specific and nonspecific compounds • Male Circumcision – cost and infrastructure limitations especially in developing world – operational, religious, political, and logistic factors • Vaccines – Still under development • PEP – Long history of use in medical settings
  • 3. Biomedical Approaches to HIV Prevention • Pre-exposure Prophylaxis (PrEP) • Treating/HIV Treatment (including after Targeting and Testing)
  • 4. Treating • HPTN 052 trials (NIAID, 2011) – HIV+ individuals initiating ART decreased transmission rates to sexual partners by 96% • The Swiss Statement/Swiss Federal Commission for HIV/AIDS – “An HIV-infected person on antiretroviral therapy with completely suppressed viraemia (“effective ART”) is not sexually infectious, i.e. cannot transmit HIV through sexual contact.” – Contingencies • the person adheres to antiretroviral therapy, the effects of which must be evaluated regularly by the treating physician, and • the viral load has been suppressed (< 40 copies/ml) for at least six months, • there are no other sexually transmitted infections.
  • 5. Treating • Uganda Couples Study (Quinn, 2000) – 415 heterosexual serodicsordant couples in Uganda – Viral load above 50,000 copies in the HIV-positive partner was most strongly associated with the risk of transmission: 23 infections per 100 person years – Viral load between 400 and 3499: 2.2 infections per 100 person years – Viral load < 1500: 0 infections
  • 7. PrEP • CAPRISA 004 trials (Karim et al. 2010) – women receiving tenofovir gel were 39% less likely to contract HIV than those receiving placebo • Pre-exposure Prophylaxis Initiative (iPrEx) trials (Grant et al. 2010) – HIV-negative gay men given Truvada had 44% lower infection rates than men given placebo
  • 8. PrEP • Partners PrEP Trial (Baeten, 2011 ) • HIV-negative partners in serodiscordant couples • HIV-negative partners taking tenofovir had 62% less risk for infection • those taking, tenofovir plus emtricitabine (Truvada) had 73% less chance of infection – Tenofovir: 68% in women 58% in men – Truvada : 62% in women, 83% in men
  • 9. Biomedical Approaches to Prevention • Research supports the efficacy of some biomedical interventions!!!
  • 10. Biomedical Interventions • Research also indicates less than optimal results for other biomedical interventions – FEM-PrEP study was halted in April 2011 • Failures related to adherence • Among those who were on Truvada and seroconverted • 26% had detectable levels of tenofovir in their blood in the last visit before they tested HIV positive
  • 11. What is Wrong with Behavioral Interventions? • There is questionable effectiveness of behavioral interventions – Focus on reducing risk for infection – Focus on person-level factors such as motivation, efficacy, temptation etc. – Focus on rational decision making--social cognitive frames • Rational operators – Perhaps unsustainable
  • 12. But is the solution to HIV prevention a complete shift from the behavioral to the biomedical without any consideration to psychological or social processes?
  • 13. NO!
  • 14. What Do the Biomedical Studies Teach Us? • Biomedical interventions despite their high level of effectiveness, involve a critical human component • Biomedical interventions only work when uptake and adherence are optimized • We cannot separate the person from the intervention
  • 15. What is the Solution? • Combining the best of biomedical treatment (e.g., PrEP or initiating HIV treatment) with behavioral components • Biomedical interventions would likely yield even better outcomes if combined with appropriate behavioral and /or social interventions • “Don’t throw out the baby with the bath water!”
  • 16. Why an Integrated Approach to HIV Prevention 1. The success of biomedical interventions is dependent on behavioral factors affecting medication adherence and treatment uptake (i.e., treatment acceptability and use) (Weiss et al. 2008)
  • 17. 2. Treatment adherence “sticking to the regimen”) plays central role in biomedical interventions including treatment for HIV (U.S., DHHS, 2011) PrEP (e.g., Grant et al. 2010) PEP (e.g., Chacko et al, 2012)
  • 18. 3. Adherence is influenced by a variety of bio-psycho-social factors that may both enhance and diminish this behavior – Patient based factors – Providers based factors – Treatment based factor – Contextual factors
  • 19. 4. Biomedical interventions without combined behavioral approaches have shown suboptimal medication adherence and treatment uptake – only 27 %of drug users in need of the Hepatitis B vaccine completed the required three dose regimen (McGregor et al. 2003) – and only 28.2% of young women at a clinic who were offered the human papillomavirus vaccine accepted and of those who accepted only 55.7% completed all three required doses (Moore, et al. 2010)
  • 20. 5. Medication adherence and treatment uptake of biomedical interventions can be addressed by behavioral interventions that enhance knowledge and build skills
  • 21. 6. Behavioral approaches attend to factors such as age, socioeconomic status, developmental understanding, gender, gender identity, sexual orientation, culture, stigma, mental health, substance abuse, attitudes, prior knowledge
  • 22. 7. Policy and recommendations have yet to be established as to whether some biomedical interventions (e.g. PrEP) will be viewed as life-long or as short-term solutions for high-risk individuals;
  • 23. SO WHAT IS A BETTER APPROACH TO HIV PREVENTION MOVING FORWARD?
  • 24. The Biopsychosocial Framework
  • 25. Application to HIV Prevention • Biological factors: the virus (e.g., PrEP and treatment) – emerging • Psychological factors: the person (behavioral intervention) – established • Social factors: the context (structural intervention) – only scratching the surface
  • 26. The Social Factors • Science clearly shows that HIV disease is fueled by… –Poverty –Discrimination –Homophobia –Victimization –Gender bias •EXPLAIN THE PATTERNS OF INFECTION IN GAY AND BISEXUAL MEN AND AFRICAN AMERICANS
  • 27. • The development of interventions and social policies to address these social ills are critical to HIV prevention – Behavioral interventions: INSUFFICIENT – PrEP/Biological interventions: INSUFFICIENT – Behavioral + Biological: ALSO LIKELY INSUFFICINET
  • 28. A NEW GENERATION OF HIV PREVENTION BIOMEDICAL APPROACHES + BEHAVIORAL SUPPORT/PROGRAMS + SOCIAL POLICIES/STRUCTURAL INTERVENTIONS
  • 29. • PREP OR TREATING to deter infection from the virus • BEHAVIORAL SUPPORT to (1) support uptake, adherence and maintenance (2) develop and understanding of PREP, and (3) to reinforce condom use and safer sex strategies • SOCIAL POLICY to combat social inequalities and decrease vulnerability to HIV infections
  • 30. A 3-Pronged Approach • biological, psychological, social • just like we approach HIV treatment with combinations of drugs across classes • The most effective HIV prevention program and policy will marry all 3 components