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Preparing for NPTs: Learning from the Past and Preparing for the Future. Anthony Lombardo, PhD July 27, 2011. Biomedical Approaches to HIV Prevention. Vaccines Microbicides Pre-exposure Prophylaxis (PrEP) Post-exposure Prophylaxis (PEP)

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preparing for npts learning from the past and preparing for the future

Preparing for NPTs: Learning from the Past and Preparing for the Future

Anthony Lombardo, PhD

July 27, 2011

biomedical approaches to hiv prevention
Biomedical Approaches to HIV Prevention
  • Vaccines
  • Microbicides
  • Pre-exposure Prophylaxis (PrEP)
  • Post-exposure Prophylaxis (PEP)
  • Socio-Behavioural Issues of New Biomedical HIV Prevention Technologies
    • Anthony Lombardo, January 2011, CATIE
  • Partial Efficacy and the Uptake of New Biomedical HIV Prevention Technologies
    • Anthony Lombardo, January 2011, CATIE
  • Utilizing the technologies
    • Awareness
    • Access
    • Acceptability
    • Adherence
  • Key socio-behavioural considerations
    • Understanding risk
    • Risk compensation
    • Context of use
    • Stigma
  • NPTs and the landscape of HIV prevention
biomedical prevention benefits
Biomedical Prevention: Benefits
  • Potential impact
    • Greater reach than behavioural interventions
    • “Easier” to implement
  • Empowerment
    • Women
    • Men
  • But what are the “real life” challenges?
importance of social science in understanding npts and their use
Importance of Social Science in Understanding NPTs and their Use
  • Need to understand why people use technologies – and why they don’t
    • As with any other technology
      • Condoms, HAART
  • Need to understand how NPTs may change risk behaviour
  • Need to address these issues to support individuals’ use of the technologies

(Imrie et al., 2007; Kippax, 2008; Rosengarten et al., 2008)

awareness of npts
Awareness of NPTs
  • Awareness is key to uptake/use
  • Awareness of the technologies tends to vary by technology and population
    • PEP: MSM, tends to be below 60%
    • PEP: HIV+ women in London clinic, 80% had not heard of PEP
    • PrEP: MSM, approximately 20 – 25%
  • Awareness improved by campaigns
acceptability of npts
Acceptability of NPTs
  • NPTs overall
    • Tend to be seen as acceptable…but a number of important considerations for acceptability:
      • Efficacy of NPT at preventing HIV
      • Side effects caused by NPT
      • Cost of NPT
  • Microbicides
    • Generally found acceptable by women, but concerns about:
      • Physical characteristics of the microbicide
        • Leakage, time of use, contraceptive properties
      • Delivery method
        • Gels, rings, tablets
      • Similar concerns about rectal microbicides, for both men and women
partial efficacy
Partial Efficacy
  • Condoms & microbicides
partial efficacy1
Partial Efficacy

Condoms and


partial efficacy2
Partial Efficacy

Condoms and


acceptability of npts1
Acceptability of NPTs
  • Gender/power relations play a role
    • Women’s use of microbicides in context of relationships
  • NPTs may be most acceptable to those most at risk for HIV infection
    • NPT studies suggest people with higher sexual risk more likely to use or be interested in using NPTs
access to npts
Access to NPTs
  • Access to NPTs impacted by individual and structural factors
    • Testing
      • Knowledge of HIV status
    • Availability
      • Technologies themselves
      • Someone who can prescribe them
    • Timely access
      • e.g., clinic hours, clinician awareness, awareness of risk
    • Cost
access to npts1
Access to NPTs
  • Disparities impact access to NPTs
    • Race, gender, socio-economic status
      • Similar to disparities in access to HAART
    • Concurrent HIV risk behaviours may impact access
      • e.g., drug use: stigma, social exclusion, housing instability, health care system access (Krüsi et al., 2010)
adherence to npts
Adherence to NPTs
  • HAART adherence as guide
  • Barriers and motivators at individual and structural levels
      • Fear of disclosure, depression, forgetting to take medications, scheduling
      • Stigma, social isolation, social networks
  • Side effects may be significant barrier
    • HIV-negative people may not tolerate side effects
  • Adherence rates
    • iPrEX trial: 2,499 HIV- MSM, 95% adherence
    • CAPRISA 004 trial: 72% of sex acts (past 30 days) covered by two doses of gel
      • 40% of 889 women had less than 50% adherence
key socio behavioural issues
Key Socio-Behavioural Issues
  • Understandings of Risk
  • Risk Compensation
  • Gender, Agency and Empowerment
understandings of risk
Understandings of Risk
  • How individuals think about their own “risk” behaviour will impact use of technologies
    • How do people decide if they have been at risk, and therefore attempt to access an NPT?
  • Understandings of risk influenced at numerous levels
    • Individual: decisions about the “safety” of a sexual partner or a sexual act
      • e.g., serosorting, strategic positioning
    • Community: setting the “criteria” for what makes a safe partner or a safe sexual act
understandings of risk1
Understandings of Risk
  • People at risk for HIV may not realize that they are, and may not access NPTs
  • PEP
    • Sayer et al. (2008): MSM in Brighton, UK
      • Men accessed PEP because of “unusual” or “rare” sexual encounters
        • Sex with a casual partner deemed ‘unsafe’, sex at a certain type of venue, sex under the influence
    • Schechter et al. (2004): Brazilian MSM
      • Top reasons for not using PEP: sex with steady partner and encounters considered ‘low risk’
  • Vaccine
    • Low perceived risk for HIV associated with less uptake of potential vaccine, among diverse populations
      • Newman, et al., 2008; Ravert & Zimet, 2009; Rhodes & Hergenrather, 2002; Rudy et al., 2005; Salazar et al., 2005
understandings of risk2
Understandings of Risk
  • People may think they are at greater risk than they actually are, leading to potential misuse of NPTs
  • The “worried well”
  • Poynten et al. (2007): PEP requests in an Australian cohort, 1998-2004
    • “relatively large number” of requests unnecessary because HIV status of partner in the exposure known in only about 1/3 of cases
  • Pinkerton et al. (1998)
    • Priority of PEP: partners of HIV+ people; receptive anal intercourse; likely HIV+ partner; extenuating circumstances (violent sex, partner with other STDs)
    • “provision of PEP to individuals with low-risk of exposures would diminish overall cost-effectiveness of the program”
    • Ethics?
risk compensation
Risk Compensation
  • People may increase their risk behaviour because of the perceived protection from NPTs
  • Evidence is mixed
  • But evidence is also “early”
    • Few NPTs in real-world application
risk compensation1
Risk Compensation
  • PrEP
    • Early evidence does not suggest an increase in risk behaviour
      • iPrEX trial: no evidence of risk compensation
      • Ghanaian PrEP trial showed no increase in risk behaviour among women in the trial (Guest et al., 2008)
      • Californian studies of MSM show under 10% of men would be less safe with efficacious PrEP (AIDS Partnership California, 2009; Al-Tayyib et al., 2009)
      • Intentions to use PrEP not associated with HIV risk factors (Mimiaga et al, 2009)
    • Reports of ‘off-label’ use of ARVs for PEP/PrEP among MSM concerning (Mansergh et al., 2010)
      • Compromising preventive and treatment aspects of ARVs
      • Reliance on unproven technologies (Kellerman et al., 2006)
risk compensation2
Risk Compensation
  • Microbicides
    • Little direct evidence, but some suggestion of an inclination towards increased risk behaviour
      • CAPRISA 004: no evidence of risk compensation
      • Possible decreasing condom use with highly effective microbicide (Thurman et al., 2009)
      • Belief in protection of microbicide in clinical trial, despite warnings about unknown efficacy (Mantell et al., 2006)
      • MSM use of dangerous/unproven rectal microbicides, such as nonoxynol-9 (Carballo-Diéguez et al., 2007; Mansergh et al., 2003)
risk compensation3
Risk Compensation
  • Vaccine
    • Trials show mixed evidence of risk compensation
      • Early San Francisco trials showed increase in insertive unprotected anal intercourse among participants (Chesney et al., 1997)
      • Other trials have found no increase in risk behaviours among participants (Bartholow et al., 2005; Lampinen et al., 2005; van Griensven et al., 2004)
    • Hypothetical vaccine studies suggest potential increase in risk behaviour
      • Concerns that “others” would increase their risk behaviour (Salazar et al., 2005; Webb et al., 1999)
      • Individuals themselves suggesting they would increase risk behaviour with efficacious HIV vaccine (Barrington et al., 2008; Crosby et al., 2006; Newman et al., 2009)
risk compensation4
Risk Compensation
  • Definitive statements about the impact of NPTs on risk behaviour are not possible at present
    • Available evidence has some shortcomings…
      • Must account for the role of risk reduction counseling in controlled NPT trials, which may not reflect “real life”
      • Studies of hypothetical use and/or risk compensation may not reflect “real life”
  • Promotion of NPTs must account for the possibility of risk compensation
  • NPTs will not provide protection against other STIs
gender agency and empowerment
Gender, Agency and Empowerment
  • NPTs may offer choice for people – especially women – who cannot control men’s use of condoms
  • Use of NPTs still impacted by gender inequalities and power relations
    • Severy et al. (2005): microbicide acceptability in context
      • Individual-level
        • Beliefs about susceptibility to HIV impact use
      • Relationship-level
        • New relationships vs. established ones; difficulties in bringing the subject up with partner; male partner views on microbicides
      • Socio-cultural level
        • Gender/economic inequalities mean women’s dependence on men; cultural norms about intravaginal practices
gender agency and empowerment1
Gender, Agency and Empowerment
  • Female-controlled prevention options may have unintended consequences (Koo et al., 2005; Mantell et al., 2006; Woodsong, 2004)
    • Repercussions if secretive use is discovered
    • Discontinuation of condoms with women’s microbicide use
    • Emphasis on women’s responsibility for sexual health, rather than shared responsibility
  • NPTs can empower other groups with difficulties in sexual negotiation
npts and landscape of hiv prevention
NPTs and Landscape of HIV Prevention
  • Combination prevention
    • NPTs alone are not enough
    • NPTs will likely not be 100% effective
    • Behavioural strategies still necessary
  • Need to go “beyond the individual”
    • NPTs used by individuals, but within a broader context
    • Use of NPTs needs to be understood from different levels in which it will be used
      • Individual, community, society

(Cohen et al., 2008; Padian et al., 2008; Vermund et al., 2009)

implementing npts
Implementing NPTs
  • Connected and complementary services
    • Risk reduction counseling
    • STI screening
    • Hepatitis vaccinations
    • Counseling
    • Ongoing HIV-status monitoring
      • e.g., PrEP: side effects; HIV infection; increases in risk behaviour

(Clauson, 2009; Paxton et al., 2007; Pozniak, 2004)

messaging and marketing npts
Messaging and Marketing NPTs
  • Emphasizing benefits and limitations of NPTs
  • Address/discourage risk compensation
  • Culturally- and gender-appropriate
  • Communicating partial effectiveness
    • How to encourage uptake with technologies that are not 100% protective…and discourage risk compensation?
  • Utilize social theory to increase uptake of messages
    • Use particular health behaviour change models
      • e.g., health belief model, stages of change, etc.
      • But must still account for contextual issues

(Access Working Group; Cassell et al., 2006; Eaton & Kalichman, 2007; Global HIV Prevention Working Group, 2006; Nodin et al., 2008)

messaging and marketing npts1
Messaging and Marketing NPTs
  • Framing approaches
    • Downplaying focus on HIV prevention
    • PEP as ‘morning after pill,’ PrEP as ‘birth control’
    • Microbicide as sexual enhancement rather than HIV prevention
  • Caution of unintended consequences
    • “Female-controlled” marketing may alienate men
    • Marketing to high-risk groups may stigmatize the NPT and reduce access
    • Marketing a product to be used covertly?

(Access Working Group; Cassell et al., 2006; Eaton & Kalichman, 2007; Global HIV Prevention Working Group, 2006; Nodin et al., 2008)

messaging and marketing npts2
Messaging and Marketing NPTs
  • Whom to message?
    • Individual users
      • Mass media
    • Social networks
      • Partners, friends, families
    • Health care practitioners
  • How are people talking about NPTs?
    • “Education” may not be the complete answer
    • How people talk about NPTs may have a big impact on how if and/or how they are used
      • e.g., controversy over MMR (measles, mumps, rubella) vaccinations
    • Require grounding in local understandings
      • Need formative research
in conclusion
In Conclusion…
  • NPTs must be understood within a broader context
    • Many issues involved in NPT access and use depending on factors beyond the individual
  • Messaging/marketing NPTs must account for this broader context
  • Risk compensation must be monitored, especially in real-world application
  • Behavioural approaches should not be abandoned for biomedical interventions
hiv prevention the bigger picture
HIV Prevention: The Bigger Picture
  • What does all of this mean for HIV prevention?
  • Need to acknowledge shortcomings of three different approaches
    • Behavioural
      • Lack of coverage
    • Biomedical
      • Science and uptake
    • Structural
      • Difficult to implement
      • Difficult to evaluate
  • Prevention needs to encompass all three levels
readings resources
Readings & Resources

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