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

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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) - PowerPoint PPT Presentation

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  • Preparing for NPTs: Learning from the Past and Preparing for the FutureAnthony Lombardo, PhDJuly 27, 2011

    Anthony Lombardo, 2010

  • Biomedical Approaches to HIV PreventionVaccinesMicrobicidesPre-exposure Prophylaxis (PrEP)Post-exposure Prophylaxis (PEP)

    Socio-Behavioural Issues of New Biomedical HIV Prevention TechnologiesAnthony Lombardo, January 2011, CATIEhttp://bit.ly/npt_sb

    Partial Efficacy and the Uptake of New Biomedical HIV Prevention TechnologiesAnthony Lombardo, January 2011, CATIEhttp://bit.ly/npt_pe

    Anthony Lombardo, 2010

  • AgendaUtilizing the technologiesAwarenessAccessAcceptabilityAdherenceKey socio-behavioural considerationsUnderstanding riskRisk compensationContext of useStigmaNPTs and the landscape of HIV prevention

    Anthony Lombardo, 2010

  • Biomedical Prevention: BenefitsPotential impactGreater reach than behavioural interventionsEasier to implementEmpowermentWomenMen

    But what are the real life challenges?

    Anthony Lombardo, 2010

  • Importance of Social Science in Understanding NPTs and their UseNeed to understand why people use technologies and why they dontAs with any other technologyCondoms, HAARTNeed to understand how NPTs may change risk behaviourNeed to address these issues to support individuals use of the technologies(Imrie et al., 2007; Kippax, 2008; Rosengarten et al., 2008)

    Anthony Lombardo, 2010

  • Awareness of NPTsAwareness is key to uptake/use

    Awareness of the technologies tends to vary by technology and populationPEP: MSM, tends to be below 60%PEP: HIV+ women in London clinic, 80% had not heard of PEPPrEP: MSM, approximately 20 25%

    Awareness improved by campaigns

    Anthony Lombardo, 2010

  • Acceptability of NPTsNPTs overallTend to be seen as acceptablebut a number of important considerations for acceptability:Efficacy of NPT at preventing HIVSide effects caused by NPTCost of NPTMicrobicidesGenerally found acceptable by women, but concerns about:Physical characteristics of the microbicideLeakage, time of use, contraceptive propertiesDelivery methodGels, rings, tabletsSimilar concerns about rectal microbicides, for both men and women

    Anthony Lombardo, 2010

  • Partial EfficacyCondoms & microbicides

    Anthony Lombardo, 2010

  • Partial EfficacyCondoms and Microbicides

    Anthony Lombardo, 2010

  • Partial EfficacyCondoms and Microbicides

    Anthony Lombardo, 2010

  • Acceptability of NPTsGender/power relations play a roleWomens use of microbicides in context of relationships

    NPTs may be most acceptable to those most at risk for HIV infectionNPT studies suggest people with higher sexual risk more likely to use or be interested in using NPTs

    Anthony Lombardo, 2010

  • Access to NPTsAccess to NPTs impacted by individual and structural factorsTestingKnowledge of HIV statusAvailabilityTechnologies themselvesSomeone who can prescribe themTimely accesse.g., clinic hours, clinician awareness, awareness of riskCost

    Anthony Lombardo, 2010

  • Access to NPTsDisparities impact access to NPTsRace, gender, socio-economic statusSimilar to disparities in access to HAARTConcurrent HIV risk behaviours may impact accesse.g., drug use: stigma, social exclusion, housing instability, health care system access (Krsi et al., 2010)

    Anthony Lombardo, 2010

  • Adherence to NPTsHAART adherence as guideBarriers and motivators at individual and structural levelsFear of disclosure, depression, forgetting to take medications, schedulingStigma, social isolation, social networksSide effects may be significant barrierHIV-negative people may not tolerate side effectsAdherence ratesiPrEX trial: 2,499 HIV- MSM, 95% adherenceCAPRISA 004 trial: 72% of sex acts (past 30 days) covered by two doses of gel40% of 889 women had less than 50% adherence

    Anthony Lombardo, 2010

  • Key Socio-Behavioural IssuesUnderstandings of RiskRisk CompensationGender, Agency and Empowerment

    Anthony Lombardo, 2010

  • Understandings of RiskHow individuals think about their own risk behaviour will impact use of technologiesHow do people decide if they have been at risk, and therefore attempt to access an NPT?Understandings of risk influenced at numerous levelsIndividual: decisions about the safety of a sexual partner or a sexual acte.g., serosorting, strategic positioningCommunity: setting the criteria for what makes a safe partner or a safe sexual act

    Anthony Lombardo, 2010

  • Understandings of RiskPeople at risk for HIV may not realize that they are, and may not access NPTsPEPSayer et al. (2008): MSM in Brighton, UKMen accessed PEP because of unusual or rare sexual encountersSex with a casual partner deemed unsafe, sex at a certain type of venue, sex under the influenceSchechter et al. (2004): Brazilian MSMTop reasons for not using PEP: sex with steady partner and encounters considered low riskVaccineLow perceived risk for HIV associated with less uptake of potential vaccine, among diverse populationsNewman, et al., 2008; Ravert & Zimet, 2009; Rhodes & Hergenrather, 2002; Rudy et al., 2005; Salazar et al., 2005

    Anthony Lombardo, 2010

  • Understandings of RiskPeople may think they are at greater risk than they actually are, leading to potential misuse of NPTsThe worried wellPoynten et al. (2007): PEP requests in an Australian cohort, 1998-2004relatively large number of requests unnecessary because HIV status of partner in the exposure known in only about 1/3 of casesPinkerton 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 programEthics?

    Anthony Lombardo, 2010

  • Risk CompensationPeople may increase their risk behaviour because of the perceived protection from NPTsEvidence is mixed But evidence is also earlyFew NPTs in real-world application

    Anthony Lombardo, 2010

  • Risk CompensationPrEPEarly evidence does not suggest an increase in risk behaviouriPrEX trial: no evidence of risk compensationGhanaian 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 ARVsReliance on unproven technologies (Kellerman et al., 2006)

    Anthony Lombardo, 2010

  • Risk CompensationMicrobicidesLittle direct evidence, but some suggestion of an inclination towards increased risk behaviourCAPRISA 004: no evidence of risk compensationPossible 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-Diguez et al., 2007; Mansergh et al., 2003)

    Anthony Lombardo, 2010

  • Risk CompensationVaccineTrials show mixed evidence of risk compensationEarly 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 behaviourConcerns 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)

    Anthony Lombardo, 2010

  • Risk CompensationDefinitive statements about the impact of NPTs on risk behaviour are not possible at presentAvailable evidence has some shortcomingsMust account for the role of risk reduction counseling in controlled NPT trials, which may not reflect real lifeStudies of hypothetical use and/or risk compensation may not reflect real lifePromotion of NPTs must account for the possibility of risk compensationNPTs will not provide protection against other STIs

    Anthony Lombardo, 2010

  • Gender, Agency and EmpowermentNPTs may offer choice for people especially women who cannot control mens use of condomsUse of NPTs still impacted by gender inequalities and power relationsSevery et al. (2005): microbicide acceptability in contextIndividual-levelBeliefs about susceptibility to HIV impact useRelationship-levelNew relationships vs. established ones; difficulties in bringing the subject up with partner; male partner views on microbicidesSocio-cultural levelGender/economic inequalities mean womens dependence on men; cultural norms about intravaginal practices

    Anthony Lombardo, 2010

  • Gender, Agency and EmpowermentFemale-controlled prevention options may have unintended consequences (Koo et al., 2005; Mantell et al., 2006; Woodsong, 2004) Repercussions if secretive use is discoveredDiscontinuation of condoms with womens microbicide useEmphasis on womens responsibility for sexual health, rather than shared responsibilityNPTs can empower other groups with difficulties in sexual negotiation

    Anthony Lombardo, 2010

  • NPTs and Landscape of HIV PreventionCombination preventionNPTs alone are not enoughNPTs will likely not be 100% effectiveBehavioural strategies still necessaryNeed to go beyond the individualNPTs used by individuals, but within a broader contextUse of NPTs needs to be understood from different levels in which it will be usedIndividual, community, society(Cohen et al., 2008; Padian et al., 2008; Vermund et al., 2009)

    Anthony Lombardo, 2010

  • NPTs in Context

    IndividualRelationship/CommunitySociety (Social, Political, Economic)AwarenessSocial relationsSocial networksMass mediaMarketing strategiesAcceptabilityOthers evaluations of microbicidesAgency to negotiate microbicide useSide effectsNorms about NPTs in social networksMeanings of sex and drug usePower relations in sexual encountersGender inequalitySocial constructions of masculinitySocial constructions of sexualityAccessSubjective risk calculations based on the type of partner or risk eventBarriers to HIV testingBarriers to timely treatmentBarriers to health care access generallyNorms about risk and safety in social networksStigma about testing; HIV diagnosis; accessing NPTsAvailability of NPTs in local settingAvailability of NPTsNPT distribution policiesPublic health care coverage of NPTsMedical culture surrounding NPTsRacial and gender disparitiesAdherenceInfluence of relationship partnerNegotiation skillsCost of treatmentsConvenience of treatmentsSocial support networksStigmaAvailability of NPTsPublic health care coverage of NPTs

    Anthony Lombardo, 2010

  • Implementing NPTsConnected and complementary servicesRisk reduction counselingSTI screeningHepatitis vaccinationsCounselingOngoing HIV-status monitoringe.g., PrEP: side effects; HIV infection; increases in risk behaviour(Clauson, 2009; Paxton et al., 2007; Pozniak, 2004)

    Anthony Lombardo, 2010

  • Messaging and Marketing NPTsEmphasizing benefits and limitations of NPTsAddress/discourage risk compensationCulturally- and gender-appropriateCommunicating partial effectivenessHow to encourage uptake with technologies that are not 100% protectiveand discourage risk compensation?Utilize social theory to increase uptake of messagesUse particular health behaviour change modelse.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)

    Anthony Lombardo, 2010

  • Messaging and Marketing NPTsFraming approachesDownplaying focus on HIV preventionPEP as morning after pill, PrEP as birth controlMicrobicide as sexual enhancement rather than HIV preventionCaution of unintended consequencesFemale-controlled marketing may alienate menMarketing to high-risk groups may stigmatize the NPT and reduce accessMarketing 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)

    Anthony Lombardo, 2010

  • Messaging and Marketing NPTsWhom to message?Individual usersMass mediaSocial networksPartners, friends, familiesHealth care practitionersHow are people talking about NPTs?Education may not be the complete answerHow people talk about NPTs may have a big impact on how if and/or how they are usede.g., controversy over MMR (measles, mumps, rubella) vaccinationsRequire grounding in local understandingsNeed formative research

    Anthony Lombardo, 2010

  • In ConclusionNPTs must be understood within a broader contextMany issues involved in NPT access and use depending on factors beyond the individualMessaging/marketing NPTs must account for this broader contextRisk compensation must be monitored, especially in real-world applicationBehavioural approaches should not be abandoned for biomedical interventions

    Anthony Lombardo, 2010

  • HIV Prevention: The Bigger PictureWhat does all of this mean for HIV prevention?Need to acknowledge shortcomings of three different approachesBehaviouralLack of coverageBiomedicalScience and uptakeStructuralDifficult to implementDifficult to evaluatePrevention needs to encompass all three levels

    Anthony Lombardo, 2010

  • Readings & ResourcesBrooks, R. A., Etzel, M., Klosinski, L. E., Leibowitz, A. A., Sawires, S., Szekeres, G., et al. (in press). Male circumcision and HIV prevention: Looking to the future. AIDS Behav.Cassell, M. M., Halperin, D. T., Shelton, J. D., & Stanton, D. (2006). Risk compensation: The Achilles' heel of innovations in HIV prevention? BMJ, 332, 605-607.Global Campaign for Microbicides. (2009). Trials Watch: Microbicides late clinical development. Available: www.global-campaign.org/download.htmGuinot, D., Ho, M. T., Poynten, I. M., McAllister, J., Pierce, A., Pell, C., et al. (2009). Cost-effectiveness of HIV nonoccupational post-exposure prophylaxis in Australia. HIV Med, 10(4), 199-208.Gupta, G. R., Parkhurst, J. O., Ogden, J. A., Aggleton, P., & Mahal, A. (2008). Structural approaches to HIV prevention. Lancet, 372, 764-775.Hanenberg, R. S., Rojanapithayakorn, W., Kunasol, P., & Sokal, D. C. (1994). Impact of Thailands HIV-control programme as indicated by the decline of sexually transmitted diseases. Lancet, 344(8917), 243-245.Millett, G. A., Flores, S. A., Marks, G., Reed, J. B., & Herbst, J. H. (2008). Circumcision status and risk of HIV and sexually transmitted infections among men who have sex with men: A meta-analysis. JAMA, 300(14), 1674-1684.Moore, J. P., Klasse, P. J., Dolan, M. J., & Ahuja, S. K. (2008). AIDS/HIV. A STEP into darkness or light? Science, 320, 753-755.Okwundu, C. I., & Okoromah, C. A. (2009). Antiretroviral pre-exposure prophylaxis (PrEP) for preventing HIV in high-risk individuals. Cochrane Database Syst Rev, 1, CD007189.Padian, N. S., Buve, A...

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