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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

    • http://bit.ly/npt_sb

  • Partial Efficacy and the Uptake of New Biomedical HIV Prevention Technologies

    • Anthony Lombardo, January 2011, CATIE

    • http://bit.ly/npt_pe


Agenda
Agenda

  • 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 Use

  • 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 Use

  • 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 Use

  • Condoms & microbicides


Partial efficacy1
Partial Efficacy Use

Condoms and

Microbicides


Partial efficacy2
Partial Efficacy Use

Condoms and

Microbicides


Acceptability of npts1
Acceptability of NPTs Use

  • 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 Use

  • 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 Use

  • 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 Use

  • 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 Use

    • Understandings of Risk

    • Risk Compensation

    • Gender, Agency and Empowerment


    Understandings of risk
    Understandings of Risk Use

    • 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 Use

    • 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 Use

    • 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 Use

    • 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 Use

    • 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 Use

    • 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 Use

    • 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 Use

    • 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 Use

    • 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 Use

    • 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 Use

    • 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 Use

    • 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 Use

    • 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 Use

    • 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 Use

    • 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… Use

    • 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 Use

    • 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 Use

    Brooks, 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.htm

    Guinot, 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 Thailand’s 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., Balkus, J., Serwadda, D., & Cates, W., Jr. (2008). Biomedical interventions to prevent HIV infection: Evidence, challenges, and way forward. Lancet, 372, 585-599.

    Rerks-Ngarm, S., Pitisuttithum, P., Nitayaphan, S., Kaewkungwal, J., Chiu, J., Paris, R., et al. (2009). Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med, 361(23), 2209-2220.

    Robertson M., Mehrotra D., Fitzgerald D., et al. (2008, February). Efficacy results from the STEP study (Merck V520 Protocol 023/HVTN 502): A phase II test-of-concept trial of the MRKAd5 HIV-1 Gag/Pol/Nef trivalent vaccine. 15th Conference on Retroviruses and Opportunistic Infections, Boston, MA.

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    Turner, A. N., Morrison, C. S., Padian, N. S., Kaufman, J. S., Salata, R. A., Chipato, T., et al. (2007). Men's circumcision status and women's risk of HIV acquisition in Zimbabwe and Uganda. AIDS, 21(13), 1779-1789.

    Weiss, H. A., Halperin, D., Bailey, R. C., Hayes, R. J., Schmid, G., & Hankins, C. A. (2008). Male circumcision for HIV prevention: From evidence to action? AIDS, 22(5), 567-574.

    Williams, B. G., Lloyd-Smith, J. O., Gouws, E., Hankins, C., Getz, W. M., Hargrove, J., et al. (2006). The potential impact of male circumcision on HIV in sub-Saharan Africa. PLoS Med, 3(7), e262.

    World Health Organization. (2009). Towards universal access: Progress report (Key Messages). Switzerland, WHO HIV/AIDS Department.


    References
    References Use

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    AIDS Partnership California. (2009). Pre-Exposure Prophylaxis and HIV Prevention: Assessing Community Needs and Preparedness in California.

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    References1
    References Use

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    References Use

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    Mimiaga, M. J., Case, P., Johnson, C. V., Safren, S. A., & Mayer, K. H. (2009). Preexposure Antiretroviral Prophylaxis Attitudes in High-Risk Boston Area Men Who Report Having Sex With Men: Limited Knowledge and Experience but Potential for Increased Utilization After Education. Journal of Acquired Immune Deficiency Syndromes, 50(1), 77-83. doi:10.1097/QAI.0b013e31818d5a27

    Newman, P. A., Duan, N., Kakinami, L., & Roberts, K. (2008). What can HIV vaccine trials teach us about future HIV vaccine dissemination? Vaccine, 26(20), 2528–2536.

    Newman, P. A., Lee, S., Duan, N., Rudy, E., Nakazono, T. K., Boscardin, J., Kakinami, L., et al. (2009). Preventive HIV Vaccine Acceptability and Behavioral Risk Compensation among a Random Sample of High-Risk Adults in Los Angeles (LA VOICES). Health Services Research, 44(6), 2167-2179. doi:10.1111/j.1475-6773.2009.01039.x

    Nodin, N., Carballo-Diéguez, A., Ventuneac, A. M., Balan, I. C., & Remien, R. (2008). Knowledge and acceptability of alternative HIV prevention bio-medical products among MSM who bareback. AIDS Care, 20(1), 106-115. doi:10.1080/09540120701449096

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