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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. 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

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  1. Preparing for NPTs: Learning from the Past and Preparing for the Future Anthony Lombardo, PhD July 27, 2011

  2. 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

  3. 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

  4. Biomedical Prevention: Benefits • Potential impact • Greater reach than behavioural interventions • “Easier” to implement • Empowerment • Women • Men • But what are the “real life” challenges?

  5. 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)

  6. 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

  7. 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

  8. Partial Efficacy • Condoms & microbicides

  9. Partial Efficacy Condoms and Microbicides

  10. Partial Efficacy Condoms and Microbicides

  11. 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

  12. 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

  13. 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)

  14. 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

  15. Key Socio-Behavioural Issues • Understandings of Risk • Risk Compensation • Gender, Agency and Empowerment

  16. 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

  17. 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

  18. 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?

  19. 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

  20. 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)

  21. 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)

  22. 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)

  23. 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

  24. 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

  25. 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

  26. 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)

  27. NPTs in Context

  28. 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)

  29. 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)

  30. 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)

  31. 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

  32. 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

  33. 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

  34. Readings & Resources 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. Rotheram-Borus, M. J., Swendeman, D., & Chovnick, G. (2009). The past, present, and future of HIV prevention: Integrating behavioral, biomedical, and structural intervention strategies for the next generation of HIV prevention. Annu Rev Clin Psychol, 5, 143-167. 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.

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