Advertisement

AIDS and Behavior

, Volume 16, Issue 5, pp 1243–1259 | Cite as

Supporting Study Product Use and Accuracy in Self-Report in the iPrEx Study: Next Step Counseling and Neutral Assessment

  • K. R. AmicoEmail author
  • Vanessa McMahan
  • Pedro Goicochea
  • Lorena Vargas
  • Julia L. Marcus
  • Robert M. Grant
  • Albert Liu
Original Paper

Abstract

The recent successes of biomedical HIV prevention approaches have sparked considerable debate over the scalability, feasibility, and acceptability of pre-exposure prophylaxis (PrEP) as a widespread prevention strategy for men who have sex with men and trans-gender. Anticipated difficulties with PrEP adherence and concerns about resources required to best support it have tempered enthusiasm of PrEP demonstration projects and roll-out. While no evidence-based approach for supporting PrEP use is presently available, a number of approaches have been developed in the context of double-blind, randomized, placebo-controlled trials of PrEP that can provide guidance in moving forward with real world support of open label PrEP use. We present the development, implementation and evaluation of feasibility and acceptability of next-step counseling (NSC) and neutral assessment (NA), the adherence support and promotion of accurate reporting approaches used in the late phases of the iPrEx study. Evaluation of the approach from the perspective of implementers of over 15,000 NSC sessions in seven different countries with almost 2,000 iPrEx participants provided support for NSC, its brevity (averaging ~14 min per follow-up session) and overall acceptability and feasibility. NA also was generally well supported, with a majority of study staff believing this approach was feasible and acceptable; however, lower acceptability for certain aspects of NA was noted amongst staff reporting NA was different from their previous interview approach. Quantitative and qualitative data gathered from implementers were used to make modifications for supporting PrEP use in the open-label extension of iPrEx.

Keywords

PrEP Adherence iPrEx Intervention Self-report Next step counseling Neutral assessment 

Resumen

Los recientes éxitos de las intervenciones biomédicas para la prevención del VIH han generado debate en relación a la cobertura, viabilidad y aceptabilidad de la profilaxis pre-exposición como una estrategia de prevención a ser usada por hombres que tienen sexo con hombres y mujeres transexuales. Las dificultades relacionadas a la adherencia y las preocupaciones acerca de los recursos que se requerirían para respaldar el servicio en condiciones óptimas han aplacado el entusiasmo para la implementación de proyectos de demostración de PrEP. Visto que no existe una estrategia basada en la evidencia que respalde el uso de PrEP, éstas se han desarrollado en el contexto de los ensayos clínicos aleatorizados, doble-ciego y controlados con placebo, los mismos que pueden servir de guía para el respaldo de su uso en el mundo real. Presentamos aquí el diseño, implementación y evaluación de la viabilidad y aceptabilidad de la Consejería del Siguiente Paso (NSC por sus siglas en inglés) y Evaluación Neutral (NA por sus siglas en inglés) de apoyo a la adherencia y a la promoción del reporte correcto de uso de la medicación durante la última fase del estudio iPrEx. La evaluación de esta estrategia por parte de los implementadores de más de 15,000 sesiones de NSC, en 7 países diferentes con casi 2,000 participantes de iPrEx, proporcionó sustento a la NSC, su brevedad (~14 min por sesión de seguimiento), su aceptabilidad y viabilidad. La NA, en general, también fue bien apoyada, y una gran mayoría del personal manifestó que el enfoque es factible y aceptable; sin embargo, se notó menor aceptabilidad de algunos aspectos de la NA entre aquellos miembros del personal que reportaron que la NA era diferente con respecto a la estrategia que usaban anteriormente. Los datos cuantitativos y cualitativos proporcionados por los implementadores se usaron para modificar las estrategias de soporte al uso de PrEP en la extensión de etiqueta abierta del iPrEx.

Notes

Acknowledgments

This work greatly benefited from the contributions and insights from Ed Wolf, consultant to AWG and NSC trainer, and the site team members implementing and otherwise supporting NSC and NA over the course of the iPrEx study. As with all iPrEx study findings and contributions, we are greatly indebted to the men and trans women around the world who participated in the global iPrEx study. This research was supported by a Grant UO1 AI064002 to Robert Grant.

Conflict of interest

The authors report no financial conflicts of interest.

References

  1. 1.
    Padian NS, McCoy SI, Balkus JE, Wasserheit JN. Weighing the gold in the gold standard: challenges in HIV prevention research. AIDS. 2010;24:621–35.PubMedCrossRefGoogle Scholar
  2. 2.
    Abdool KQ, Abdool KSS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329:1168–74.CrossRefGoogle Scholar
  3. 3.
    Grant RM, Lama JR, Anderson PL, McMahan V, et al. Pre-exposure chemoprophylaxis for HIV prevention in men who have sex with men. NEJM. 2010. doi: 10.1056/NEJMoa1011205.Google Scholar
  4. 4.
    Baeten J, Celum C, on behalf of Partners PrEP Study Team. Antiretroviral pre-exposure prophylaxis for HIV-1 prevention among heterosexual African men and women: the partners PrEP study. In: 6th international AIDS Society conference on HIV pathogenesis treatment and prevention, Rome; 2011.Google Scholar
  5. 5.
    Thigpen MC, Kebaabetswa PM, Smith DK, et al. Daily oral antiretroviral use for the prevention of HIV infection in heterosexually active young adults in Botswana: results from the TDF2 study.In: 6th international AIDS society conference on HIV pathogenesis treatment and prevention. Rome; 2011.Google Scholar
  6. 6.
    Leibowitz AA, Parker KB, Rotheram-Borus MJ. A US policy perspective on oral preexporsure prophylaxis for HIV. AJPH. 2011;101(6):982–5.CrossRefGoogle Scholar
  7. 7.
    Amico KR, Liu A, McMahan V et al. Adherence indicators and pre-exposure prophylaxis (PrEP) drug levels in the iPrEx study.In: 18th conference on retroviruses and opportunistic infections (CROI). Boston, US; 2011.Google Scholar
  8. 8.
    Anderson PL, Lama JR, Buchbinder S et al. Interpreting detection rates of intracellular emtricitabine–triphosphate (FTC-TP) and tenofovir-diphosphate (TFV-DP) in the iPrEx trial.In: 18th conference on retroviruses and opportunistic infections (CROI). Boston, US; 2011.Google Scholar
  9. 9.
    Grant R, Lama J, Glidden D et al. Pre-exposure chemprophylaxis for prevention of HIV among trans-women and MSM: iPREx study.In: 18th conference on retroviruses and opportunistic infections (CROI). Boston, US; 2011.Google Scholar
  10. 10.
    Vargas L, Amico KR, Goicochea P et al. Pill-taking support and assessment: Self reported perceptions of participants in a PrEP trial. International Association of Physicians in Adherence Care Conference. Miami, USA, 2010. [abstract # 62257].Google Scholar
  11. 11.
    Bartholomew LK, Parcel GS, Kok G, Gottlieb NH: planning health promotion programs. An Intervention Mapping approach. 2nd edn. San Francisco, CA, Jossey-Bass; 2006.Google Scholar
  12. 12.
    Kok G, Schaalma H, Ruiter RA, van Empelen P, Brug J. Intervention mapping: protocol for applying health psychology theory to prevention programmes. J Health Psychol. 2004;9(1):85–98.PubMedCrossRefGoogle Scholar
  13. 13.
    US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH). Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. 2009, Dec. Accessed 27 Feb 2012 from http://www.ispor.org/workpaper/FDA%20PRO%20Guidance.pdf.
  14. 14.
    Williams AB, Amico KR, Bova C, Womack JA. A proposal for quality standards for measuring medication adherence in research. AIDS and Behav. 2012. doi: 10.1007/s10461-012-0172-7.
  15. 15.
    Fisher JD, Fisher WA, Amico KR, Harman JJ. An information-motivation-behavioral skills model of adherence to antiretroviral therapy. Health Psychol. 2006;25(4):462–73.PubMedCrossRefGoogle Scholar
  16. 16.
    Fisher JD, Amico KR, Fisher WA, Harman JJ. The information-motivation-behavioral skills model of antiretroviral adherence and its applications. Curr HIV/AIDS Rep. 2008;5(4):193–203.PubMedCrossRefGoogle Scholar
  17. 17.
    Wilson IB, Carter AE, Berg KM. Improving the self-report of HIV antiretroviral medication adherence: is the glass half full or half empty? Curr HIV/AIDS Rep. 2009;6(4):177–86.PubMedCrossRefGoogle Scholar
  18. 18.
    Fisher JD, Fisher WA, Cornman DH, Amico KR, Bryan A, Friedland GH. Clinician-delivered Intervention during routine clinical care reduces risky sexual behavior of HIV infected patients. J Acquir Immune Defic Syndr. 2006;41(1):44–52.PubMedCrossRefGoogle Scholar
  19. 19.
    Rollnick S, Miller WR, Butler CC. Motivational Interviewing in Health Care: Helping Patients Change Behavior. New York: Guilford Press; 2008.Google Scholar
  20. 20.
    Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psych Bull. 1992;111(3):455–74.CrossRefGoogle Scholar
  21. 21.
    Centers for Disease Control and Prevention. Morbidity and mortality weekly report (MMWR), Interim guidance: preexposure prophylaxis for the prevention of HIV infection in men who have sex with men. 2011, Jan 28; 60(03); 65–68. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6003a1.htm?s_cid=mm6003a1_w Accessed 25 Sept 2011.
  22. 22.
    Golub SA, Operario D, Gorbach PM. Pre-exposure prophylaxis state of the science: empirical analogies for research and implementation. Curr HIV/AIDS Rep. 2010;7(4):201–9.PubMedCrossRefGoogle Scholar
  23. 23.
    Myers GM, Mayer KH. Oral preexposure anti-HIV prophylaxis for high-risk US populations: current considerations in light of new findings. AIDS Pt Care STDs. 2011;25(2):63–71.CrossRefGoogle Scholar
  24. 24.
    Stirratt MJ, Gordon CM. Adherence to biomedical HIV prevention methods: considerations drawn from HIV treatment adherence research. Curr HIV/AIDS Rep. 2008;5(4):186–92.PubMedCrossRefGoogle Scholar
  25. 25.
    Amico KR, Harman JJ, Johnson BT. Efficacy of antiretroviral therapy adherence interventions: a research synthesis of trials, 1996 to 2004. J AIDS. 2006;41(3):285–97.Google Scholar
  26. 26.
    Centers for Disease Control and Prevention. Compendium of evidence-based HIV behavioral interventions: medication adherence chapter. http://www.cdc.gov/hiv/topics/research/prs/ma-chapter.htm Accessed 25 Sept 2011.
  27. 27.
    de Bruin M, Viechtbauer W, Schaalma HP, Kok G, Abraham C, Hospers HJ. Standard care impacts intervention effects in HAART adherence RCTs: a meta-analysis. Arch Intern Med. 2010;170(3):240–50.PubMedCrossRefGoogle Scholar
  28. 28.
    Simoni JM, Pearson CR, Pantalone DW, Marks G, Crepaz N. Efficacy of interventions in improving highly active antiretroviral therapy adherence and HIV-1 RNA viral load––a meta-analytic review of randomized controlled trials. J AIDS. 2006;43:S23–35.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2012

Authors and Affiliations

  • K. R. Amico
    • 1
    • 2
    Email author
  • Vanessa McMahan
    • 3
  • Pedro Goicochea
    • 3
  • Lorena Vargas
    • 4
  • Julia L. Marcus
    • 3
  • Robert M. Grant
    • 3
    • 5
  • Albert Liu
    • 6
  1. 1.Center for Health Intervention and Prevention, University of ConnecticutStorrsUSA
  2. 2.Applied Health ResearchBrightonUSA
  3. 3.Gladstone Institute of Virology and ImmunologySan FranciscoUSA
  4. 4.Investigaciones Medicas en SaludIquitosPeru
  5. 5.University of CaliforniaSan FranciscoUSA
  6. 6.San Francisco Department of Public HealthSan FranciscoUSA

Personalised recommendations