Skip to main content
SpringerLink
Log in

Use of a Novel Technology to Track Adherence to Product Use in a Microbicide Trial of Short Duration (MTN-007)

  • Original Paper
  • Published:
AIDS and Behavior Aims and scope Submit manuscript

Abstract

Adherence measurement in microbicide trials is challenging. To decrease recall and social desirability bias, we used an interactive voice response system (IVR) in a rectal microbicide trial. Forty-six participants were asked to report product use daily for 1 week. Participants received an incentive per call plus a bonus for calling every day. We examined adherence to calling the IVR and to gel use; we compared the latter to applicator counts. Adherence to calling the IVR daily was high (mean = 89.9 %, SD = 20.7 %). Adherence to gel use per IVR was very good (mean = 90.7 %, SD = 19.1 %), and consistent with applicator counts in 80.4 % of cases. Neither adherence to calling nor gel use were associated with temporal factors like day calls started, number of days since first call, or weekday vs. weekend. Daily reporting allowed identification of irregular product use. IVR appears useful for daily reporting in brief trials.

Resumen

La medición de la adherencia en ensayos clínicos de microbicidas es compleja. Para reducir el sesgo de la memoria y de la deseabilidad social, usamos un sistema interactivo de respuesta de voz (IVR) en un ensayo de un microbicida rectal. Se les pidió a cuarenta y seis participantes que reportaran diariamente su uso del producto durante una semana. Los participantes recibieron un incentivo por cada llamada más un bono por llamar todos los días. Examinamos la adherencia a llamar al IVR y al uso del gel; comparamos lo último con el recuento de aplicadores usados. La adherencia a llamar al IVR diariamente fue alta (media = 89.9 %, desviación estándar = 20.7 %). La adherencia al uso del gel basada en las respuestas al IVR fue muy buena (media = 90.7 %, desviación estándar = 19.1 %), y fue consistente con el recuento de aplicadores usados en el 80.4 % de los casos. Ni la adherencia a llamar ni el uso del gel estuvieron asociados con factores temporales tales como el día en que se iniciaron las llamadas, el número de días desde la primera llamada, o días de semana vs. fin de semana. El reporte diario nos permitió identificar el uso irregular del producto. El IVR parece ser útil para el reporte diario en ensayos breves.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Muchomba FM, Gearing RE, Simoni JM, El-Bassel N. State of science of adherence in pre-exposure prophylaxis and microbicide trials. J Acquir Immune Defic Syndr. 2012;61(4):490–8.

    Article  PubMed  CAS  Google Scholar 

  2. Mensch B, Hewett P, Abbott S, Rankin J, Littlefield S, Ahmed K, et al. Assessing the reporting of adherence and sexual activity in a simulated microbicide trial in South Africa: an interview mode experiment using a placebo gel. AIDS Behav. 2011;15(2):407–21.

    Article  PubMed  Google Scholar 

  3. Van der Straten A, Montgomery E, Pillay D, Cheng H, Naidoo A, Cele Z. Feasibility, performance, and acceptability of the Wisebag™ for potential monitoring of daily gel applicator use in Durban, South Africa. AIDS Behav. 2013;17(2):1–9.

    Article  Google Scholar 

  4. Haberer J, Robbins G, Ybarra M, Monk A, Ragland K, Weiser S, et al. Real-time electronic adherence monitoring is feasible, comparable to unannounced pill counts, and acceptable. AIDS Behav. 2012;16(2):375–82.

    Article  PubMed  Google Scholar 

  5. Haberer J, Kahane J, Kigozi I, Emenyonu N, Hunt P, Martin J, et al. Real-time adherence monitoring for HIV antiretroviral therapy. AIDS Behav. 2010;14(6):1340–6.

    Article  PubMed  Google Scholar 

  6. Austin MN, Rabe LK, Hillier SL. Limitations of the dye-based method for determining vaginal applicator use in microbicide trials. Sex Transm Dis. 2009;36(6):368–71.

    Article  PubMed  CAS  Google Scholar 

  7. Mauck CK, Schwartz JL. Dyeing to know: the use of vaginal applicator staining and other techniques to assess adherence to product use in microbicide trials. Sex Transm Dis. 2012;39(9):713–5.

    Article  PubMed  Google Scholar 

  8. Morey TE, Wasdo S, Wishin J, Quinn B, Straten A van der, Booth M, et al. Feasibility of a Breath Test for Monitoring Adherence to Vaginal Administration of Antiretroviral Microbicide Gels. J Clin Pharmacol [Internet]. 2012 Jan 31 [cited 2012 Oct 5]; Available from: http://jcp.sagepub.com/content/early/2012/01/30/0091270011434157.

  9. Mensch BS, Hewett PC, Erulkar A. The reporting of sensitive behavior by adolescents: a methodological experiment in Kenya. Demography. 2003;40(2):247–68.

    Article  PubMed  Google Scholar 

  10. Tolley EE, Harrison PF, Goetghebeur E, Morrow K, Pool R, Taylor D, et al. Adherence and its measurement in phase 2/3 microbicide trials. AIDS Behav. 2010;14(5):1124–36.

    Article  PubMed  Google Scholar 

  11. Pool R, Montgomery CM, Morar NS, Mweemba O, Ssali A, Gafos M, et al. A mixed methods and triangulation model for increasing the accuracy of adherence and sexual behaviour data: the Microbicides Development Programme. PLoS ONE. 2010;5(7):e11600.

    Article  PubMed  Google Scholar 

  12. Schroder KEE, Johnson CJ. Interactive voice response technology to measure HIV-related behavior. Curr HIV/AIDS Rep. 2009;6(4):210–6.

    Article  PubMed  Google Scholar 

  13. Hensel DJ, Harezlak J, Craig D, Fortenberry JD. The feasibility of cell phone based electronic diaries for STI/HIV research. BMC Med Res Methodol. 2012;12(1):75.

    Article  PubMed  Google Scholar 

  14. Bradley J, Ramesh BM, Rajaram S, Lobo A, Gurav K, Isac S, et al. The feasibility of using mobile phone technology for sexual behaviour research in a population vulnerable to HIV: a prospective survey with female sex workers in South India. AIDS Care. 2012;24(6):695–703.

    Article  PubMed  Google Scholar 

  15. Morrison DM, Leigh BC, Gillmore MR. Daily data collection: a comparison of three methods. J Sex Res. 1999;36(1):76–81.

    Article  Google Scholar 

  16. Minnis AM, Padian NS. Reliability of adolescents’ self-reported sexual behavior: a comparison of two diary methodologies. J Adolesc Health. 2001;28(5):394–403.

    Article  PubMed  CAS  Google Scholar 

  17. Kranzler HR, Abu-Hasaballah K, Tennen H, Feinn R, Young K. Using daily interactive voice response technology to measure drinking and related behaviors in a pharmacotherapy study. Alcohol Clin Exp Res. 2004;28(7):1060–4.

    Article  PubMed  Google Scholar 

  18. Tourangeau R, Smith TW. Asking sensitive questions: the impact of data collection mode, question format, and question context. Public Opin Q. 1996;60(2):275–304.

    Article  Google Scholar 

  19. Bender BG, Apter A, Bogen DK, Dickinson P, Fisher L, Wamboldt FS, et al. Test of an interactive voice response intervention to improve adherence to controller medications in adults with asthma. J Am Board Fam Med. 2010;23(2):159–65.

    Article  PubMed  Google Scholar 

  20. Pop-Eleches C, Thirumurthy H, Habyarimana JP, Zivin JG, Goldstein MP, de Walque D, et al. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS. 2011;25(6):825–34.

    Article  PubMed  Google Scholar 

  21. McGowan I, Hoesley C, Cranston RD, Andrew P, Janocko L, Dai JY, et al. A phase 1 randomized, double blind, placebo controlled rectal safety and acceptability study of tenofovir 1 % gel (MTN-007). PLoS ONE. 2013;8(4):e60147.

    Article  PubMed  CAS  Google Scholar 

  22. Stritzke W, Dandy J, Durkin K, Houghton S. Use of interactive voice response (IVR) technology in health research with children. Behav Res Methods. 2005;37(1):119–26.

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

Support for this study was received from the National Institute of Allergy and Infectious Diseases, Division of AIDS (5UM1AI068633), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (U01 HD040533, U01 HD040474), the National Institute of Mental Health, and CONRAD. The study was designed and implemented by the Microbicide Trials Network (MTN-007). Additional support came from the National Institute of Mental Health to the HIV Center for Clinical and Behavioral Studies at NY State Psychiatric Institute and Columbia University (P30-MH43520; Principal Investigator: Anke A. Ehrhardt, Ph.D.). The content is solely the responsibility of the authors and does not necessarily represent the official views of NIH. The authors want to thank the MTN-007 study team, including staff from the study sites, the coordinating center, and the statistical center for their contributions to this study. They also want to thank the participants who generously offered their time and input.

Author information

Authors and Affiliations

  1. HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute, Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA

    Cheng-Shiun Leu, Marina Mabragaña, Rebecca Giguere, Curtis Dolezal & Alex Carballo-Diéguez

  2. Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, USA

    Ian McGowan

Authors
  1. Cheng-Shiun Leu
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Marina Mabragaña
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Rebecca Giguere
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Curtis Dolezal
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Alex Carballo-Diéguez
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Ian McGowan
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Cheng-Shiun Leu.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Leu, CS., Mabragaña, M., Giguere, R. et al. Use of a Novel Technology to Track Adherence to Product Use in a Microbicide Trial of Short Duration (MTN-007). AIDS Behav 17, 3101–3107 (2013). https://doi.org/10.1007/s10461-013-0549-2

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10461-013-0549-2

Keywords

Search

Navigation