Advertisement

AIDS and Behavior

, Volume 18, Issue 5, pp 833–840 | Cite as

Monitoring Microbicide Gel Use with Real-Time Notification of the Container’s Opening Events: Results of the CAPRISA Wisebag Study

  • Tanuja N. Gengiah
  • Michele Upfold
  • Anushka Naidoo
  • Leila E. Mansoor
  • Paul J. Feldblum
  • Quarraisha Abdool Karim
  • Salim S. Abdool Karim
Original Paper

Abstract

Accurate estimation of the effectiveness of a microbicide for HIV prevention requires valid measurement of adherence to product use. A microbicide gel applicator container (Wisebag), fitted with cell phone technology to transmit opening events and text message reminders, was developed to monitor each opening event of the container as a proxy for gel use and adherence. Ten women were enrolled in a pilot study and followed for up to 4 months. Wisebag opening (WBO) dates and times were recorded and correlated with self-reported sex acts and gel applicator returns. During the 33 monthly follow-up visits, 47.8 % (77/161) of the recorded number of WBO events were concordant with the number of empty (used) applicators returned. The discrepancies were likely due to removal of more than one applicator during a single opening event. When the date and time of the WBO event data was assessed in relation to three different self-report adherence measures, agreement was fairly modest. The Wisebag was found to be acceptable as a storage container and the cell phone reminders generated were useful in supporting the dosing strategy. We recommend that the Wisebag be considered for larger scale and lengthier testing in microbicide trials.

Keywords

Adherence Electronic monitoring Microbicides Clinical trials HIV prevention 

Notes

Acknowledgments

We thank Kershani Naidoo, Bernadene Moodley, Cynthia Velile Ngcobo, Bhavna Maharaj, Nolwazi Thandiwe Nzimande, Londeka Zondi and Gugulethu Masinga for conducting the informed consent and acceptability interviews. The CAPRISA Wisebag is manufactured by Wisepill Technologies (www.wisepill.com) and the CAPRISA Wisebag study was sponsored by Lifelab. Lloyd Marshall’s support and development of the prototype bags is acknowledged. Precious Sikhakane assisted with CRF development and data oversight of the Wisebag study. The CAPRISA 004 Tenofovir Gel trial is supported by the Centre for the AIDS Program of Research in South Africa (CAPRISA), the United States Agency for International Development (USAID), Family Health International (FHI) (cooperative agreement # GPO-A-00-05-00022-00, contract # 132119), and LIFElab, a biotechnology center of the South African Department of Science and Technology. Support from CONRAD for the product manufacturing and packaging as well as support from Gilead Sciences for the Tenofovir used in the production of gel is gratefully acknowledged. We thank the US National Institutes for Health’s Comprehensive International Program of Research on AIDS (CIPRA Grant # AI51794) and the Columbia University-Southern African Fogarty AIDS International Training and Research Programme (AITRP Grant # D43TW00231) for the research infrastructure and training that made this trial possible.

Conflict of interest

All authors report no conflicts of interest.

References

  1. 1.
    Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329(5996):1168–74.PubMedCentralPubMedCrossRefGoogle Scholar
  2. 2.
    Lagakos SW, Gable AR. Methodological challenges in biomedical HIV prevention trials. Washington, DC: Institute of medicine; 2008.Google Scholar
  3. 3.
    Schroder KE, Carey MP, Vanable PA. Methodological challenges in research on sexual risk behavior: II. Accuracy of self-reports. Ann Behav Med. 2003;26(2):104–23.PubMedCentralPubMedCrossRefGoogle Scholar
  4. 4.
    Tolley EE, Harrison PF, Goetghebeur E, et al. Adherence and its measurement in phase 2/3 microbicide trials. AIDS Behav. 2009;14:1124–36.PubMedCentralCrossRefGoogle Scholar
  5. 5.
    Berg KM, Arnsten JH. Practical and conceptual challenges in measuring antiretroviral adherence. J Acquir Immune Defic Syndr. 2006;43(Suppl 1):S79–87.PubMedCentralPubMedCrossRefGoogle Scholar
  6. 6.
    Simoni JM, Kurth AE, Pearson CR, et al. Self-report measures of antiretroviral therapy adherence: a review with recommendations for HIV research and clinical management. AIDS Behav. 2006;10(3):227–45.PubMedCrossRefGoogle Scholar
  7. 7.
    Pequegnat W, Fishbein M, Celentano D, et al. NIMH/APPC workgroup on behavioral and biological outcomes in HIV/STD prevention studies: a position statement. Sex Transm Dis. 2000;27(3):127–32.PubMedCrossRefGoogle Scholar
  8. 8.
    Haberer JE, Kahane J, Kigozi I, et al. Real-time adherence monitoring for HIV antiretroviral therapy. AIDS Behav. 2010;14:1340–6.PubMedCentralPubMedCrossRefGoogle Scholar
  9. 9.
    Krummenacher I, Cavassini M, Bugnon O, Schneider MP. An interdisciplinary HIV-adherence program combining motivational interviewing and electronic antiretroviral drug monitoring. AIDS Care. 2011;23:1–12.CrossRefGoogle Scholar
  10. 10.
    Lyimo RA, van den Boogaard J, Msoka E, et al. Measuring adherence to antiretroviral therapy in northern Tanzania: feasibility and acceptability of the medication event monitoring system. BMC Public Health. 2011;11(1):92.PubMedCentralPubMedCrossRefGoogle Scholar
  11. 11.
    Daniels T, Goodacre L, Sutton C, et al. Accurate assessment of adherence: self and clinician report versus electronic monitoring of nebulizers. Chest. 2011;140:425–32.PubMedCrossRefGoogle Scholar
  12. 12.
    Russell-Minda E, Jutai J, Speechley M, et al. Health technologies for monitoring and managing diabetes: a systematic review. J Diabetes Sci Technol. 2009;3(6):1460–71.PubMedCentralPubMedCrossRefGoogle Scholar
  13. 13.
    Walji MF, Coker O, Valenza JA, et al. A persuasive toothbrush to enhance oral hygiene adherence. AMIA Annu Symp Proc. 2008:1167.Google Scholar
  14. 14.
    Boyce JM, Cooper T, Dolan MJ. Evaluation of an electronic device for real-time measurement of alcohol-based hand rub use. Infect Control Hosp Epidemiol. 2009;30(11):1090–5.PubMedCrossRefGoogle Scholar
  15. 15.
    Shet A, Arumugam K, Rodrigues R, et al. Designing a mobile phone-based intervention to promote adherence to antiretroviral therapy in South India. AIDS Behav. 2010;14(3):716–20.PubMedCrossRefGoogle Scholar
  16. 16.
    Liu H, Golin CE, Miller LG, et al. A comparison study of multiple measures of adherence to HIV protease inhibitors. Ann Intern Med. 2001;134(10):968–77.PubMedCrossRefGoogle Scholar
  17. 17.
    Pool R, Montgomery CM, Morar NS, 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.PubMedCentralPubMedCrossRefGoogle Scholar
  18. 18.
    van der Straten A, Montgomery E, Pillay D, et al. Feasibility, performance, and acceptability of the Wisebag for potential monitoring of daily gel applicator use in Durban, South Africa. AIDS Behav. 2013;17(2):640–8.PubMedCentralPubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • Tanuja N. Gengiah
    • 1
  • Michele Upfold
    • 1
  • Anushka Naidoo
    • 1
  • Leila E. Mansoor
    • 1
  • Paul J. Feldblum
    • 2
  • Quarraisha Abdool Karim
    • 1
    • 3
  • Salim S. Abdool Karim
    • 1
    • 3
  1. 1.Centre for the AIDS Programme of Research in South Africa (CAPRISA), Doris Duke Medical Research Institute (2nd Floor)University of KwaZulu-NatalDurbanSouth Africa
  2. 2.FHI360DurhamUSA
  3. 3.Department of Epidemiology, Mailman School of Public HealthColumbia UniversityNew YorkUSA

Personalised recommendations