AIDS and Behavior

, Volume 15, Issue 2, pp 389–395

Notes on the Frequency of Routinely Collected and Self-Reported Behavioral Data in HIV Prevention Trials

  • Douglas J. Taylor
  • Che-Chin Lie
  • Mark A. Weaver
  • Elizabeth Tolley
  • Lut Van Damme
  • Vera Halpern
  • Paul Feldblum
  • Folasade Ogunsola
  • Orikomaba Obunge
  • Gita Ramjee
  • Michel Alary
  • Florence Mirembe
Original Paper

DOI: 10.1007/s10461-010-9822-9

Cite this article as:
Taylor, D.J., Lie, CC., Weaver, M.A. et al. AIDS Behav (2011) 15: 389. doi:10.1007/s10461-010-9822-9

Abstract

HIV prevention trials typically randomize thousands of participants to active or control intervention arms, with regular (e.g. monthly) clinic visits over one or more years of follow-up. Because HIV infection rates are often lower than 3 per 100 person-years even in high prevalence settings, tens of thousands of clinic visits may take place before the number of infections required to achieve adequate study power has been observed. In addition to clinical outcomes, the multitude of study visits provides an opportunity to assess adherence and related participant behaviors in great detail. These data may be used to refine counseling messages, gain insight into patterns of behavior, and perform supporting analyses in an attempt to obtain more precise estimates of treatment efficacy. Exploratory analyses were performed to assess how our understanding of participant behaviors and their relationships to biological outcomes in two recent prevention trials might have been impacted had the frequency of routine behavioral data collection been reduced from monthly to just months 1, 3, 6, 9, and 12. Results were comparably informative in the reduced case, suggesting that unnecessarily extensive amounts of routine behavioral data may be collected in these trials.

Keywords

AdherenceMicrobicideTrajectory analysis

Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Douglas J. Taylor
    • 1
  • Che-Chin Lie
    • 1
  • Mark A. Weaver
    • 1
  • Elizabeth Tolley
    • 1
  • Lut Van Damme
    • 1
  • Vera Halpern
    • 1
  • Paul Feldblum
    • 1
  • Folasade Ogunsola
    • 2
  • Orikomaba Obunge
    • 3
  • Gita Ramjee
    • 4
  • Michel Alary
    • 5
  • Florence Mirembe
    • 6
  1. 1.FHIDurhamUSA
  2. 2.College of MedicineUniversity of LagosLagosNigeria
  3. 3.University of Port Harcourt Teaching HospitalPort HarcourtNigeria
  4. 4.HIV Prevention Research UnitSouth African Medical Research CouncilDurbanSouth Africa
  5. 5.URESP, Centre de recherche FRSQ du CHA universitaire de QuébecQuebecCanada
  6. 6.Makarere UniversityKampalaUganda