IDEAS home Printed from https://ideas.repec.org/a/spr/stabio/v12y2020i3d10.1007_s12561-020-09274-3.html
   My bibliography  Save this article

Design and Analysis Considerations for a Sequentially Randomized HIV Prevention Trial

Author

Listed:
  • David Benkeser
  • Keith Horvath
  • Cathy J. Reback

    (Friends Research Institute, Inc)

  • Joshua Rusow

    (Friends Research Institute, Inc)

  • Michael Hudgens

Abstract

The TechStep study is an ongoing randomized controlled trial in HIV-negative transgender youths and young adults, which will evaluate the efficacy of mobile health interventions for reducing risk behaviors. Several mobile interventions are available, which complicates the design. To evaluate different combinations of mHealth interventions, TechStep is utilizing a sequentially randomized design. In this work, we discuss the motivation for this design, propose robust methodology for the analysis of the trial, and evaluate the methodology via simulation.

Suggested Citation

  • David Benkeser & Keith Horvath & Cathy J. Reback & Joshua Rusow & Michael Hudgens, 2020. "Design and Analysis Considerations for a Sequentially Randomized HIV Prevention Trial," Statistics in Biosciences, Springer;International Chinese Statistical Association, vol. 12(3), pages 446-467, December.
    • Handle: RePEc:spr:stabio:v:12:y:2020:i:3:d:10.1007_s12561-020-09274-3
    DOI: 10.1007/s12561-020-09274-3
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1007/s12561-020-09274-3
    File Function: Abstract
    Download Restriction: Access to the full text of the articles in this series is restricted.
    File URL: https://libkey.io/10.1007/s12561-020-09274-3?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. P. W. Lavori & R. Dawson, 2000. "A design for testing clinical strategies: biased adaptive within‐subject randomization," Journal of the Royal Statistical Society Series A, Royal Statistical Society, vol. 163(1), pages 29-38.
    2. Murphy, S. A. & Bingham, D., 2009. "Screening Experiments for Developing Dynamic Treatment Regimes," Journal of the American Statistical Association, American Statistical Association, vol. 104(485), pages 391-408.
    3. repec:aph:ajpbhl:10.2105/ajph.2016.303571_2 is not listed on IDEAS
    4. repec:aph:ajpbhl:10.2105/ajph.2016.303578_7 is not listed on IDEAS
    5. van der Laan Mark J. & Rubin Daniel, 2006. "Targeted Maximum Likelihood Learning," The International Journal of Biostatistics, De Gruyter, vol. 2(1), pages 1-40, December.
    6. Meerwijk, E.L. & Sevelius, J.M., 2017. "Transgender population size in the United States: A meta-regression of population-based probability samples," American Journal of Public Health, American Public Health Association, vol. 107(2), pages 1-8.
    7. Heejung Bang & James M. Robins, 2005. "Doubly Robust Estimation in Missing Data and Causal Inference Models," Biometrics, The International Biometric Society, vol. 61(4), pages 962-973, December.
    8. van der Laan Mark J. & Gruber Susan, 2012. "Targeted Minimum Loss Based Estimation of Causal Effects of Multiple Time Point Interventions," The International Journal of Biostatistics, De Gruyter, vol. 8(1), pages 1-41, May.
    9. Gruber Susan & van der Laan Mark J., 2012. "Targeted Minimum Loss Based Estimation of a Causal Effect on an Outcome with Known Conditional Bounds," The International Journal of Biostatistics, De Gruyter, vol. 8(1), pages 1-18, July.
    10. Crissman, H.P. & Berger, M.B. & Graham, L.F. & Dalton, V.K., 2017. "Transgender demographics: A household probability sample of US adults, 2014," American Journal of Public Health, American Public Health Association, vol. 107(2), pages 213-215.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Ying Qing Chen, 2020. "Introduction to Special Issue on ‘Statistical Methods for HIV/AIDS Research’," Statistics in Biosciences, Springer;International Chinese Statistical Association, vol. 12(3), pages 263-266, December.
    2. Lan Wen & Miguel A. Hernán & James M. Robins, 2022. "Multiply robust estimators of causal effects for survival outcomes," Scandinavian Journal of Statistics, Danish Society for Theoretical Statistics;Finnish Statistical Society;Norwegian Statistical Association;Swedish Statistical Association, vol. 49(3), pages 1304-1328, September.
    3. Lina M. Montoya & Michael R. Kosorok & Elvin H. Geng & Joshua Schwab & Thomas A. Odeny & Maya L. Petersen, 2023. "Efficient and robust approaches for analysis of sequential multiple assignment randomized trials: Illustration using the ADAPT‐R trial," Biometrics, The International Biometric Society, vol. 79(3), pages 2577-2591, September.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Susan Gruber & Mark J. van der Laan, 2013. "An Application of Targeted Maximum Likelihood Estimation to the Meta-Analysis of Safety Data," Biometrics, The International Biometric Society, vol. 69(1), pages 254-262, March.
    2. Lina M. Montoya & Michael R. Kosorok & Elvin H. Geng & Joshua Schwab & Thomas A. Odeny & Maya L. Petersen, 2023. "Efficient and robust approaches for analysis of sequential multiple assignment randomized trials: Illustration using the ADAPT‐R trial," Biometrics, The International Biometric Society, vol. 79(3), pages 2577-2591, September.
    3. Kara E. Rudolph & Jonathan Levy & Mark J. van der Laan, 2021. "Transporting stochastic direct and indirect effects to new populations," Biometrics, The International Biometric Society, vol. 77(1), pages 197-211, March.
    4. Mireille E. Schnitzer & Erica E.M. Moodie & Mark J. van der Laan & Robert W. Platt & Marina B. Klein, 2014. "Modeling the impact of hepatitis C viral clearance on end-stage liver disease in an HIV co-infected cohort with targeted maximum likelihood estimation," Biometrics, The International Biometric Society, vol. 70(1), pages 144-152, March.
    5. Hugo Bodory & Martin Huber & Lukáš Lafférs, 2022. "Evaluating (weighted) dynamic treatment effects by double machine learning [Identification of causal effects using instrumental variables]," The Econometrics Journal, Royal Economic Society, vol. 25(3), pages 628-648.
    6. Philipp Baumann & Enzo Rossi & Michael Schomaker, 2022. "Estimating the effect of central bank independence on inflation using longitudinal targeted maximum likelihood estimation," IFC Bulletins chapters, in: Bank for International Settlements (ed.), Machine learning in central banking, volume 57, Bank for International Settlements.
    7. Audrey Renson & Michael G. Hudgens & Alexander P. Keil & Paul N. Zivich & Allison E. Aiello, 2023. "Identifying and estimating effects of sustained interventions under parallel trends assumptions," Biometrics, The International Biometric Society, vol. 79(4), pages 2998-3009, December.
    8. Matthew Blackwell & Anton Strezhnev, 2022. "Telescope matching for reducing model dependence in the estimation of the effects of time‐varying treatments: An application to negative advertising," Journal of the Royal Statistical Society Series A, Royal Statistical Society, vol. 185(1), pages 377-399, January.
    9. Paul Frédéric Blanche & Anders Holt & Thomas Scheike, 2023. "On logistic regression with right censored data, with or without competing risks, and its use for estimating treatment effects," Lifetime Data Analysis: An International Journal Devoted to Statistical Methods and Applications for Time-to-Event Data, Springer, vol. 29(2), pages 441-482, April.
    10. Yiyi Huo & Yingying Fan & Fang Han, 2023. "On the adaptation of causal forests to manifold data," Papers 2311.16486, arXiv.org, revised Dec 2023.
    11. Antonelli Joseph & Cefalu Matthew, 2020. "Averaging causal estimators in high dimensions," Journal of Causal Inference, De Gruyter, vol. 8(1), pages 92-107, January.
    12. Iván Díaz & Elizabeth Colantuoni & Daniel F. Hanley & Michael Rosenblum, 2019. "Improved precision in the analysis of randomized trials with survival outcomes, without assuming proportional hazards," Lifetime Data Analysis: An International Journal Devoted to Statistical Methods and Applications for Time-to-Event Data, Springer, vol. 25(3), pages 439-468, July.
    13. Frölich, Markus & Huber, Martin & Wiesenfarth, Manuel, 2017. "The finite sample performance of semi- and non-parametric estimators for treatment effects and policy evaluation," Computational Statistics & Data Analysis, Elsevier, vol. 115(C), pages 91-102.
    14. Zhiwei Zhang & Zhen Chen & James F. Troendle & Jun Zhang, 2012. "Causal Inference on Quantiles with an Obstetric Application," Biometrics, The International Biometric Society, vol. 68(3), pages 697-706, September.
    15. Cousineau, Martin & Verter, Vedat & Murphy, Susan A. & Pineau, Joelle, 2023. "Estimating causal effects with optimization-based methods: A review and empirical comparison," European Journal of Operational Research, Elsevier, vol. 304(2), pages 367-380.
    16. Torben Martinussen & Mats Julius Stensrud, 2023. "Estimation of separable direct and indirect effects in continuous time," Biometrics, The International Biometric Society, vol. 79(1), pages 127-139, March.
    17. David Cheng & Ashwin N. Ananthakrishnan & Tianxi Cai, 2021. "Robust and efficient semi‐supervised estimation of average treatment effects with application to electronic health records data," Biometrics, The International Biometric Society, vol. 77(2), pages 413-423, June.
    18. Stephens Alisa & Tchetgen Tchetgen Eric & De Gruttola Victor, 2014. "Locally Efficient Estimation of Marginal Treatment Effects When Outcomes Are Correlated: Is the Prize Worth the Chase?," The International Journal of Biostatistics, De Gruyter, vol. 10(1), pages 1-17, May.
    19. van der Laan Mark J., 2010. "Targeted Maximum Likelihood Based Causal Inference: Part I," The International Journal of Biostatistics, De Gruyter, vol. 6(2), pages 1-45, February.
    20. Rahul Singh & Liyuan Xu & Arthur Gretton, 2021. "Sequential Kernel Embedding for Mediated and Time-Varying Dose Response Curves," Papers 2111.03950, arXiv.org, revised Jul 2023.

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:stabio:v:12:y:2020:i:3:d:10.1007_s12561-020-09274-3. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.