deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03512418

Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps) (PrEPSteps)

Sponsor: Brigham and Women's Hospital

Conditions HIV Infections Substance Use Disorders
Interventions Digital pill PrEPsteps Truvada
Updated 21 times since 2018 Last updated: Sep 13, 2025 Started: Jun 20, 2019 Primary completion: Apr 10, 2024 Completion: Apr 10, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates HIV Infections and Substance Use Disorders and is currently completed. Brigham and Women's Hospital leads this study, which shows 21 recorded versions since 2019 — indicating substantial longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Mar 2019 · 5 months · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~Aug 2019 · 4 months · monthly snapshot~Aug 2019 – ~Feb 2020 · 6 months · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~May 2020 · 2 months · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Apr 2022 · 7 months · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jan 2023 · 7 months · monthly snapshot~Jan 2023 – ~Dec 2023 · 11 months · monthly snapshot~Dec 2023 – ~Apr 2024 · 4 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2025 · 13 months · monthly snapshot~Oct 2025 – present · 9 months · monthly snapshot

Change History

21 versions recorded

  1. Oct 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Oct 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  4. Apr 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  5. Dec 2023 — Apr 2024 [monthly]

    Recruiting PHASE3

▶ Show 16 earlier versions

  1. Jan 2023 — Dec 2023 [monthly]

    Recruiting PHASE3

  2. Jun 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

  3. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

  4. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE3

  5. Sep 2021 — Apr 2022 [monthly]

    Recruiting PHASE3

  6. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  7. Jan 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  8. May 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  9. Mar 2020 — May 2020 [monthly]

    Recruiting PHASE3

  10. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE3

  11. Aug 2019 — Feb 2020 [monthly]

    Recruiting PHASE3

  12. Apr 2019 — Aug 2019 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  13. Mar 2019 — Apr 2019 [monthly]

    Not Yet Recruiting PHASE3

  14. Oct 2018 — Mar 2019 [monthly]

    Not Yet Recruiting PHASE3

  15. Jun 2018 — Oct 2018 [monthly]

    Not Yet Recruiting PHASE3

  16. May 2018 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Brigham and Women's Hospital
  • Gilead Sciences
  • National Institute on Drug Abuse (NIDA)
  • The Fenway Institute
Data source: Brigham and Women's Hospital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations