Last reviewed · How we verify
NCT03693040
Digital Health Feedback System (DHFS) for Longitudinal Monitoring of ARVs Used in HIV Pre-exposure Prophylaxis (PrEP)
NA trial testing Digital Health Feedback System in HIV Prevention in 100 participants. Status unknown.
31 December 2021
Quick facts
| Lead sponsor | University of California, San Diego |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 100 |
| Start date | 1 December 2016 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2022 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Digital Health Feedback System
Conditions studied
- HIV Prevention — all drugs for HIV Prevention →
Sponsor
University of California, San Diego
Who can join
18 and older, any sex, with HIV Prevention. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect information about patients taking their Pre-Exposure Prophylaxis (PrEP) medication for HIV prevention. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which gives healthcare providers information about when patients have taken their PrEP medication. The purpose of the study is to demonstrate that the DHFS is easy to use and acceptable to people taking PrEP; that patients will persist with its use; and that the system provides valid, accurate measures of adherence.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Digital Pills with Ingestible Sensors: Patent Landscape Analysis.
Litvinova O, Klager E, Tzvetkov NT, Kimberger O, et al · · 2022 · cited 13× · PMID 36015173 · DOI 10.3390/ph15081025 -
Ingestible Electronic Sensors for Monitoring Real-time Adherence to HIV Pre-exposure Prophylaxis and Antiretroviral Therapy.
Goodman GR, Vaz C, Albrechta H, Boyer EW, et al · · 2022 · cited 7× · PMID 36048309 · DOI 10.1007/s11904-022-00625-x -
Supporting the Art: Medication Adherence Patterns in Persons Prescribed Ingestible Sensor-enabled Oral Pre-Exposure Prophylaxis to Prevent Human Immunodeficiency Virus Infection.
Browne SH, Vaida F, Umlauf A, Tucker AJ, et al · · 2023 · cited 6× · PMID 36484300 · DOI 10.1093/cid/ciac280 -
Bibliometric analysis and evidence of clinical efficacy and safety of digital pills.
Litvinova O, Klager E, Yeung AWK, Tzvetkov NT, et al · · 2023 · cited 3× · PMID 36755951 · DOI 10.3389/fphar.2023.1023250 -
User Experience of Persons Using Ingestible Sensor-Enabled Pre-Exposure Prophylaxis to Prevent HIV Infection: Cross-Sectional Survey Study.
Browne S, Umlauf A, Moore DJ, Benson CA, et al · · 2024 · PMID 38722201 · DOI 10.2196/53596
Verify or expand the search:
- PubMed search for NCT03693040
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Digital Health Feedback System
Trials testing the same drug.
- NCT01960257 — Wirelessly Observed Therapy in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis · Phase 4 · completed
Other recruiting trials for HIV Prevention
Currently open trials in the same condition.
- NCT07194902 — HIV Self-testing for Partners of HIV-uninfected Postpartum Women · NA · recruiting
- NCT07218211 — Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP · Phase 4 · recruiting
- NCT07349758 — Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers · Phase 1 · recruiting
- NCT07433985 — California MEPS Hub · NA · recruiting
- NCT07002866 — Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda · NA · recruiting
Other University of California, San Diego trials
Trials by the same sponsor.
- NCT07342543 — Guided Physical Activity Counseling for Hypertension in Primary Care · NA · not yet recruiting
- NCT06505317 — Artificial Intelligence for Early Detection of Peripheral Artery Disease · NA · not yet recruiting
- NCT07211802 — CKM For Safe Use of SGLT2i in Type 1 Diabetes · Phase 3 · not yet recruiting
- NCT07524751 — Culturally Adapted Pain Management for Indigenous Peoples · NA · not yet recruiting
- NCT07518784 — Accurate Point of Care Liver Disease Diagnostics (Phase 2) · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03693040 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Diego
- Last refreshed: 23 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03693040.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing