NCT07217730

Brief Summary

The PHX-AFK-US Protocol is a coalition-backed regulatory scaffold designed to restore healthcare integrity across U.S. facilities. It targets fraud, kickback schemes, and supply chain opacity through validator governance, smart contract enforcement, and public transparency. Anchored by notarized affidavits, NFT fiscal instruments, and dashboard oversight, this protocol empowers whistleblowers, mobilizes validators, and escalates complaints to federal and state regulators. It integrates secure audit trails, DAO voting logic, and asset freeze triggers to ensure accountability, reform, and systemic trust.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
103mo left

Started Oct 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Oct 2025Oct 2034

First Submitted

Initial submission to the registry

October 13, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

October 13, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2025

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2034

Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

9 years

First QC Date

October 13, 2025

Last Update Submit

October 15, 2025

Conditions

Keywords

Healthcare IntegrityAnti-FraudKickback PreventionSecure Supply ChainValidator GovernanceCoalition OversightNFT Fiscal InstrumentsSmart Contract EnforcementDAO VotingSHA-256 NotarizationWhistleblower AffidavitsRegulatory EscalationPublic TransparencyAudit TrailAsset Freeze LogicCMS / DOJ / OIG ComplaintsProcurement ReformPhantom BillingReferral SchemesMedical Device ProvenanceCoalition DashboardPublic Health ExchangeSOP ViolationsFacility SanctionsDeFi Escrow Logic

Outcome Measures

Primary Outcomes (1)

  • Change in Fraudulent Billing and Kickback Incidents Across Enrolled Facilities

    Description: This outcome measures the change in frequency and severity of fraudulent billing practices-including upcoding, phantom billing, and referral-based kickback schemes-across facilities enrolled in the SHA-256 Trial Protocols. Facilities are assessed using the Unified Impact Index derived from: Historical billing anomalies Validator audit results Whistleblower declarations SHA-256 hash-anchored incident reports Facilities are ranked and monitored for reform compliance, ethical standards, and onboarding validation. All scoring logic is notarized and displayed via coalition dashboards. Time Frame: Baseline to 12 Months Post-Validator Onboarding.

    Baseline to 12 Months Post-Validator Onboarding

Secondary Outcomes (1)

  • Change in Supply-Chain Traceability and Compliance Across Enrolled Facilities

    Baseline to 12 Months Post-Validator Onboarding

Study Arms (1)

Flagged Healthcare Facilities - Validator Oversight Cohort

This cohort consists of U.S. healthcare facilities identified through validator affidavits, whistleblower declarations, and coalition intelligence as exhibiting patterns of fraud, kickback schemes, or supply chain vulnerabilities. Facilities are enrolled into the PHX-AFK-US Protocol for prospective observation, reform enforcement, and regulatory escalation. Each facility is subject to smart contract triggers, DAO voting logic, and public dashboard transparency. No biospecimens are retained; all data is notarized via SHA-256 hash anchors and integrated into NFT fiscal declarations and validator ballot modules.

Other: Validator-Governed Reform & Regulatory Escalation ProtocolDevice: Coalition-Grade Validator Dashboard Module (CVDM-1)Drug: Coalition-Flagged Pharmaceutical Audit Trigger (CFPAT-1)

Interventions

This intervention deploys a validator-governed framework to monitor, escalate, and reform healthcare facilities exhibiting fraud, kickback schemes, and supply chain vulnerabilities. It integrates notarized affidavits, smart contract enforcement, NFT fiscal declarations, and DAO voting logic to trigger sanctions, regulatory complaints, and operational restructuring. Facilities are observed prospectively, with all actions logged to a public dashboard and anchored via SHA-256 hash notarization. No biospecimens are retained; all data is legal, technical, and governance-based.

Also known as: PHX-AFK-US Protocol
Flagged Healthcare Facilities - Validator Oversight Cohort

The Coalition-Grade Validator Dashboard Module (CVDM-1) is a secure, web-based device deployed across enrolled healthcare facilities to enable real-time validator oversight, whistleblower affidavit intake, and smart contract enforcement. It integrates QR-linked audit trails, NFT fiscal declarations, and DAO voting logic. The device anchors all inputs via SHA-256 hash notarization and transmits reform metrics to coalition dashboards. CVDM-1 supports public transparency, regulatory escalation, and validator governance across the PHX-AFK-US Protocol. It does not collect biospecimens and operates solely within legal, technical, and governance domains.

Also known as: PHX-AFK-US Governance Terminal
Flagged Healthcare Facilities - Validator Oversight Cohort

The Coalition-Flagged Pharmaceutical Audit Trigger (CFPAT-1) is a governance-based drug intervention targeting facilities with suspected fraud, kickback schemes, or supply chain irregularities involving pharmaceuticals. While not a therapeutic agent, CFPAT-1 functions as a regulatory scaffold that flags drug procurement, formulary manipulation, and referral-linked prescribing patterns. It integrates validator ballots, smart contract logic, and SHA-256 hash anchors to escalate complaints to CMS, DOJ, and state boards. All flagged drugs are traced via QR-linked audit trails and NFT fiscal declarations. No biospecimens are retained; the intervention operates within legal, technical, and governance domains.

Also known as: CFPAT-1
Flagged Healthcare Facilities - Validator Oversight Cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of U.S. healthcare facilities identified through coalition-backed validator affidavits and whistleblower declarations. These facilities exhibit patterns of fraud, kickback schemes, and supply chain vulnerabilities. The population is monitored prospectively via smart contract triggers, DAO voting, and public dashboard metrics.

You may qualify if:

  • Facility has documented billing, compliance, or procurement irregularities.
  • Facility participates in coalition validator onboarding and SHA-256 protocol enrollment.
  • Facility provides access to billing, procurement, and whistleblower-anchored datasets for auditing.

You may not qualify if:

  • Facility refuses validator onboarding or coalition integration.
  • Facility lacks traceable procurement or compliance records.
  • Facility has no whistleblower declaration or validation artifact.
  • Facility operates outside U.S. jurisdiction or coalition-recognized governance zones.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Truway Health, Inc. , View 34, 401 E 34th Street, S11P, New York, NY 10016

New York, New York, 10016, United States

Location

Study Officials

  • Gavin C Solomon, President & CEO

    Truway Health, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2025

First Posted

October 16, 2025

Study Start

October 13, 2025

Primary Completion (Estimated)

October 13, 2034

Study Completion (Estimated)

October 13, 2034

Last Updated

October 20, 2025

Record last verified: 2025-10

Locations