Project AWARE 2.0 to Improve Awareness, Willingness and A... | NCT06343220

Studies
Project AWARE 2.0 to Improve Awareness, Willingness and Ability for Research and Enrollment in Clinical Research

NCT06343220

Sponsor

Huntington Study Group

Status

Completed

Last Update Posted

Dec 23, 2025Actual

Enrollment

131Actual

Phase

Not provided

Conditions

Huntington Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 10, 2024Actual

Primary Completion Date

Dec 22, 2025Actual

Completion Date

Dec 22, 2025Actual

First Submitted Date

Mar 26, 2024

First Submission Date that Met QC Criteria

Mar 26, 2024

First Posted Date

Apr 2, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2025

Last Update Posted Date

Dec 23, 2025Actual

Name	Class
Roche Products Limited	UNKNOWN
Neurotargeting LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

The Project AWARE 2.0 Survey will be offered to HD families via HSG's online platform called myHDstory®. The survey will obtain input and knowledge about their feelings, attitudes, and beliefs concerning clinical research and the process by which HD studies are communicated and conducted. Project AWARE 2.0 is intended to provide the HD research community with the insight and tools to help (a) improve prospective research participants' awareness, willingness, and ability to participate in clinical research for HD; and (b) design clinical studies and trials in the future.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

131Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Examine awareness	To examine prospective research participants' awareness, willingness, and ability to participate in clinical research for HD.	December 2024
Provide the HD research community with the insight.	Provide the HD research community with insight to design clinical studies and trials in the future.	December 2024

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must either have HD or be at risk for having HD
Participants must be 18 years of age or older
Participants must live in the United States
Inclusion of participants will not be based on race, gender, or ethnicity.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Must either have HD or be at risk for having HD.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amy Brown, MD, MS	HSG	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huntington Study Group		Rochester	New York	14618	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The Project AWARE 2.0 Survey is intended to gain knowledge about the feelings, attitudes, and beliefs of HD family members, care partners and others affected by HD towards the way drug trials and observational studies are communicated and conducted. Answers to these questions will provide valuable information to the HD research community when designing and conducting drug trials and observational studies.

Types

Not provided

Time Frame

2024

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006816	Huntington Disease
C563757	Charcot-Marie-Tooth Disease, Axonal, Type 2A2

Ancestor Terms

ID	Term
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided