- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06943599
Strategies for Improving Linkage-to-Care After Eye Disease Screening
April 27, 2026 updated by: University of California, San Francisco
Village Integrated Eye Worker II Linkage-to-Care Trial
The goal of this randomized, parallel-group, controlled trial is to compare methods of improving linkage-to-care for participants in the Village Integrated Eye Worker II (VIEW II) trial who are referred to the eye hospital following eye disease screening.
Participants who are referred to the hospital at an eye screening visit will be randomized to three different linkage-to-care interventions: (1) text message reminders, (2) reminders from health workers, or (3) no intervention.
The primary outcome of the trial will be whether or not the participant presented to the eye hospital for a referral visit by 21 days following screening.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
3000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Krisianne Aromin
- Email: krisianne.aromin@ucsf.edu
Study Contact Backup
- Name: Jeremy Keenan, MD, MPH
- Phone Number: (415) 476-1442
- Email: jeremy.keenan@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94158
- Recruiting
- University of California, San Francisco
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participant of the VIEW II study referred to the eye hospital at their eye screening visit.
Exclusion Criteria:
- Residence in an area without reliable mobile connectivity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No Intervention
|
|
|
Experimental: Text Message Reminders
|
Participants referred to the eye hospital after screening will receive a text message reminding them to attend their referral visit.
|
|
Experimental: Health Worker
|
Participants referred to the eye hospital after screening will receive a home visit from a health worker reminding them to attend their referral visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Referral Visit Attendance
Time Frame: 21 days after screening
|
The count of participants who attend the referral visit.
|
21 days after screening
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeremy Keenan, MD, MPH, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2026
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Study Registration Dates
First Submitted
April 11, 2025
First Submitted That Met QC Criteria
April 17, 2025
First Posted (Actual)
April 24, 2025
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Diabetes Mellitus
- Diabetic Angiopathies
- Diabetes Complications
- Retinal Diseases
- Retinal Degeneration
- Ocular Hypertension
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Patient Acceptance of Health Care
- Diabetic Retinopathy
- Eye Diseases
- Macular Degeneration
- Glaucoma
- Patient Compliance
Other Study ID Numbers
- 17-22776-3
- UG1EY036346 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified data including age, cluster identifier, referral visit attendance
IPD Sharing Time Frame
De-identified data will be shared after publication of the major findings of the study, which we anticipate will occur around 6 months after the study conclusion.
IPD Sharing Access Criteria
Other investigators can access the data if approved by the Trial Coordinating Center.
Requests should be sent to the study contact(s).
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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