NCT07317687

Brief Summary

West Virginia faces rising rates of HIV, hepatitis, and syphilis, particularly among individuals experiencing homelessness, substance use, and mental health challenges. Traditional blood-draw testing for these infections is often hindered by mistrust, logistical barriers, and delays in results. This study, conducted by the West Virginia University (WVU) Street Medicine program, evaluates a rapid, point-of-care fingerstick test for HIV, Hepatitis C, and syphilis that provides results within 10-20 minutes during mobile clinic visits. Participants may choose rapid testing, traditional blood draw (which also includes Hepatitis B screening), or decline testing. All participants will be invited to complete a brief survey about the experiences with screening methods. The goal is to assess whether rapid testing improves screening uptake, linkage to care, and patient satisfaction, ultimately reducing barriers and disease burden in high-risk populations.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Jan 2028

First Submitted

Initial submission to the registry

December 19, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 20, 2026

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

December 19, 2025

Last Update Submit

January 15, 2026

Conditions

Keywords

Street MedicineRapid Fingerstick Testing

Outcome Measures

Primary Outcomes (3)

  • Percentage of Finger Stick

    Percentage of participants that opted to take the rapid finger stick test.

    Day 1

  • Percentage of Blood Draw

    Percentage of participants that opted to take the blood draw test.

    Day 1

  • Percentage that decline screening

    Percentage of participants that opted to decline screening

    Day 1

Study Arms (3)

Participants receiving fingerstick test

* Will get a quick fingerstick test for HIV, Hepatitis C, and syphilis. * Will receive results in 10-20 minutes. * If positive, will be offered immediate care and/or a referral. * If positive, blood draw will be offered on site to confirm results or referred to a WVU Medicine clinic location for follow-up blood test. * Will be invited to answer survey questions about the feelings and experiences with screening (about 15-30 minutes).

Diagnostic Test: Rapid Fingerstick Test

Participants receiving blood-draw test

Participants receiving blood-draw test: * Will get a blood draw to test for HIV, Hepatitis B \& C, and syphilis * Will receive results in approximately 3 days (via MyChart message and phone call, or in person at site) * If positive, will be offered immediate care and/or a referral for follow-up care. • Will be invited to answer questions about the feelings and experiences with screening (about 15 minutes).

Diagnostic Test: Blood Draw for lab test

Participants who decline screening

Participants who decline screening: • Will be invited to answer survey questions about the feelings and experiences with screening (about 15-30 minutes).

Interventions

Rapid Fingerstick TestDIAGNOSTIC_TEST

Fingerstick test for HIV, Hepatitis B and C, and Syphilis that gives results within 10-20 minutes

Participants receiving fingerstick test

Blood draw to test for HIV, Hepatitis B \& C, and syphilis which can take up to 3 days for results

Participants receiving blood-draw test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will include patients in Berkeley and Jefferson Counties of West Virginia who visit the WVU Medicine Street Medicine Clinic.

You may qualify if:

  • Patients of the WVU Medicine Street Medicine team

You may not qualify if:

  • Patients under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WVU Department of Family Medicine - Eastern Division

Harpers Ferry, West Virginia, 25425, United States

Location

MeSH Terms

Conditions

Hepatitis CSyphilisHepatitis B

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesTreponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesGenital DiseasesUrogenital DiseasesHepadnaviridae InfectionsDNA Virus Infections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Madison Humerick, MD

    West Virginia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Madison Humerick, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Family Medicine - Eastern

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 5, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

January 20, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations