HIV Testing in Community Health Center Dental Clinics

NCT ID: NCT07089849

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

6715 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-09-30

Study Completion Date

2028-03-31

Brief Summary

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This is a cluster randomized trial among dental clinics (n=4) to evaluate whether rapid HIV testing (RHT) during dental visits improves HIV testing rates compared to referral for laboratory HIV testing. Clinics will be randomized to either RHT or referral for HIV testing for a nine-month period - HIV testing will be offered to n\~6700 patients by \~ 15 dental providers (dentists and dental hygienists). Outcomes will be assessed using electronic health record reports (EHR), which will include the completion rates of HIV testing among dental patients (84 days after dental visit) and the frequency at which dental providers offer HIV testing (Upon completion of the 9-month testing period).

The objectives of this study are to:

* Compare the effectiveness of on-site rapid HIV testing versus referral to a CHC lab in increasing HIV test completion within 84 days of a dental clinic visit, using EHR data.
* Assess the sustainability of the HIV testing protocol by evaluating changes in dental clinic HIV testing rates over time.

Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a cluster randomized trial among dental clinics (n=4)
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Rapid HIV Testing

Dental clinics randomized into this arm will offer Rapid HIV Testing at the patient's dental visit.

Group Type EXPERIMENTAL

Rapid HIV testing

Intervention Type OTHER

At the designated sites for RHT, providers will offer RHT to patients as part of their dental routine care.

Referral HIV Testing

Dental clinics randomized into this arm will offer a referral for HIV Testing during the patient's dental visit.

Group Type ACTIVE_COMPARATOR

Referral for HIV testing

Intervention Type OTHER

At the designated sites for HIV testing referral, providers will offer an HIV test referral to the affiliated CHC laboratory to patients as part of their dental routine care.

Interventions

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Rapid HIV testing

At the designated sites for RHT, providers will offer RHT to patients as part of their dental routine care.

Intervention Type OTHER

Referral for HIV testing

At the designated sites for HIV testing referral, providers will offer an HIV test referral to the affiliated CHC laboratory to patients as part of their dental routine care.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Community health center:

* Must be located in Suffolk County in Massachusetts.
* Must provide dental care services.
* Must possess the infrastructure necessary for laboratory-based HIV testing and counseling or have an affiliation with a laboratory that provides these service.

Provider:

* Dental care provider working at a participating community health center during the study period.

Patient:

* Be 18 years of age or older.
* Receive dental care at a participating community health center during the study period.

Exclusion Criteria

Patient:

* Self-report to be HIV positive at the time of the RHT/ referral.
* Had an HIV test within 12 months (self-report or documented in EHR).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Henshaw, DDS MPH

Role: PRINCIPAL_INVESTIGATOR

Boston University Goldman School of Dental Medicine

Curt Beckwith, MD FACP FIDSA

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital/Rhode Island Hospital

Locations

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South End Community Health Center

Boston, Massachusetts, United States

Site Status

Uphams Corner Health Center

Boston, Massachusetts, United States

Site Status

East Boston Neighborhood Health

Boston, Massachusetts, United States

Site Status

Geiger Gibson Community Health Center

Dorchester, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Michelle Henshaw, DDS MPH

Role: CONTACT

(617) 358-6111

Gabriel Federo Hungria, MD MSCR

Role: CONTACT

(617) 358-6490

Other Identifiers

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5UH3DE031249-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-43301

Identifier Type: -

Identifier Source: org_study_id

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