HIV Testing in Community Health Center Dental Clinics

NCT07089849 | Not Yet Recruiting

• 2 other identifiers: H-433015UH3DE031249-04
• Study Type: interventional
• Target: 6,715
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

HIV

Keywords

Rapid HIV test; Referral for HIV test; Community Health Center Dental Clinics; Behavioral Model for Vulnerable Populations

Outcome Measures

Primary Outcomes (2)

• HIV Test Completed

  The number of dental patients completing at least one HIV test within 84 days of their dental visit abstracted from the Electronic Health Records (EHR).

  84 days

• Sustainability

  The number of dental patients completing at least one HIV test within 9 months of their dental visit abstracted from the Electronic Health Records (EHR).

  9 months

Study Arms (2)

Rapid HIV Testing

EXPERIMENTAL

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

Other: Rapid HIV testing

Referral HIV Testing

ACTIVE COMPARATOR

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

Other: Referral for HIV testing

Interventions

Rapid HIV testing OTHER

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

Rapid HIV Testing

Referral for HIV testing 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.

Referral HIV Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boston University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (4)

South End Community Health Center

Boston, Massachusetts, 02118, United States

Location

Uphams Corner Health Center

Boston, Massachusetts, 02125, United States

Location

East Boston Neighborhood Health

Boston, Massachusetts, 02128, United States

Location

Geiger Gibson Community Health Center

Dorchester, Massachusetts, 02125, United States

Location

MeSH Terms

Interventions

Referral and Consultation; HIV Testing

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration; Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Michelle Henshaw, DDS MPH

  Boston University Goldman School of Dental Medicine

  PRINCIPAL INVESTIGATOR

• Curt Beckwith, MD FACP FIDSA

  The Miriam Hospital/Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Henshaw, DDS MPH

CONTACT

(617) 358-6111; mhenshaw@bu.edu

Gabriel Federo Hungria, MD MSCR

CONTACT

(617) 358-6490; gfedero@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a cluster randomized trial among dental clinics (n=4)

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 28, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)