CClinicalTrials.gg
Not yet recruitingNCT07089849TEETHUpdated Sep 30, 2026

HIV Testing in Community Health Center Dental Clinics

An interventional study of Rapid HIV testing and Referral for HIV testing in HIV, sponsored by Boston University. Not yet recruiting at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Boston University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
6,715
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • HIV

Keywords

  • Rapid HIV test
  • Referral for HIV test
  • Community Health Center Dental Clinics
  • Behavioral Model for Vulnerable Populations
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6,715 participants (estimated)

Study arms

  • Experimental
    Rapid HIV Testing

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

    Other: Rapid HIV testing

  • Active comparator
    Referral HIV Testing

    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

  • OtherRapid HIV testing

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

  • OtherReferral 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.

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 84 days

  2. 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).

    Time frame: 9 months

06

Study locations

4 sites
  • South End Community Health Center
    Boston, Massachusetts 02118, United States
  • Uphams Corner Health Center
    Boston, Massachusetts 02125, United States
  • East Boston Neighborhood Health
    Boston, Massachusetts 02128, United States
  • Geiger Gibson Community Health Center
    Dorchester, Massachusetts 02125, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07089849
Lead sponsor
Boston University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Responsible party
Sponsor
First posted
Jul 28, 2025
Start date
Jan 2027 (estimated)
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Sep 30, 2026

Study contacts

Michelle Henshaw, DDS MPH
Contact
mhenshaw@bu.edu
(617) 358-6111
Gabriel Federo Hungria, MD MSCR
Contact
gfedero@bu.edu
(617) 358-6490
Michelle Henshaw, DDS MPH
principal investigator · Boston University Goldman School of Dental Medicine
Curt Beckwith, MD FACP FIDSA
principal investigator · The Miriam Hospital/Rhode Island Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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