HIVTEETHNCT07089849
HIV Testing in Community Health Center Dental Clinics
A study testing Rapid HIV testing and Referral for HIV testing in people with HIV, run by Boston University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Rapid HIV testing and Referral for HIV testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,715 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2027to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- Patient:
- Be 18 years of age or older.
- Receive dental care at a participating community health center during the study period.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
South End Community Health Center
Boston, Massachusetts, 02118
Uphams Corner Health Center
Boston, Massachusetts, 02125
East Boston Neighborhood Health
Boston, Massachusetts, 02128
Geiger Gibson Community Health Center
Dorchester, Massachusetts, 02125
About this study
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
- Being tested
- Rapid HIV testing, Referral for HIV testing
- Keywords
- Rapid HIV test, Referral for HIV test, Community Health Center Dental Clinics, Behavioral Model for Vulnerable Populations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid HIV testingOther
At the designated sites for RHT, providers will offer RHT to patients as part of their dental routine care.
Referral for HIV testingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Rapid HIV Testing | Experimental | Dental clinics randomized into this arm will offer Rapid HIV Testing at the patient's dental visit. Receives: 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. Receives: Other: Referral for HIV testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study startJan 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster randomized trial among dental clinics (n=4)
- Masking
- None (open label)
- Enrolment
- 6,715 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Michelle Henshaw, DDS MPH, Principal investigator, Boston University Goldman School of Dental MedicineCurt Beckwith, MD FACP FIDSA, Principal investigator, The Miriam Hospital/Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089849
- Sponsor's protocol ID
- H-43301
- Other IDs
- 5UH3DE031249-04
- Acronym
- TEETH
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Testing in Community Health Center Dental Clinics
- ClinicalTrials.gov ID
- NCT07089849
- Acronym / sponsor ID
- TEETH / H-43301
- Conditions
- HIV
- Keywords
- Rapid HIV test, Referral for HIV test, Community Health Center Dental Clinics, Behavioral Model for Vulnerable Populations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,715 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a cluster randomized trial among dental clinics (n=4)
| Arm | Type | Receives |
|---|---|---|
| Rapid HIV Testing | Experimental | Other: Rapid HIV testingDental clinics randomized into this arm will offer Rapid HIV Testing at the patient's dental visit. |
| Referral HIV Testing | Active comparator | Other: Referral for HIV testingDental clinics randomized into this arm will offer a referral for HIV Testing during the patient's dental visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Dental care provider working at a participating community health center during the study period.
- Be 18 years of age or older.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid HIV testingAt the designated sites for RHT, providers will offer RHT to patients as part of their dental routine care. | Other | Rapid HIV Testing |
| Referral for HIV testingAt 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. | Other | Referral HIV Testing |
Primary outcome
HIV Test Completed
Time frame: 84 days
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).
Sustainability
Time frame: 9 months
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid HIV testing and Referral for HIV testing in people with HIV, run by Boston University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Henshaw, DDS MPH ((617) 358-6111, mhenshaw@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Test Completed (time frame: 84 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.