Rapid HIV Testing for Increased Detection

(TEETH Trial)

Not yet recruiting at 3 trial locations

Overseen By Gabriel Federo Hungria, MD MSCR

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Disqualifiers: HIV positive, Recent HIV test, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if offering rapid HIV testing during dental visits increases testing rates compared to providing referrals for lab testing. Dental clinics will either administer the rapid test on-site or refer patients elsewhere for testing. Individuals receiving dental care at a participating clinic in Suffolk County who have not had an HIV test in the past year may qualify for this trial. The trial will measure how many people complete HIV testing within 84 days of their dental visit. As an unphased trial, this study presents a unique opportunity to contribute to innovative public health strategies that could enhance the accessibility of HIV testing.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on HIV testing during dental visits.

What prior data suggests that this rapid HIV testing protocol is safe?

A previous study showed that rapid HIV tests like OraQuick and INSTI are safe and easy to use. Clinics widely use these tests, which provide quick results without causing harm. Research indicates that these tests are suitable for regular use and have not reported any major side effects. This makes them generally safe for use during visits, such as those to a dental clinic. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for Rapid HIV Testing because this approach could significantly increase the detection rates of HIV. Unlike traditional methods, which often require patients to follow up at specialized clinics for testing, rapid testing can be done immediately during a visit to the dentist. This not only makes testing more accessible but also provides instant results, which could lead to quicker diagnosis and treatment. Additionally, by integrating HIV testing into routine dental visits, it has the potential to reach individuals who might not otherwise seek out testing, thereby expanding the reach of HIV screening efforts.

What evidence suggests that this trial's treatments could be effective for increasing HIV testing rates?

This trial will compare Rapid HIV Testing with Referral for HIV Testing. Studies have shown that rapid HIV tests are highly reliable, with both sensitivity and specificity at 98.7%. This accuracy ensures they effectively identify who has HIV and who does not. Rapid tests have also resulted in 29% more people with HIV learning their status compared to older methods. These tests are most effective for infections present for some time but may miss very recent infections. Overall, rapid HIV testing is a trusted and effective method to increase testing rates and help more people know their status sooner. ^{6 7 8 9 10}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

This trial is for dental patients at community health center clinics. It's designed to see if offering rapid HIV testing in the dental setting increases the number of people getting tested, compared to just giving them a referral for an HIV test elsewhere.

Inclusion Criteria

Community health center must be located in Suffolk County in Massachusetts

Community health center must provide dental care services

Community health center must possess the infrastructure necessary for laboratory-based HIV testing and counseling or have an affiliation with a laboratory that provides these services

Exclusion Criteria

Patient self-reports to be HIV positive at the time of the RHT/referral

Patient had an HIV test within 12 months (self-report or documented in EHR)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Dental clinics offer either Rapid HIV Testing or referral for HIV Testing during dental visits

9 months

Visits coincide with regular dental appointments

Follow-up

Participants are monitored for HIV test completion within 84 days of their dental visit

84 days

What Are the Treatments Tested in This Trial?

Interventions

• Rapid HIV testing
• Referral for HIV testing

Trial Overview

The study compares two methods: one where patients are offered rapid HIV tests during their dental visit, and another where they're referred to get tested outside of the clinic. The effectiveness will be measured by how many complete the test within 84 days.

How Is the Trial Designed?

Group I: Rapid HIV Testing Experimental Treatment 1 Intervention

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

Group II: Referral HIV Testing Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3260470/

Revising Expectations from Rapid HIV Tests in the ...

On confirmatory tests, 5 of the 841 patients with reportable test results were confirmed to be HIV-infected, yielding an estimated HIV prevalence of 0.6% (CI, ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S073288932500029X

Evaluating the accuracy of multiple rapid diagnostic tests ...

Results. The response rate was 98.25 %. Sensitivity and specificity were both 98.7 %, with agreement at 98.7 % (kappa 0.97, p < 0.001). Northern Cape showed the ...

3.

aidsmap.com

aidsmap.com/about-hiv/how-accurate-are-rapid-point-care-tests-hiv

How accurate are rapid, point-of-care tests for HIV?

Rapid tests are usually reliable for long-standing infections, but are sometimes unable to detect recent HIV infections acquired in the past ...

4.

cdc.gov

cdc.gov/mmwr/preview/mmwrhtml/00051718.htm

Update: HIV Counseling and Testing Using Rapid Tests

Using the rapid test, during 1995, a total of 697,495 more persons would have learned their HIV status, an increase of 29% for HIV-positive persons and of 50% ...

5.

kff.org

kff.org/hiv-aids/hiv-testing-in-the-united-states/

HIV Testing in the United States

This fact sheet provides information on key HIV testing statistics, testing recommendations as advised by the U.S. Centers for Disease ...

6.

chembio.com

chembio.com/wp-content/uploads/2021/12/MSDS-006-HIV-STAT-PAK-English-Rev-4.pdf

HIV 1/2 STAT-PAK® Assay

SAFETY DATA SHEET. SECTION 1 ... This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results.

7.

orasure.com

orasure.com/products/documentation/OraQuick-Advance-HIV.html

OraQuick ADVANCE HIV Test

Oral fluid rapid HIV 1/2 antibody test used to support routine clinical STD testing ... OraQuick ADVANCE Rapid HIV Antibody Test Safety Data Sheet - AUS-ENG. 03/ ...

8.

insti.com

insti.com/wp-content/uploads/2019/06/INSTI-HIV-1-HIV-2-and-Syphilis-Test-Controls-SDS_Rev4.pdf?srsltid=AfmBOooupAjSolqbtSrCpsMuiFHT9xJaUr7MLC8B6EyRYnRge0sWBF0N

SAFETY DATA SHEET - INSTI

The HIV-1 and HIV-2 Positive Controls will produce a reactive test result and have been manufactured to produce a faint blue test dot on the test spot. The ...

9.

chembio.com

chembio.com/wp-content/uploads/2021/12/MSDS-005-Chembio-HIV-Rapid-Test-Control-Pack-PN-60-9549-0-Rev-2.pdf

SAFETY DATA SHEET

SAFETY DATA SHEET. SECTION 1 ... A heat inactivation procedure was carried out on each member of the Chembio HIV Rapid Test Control Pack.

10.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6284408/

HIV rapid screening tests and self-tests: Be aware of ...

The sensitivity was excellent (100%) for the patients infected with HIV-2 or co-infected with HIV-1 and HIV-2 (n = 15), except for the BioTechMed test, which ...