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Quick syphilis test at family planning visits studied in Hawai'i

NCT ID NCT07358949

Diagnosis Sponsor: Queen's Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 4 times

Summary

This study looks at whether offering a rapid syphilis test during family planning visits (for birth control or abortion) is practical and acceptable to patients. About 70 participants will get a fingerstick test with results in 10-15 minutes, instead of waiting days. The goal is to see if this approach helps more people get tested and treated quickly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The Queens Options Center serves as a referral center for family planning services for patients throughout the state. From prior literature, the patients most impacted by persistent or continued syphilis infections are those who are structurally vulnerable, including those who are under- or uninsured, experiencing poverty, unhoused, or actively using substances. By screening universally, we may decrease the stigmatization associated with individual behavior-based screening. We acknowledge that there is a risk of increased false positives by screening universally . To mitigate this, we recommend that a participant with a positive rapid test also obtain serological testing with RPR, which is already required for treatment monitoring. As stated above, prior studies have established that the sensitivity and specificity of the SHC are greater than 95%.

Ages

14 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 14 years or older * Seeking contraception or abortion services * Sexually active (engages in any form of sexual activity with another person) * Denies history of syphilis infection * Can speak and read English * Displays capacity for informed consent Exclusion Criteria: * Confirmed history (by patient report or medical records) of syphilis * Home address outside Hawai'i * Currently incarcerated Number of Subjects: Recommendations for sample size in pilot studies range from 70 to 100 patients.28 Given this is a nonrandomized feasibility study with no comparator (i.e., to a control or to serological testing), we aim to enroll 50 to 75 participants to support analysis for correlation between variables while being able to achieve relatively small confidence intervals. This number takes into account the practical considerations of study personnel resources and in-person patient volume in our clinic. All patients eligible for the rapid syphilis testing will be approached for study participation.

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Conditions

The condition(s) this trial relates to.

syphilis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Syphilis infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Queen's Medical Center, 1004 Clinic POB1

    RECRUITING

    Honolulu, Hawaii, 96813, United States

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