A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities

September 16, 2026 updated by: Patricia Kissinger, Tulane University

A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities in Black Youth Living in the Deep South

This study includes testing for four STIs (chlamydia, gonorrhea, syphilis, and HIV) at no cost. If positive, individual subjects will also be counseled and offered options for treatment for themselves and their sex partners that may include no cost expedited treatment and the option to be rescreened 3 months after treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2322

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University Celia Scott Weatherhead School of Public Health and Tropical Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patricia Kissinger, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Identifies as African American or Black
  • 15-26 years of age
  • Lives or spends most of their time in Orleans Parish
  • Had vaginal sex at least once
  • Provide a urine or vaginal swab
  • Not taken azithromycin or cefixime in the last 7 days

Exclusion Criteria:

  • Unwilling or unable to provide informed consent
  • Unable to speak or understand English
  • Previously enrolled in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chlamydia, gonorrhea, syphilis, and HIV screening

Community screening of individuals for chlamydia and gonorrhea is not normally done. We are testing to see if this intervention will impact the rates of chlamydia among women.
Other: Chlamydia, gonorrhea, syphilis, and HIV screening

Individuals aged 15-26 years old will be tested for chlamydia, gonorrhea, HIV, and syphilis at community based venues. Individuals who test positive for chlamydia and gonorrhea and their sexual partners will be offered expedited treatment at participating pharmacies. Individuals who test positive will be asked to be rescreened for Ct/GC at 3 months post treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of chlamydia in women
Time Frame: up to 60 months

Primary outcome
up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Index participant medication pickup rate
Time Frame: up to 60 months

Percentage of index participants who obtain their prescribed medication from a partnering pharmacy among all index participants who report intending to pick up the medication. Medication receipt will be determined from pharmacy billing records. Rates will be calculated monthly.
up to 60 months
Partner medication pickup rate
Time Frame: 60 months

Percentage of partners who obtain their prescribed medication from a partnering pharmacy among all partners reported as intending to pick up the medication. Medication receipt will be determined from pharmacy billing records. Rates will be calculated monthly.
60 months
Self reported treatment of index participants and partners
Time Frame: 60 months

Number and percentage of index participants who report that they and all applicable partner(s) received treatment. The denominator will include index participants who provide follow-up information about their own and their partner(s)' treatment status.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tulane University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

May 20, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 21, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-377

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will provide de-identified data to persons who submit a reasonable request with appropriate institutional approval after the primary and secondary request questions have been published.

IPD Sharing Time Frame

IPD and supporting information will be available from 2030 to 2033 (3 years).

IPD Sharing Access Criteria

Any person with IRB approval from their institution who has a coherent plan for analysis can be provided with a CSV file and coding guide in a de-identified format.

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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