NCT06428643

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,322

participants targeted

Target at P75+ for not_applicable

Timeline
40mo left

Started Aug 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Aug 2025Sep 2029

First Submitted

Initial submission to the registry

May 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 14, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

May 20, 2024

Last Update Submit

April 30, 2026

Conditions

Keywords

ScreeningExpedited Treatment

Outcome Measures

Primary Outcomes (1)

  • Rate of chlamydia in women

    Primary outcome

    up to 60 months

Secondary Outcomes (1)

  • Rate of gonorrhea in women

    up to 60 months

Study Arms (1)

Chlamydia, gonorrhea, syphilis, and HIV screening

EXPERIMENTAL

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

Interventions

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.

Chlamydia, gonorrhea, syphilis, and HIV screening

Eligibility Criteria

Age15 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Identifies as African American or Black
  • years of age
  • Lives or spends most of their time in Orleans Parish
  • Had vaginal sex at least once

You may not qualify if:

  • Unwilling or unable to provide informed consent
  • Unable to speak or understand English
  • Previously enrolled in the study
  • Known to be pregnant
  • Known HIV positive status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tulane University Celia Scott Weatherhead School of Public Health and Tropical Medicine

New Orleans, Louisiana, 70112, United States

RECRUITING

MeSH Terms

Conditions

Chlamydia InfectionsGonorrheaAcquired Immunodeficiency SyndromeSyphilis

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

Chlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital DiseasesNeisseriaceae InfectionsHIV InfectionsBlood-Borne InfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesImmunologic Deficiency SyndromesImmune System DiseasesTreponemal InfectionsSpirochaetales Infections

Intervention Hierarchy (Ancestors)

Microbiological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Patricia Kissinger, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
None (Open Label)
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Community based screening of young men for chlamydia, gonorrhea, HIV, and syphilis. Expedited treatment for positive subjects and their sexual partners.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2024

First Posted

May 24, 2024

Study Start

August 14, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2029

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations