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

NCT06428643 | Recruiting

• 1 other identifier: 2024-377
• Study Type: interventional
• Target: 2,322
• Locations: 1 country
• Sites: 1

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.

Conditions

Chlamydia; Gonorrhea; Hiv; Syphilis

Keywords

Screening; Expedited Treatment

Outcome Measures

Primary Outcomes (1)

• Rate of chlamydia in women

  Primary outcome

  up to 60 months

Secondary Outcomes (3)

• Index participant medication pickup rate

  up to 60 months

• Partner medication pickup rate

  60 months

• Self reported treatment of index participants and partners

  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

Chlamydia, gonorrhea, syphilis, and HIV screening OTHER

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

• Age: 15 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (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
• Provide a urine or vaginal swab
• Not taken azithromycin or cefixime in the last 7 days

You may not qualify if:

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

Sponsors & Collaborators

• Tulane University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

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 Infections; Gonorrhea; Acquired Immunodeficiency Syndrome; Syphilis

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Neisseriaceae Infections; HIV Infections; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Treponemal Infections; Spirochaetales Infections

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Patricia Kissinger, PhD

CONTACT

504-988-7320; kissing@tulane.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Community based screening of young men for chlamydia, gonorrhea, HIV, and syphilis. Expedited treatment for positive subjects and their sexual partners.

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: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: IPD and supporting information will be available from 2030 to 2033 (3 years).
• 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.

Locations

US (1)