## Protocol Section
### Identification Module
**NCT ID:** NCT06428643

**Brief Title:** A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities

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

#### Organization Study ID Info
**ID:** 2024-377
#### Organization
**Class:** OTHER
**Full Name:** Tulane University
### Status Module
#### Completion Date
**Date:** 2029-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2028-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institutes of Health (NIH)

**Class:** NIH

**Name:** National Institute of Allergy and Infectious Diseases (NIAID)

#### Lead Sponsor

**Class:** OTHER

**Name:** Tulane University

#### Responsible Party

**Investigator Affiliation:** Tulane University

**Investigator Full Name:** Patricia Kissinger

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Chlamydia

- Gonorrhea

- Hiv

- Syphilis

**Keywords:**

- Screening

- Expedited Treatment

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

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

##### Masking Info

**Masking:** NONE

**Masking Description:** None (Open Label)

**Primary Purpose:** SCREENING

#### Enrollment Info

**Count:** 2322

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Chlamydia, gonorrhea, syphilis, and HIV screening

**Label:** Chlamydia, gonorrhea, syphilis, and HIV screening

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Chlamydia, gonorrhea, syphilis, and HIV screening

**Description:** 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.

**Name:** Chlamydia, gonorrhea, syphilis, and HIV screening

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Primary outcome

**Measure:** Rate of chlamydia in women

**Time Frame:** up to 60 months

#### Secondary Outcomes

**Description:** Secondary outcome

**Measure:** Rate of gonorrhea in women

**Time Frame:** up to 60 months

### Eligibility Module

**Eligibility Criteria:** 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

Exclusion Criteria:

* 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

**Healthy Volunteers:** True

**Maximum Age:** 26 Years

**Minimum Age:** 15 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kissing@tulane.edu

**Name:** Patricia Kissinger, PhD

**Phone:** 504-988-7320

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002694

- Term: Chlamydiaceae Infections

- ID: D000016905

- Term: Gram-Negative Bacterial Infections

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000007239

- Term: Infections

- ID: D000015231

- Term: Sexually Transmitted Diseases, Bacterial

- ID: D000012749

- Term: Sexually Transmitted Diseases

- ID: D000003141

- Term: Communicable Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000016870

- Term: Neisseriaceae Infections

- ID: D000014211

- Term: Treponemal Infections

- ID: D000013145

- Term: Spirochaetales Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16364

- Name: Syphilis

- Relevance: HIGH

- As Found: Syphilis

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: LOW

- As Found: Unknown

- ID: M5934

- Name: Chlamydia Infections

- Relevance: HIGH

- As Found: Chlamydia

- ID: M9174

- Name: Gonorrhea

- Relevance: HIGH

- As Found: Gonorrhea

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M19249

- Name: Gram-Negative Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17935

- Name: Sexually Transmitted Diseases, Bacterial

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19218

- Name: Neisseriaceae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M16964

- Name: Treponemal Infections

- Relevance: LOW

- As Found: Unknown

- ID: T5701

- Name: Treponema Infection

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002690

- Term: Chlamydia Infections

- ID: D000006069

- Term: Gonorrhea

- ID: D000013587

- Term: Syphilis

### Misc Info Module

- Version Holder: 2024-05-31
