## Protocol Section
### Identification Module
**NCT ID:** NCT06436430

**Brief Title:** Cross-sectional Investigational Study to Evaluate the Sensitivity, Specificity, and Utility of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) to Diagnose Infectious Syphilis in Participants Attending the Sexual Health Clinic in Ottawa, Ontario.

**Official Title:** A Cross-sectional Investigational Study to Evaluate the Sensitivity, Specificity, and Utility of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) to Diagnose Infectious Syphilis in Participants Attending the Sexual Health Clinic in Ottawa, Ontario. The MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test is Authorized for Investigational Use.

#### Organization Study ID Info
**ID:** 2.0
#### Organization
**Class:** INDUSTRY
**Full Name:** MedMira Laboratories Inc.
### Status Module
#### Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** MedMira Laboratories Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study is to test the Multiplo Complete Syphilis (TP/nTP) Antibody Test for its performance in an urban STI clinic using finger-prick obtained whole blood to perform the POCT at the clinic.

**Detailed Description:** The evaluation will determine the sensitivity and specificity of the POCT results compared to results obtained by the standard conventional syphilis serology tests performed at the Public Health Ontario Laboratory. The evaluation will also include a survey on patients' acceptability of syphilis POCT, and a survey of health care providers for feasibility of its use in the clinic.

### Conditions Module

**Conditions:**

- Treponema Pallidum

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 600

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects are tested with investigational devices and conventional syphilis serology tests.

**Intervention Names:**

- Device: Multiplo Complete Syphilis (TP/nTP) Antibody Test

**Label:** Experimental Diagnostic: Multiplo Complete Syphilis (TP/nTP) Antibody Test

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental Diagnostic: Multiplo Complete Syphilis (TP/nTP) Antibody Test

**Description:** All subjects tested with both investigational devices and conventional syphilis serology tests.

**Name:** Multiplo Complete Syphilis (TP/nTP) Antibody Test

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** To test this hypothesis we propose to use the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) (MedMira Inc., Halifax, Nova Scotia) in parallel with the conventional laboratory testing methods as the gold standard, in the Sexual Health Clinic in Ottawa, Ontario. The sensitivity and specificity of the Multiplo® Complete Syphilis POCT shall be determined against results obtained by the gold standard.

**Measure:** To determine if a POCT for syphilis administered at a clinic, can provide comparable results to those obtained by conventional laboratory testing.

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** The acceptability of POCT by clients will be done by asking recruited participants to take part in a survey for their opinion after POCT testing, while feasibility of using POCT in a clinic will be done by surveying the health care providers (HCPs) for their opinion at the end of the study. Responses will be tabulated to determine the most common responses among these groups.

**Measure:** To evaluate the feasibility and utility (acceptability by patients) of this POCT in the patient population under study.

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Able to provide consent
* Patients Requiring Syphilis testing as part of care plan
* Patients attending Clinic for follow up appointments following diagnosis with syphilis infection.
* Patients who have had other STIs in the past, or being suspected of having other STIs are not excluded as long as testing for syphilis is part of provided care
* Minimum 16 years of age

Exclusion Criteria:

* Unable to provide informed consent due to possible intoxication and/or with extreme distress or confused
* Patients below the age of 16 years.

**Healthy Volunteers:** True

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** support@medmira.com

**Name:** Jennifer MacLellan

**Phone:** 902-450-1588

**Role:** CONTACT

**Contact 2:**

**Name:** Kayla Turner

**Phone:** 9024501588

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Ottawa

**Contacts:**

***Contact 1:***

- **Email:** pjobyrne@uottawa.ca

- **Name:** Patrick O'Byrne

- **Phone:** 613 562 5800

- **Phone Ext:** 8917

- **Role:** CONTACT

**Country:** Canada

**Facility:** Sexual Health Clinic

**State:** Ontario

#### Overall Officials

**Official 1:**

**Affiliation:** Sexual Health Clinic

**Name:** Patrick O'Byrne, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000013145

- Term: Spirochaetales Infections

- ID: D000016905

- Term: Gram-Negative Bacterial Infections

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000015231

- Term: Sexually Transmitted Diseases, Bacterial

- ID: D000012749

- Term: Sexually Transmitted Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BXS

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

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M16364

- Name: Syphilis

- Relevance: HIGH

- As Found: Syphilis

- ID: M16964

- Name: Treponemal Infections

- Relevance: HIGH

- As Found: Treponema Pallidum

- 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: T5701

- Name: Treponema Infection

- Relevance: HIGH

- As Found: Treponema Pallidum

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013587

- Term: Syphilis

- ID: D000014211

- Term: Treponemal Infections

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: HIGH

- As Found: Given

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000906

- Term: Antibodies

### Misc Info Module

- Version Holder: 2024-05-31
