Clinical trials: Point of Care STI Testing
HIV Infections
Testing of INSTI™ HIV-1 Antibody Test Kit in Volunteer Subjects at Risk for HIV Infection
Each year up to 22 million persons in the US are tested for HIV. Currently available "rapid" tests do not provide test results for at least 30 minutes from the collection of serum and plasma from the subject.
- Trial name
- NCT00514605
- Testing
- Behavioral counseling, HIV-1 Antibody Test Kit
- Where
- 14 sites in United States
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Syphilis, Treponema Pallidum
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.
Due to the recent resurgence of infectious syphilis in Canada and the changing epidemiology of the disease to involve heterosexuals and females of child bearing age leading to a record number of congenital syphilis cases and…
- Trial name
- NCT06586905
- Testing
- Medical Device
- Where
- Canada
- Volunteers
- 1,300 people, healthy volunteers welcome
- Sponsor
- MedMira Laboratories Inc.
HIV - Human Immunodeficiency Virus, HBV (Hepatitis B Virus)
MAGIA H3S Point of Care Test Performance for HIV, HBV, HCV, and Syphilis Screening in Pregnant Women in DR Congo
Performance study to evaluate the clinical performance of the In-Vitro Diagnostic Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and…
- Conditions
- HIV - Human Immunodeficiency Virus, HBV (Hepatitis B Virus), Hepatitis C Virus (HCV), Syphilis
- Trial name
- MAGICS MAM (NCT07388979)
- Testing
- MAGIA H3S
- Volunteers
- 7,500 people, healthy volunteers welcome
- Sponsor
- Gardiens de Vies
Neisseria Gonorrheae Infection
Performance, Acceptability, and Usability of a Novel Rapid Lateral Flow Test for Detecting Neisseria Gonorrhoeae in Pregnant and Symptomatic Women Attending Clinics in South Africa.
Previous studies of the Neisseria gonorrhoeae (NG) lateral flow assay (LFA) have shown promising results. In East London, South Africa, the LFA demonstrated a sensitivity of 80% in asymptomatic women.
- Trial name
- GO-SA (NCT07530406)
- Testing
- Novel Lateral Flow Assay for Neisseria gonorrhoeae
- Where
- South Africa
- Volunteers
- 1,239 people, healthy volunteers welcome
- Sponsor
- Foundation for Professional Development (Pty) Ltd
HIV Infections, Syphilis
Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC)
This study proposes to investigate the performance of existing and new technologies for HIV diagnosis, one of the key strategies for Ending the HIV Epidemic in the U.S.
- Trial name
- EHPOC (NCT04793750)
- Testing
- Cepheid GeneXpert HIV-1 Qual POC HIV VL test, DPP HIV-Syphilis test system, OraQuick
- Where
- 3 sites in United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Chlamydia Trachomatis Genital Infection, Gonorrhea
Point of Care Rapid STI Test Optimization and Validation Extension
The purpose of this sub-study (PROVE) is to support and facilitate the validation of commercially available point of care (POC) sexually transmitted infection (STI) diagnostic test kits/devices for potential on-site laboratory…
- Conditions
- Chlamydia Trachomatis Genital Infection, Gonorrhea, Trichomoniasis
- Trial name
- PROVE (NCT06566677)
- Where
- South Africa
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Wits RHI Research Centre Clinical Research Site
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
Outcomes From Point-of-Care Sexually Transmitted Infection (STI) Testing in an Urban Sexual Health Clinic: A Randomized Trial
The goal of this clinical trial is to learn about the impact of a point-of-care test for gonorrhea and chlamydia in people without symptoms who are seeking sexually transmitted infection testing.
- Trial name
- NCT07399873
- Testing
- Point-of-care assay for chlamydia and gonorrhea, Laboratory-based chlamydia and gonorrhea NAAT, CRISPR-based assay
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Screening for Syphilis Infections
Syph-Check Syphilis Antibody Point of Care (POC) Test
The study is designed to evaluate the performance of a rapid membrane test in a clinic or doctor's office setting to identify potential patients infected with syphilis and compare the results to currently licensed laboratory…
- Trial name
- SyphPoc (NCT00732355)
- Testing
- Syph-Check POC
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Healthcare Providers Direct, Inc.
Treponema Pallidum Infection, Chlamydia Trachomatis Infection
Improving Maternal and Child Health Through Point-of-care STI Testing
The goal of this clinical trial is to learn if point-of-care tests (POCTs) for sexually transmitted infections (STIs) improve the timely treatment of syphilis, chlamydia, gonorrhea, and trichomonas in pregnant women.
- Conditions
- Treponema Pallidum Infection, Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection, Trichomonas Vaginalis Vaginitis
- Trial name
- MATCH-POINT (NCT07290439)
- Testing
- Point-of-care STI tests, Standard of care STI testing
- Where
- United States
- Volunteers
- 756 people, healthy volunteers welcome
- Sponsor
- Emory University
HIV Infection, HCV Coinfection
Testing and Linkage to Care for Injecting Drug Users in Kenya
Testing and Linkage to Care for Injecting Drug Users in Kenya: Interventions for people who inject drugs (PWID) in sub-Saharan African have been almost entirely absent, despite the fact that in countries like Kenya they…
- Trial name
- NCT01557998
- Testing
- POC CD4 and Peer Case Management, HCV+PWID, Control - No intervention
- Where
- Kenya
- Volunteers
- 9,449 people, healthy volunteers welcome
- Sponsor
- Yale University
Point-of-Care Testing, HIV
Ayaangwaamiziwin Initiative: Carefulness and Preparedness
The goal of this clinical trial is to implement a test, treat, and connect intervention approach using HIV and syphilis rapid point-of-care (POC) testing in 3 Canadian Prairie provinces (Alberta, Manitoba, and Saskatchewan)…
- Conditions
- Point-of-Care Testing, HIV, Syphilis
- Trial name
- AI (NCT06893159)
- Testing
- INSTI HIV-1/2 Antibody Test, INSTI Multiplex HIV-1/2 Syphilis Antibody Test, Multiplo Complete Syphilis (TP/nTP) Antibody Test
- Where
- 8 sites in Canada
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
Syphilis Infection, Syphilis
Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites
This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study.
- Trial name
- NCT06365606
- Testing
- iStatis Syphilis Ab Test
- Where
- South Africa
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Cervical Cancer, HPV Infection
ELEVATE Acceptability Study
This study includes a community-based, two-arm prospective acceptability study, whereby arm 1 consists of an educational session on sexual health and cervical cancer (screening) and a follow-up assessment after 3 months.
- Conditions
- Cervical Cancer, HPV Infection, Acceptability of Health Care
- Trial name
- ELEVATE AS (NCT06136702)
- Testing
- Educational session, Self-sampling, Follow-up assessment
- Where
- 4 sites in Belgium, Brazil and 2 more
- Volunteers
- 1,048 people, healthy volunteers welcome
- Sponsor
- University Ghent
Syphilis, HIV Infections
Syphilis and HIV Point of Care Testing (POCT) in Saskatchewan
The goal of this clinical trial is to learn about Syphilis and HIV point of care testing among inner city, remote, rural and hard to reach populations in Saskatchewan. The main question[s] it aims to answer are: 1.
- Trial name
- SHIVER (NCT05863117)
- Testing
- Reveal Rapid TP (from MedMira)
- Where
- 2 sites in Canada
- Volunteers
- 1,650 people, healthy volunteers welcome
- Sponsor
- Wellness Wheel Medical Clinic
HIV, Syphilis
Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test
This is a diagnostic validation study for a combined Syphilis/HIV test made by MBio Diagnostics, Inc (MBio, Boulder, CO, USA). Although the MBio Syphilis/HIV diagnostic platform is designed for use at point of care (POC), it is…
- Trial name
- MBIO (NCT01530672)
- Testing
- MBIO POC combined HIV syphilis test ( SnapEsi)
- Where
- 2 sites in Kenya
- Volunteers
- 2,900 people, healthy volunteers welcome
- Sponsor
- PATH
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT
Sexually transmitted infections (STIs) caused by Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are increasing in France, with a significant proportion of asymptomatic infections.
- Conditions
- Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection, Sexually Transmitted Infections, Antimicrobial Resistance / Antibiotic Overuse
- Trial name
- OPTIMISE (NCT07884656)
- Testing
- cobas® Liat® CT/NG Point-of-Care Test
- Where
- 2 sites in France
- Volunteers
- 404 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Syphilis, Syphilis Infection
Retrospective Study of iStatis Syphilis Ab Test (POC)
The purpose of this retrospective clinical trial is to establish the clinical performance of the iStatis Syphilis AbTest. The data will be used to demonstrate the product is safe and effective for its intended use.
- Trial name
- NCT06367621
- Testing
- iStatis Syphilis Antibody Test
- Where
- South Africa
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Oropharyngeal Squamous Cell Carcinoma, Human Papillomavirus Infection
Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer
The purpose of this research study is to determine if saliva and oral swab samples can be used to detect human papillomavirus in patients with cancer.
- Trial name
- NCT06362421
- Testing
- Pre-Radiation Dental Evaluation/Sample Collection, Pre-Study Visit, Oral Medicine Consultation Visit/Sample Collection
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Syphilis
Investigational Study to Evaluate the DPP® Syphilis Screen & Confirm Antibody Point-of-care Test (POCT) to Diagnose Infectious Syphilis
The goal of this observational study is to evaluate the sensitivity, specificity, and utility of the DPP® Syphilis Screen \& Confirm antibody point-of-care test (POCT) to diagnose infectious syphilis in participants attending the…
- Trial name
- NCT06927843
- Testing
- point of care test
- Where
- Canada
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- University of Manitoba
Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV
Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)
Performance study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and…
- Conditions
- Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV, HBV, HCV
- Trial name
- MAGICS IBCS (NCT07170748)
- Where
- 2 sites in Côte d’Ivoire, Kenya
- Volunteers
- 2,950 people, healthy volunteers welcome
- Sponsor
- MagIA Diagnostics