Clinical trials: Point of Care STI Testing
Syphilis, Syphilis, Congenital
Congenital and Maternal Point of Care Rapid Testing for Syphilis Study, Uganda
Syphilis is an infection which affects about 1 in 25 pregnant women in Uganda. If the infection is not diagnosed and treated this can be a risk to the mother and unborn baby's health.
- Trial name
- COMPARTS (NCT07173764)
- Where
- Uganda
- Volunteers
- 24 people
- Sponsor
- St George's, University of London
Syphilis
Point of Care Tests for Syphilis and HIV
This study will evaluate the performance of two point-of-care dual syphilis and HIV tests [Multiplo TP/HIV test (MedMira Inc, Halifax, Nova Scotia) and the INSTI Multiplex HIV-1/HIV-2/Syphilis Antibody Test (bioLytical…
- Trial name
- PoSH (NCT04514848)
- Testing
- INSTI Multiplex HIV-1/2 Syphilis AB test, Multiplo Rapid TP/HIV test
- Where
- Canada
- Volunteers
- 1,526 people
- Sponsor
- University of Alberta
STI
Comparing a Novel Point-of-care Cytokine Biomarker Lateral Flow Test With Nucleic Acid Amplification Tests for Detection of Sexually Transmitted Infections and Bacterial Vaginosis
1. To evaluate the performance of a lateral flow POC test, namely the Genital InFlammation Test (GIFT), for identifying women with inflammatory STIs and BV, who are at higher risk of HIV infection and reproductive complications…
- Trial name
- GIFT (NCT05723484)
- Testing
- GIFT Device
- Where
- 3 sites in Madagascar, South Africa and 1 more
- Volunteers
- 675 people
- Sponsor
- University of Cape Town
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
Sexually Transmitted Disease, Bacterial Vaginosis
Women's Improvement of Sexual Health (WISH) Demonstration Project
The current standard of care for urogenital infections in Rwanda is syndromic management. Many urogenital infections are asymptomatic and therefore completely missed, and the management of vaginal discharge syndrome is known to…
- Conditions
- Sexually Transmitted Disease, Bacterial Vaginosis, Vaginal Candidiasis, Urinary Tract Infections
- Trial name
- WISH (NCT03045809)
- Testing
- Urogenital infection point-of-care tests
- Where
- Rwanda
- Volunteers
- 705 people, healthy volunteers welcome
- Sponsor
- Janneke van de Wijgert
HIV Testing, HIV Infections
Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood
Point-of-care (POC) tests for HIV are easy to use, rapid and provide accurate results while the patient is still in-front of a healthcare provider (HCP).
- Trial name
- NCT04810559
- Testing
- OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test
- Where
- 4 sites in Canada
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
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
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
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
Maternal Syphilis During Pregnancy - Baby Not Yet Delivered, Congenital Syphilis
Point-Of-Care Testing for Congenital Syphilis in Mothers and Newborns
A dramatic rise in syphilis has been recently reported in the US between 2000-2017, which was followed also by a dramatic rise in congenital syphilis (CS).
- Trial name
- NCT03814096
- Testing
- Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ)
- Where
- 2 sites in United States
- Sponsor
- Stanford University
HIV/AIDS, Infant Morbidity
Impact of Point-of-Care EID for HIV-Exposed Infants
This mixed methods study will utilize a randomized step-wedge design to assess the impact of point-of-care (POC) versus conventional early infant diagnosis (EID) on key outcomes including timely return of results to caregivers…
- Conditions
- HIV/AIDS, Infant Morbidity, Pediatric HIV Infection, Transmission, Perinatal Infection
- Trial name
- POC-EID (NCT03824067)
- Testing
- Point of Care Early Infant Diagnosis, Standard of Care Early Infant Diagnosis
- Where
- 2 sites in Kenya, Zimbabwe
- Volunteers
- 9,539 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
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
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
Gonorrhoea
Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea
The purpose of this study is to develop a laboratory-based assay that will be a real-time PCR test to detect the organism N. gonorrhoeae and its most important genetic markers of antimicrobial resistance.
- Trial name
- RaDAR-Go (NCT02350907)
- Where
- 3 sites in Switzerland
- Volunteers
- 261 people
- Sponsor
- University of Bern
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
HIV Infections
Improving HIV Diagnosis, Linkage to Care, and Prevention Services With HIV Point-of-Care Nucleic Acid Tests
This project (NCT04880200) will develop, implement, and evaluate models for use of point-of-care nucleic acid testing (POC NAT) among HIV-negative persons seeking HIV testing, PEP, and PrEP and HIV-positive persons in community…
- Trial name
- GAIN (NCT04880200)
- Testing
- POC NAT & Adherence Intervention
- Where
- United States
- Volunteers
- 194 people
- Sponsor
- University of Washington
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)
Combating Related Epidemics in HCV
This is a two-arm cluster randomized control trial to evaluate the effectiveness of a single-visit point-of-care (POC) test and treat bundle (intervention arm) compared to the current standard-of-care (SOC, control arm).
- Conditions
- HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV), HEPATITIS C (HCV)
- Trial name
- CREST (NCT07560046)
- Testing
- Cepheid GeneXpert HCV Test, Abbott Determine HIV - 1/2 Ag/Ab, Abbott Determine HbsAg 2
- Volunteers
- 1,280 people
- Sponsor
- Duke University
HIV Infections, Syphilis Infection
Multiplo Near Patient Non-HCP Study
To help reach the undiagnosed living with HIV and/or syphilis in Canada, point-of-care (POC) tests for HIV and Syphilis may have substantial utility for increased identification of infected individuals through their relative ease…
- Trial name
- NCT06463314
- Testing
- Multiplo TP/HIV Antibody Test
- Where
- 4 sites in Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- Unity Health Toronto
Human Immunodeficiency Virus
Mater-Bronx Rapid HIV Testing Project.
In the M-BRiHT study we aim to implement a programme of opportunistic HIV screening in the Emergency Department, Mater Misericordiae University Hospital.
- Trial name
- M-BRiHT (NCT01778374)
- Testing
- No participant choice of counselor, Participant choice of counselor
- Where
- Ireland
- Volunteers
- 17,000 people, healthy volunteers welcome
- Sponsor
- University College Dublin
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