Clinical trials: Point of Care STI Testing
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
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
Neisseria Gonorrhea, Trichomoniasis Vaginalis
Acceptability Research on Integrated Point of Care Sexually Transmitted Infection (STI) Testing and Expedited Partner Therapy (EPT)
This protocol builds on nearly a decade of collaborative HIV/STI prevention research to conduct a prospective cohort study of Adolescent Girls and Young Women (AGYW) eligible for PrEP in South Africa in which we will assess the…
- Conditions
- Neisseria Gonorrhea, Trichomoniasis Vaginalis, Chlamydia Trachomatis Infection
- Trial name
- ARISE (NCT06570733)
- Where
- South Africa
- Volunteers
- 305 people
- Sponsor
- Wits RHI Research Centre Clinical Research Site
HIV/AIDS, HIV-1-infection
Simplifying Treatment and Monitoring for HIV (STREAM HIV)
This study seeks to determine the clinical efficacy and cost effectiveness of implementing an integrated model for HIV monitoring using point of care (POC) tenofovir (TFV) adherence testing and POC viral load (VL) monitoring in…
- Trial name
- NCT04341779
- Testing
- Point-of-care viral load testing and tenofovir adherence testing
- Where
- South Africa
- Volunteers
- 539 people
- Sponsor
- University of Washington
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
HIV Infections, HIV/AIDS
Evaluating the Feasibility of Point of Care Birth Testing in Eswatini
This study aims to assess the feasibility and utility of birth testing using point-of-care (POC) testing in maternity settings in Eswatini.
- Conditions
- HIV Infections, HIV/AIDS, Pediatric HIV Infection, Transmission, Perinatal Infection
- Trial name
- NCT04206878
- Testing
- Point-of-care birth test
- Where
- Eswatini
- Volunteers
- 3,316 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
Point of Care STI Testing
Point of Care STI Testing
The proposed research hypothesizes that point-of-care testing (POCT) for sexually transmitted infections (STIs) gonorrhea and chlamydia will be a feasible, acceptable, and appropriate implementation strategy for improving HIV…
- Trial name
- NCT06844045
- Testing
- Gonorrhea/chlamydia Point-of-Care Testing
- Where
- United States
- Volunteers
- 6,460 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
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
Syphilis
The Feasibility of Implementing Syphilis Point-of-care Testing Into a Prenatal Clinic for People Facing Barriers to Care
The goal of this clinical trial is to learn if a finger-prick blood test for rapid diagnosis of syphilis infection can be implemented in a low-barrier prenatal clinic for people at risk of syphilis in pregnancy.
- Trial name
- PRESSING (NCT06829602)
- Testing
- Rapid Syphilis/HIV point-of-care test
- Where
- Canada
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- McMaster University
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, 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/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
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
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, 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