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
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
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 Infections
Piloting At-birth Point of Care HIV Testing Strategies in Kenya
Innovative strategies to expedite HIV diagnosis among exposed infants, including at-birth testing and two portable point-of-care (POC) diagnostic systems, will be piloted using an implementation framework.
- Trial name
- NCT03435887
- Testing
- Alere q HIV-1/2 Detect for point of care infant testing, GeneXpert HIV-1 Qual for point of care infant testing, HIV DNA PCR testing (Standard of Care)
- Where
- 5 sites in United States, Kenya
- Volunteers
- 1,999 people
- Sponsor
- University of Kansas Medical Center
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
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
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/AIDS
HIV Jail POC-AgAB Testings
"Enhancing a universal testing and treatment strategy in jail to promote viral load suppression among justice-involved people living with HIV" is an observational research study led by Dr.
- Trial name
- NCT04296331
- Testing
- POC, Ag/Ab, POC + Ag/Ab
- Where
- United States
- Volunteers
- 6,613 people
- Sponsor
- Montefiore Medical Center
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
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
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, PrEP
The ACT-PrEP Study
AIM: To evaluate the integration of point-of-care etiological STI testing, cognitive behavioral counselling (CBC), and sexual partner engagement strategies to improve STI management, PrEP uptake and 3-month PrEP persistence among…
- Conditions
- HIV, PrEP, Acceptability, Appropriateness
- Trial name
- NCT07867990
- Testing
- POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women., Standard of Care
- Volunteers
- 120 people
- Sponsor
- University of California, Los Angeles
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