Point of Care STI TestingNCT06844045
Point of Care STI Testing
A study testing Gonorrhea/chlamydia Point-of-Care Testing in people with Point of Care STI Testing, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
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 testing and Pre-exposure prophylaxis (PrEP) delivery in youth, by increasing opportunities… Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Point of Care STI Testing
- What is being tested?
- Gonorrhea/chlamydia Point-of-Care Testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,460 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients age 16-24 years receiving POCT or lab-based GC/CT testing
Who cannot join
- Patients with known HIV or active PrEP prescriptions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Susan Lee, MPH, 215-590-1000, lees8@chop.edu
Nadia Dowshen
About this study
Official title: Clinical and Implementation Outcomes of a Point of Care Sexually Transmitted Infection Testing Strategy to Improve HIV Prevention Service Delivery in Adolescents
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 testing and Pre-exposure prophylaxis (PrEP) delivery in youth, by increasing opportunities for clinician-patient counseling, decreasing loss to follow up, and allowing for same-day HIV prevention service provision. This hypothesis will be tested in a pragmatic non-randomized trial comparing clinical (HIV testing and PrEP counseling and prescription) and implementation (feasibility, acceptability, and appropriateness) outcomes between adolescents receiving POCT compared to laboratory-based testing at three clinics within a large pediatric health system.
- Conditions
- Point of Care STI Testing
- Being tested
- Gonorrhea/chlamydia Point-of-Care Testing
- Keywords
- HIV Prevention, HIV Testing, HIV Pre-Exposure Prophylaxis, Gonorrhea, Chlamydia, Sexually Transmitted Infections
- Medical subject headings
- Gonorrhea, Chlamydia Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonorrhea/chlamydia Point-of-Care TestingBehavioural
Point-of-care testing for sexually transmitted infections.
| Study group | Role | What they receive |
|---|---|---|
| Point-of-Care Tested | Experimental | Participants in the intervention arm have received point-of-care testing for sexually transmitted infections. Receives: Behavioral: Gonorrhea/chlamydia Point-of-Care Testing |
| Lab Tested | No intervention | Participants in the control arm have received lab-based testing for sexually transmitted infections. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of HIV Test Completion
Rates of HIV test completion on the day of gonorrhea/chlamydia testing will be compared between those who receive point-of-care vs. lab-based STI testing.
Measured: Day 1 - Measured on date of STI testing
Secondary outcomes (2)
Number of participants who received PrEP counseling
PrEP counseling will be measured using visit note data from the date of the STI testing encounter
Measured: Day 1 - Same day as STI testing encounter
Time to STI treatment
Days between STI test order and delivery of antibiotics for STI treatment, measured using EHR data
Measured: Time from STI diagnosis to treatment, up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start24 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Point of Care STI TestingStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Sarah Wood, Icahn School of Medicine at Mount Sinai
- Investigators
- Sarah Wood, MD, MSHP, Principal investigator, Mount Sinai Adolescent Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844045
- Sponsor's protocol ID
- GCO 24-1934
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Implementation Outcomes of a Point of Care Sexually Transmitted Infection Testing Strategy to Improve HIV Prevention Service Delivery in Adolescents
- ClinicalTrials.gov ID
- NCT06844045
- Acronym / sponsor ID
- GCO 24-1934
- Conditions
- Point of Care STI Testing
- Keywords
- HIV Prevention, HIV Testing, HIV Pre-Exposure Prophylaxis, Gonorrhea, Chlamydia, Sexually Transmitted Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,460 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 testing and Pre-exposure prophylaxis (PrEP) delivery in youth, by increasing opportunities for clinician-patient counseling, decreasing loss to follow up, and allowing for same-day HIV prevention service provision. This hypothesis will be tested in a pragmatic non-randomized trial comparing clinical (HIV testing and PrEP counseling and prescription) and implementation (feasibility, acceptability, and appropriateness) outcomes between adolescents receiving POCT compared to laboratory-based testing at three clinics within a large pediatric health system.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Point-of-Care Tested | Experimental | Behavioral: Gonorrhea/chlamydia Point-of-Care TestingParticipants in the intervention arm have received point-of-care testing for sexually transmitted infections. |
| Lab Tested | No intervention | –Participants in the control arm have received lab-based testing for sexually transmitted infections. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients age 16-24 years receiving POCT or lab-based GC/CT testing
Key exclusion criteria (1 listed)
- Patients with known HIV or active PrEP prescriptions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gonorrhea/chlamydia Point-of-Care TestingPoint-of-care testing for sexually transmitted infections. | Behavioural | Point-of-Care Tested |
Primary outcome
Rates of HIV Test Completion
Time frame: Day 1 - Measured on date of STI testing
Rates of HIV test completion on the day of gonorrhea/chlamydia testing will be compared between those who receive point-of-care vs. lab-based STI testing.
2 secondary outcomes
Number of participants who received PrEP counseling
Time frame: Day 1 - Same day as STI testing encounter
Time to STI treatment
Time frame: Time from STI diagnosis to treatment, up to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for Point of Care STI Testing
Not yet recruiting
Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
Not yet recruitingPhase 4
Combating Related Epidemics in HCV
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)
Not yet recruiting
The ACT-PrEP Study
HIV, PrEP
Not yet recruiting
Outcomes From Point-of-Care Sexually Transmitted Infection (STI) Testing in an Urban Sexual Health Clinic: A Randomized Trial
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
Recruiting
Improving Maternal and Child Health Through Point-of-care STI Testing
Treponema Pallidum Infection, Chlamydia Trachomatis Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Wood, MD, MSHP principal investigator
Mount Sinai Adolescent Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gonorrhea/chlamydia Point-of-Care Testing in people with Point of Care STI Testing, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naomi Pressman, MS, RD ((212) 731-7810, naomi.pressman@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of HIV Test Completion (time frame: Day 1 - Measured on date of STI testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.