STDSTOPNCT03246815
STD Testing in Outpatient Practices
An observational study of STD, run by University of Pittsburgh at 1 site in United States.
Trial summary
National guidelines have recommended routine STD screening (chlamydia and gonorrhea) for sexually active young women under the age of 25. Despite these recommendations, many young women are not being screened for STDs, with some estimates that less than 50% of women receiving health care are screened for chlamydia. Read more about this study
- Who is it for?
- Ages 15 to 24 years, women only
- Conditions the study is for
- STD
- How many people
- 6,771 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2017to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 24 years
- Women only
- Child, Adult
Study population: Young women at risk for STDs
Who may be able to join
- Women ages 15-24 Sexually Active Receiving care in one of the primary care offices affiliated with UPMC selected for this study.
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of UPMC/associated community clinics
Pittsburgh, Pennsylvania, 15213
About this study
Official title: STD Testing in Outpatient Practices-The STOP STDs Study
National guidelines have recommended routine STD screening (chlamydia and gonorrhea) for sexually active young women under the age of 25. Despite these recommendations, many young women are not being screened for STDs, with some estimates that less than 50% of women receiving health care are screened for chlamydia. Untreated STDs can lead to important sequelae to women's reproductive health including pelvic inflammatory disease, infertility and ectopic pregnancy. One of the most important barriers to widespread STD screening is provider failure to recognize an opportunity for STD screening. The goal of this study is to determine whether offering STD screening (chlamydia and gonorrhea) by a non-physician member of the medical practice (who receives an automated alert indicating STD screening should be offered) will be associated with a higher rate of STD screening in young women attending primary care practices compared to usual care (where a physician offers screening with no electronic alert). This study will be performed in UPMC-affiliated primary care practices (Family Practice, Internal Medicine, OB/GYN, Pediatrics). Practices will be assigned to the intervention or usual care. The intervention will be an auto-task in the electronic medical record to the non-physician/NP/PA medical staff (medical assistants, LPNs, RNs) to offer chlamydia and gonorrhea screening via urine or self-collected vaginal sampling, in an opt-out manner, to eligible women. Practices assigned to the usual care group will not have the intervention. STD screening rates (# women undergoing STD screening/# eligible women) will be compared between the to groups (intervention practices and control practices). Results of this study may be important to guide national STD screening recommendations and will address critical barriers to widespread STD screening.
- Conditions
- STD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| universal opt-out screening for STDs | Patients who present to primary care practices who employee a universal opt-out strategy to medical assistants or nurses | |
| without universal opt-out screening for STDs | Patients who present to primary care practices who do not employee a universal opt-out strategy to medical assistants or nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of STD Screening
Rate of screening (Chlamydia and Gonorrhea) in young women attending primary care practices
Measured: Day 1
Number of Chlamydia and Gonorrhea infections identified
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start12 Jun 2017
- Primary completion11 Nov 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for STDStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 6,771 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- CDC Foundation
- Responsible party
- Principal investigator, Harold Wiesenfeld, University of Pittsburgh
- Investigators
- Harold C Wiesenfeld, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246815
- Sponsor's protocol ID
- PRO14110416
- Acronym
- STOP
- Status last verified
- Mar 2021
- First submitted
- 18 Jul 2017
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wiesenfeld HC, Hong J, Xu T, Cuffe KM, Bernstein KT, Gift TL, Fischer GS. A Staff-Directed Electronic Medical Record Alert to Increase Chlamydia Screening: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2615360. doi: 10.1001/jamanetworkopen.2026.15360.
PubMed 42213436
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STD Testing in Outpatient Practices-The STOP STDs Study
- ClinicalTrials.gov ID
- NCT03246815
- Acronym / sponsor ID
- STOP / PRO14110416
- Conditions
- STD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,771 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- CDC Foundation
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 11 Aug 2017 (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.
National guidelines have recommended routine STD screening (chlamydia and gonorrhea) for sexually active young women under the age of 25. Despite these recommendations, many young women are not being screened for STDs, with some estimates that less than 50% of women receiving health care are screened for chlamydia. Untreated STDs can lead to important sequelae to women's reproductive health including pelvic inflammatory disease, infertility and ectopic pregnancy. One of the most important barriers to widespread STD screening is provider failure to recognize an opportunity for STD screening. The goal of this study is to determine whether offering STD screening (chlamydia and gonorrhea) by a non-physician member of the medical practice (who receives an automated alert indicating STD screening should be offered) will be associated with a higher rate of STD screening in young women attending primary care practices compared to usual care (where a physician offers screening with no electronic alert). This study will be performed in UPMC-affiliated primary care practices (Family Practice, Internal Medicine, OB/GYN, Pediatrics). Practices will be assigned to the intervention or usual care. The intervention will be an auto-task in the electronic medical record to the non-physician/NP/PA medical staff (medical assistants, LPNs, RNs) to offer chlamydia and gonorrhea screening via urine or self-collected vaginal sampling, in an opt-out manner, to eligible women. Practices assigned to the usual care group will not have the intervention. STD screening rates (# women undergoing STD screening/# eligible women) will be compared between the to groups (intervention practices and control practices). Results of this study may be important to guide national STD screening recommendations and will address critical barriers to widespread STD screening.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| universal opt-out screening for STDs | – | –Patients who present to primary care practices who employee a universal opt-out strategy to medical assistants or nurses |
| without universal opt-out screening for STDs | – | –Patients who present to primary care practices who do not employee a universal opt-out strategy to medical assistants or nurses |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Young women at risk for STDs
Key inclusion criteria (1 listed)
- Women ages 15-24 Sexually Active Receiving care in one of the primary care offices affiliated with UPMC selected for this study.
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of STD Screening
Time frame: Day 1
Rate of screening (Chlamydia and Gonorrhea) in young women attending primary care practices
Number of Chlamydia and Gonorrhea infections identified
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 42213436Wiesenfeld HC, Hong J, Xu T, Cuffe KM, Bernstein KT, Gift TL, Fischer GS. A Staff-Directed Electronic Medical Record Alert to Increase Chlamydia Screening: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2615360. doi: 10.1001/jamanetworkopen.2026.15360.
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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. This study is not recruiting at the moment.
Harold C Wiesenfeld, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STD, run by University of Pittsburgh 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: finished, as of the sponsor's last update on 10 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of STD Screening (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03246815, which also lists 1 linked publication.
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 10 Mar 2021.