CClinicalTrials.gg
CompletedNCT03246815STOPUpdated Mar 10, 2021

STD Testing in Outpatient Practices

An observational study in STD, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to female participants aged 15 Years to 24 Years. Per ClinicalTrials.gov, last updated 2021-03-10.

Sponsored by University of Pittsburgh · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
6,771
Ages
15 Years to 24 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • STD
03

In context

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 24 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Young women at risk for STDs

Inclusion criteria

Women ages 15-24 Sexually Active Receiving care in one of the primary care offices affiliated with UPMC selected for this study.

Exclusion criteria

Exclusion Criteria:

Pregnancy

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
6,771 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Rate of STD Screening

    Rate of screening (Chlamydia and Gonorrhea) in young women attending primary care practices

    Time frame: Day 1

  2. Number of Chlamydia and Gonorrhea infections identified

    Time frame: Day 1

07

Study locations

1 site
  • Magee-Womens Hospital of UPMC/associated community clinics
    Pittsburgh, Pennsylvania 15213, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03246815
Lead sponsor
University of Pittsburgh
Collaborators
CDC Foundation
Responsible party
Harold Wiesenfeld (Principal Investigator, University of Pittsburgh) — Principal investigator
First posted
Aug 11, 2017
Start date
Jun 12, 2017
Primary completion
Nov 11, 2019
Completion
Dec 30, 2020
Last update
Mar 10, 2021

Study contacts

Harold C Wiesenfeld, MD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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