STD Testing in Outpatient Practices (STOP)

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.

Study Overview

• Status: Completed
• Conditions: STD

• Study Type: Observational
• Enrollment (Actual): 6771

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Young women at risk for STDs

Description

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:

Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of STD Screening	Rate of screening (Chlamydia and Gonorrhea) in young women attending primary care practices	Day 1
Number of Chlamydia and Gonorrhea infections identified		Day 1

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: CDC Foundation
• Investigators: Principal Investigator: Harold C Wiesenfeld, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2017
• Primary Completion (Actual): November 11, 2019
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PRO14110416

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No