STD Testing in Outpatient Practices

NCT03246815 | Completed

• 1 other identifier: PRO14110416
• Study Type: observational
• Target: 6,771
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

STD

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 15 Years - 24 Years
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young women at risk for STDs

You may qualify if:

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

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• University of Pittsburgh: lead
• CDC Foundation: collaborator

Study Sites (1)

Magee-Womens Hospital of UPMC/associated community clinics

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

• Harold C Wiesenfeld, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: August 11, 2017
• Study Start: June 12, 2017
• Primary Completion: November 11, 2019
• Study Completion: December 30, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Locations

US (1)