STD Testing in Outpatient Practices

STD Clinical Trial

— STOP  

Official title:

STD Testing in Outpatient Practices-The STOP STDs Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246815
• Other study ID #: PRO14110416
• Status: Completed
• Start date: June 12, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6771
• Est. completion date: December 30, 2020
• Est. primary completion date: November 11, 2019
• Gender: Female
• Age group: 15 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• STD

Locations

Country	Name	City	State
United States	Magee-Womens Hospital of UPMC/associated community clinics	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	CDC Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of STD Screening	Rate of screening (Chlamydia and Gonorrhea) in young women attending primary care practices	Day 1
Primary	Number of Chlamydia and Gonorrhea infections identified		Day 1