STOP: STD Testing in Outpatient Practices

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT03246815
Collaborator
CDC Foundation (Other)
6,771
1
42.6
158.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    6771 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    STD Testing in Outpatient Practices-The STOP STDs Study
    Actual Study Start Date :
    Jun 12, 2017
    Actual Primary Completion Date :
    Nov 11, 2019
    Actual Study Completion Date :
    Dec 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Rate of STD Screening [Day 1]

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

    2. Number of Chlamydia and Gonorrhea infections identified [Day 1]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 24 Years
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Magee-Womens Hospital of UPMC/associated community clinics Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • University of Pittsburgh
    • CDC Foundation

    Investigators

    • Principal Investigator: Harold C Wiesenfeld, MD, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Harold Wiesenfeld, Principal Investigator, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT03246815
    Other Study ID Numbers:
    • PRO14110416
    First Posted:
    Aug 11, 2017
    Last Update Posted:
    Mar 10, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 10, 2021