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Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections

This study has been completed.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01184157
First received: August 17, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

This study randomizes women using long-acting reversible methods of contraception to home-based STD screening through the mail compared to screening available in a clinical setting. We hypothesize that women randomized to home-based screening will be more likely to complete screening.


Condition Intervention
Chlamydia
Gonorrhea
 Behavioral: Home screening
Behavioral: Clinic screening

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections in Long-Acting Reversible Contraceptive Users

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Number of tests received [ Designated as safety issue: No ]

Arms Assigned Interventions
Experimental: Home
Home-based STI screening using self-obtained vaginal swabs and postal return of samples.
 Behavioral: Home screening
Active Comparator: Clinic
Receive STI screening in a clinical setting such as a private physician or clinic.
 Behavioral: Clinic screening

  Eligibility

Ages Eligible for Study:   14 Years to 45 Years
Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Participant in Contraceptive CHOICE cohort study
  • Using a long-acting reversible method of contraception
  • Completed baseline clinical survey in the Contraceptive CHOICE cohort study

Exclusion Criteria:

  • Living outside the United States at time of annual STI screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184157

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jeffrey Peipert, MD, PhD Washington University School of Medicine
  More Information

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jeffrey Peipert, MD PhD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01184157     History of Changes
Other Study ID Numbers: 07-0256
Study First Received: August 17, 2010
Last Updated: August 17, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chlamydia Infections
Gonorrhea
Sexually Transmitted Diseases
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
 Sexually Transmitted Diseases, Bacterial
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 22, 2013