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Randomized Trial of Home Versus Clinic-Based STD Testing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeffrey Peipert, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01654991
First received: July 29, 2012
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

This study randomizes St. Louis men to home-based STD screening or clinic-based STD screening. Home-based screening will be completed through the mail and clinic-based screening in a local clinical setting. We hypothesize that men 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: A Randomized Trial of Home Versus Clinic-Based STD Testing Among Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Number of men who complete testing in each study arm [ Time Frame: 12 weeks after enrollment ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clinic-Based Testing
Clinic-based STD screening using self-obtained urine samples in a local university clinical setting.
 Behavioral: Clinic Screening
Clinic-based STD screening using self-obtained urine samples in a local university clinical setting.
Experimental: Home-Based Testing
Home-based STD screening using self-obtained urine samples and study paid postal return of samples.
 Behavioral: Home Screening
Home-based STD screening using self-obtained urine samples and study paid postal return of samples.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men
  • Ages 18-45
  • Residing in St. Louis City or County
  • English-speaking

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654991

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jeffrey F Peipert, MD, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Jeffrey Peipert, Robert J. Terry Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01654991     History of Changes
Other Study ID Numbers: 201105031
Study First Received: July 29, 2012
Last Updated: July 29, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 16, 2013