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Randomized Trial of Home Versus Clinic-Based STD Testing

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ClinicalTrials.gov Identifier: NCT01654991
Recruitment Status : Completed
First Posted : August 1, 2012
Last Update Posted : November 1, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Chlamydia Gonorrhea Behavioral: Home Screening Behavioral: Clinic Screening

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Randomized Trial of Home Versus Clinic-Based STD Testing Among Men
Study Start Date : June 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Number of men who complete testing in each study arm [ Time Frame: 12 weeks after enrollment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654991


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Jeffrey F Peipert, MD, PhD Washington University School of Medicine
More Information

Publications:
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
First Posted: August 1, 2012    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

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