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: October 30, 2013
Last verified: October 2013
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Jeffrey F Peipert, MD, PhD Washington University School of Medicine