Randomized Trial of Home Versus Clinic-Based STD Testing

October 30, 2013 updated by: Jeffrey Peipert, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

A Randomized Trial of Home Versus Clinic-Based STD Testing Among Men

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of men who complete testing in each study arm
Time Frame: 12 weeks after enrollment
12 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 29, 2012

First Submitted That Met QC Criteria

July 29, 2012

First Posted (Estimate)

August 1, 2012

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 30, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201105031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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