Back to resultsRandomized Trial of Home Versus Clinic-Based STD Testing
Primary Purpose
Chlamydia, Gonorrhea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Screening
Clinic Screening
Sponsored by
About this trial
This is an interventional screening trial for Chlamydia
Eligibility Criteria
Inclusion Criteria:
- Men
- Ages 18-45
- Residing in St. Louis City or County
- English-speaking
Exclusion Criteria:
-
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Clinic-Based Testing
Home-Based Testing
Arm Description
Clinic-based STD screening using self-obtained urine samples in a local university clinical setting.
Home-based STD screening using self-obtained urine samples and study paid postal return of samples.
Outcomes
Primary Outcome Measures
Number of men who complete testing in each study arm
Secondary Outcome Measures
Full Information
NCT ID
NCT01654991
First Posted
July 29, 2012
Last Updated
October 30, 2013
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT01654991
Brief Title
Randomized Trial of Home Versus Clinic-Based STD Testing
Official Title
A Randomized Trial of Home Versus Clinic-Based STD Testing Among Men
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydia, Gonorrhea
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinic-Based Testing
Arm Type
Active Comparator
Arm Description
Clinic-based STD screening using self-obtained urine samples in a local university clinical setting.
Arm Title
Home-Based Testing
Arm Type
Experimental
Arm Description
Home-based STD screening using self-obtained urine samples and study paid postal return of samples.
Intervention Type
Behavioral
Intervention Name(s)
Home Screening
Intervention Description
Home-based STD screening using self-obtained urine samples and study paid postal return of samples.
Intervention Type
Behavioral
Intervention Name(s)
Clinic Screening
Intervention Description
Clinic-based STD screening using self-obtained urine samples in a local university clinical setting.
Primary Outcome Measure Information:
Title
Number of men who complete testing in each study arm
Time Frame
12 weeks after enrollment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men
Ages 18-45
Residing in St. Louis City or County
English-speaking
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey F Peipert, MD, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20308834
Citation
Graseck AS, Secura GM, Allsworth JE, Madden T, Peipert JF. Home screening compared with clinic-based screening for sexually transmitted infections. Obstet Gynecol. 2010 Apr;115(4):745-752. doi: 10.1097/AOG.0b013e3181d4450d.
Results Reference
result
PubMed Identifier
21099596
Citation
Graseck AS, Secura GM, Allsworth JE, Madden T, Peipert JF. Home compared with clinic-based screening for sexually transmitted infections: a randomized controlled trial. Obstet Gynecol. 2010 Dec;116(6):1311-1318. doi: 10.1097/AOG.0b013e3181fae60d.
Results Reference
result
PubMed Identifier
21124216
Citation
Shih SL, Graseck AS, Secura GM, Peipert JF. Screening for sexually transmitted infections at home or in the clinic? Curr Opin Infect Dis. 2011 Feb;24(1):78-84. doi: 10.1097/QCO.0b013e32834204a8.
Results Reference
result
Learn more about this trial
Randomized Trial of Home Versus Clinic-Based STD Testing
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