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NCT01654991 Clinical Trial

Randomized Trial of Home Versus Clinic-Based STD Testing

Gonorrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01654991
Other study ID # 201105031
Secondary ID
Status Completed
Phase N/A
First received July 29, 2012
Last updated October 30, 2013
Start date June 2010
Est. completion date December 2011

Study information
Verified date October 2013
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Men

- Ages 18-45

- Residing in St. Louis City or County

- English-speaking

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Behavioral:
• Home Screening
Home-based STD screening using self-obtained urine samples and study paid postal return of samples.
• Clinic Screening
Clinic-based STD screening using self-obtained urine samples in a local university clinical setting.

Locations
Country Name City State
United States Washington University School of Medicine St. Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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):1311-8. doi: 10.1097/AOG.0b013e3181fae60d. — View 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):745-52. doi: 10.1097/AOG.0b013e3181d4450d. — View 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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of men who complete testing in each study arm 12 weeks after enrollment No
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