NCT01654991

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

1.5 years

First QC Date

July 29, 2012

Last Update Submit

October 30, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of men who complete testing in each study arm

    12 weeks after enrollment

Study Arms (2)

Clinic-Based Testing

ACTIVE COMPARATOR

Clinic-based STD screening using self-obtained urine samples in a local university clinical setting.

Behavioral: Clinic Screening

Home-Based Testing

EXPERIMENTAL

Home-based STD screening using self-obtained urine samples and study paid postal return of samples.

Behavioral: Home Screening

Interventions

Home ScreeningBEHAVIORAL

Home-based STD screening using self-obtained urine samples and study paid postal return of samples.

Home-Based Testing

Clinic-based STD screening using self-obtained urine samples in a local university clinical setting.

Clinic-Based Testing

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Chlamydia InfectionsGonorrhea

Condition Hierarchy (Ancestors)

Chlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital DiseasesNeisseriaceae Infections

Study Officials

  • Jeffrey F Peipert, MD, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Robert J. Terry Professor

Study Record Dates

First Submitted

July 29, 2012

First Posted

August 1, 2012

Study Start

June 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations