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Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections

Primary Purpose

Chlamydia, Gonorrhea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home screening
Clinic screening
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Chlamydia

Eligibility Criteria

14 Years - 45 Years (Child, Adult)Female

Inclusion Criteria:

  • Participant in Contraceptive CHOICE cohort study
  • Using a long-acting reversible method of contraception
  • Completed baseline clinical survey in the Contraceptive CHOICE cohort study

Exclusion Criteria:

  • Living outside the United States at time of annual STI screening

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home

Clinic

Arm Description

Home-based STI screening using self-obtained vaginal swabs and postal return of samples.

Receive STI screening in a clinical setting such as a private physician or clinic.

Outcomes

Primary Outcome Measures

Number of tests received

Secondary Outcome Measures

Full Information

First Posted
August 17, 2010
Last Updated
August 17, 2010
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01184157
Brief Title
Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections
Official Title
Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections in Long-Acting Reversible Contraceptive Users
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study randomizes women using long-acting reversible methods of contraception to home-based STD screening through the mail compared to screening available in a clinical setting. We hypothesize that women 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

8. Arms, Groups, and Interventions

Arm Title
Home
Arm Type
Experimental
Arm Description
Home-based STI screening using self-obtained vaginal swabs and postal return of samples.
Arm Title
Clinic
Arm Type
Active Comparator
Arm Description
Receive STI screening in a clinical setting such as a private physician or clinic.
Intervention Type
Behavioral
Intervention Name(s)
Home screening
Intervention Type
Behavioral
Intervention Name(s)
Clinic screening
Primary Outcome Measure Information:
Title
Number of tests received

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Eligibility Criteria
Inclusion Criteria: Participant in Contraceptive CHOICE cohort study Using a long-acting reversible method of contraception Completed baseline clinical survey in the Contraceptive CHOICE cohort study Exclusion Criteria: Living outside the United States at time of annual STI screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey 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
63108
Country
United States

12. IPD Sharing Statement

Citations:
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
derived

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Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections

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