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

This study has been completed.

Sponsor:

Information provided by:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT01184157

First received: August 17, 2010

Last updated: NA

Last verified: August 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

August 17, 2010

Last Updated Date

August 17, 2010

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Number of tests received [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections in Long-Acting Reversible Contraceptive Users

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Chlamydia
Gonorrhea

Intervention ^ICMJE

Behavioral: Home screening
Behavioral: Clinic screening

Study Arm (s)

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

Intervention: Behavioral: Home screening
Active Comparator: Clinic
Receive STI screening in a clinical setting such as a private physician or clinic.

Intervention: Behavioral: Clinic screening

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

14 Years to 45 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01184157

Other Study ID Numbers ^ICMJE

07-0256

Has Data Monitoring Committee

Responsible Party

Jeffrey Peipert, MD PhD, Washington University School of Medicine

Study Sponsor ^ICMJE

Washington University School of Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jeffrey Peipert, MD, PhD

Washington University School of Medicine

Information Provided By

Washington University School of Medicine

Verification Date

August 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top