NCT01184157

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.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2010

Completed
Last Updated

August 18, 2010

Status Verified

August 1, 2010

First QC Date

August 17, 2010

Last Update Submit

August 17, 2010

Conditions

ChlamydiaGonorrhea

Outcome Measures

Primary Outcomes (1)

  • Number of tests received

Study Arms (2)

Home

EXPERIMENTAL

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

Behavioral: Home screening

Clinic

ACTIVE COMPARATOR

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

Behavioral: Clinic screening

Interventions

Home screeningBEHAVIORAL
Home
Clinic screeningBEHAVIORAL
Clinic

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (1)

  • 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.

    PMID: 21099596DERIVED

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 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
OTHER

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 18, 2010

Last Updated

August 18, 2010

Record last verified: 2010-08

Locations

US(1)