Home Screening for Chlamydia Surveillance | NCT00177437

Studies
Home Screening for Chlamydia Surveillance

NCT00177437

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Dec 13, 2007Estimated

Enrollment

403

Phase

Phase 3

Conditions

Chlamydia Trachomatis
Gonorrhea

Interventions

home testing kit

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1999

Primary Completion Date

Not provided

Completion Date

Sep 2005Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2007

Last Update Posted Date

Dec 13, 2007Estimated

Name	Class
Agency for Healthcare Research and Quality (AHRQ)	FED

Description Module

Brief Summary

This is a randomized controlled trial to determine whether a home screening test for chlamydia and gonorrhea will lead to increased use of screening tests and increased detection of sexually transmitted diseases.

Detailed Description

This is a phase III randomized controlled trial. We enrolled 403 young women from a variety of clinical settings and neighborhoods in the Pittsburgh, PA region. Women completed a baseline questionnaire and then were randomized to either an intervention group (receive home testing kit every six months) or to a control group (receive a letter suggesting a clinic visit for screening). Participants were followed for 2 years, and medical chart abstraction was done to document tests done in clinical settings. The final study end points were number of tests completed, number of screening tests completed, number of STDs detected, and incident cases of pelvic inflammatory disease.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

403

Name	Type	Description	Arm Group Labels	Other Names
home testing kit	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
chlamydia and gonorrhea tests completed
chlamydia and gonorrhea infections detected

Secondary Outcomes

Measure	Description	Time Frame
pelvic inflammatory disease cases detected

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: age 15 to 29, 2 or more risk factors for STDs, sexually active -

Exclusion Criteria: currently pregnant, homeless

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

29 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roberta B Ness, MD, MPH	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh		Pittsburgh	Pennsylvania	15213	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17301105	Derived	Cook RL, Ostergaard L, Hillier SL, Murray PJ, Chang CC, Comer DM, Ness RB; DAISY study team. Home screening for sexually transmitted diseases in high-risk young women: randomised controlled trial. Sex Transm Infect. 2007 Jul;83(4):286-91. doi: 10.1136/sti.2006.023762. Epub 2007 Feb 14.

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses