Home Screening for Chlamydia Surveillance
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | December 12, 2007 | ||||
| Start Date ICMJE | June 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00177437 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
pelvic inflammatory disease cases detected | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Home Screening for Chlamydia Surveillance | ||||
| Official Title ICMJE | Home Screening for Chlamydia Surveillance | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: home testing kit | ||||
| Study Arm (s) | |||||
| Publications * | 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. Epub 2007 Feb 14. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 403 | ||||
| Completion Date | September 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: age 15 to 29, 2 or more risk factors for STDs, sexually active - Exclusion Criteria: currently pregnant, homeless - |
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| Gender | Female | ||||
| Ages | 15 Years to 29 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00177437 | ||||
| Other Study ID Numbers ICMJE | 0404024 | ||||
| Has Data Monitoring Committee | |||||
| Responsible Party | |||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||
| Collaborators ICMJE | Agency for Healthcare Research and Quality (AHRQ) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||
| Verification Date | December 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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