Document Detail

Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT).
MedLine Citation:
PMID:  17374567     Owner:  NLM     Status:  MEDLINE    
This manuscript describes the randomized clinical trial titled Stage-Matched Intervention to Increase Dual Method Use or Project PROTECT. Project PROTECT compared two approaches to promote the use of dual methods of contraception among high-risk women. The intervention arm received tailored individualized feedback based on the Transtheoretical Model of Behavior Change using a computer-based multimedia program. The control arm received general information on contraception. The primary outcomes of this trial were 1) self-reported use of dual methods of contraception and 2) the biological outcomes of an unintended pregnancy or an incident or recurrent sexually transmitted disease. In this report, we describe the significance and background of the problem, the specific aims of the study, study organization, patient selection, randomization, outcome variables, data collection, procedures used for follow-up and testing, primary and secondary outcomes, and statistical analyses. We also describe participant characteristics and procedures used to assure patient safety and trial monitoring.
Jeffrey Peipert; Colleen A Redding; Jeffrey Blume; Jenifer E Allsworth; Karen Iannuccillo; Faye Lozowski; Kenneth Mayer; Patricia J Morokoff; Joseph S Rossi
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural     Date:  2007-02-07
Journal Detail:
Title:  Contemporary clinical trials     Volume:  28     ISSN:  1551-7144     ISO Abbreviation:  Contemp Clin Trials     Publication Date:  2007 Sep 
Date Detail:
Created Date:  2007-08-13     Completed Date:  2007-10-19     Revised Date:  2014-06-06    
Medline Journal Info:
Nlm Unique ID:  101242342     Medline TA:  Contemp Clin Trials     Country:  United States    
Other Details:
Languages:  eng     Pagination:  626-37     Citation Subset:  IM    
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MeSH Terms
Contraception / methods*,  psychology
Contraception Behavior
Multicenter Studies as Topic
Pregnancy, Unplanned
Research Design*
Risk Factors
Sexually Transmitted Diseases / prevention & control
Socioeconomic Factors
Statistics as Topic
Treatment Outcome
Grant Support
1R01-HD36663-01/HD/NICHD NIH HHS; K24 HD01298-03/HD/NICHD NIH HHS; R01 HD036663/HD/NICHD NIH HHS

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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