CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 550 enrolled
Drug / intervention
Individualized Intervention +1 morebehavioral
Likely dose
Not stated in record
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Search/NCT00436306
NCT00436306Phase 4Completed

Stage Matched Intervention to Increase Dual Method Use

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·interventional·Posted Feb 19, 2007·Updated Oct 8, 2015

In Brief

A Phase 4 clinical trial evaluating Individualized Intervention and Computer-based contraceptive information for Contraception and 2 related conditions. Completed, enrolled 550 participants across 1 site.

Detailed Summary

The primary purpose of Project PROTECT was to evaluate two different intervention approaches that encourage young women to use dual methods of contraception. The individualized intervention is a computer assisted, fully-tailored, interactive intervention based on the transtheoretical model of behavior change. This intervention was compared to an enhanced standard care intervention that provided computer-based, non-tailored information and advice regarding the use of contraceptive methods. The two primary outcomes of this trial include: 1) a behavioral outcome: the reported use of dual methods of contraception; and 2) a biological outcome: an incident or recurrent STI or unintended pregnancy. The hypotheses of this trial were: 1) the individualized intervention will result in a greater increase in dual contraceptive use than the standard care approach; and 2) the individualized intervention would result in greater protection against incident or recurrent cases of sexually transmitted infections and unplanned pregnancies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 19, 2007
Enrollment StartOct 1, 1999
Primary CompletionDec 1, 2005
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 19.4 years ago

Interventions

Individualized Interventionbehavioral

Individualized Intervention is a computer-based, stage-matched, tailored intervention to promote the use of dual methods of contraception for STD and unplanned pregnancy prevention.

Computer-based contraceptive informationbehavioral

Contraceptive method information is provided on a computer.