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Stage Matched Intervention to Increase Dual Method Use

NCT00436306 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2015-10-08

No results posted yet for this study

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.

Conditions

  • Contraception
  • Sexually Transmitted Diseases
  • Pregnancy

Interventions

BEHAVIORAL

Individualized Intervention

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.

BEHAVIORAL

Computer-based contraceptive information

Contraceptive method information is provided on a computer.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • Jeffrey F Peipert, MD, MPH · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-10-31
Primary Completion
2005-12-31
Completion
2005-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00436306 on ClinicalTrials.gov