Stage Matched Intervention to Increase Dual Method Use

Completed · Phase 4

Conditions studied: Contraception, Sexually Transmitted Diseases, Pregnancy

In brief

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.

Key facts

Study ID

NCT00436306

Run by

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

People needed

550

Starts

1999-10-01

Expected to finish

2005-12-01

Last updated by the study team

2015-10-08

Who can join

Age: 13 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• English-speaking
• Sexually active with a male partner in the past 6 months
• Desire to avoid conception for 24 months or more
• High risk for unintended pregnancy or STI:
• Age less than 25
• Age 25 and older with:
• History of unplanned pregnancy
• History of a sexually transmitted infection
• Inconsistent use of contraception
• Other factors felt to place a patient at above average risk for unplanned pregnancy or STI

You may not qualify if…

• currently using dual methods of contraception consistently and correctly.
• incompetent or unable to give consent;
• currently pregnant or desires pregnancy in the next 24 months.

Where it is running

• Women & Infants Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.