Stage Matched Intervention to Increase Dual Method Use
PROTECT
1 other identifier
interventional
550
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 1999
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 15, 2007
CompletedFirst Posted
Study publicly available on registry
February 19, 2007
CompletedOctober 8, 2015
October 1, 2015
6.2 years
February 15, 2007
October 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Behavioral: reported use of dual methods of contraception
Outcome: ANY use of dual methods of contraception. Also evaluated consistent condom use.
24 months
Biological: incident sexually transmitted infection or unintended pregnancy
ANY sexually transmitted infection OR unintended pregnancy.
24 months
Secondary Outcomes (2)
Secondary outcomes will include intermediate outcomes variables such as
24 months
changes in stage of change, processes of change, decisional balance, and self-efficacy.
24 months
Study Arms (2)
Individualized Intervention: stage-matched/tailored counseling
EXPERIMENTALIndividualized Intervention is a computer-based, stage-matched, tailored intervention to promote the use of dual methods of contraception for STD and unplanned pregnancy prevention.
Control: Enhanced usual care counseling
PLACEBO COMPARATORThe Enhanced Usual Care arm was the control group. It provided computer-based information regarding contraceptive methods, but was not individualized or tailored to the participant stage of change.
Interventions
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.
Contraceptive method information is provided on a computer.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women & Infants Hospital
Providence, Rhode Island, 02905, United States
Related Publications (10)
Peipert J, Redding CA, Blume J, Allsworth JE, Iannuccillo K, Lozowski F, Mayer K, Morokoff PJ, Rossi JS. Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT). Contemp Clin Trials. 2007 Sep;28(5):626-37. doi: 10.1016/j.cct.2007.01.012. Epub 2007 Feb 7.
PMID: 17374567BACKGROUNDMatteson KA, Peipert JF, Allsworth J, Phipps MG, Redding CA. Unplanned pregnancy: does past experience influence the use of a contraceptive method? Obstet Gynecol. 2006 Jan;107(1):121-7. doi: 10.1097/01.AOG.0000192170.16746.ea.
PMID: 16394049RESULTPeipert JF, Lapane KL, Allsworth JE, Redding CA, Blume JL, Lozowski F, Stein MD. Women at risk for sexually transmitted diseases: correlates of intercourse without barrier contraception. Am J Obstet Gynecol. 2007 Nov;197(5):474.e1-8. doi: 10.1016/j.ajog.2007.03.032. Epub 2007 Aug 21.
PMID: 17714677RESULTPeipert JF, Lapane KL, Allsworth JE, Redding CA, Blume JD, Stein MD. Bacterial vaginosis, race, and sexually transmitted infections: does race modify the association? Sex Transm Dis. 2008 Apr;35(4):363-7. doi: 10.1097/OLQ.0b013e31815e4179.
PMID: 18360319RESULTKrings KM, Matteson KA, Allsworth JE, Mathias E, Peipert JF. Contraceptive choice: how do oral contraceptive users differ from condom users and women who use no contraception? Am J Obstet Gynecol. 2008 May;198(5):e46-7. doi: 10.1016/j.ajog.2007.12.025. Epub 2008 Mar 7.
PMID: 18313637RESULTPeipert JF, Redding CA, Blume JD, Allsworth JE, Matteson KA, Lozowski F, Mayer KH, Morokoff PJ, Rossi JS. Tailored intervention to increase dual-contraceptive method use: a randomized trial to reduce unintended pregnancies and sexually transmitted infections. Am J Obstet Gynecol. 2008 Jun;198(6):630.e1-8. doi: 10.1016/j.ajog.2008.01.038. Epub 2008 Apr 8.
PMID: 18395692RESULTKuroki LM, Allsworth JE, Redding CA, Blume JD, Peipert JF. Is a previous unplanned pregnancy a risk factor for a subsequent unplanned pregnancy? Am J Obstet Gynecol. 2008 Nov;199(5):517.e1-7. doi: 10.1016/j.ajog.2008.03.049. Epub 2008 May 12.
PMID: 18468575RESULTAllsworth JE, Anand M, Redding CA, Peipert JF. Physical and sexual violence and incident sexually transmitted infections. J Womens Health (Larchmt). 2009 Apr;18(4):529-34. doi: 10.1089/jwh.2007.0757.
PMID: 19245303RESULTAllsworth JE, Peipert JF. Severity of bacterial vaginosis and the risk of sexually transmitted infection. Am J Obstet Gynecol. 2011 Aug;205(2):113.e1-6. doi: 10.1016/j.ajog.2011.02.060. Epub 2011 Feb 27.
PMID: 21514555RESULTPeipert JF, Zhao Q, Meints L, Peipert BJ, Redding CA, Allsworth JE. Adherence to dual-method contraceptive use. Contraception. 2011 Sep;84(3):252-8. doi: 10.1016/j.contraception.2011.01.023. Epub 2011 Apr 16.
PMID: 21843690RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey F Peipert, MD, MPH
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Robert J. Terry Professor
Study Record Dates
First Submitted
February 15, 2007
First Posted
February 19, 2007
Study Start
October 1, 1999
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
October 8, 2015
Record last verified: 2015-10