Stage Matched Intervention to Increase Dual Method Use

Pregnancy Clinical Trial

— PROTECT  

Official title:

Stage Matched Intervention to Increase Dual Method Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436306
• Other study ID #: R01HD036663
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2007
• Last updated: October 6, 2015
• Start date: October 1999
• Est. completion date: December 2005

Study information

• Verified date: October 2015
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Protection from both sexually transmitted infections (STIs), human immunodeficiency virus (HIV), and unintended pregnancy can be achieved with the use of dual methods of contraception. This proposal was designed to develop, implement, and evaluate the impact of an innovative, computer-assisted stage-based individualized interactive intervention (Individualized Intervention) based on the transtheoretical compared to enhanced standard care counseling on the use of dual methods of contraception. Primary outcomes, including behavioral and biological outcomes, were assessed in this randomized clinical trial of 550 high-risk women. Participants were followed at 6 month intervals for 24 months with follow-up interviews to determine reported use of dual methods of contraception (behavioral outcome). Clinical examinations at 12 and 24 months and with new onset of symptoms assessed biological outcomes including incident or recurrent cases of STI and unintended pregnancy. Secondary outcomes included intermediate outcome variables such as changes in stage of change, processes of change, decisional balance, and self-efficacy. The primary hypotheses of this study were: 1. the Individualized Intervention will result in increased dual contraceptive use; 2. the Individualized Intervention will result in protection against new cases of STIs, re-infection with sexually transmitted organisms, and unplanned pregnancies; and 3. the Individualized Intervention will lead to the greatest changes in secondary outcome measures. If found to be effective, the stage-matched intervention has potential for widespread dissemination in schools, clinics, offices, and community centers to prevent STIs/HIV and unintended pregnancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 35 Years

Eligibility

Inclusion Criteria:

1. English-speaking

2. Sexually active with a male partner in the past 6 months

3. Desire to avoid conception for 24 months or more

4. 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

Exclusion Criteria:

1. currently using dual methods of contraception consistently and correctly.

2. incompetent or unable to give consent;

3. currently pregnant or desires pregnancy in the next 24 months.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception
• Pregnancy
• Sexually Transmitted Diseases

Intervention

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.
• Computer-based contraceptive information
Contraceptive method information is provided on a computer.

Locations

Country	Name	City	State
United States	Women & Infants Hospital	Providence	Rhode Island

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (10)

Allsworth 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. — View Citation

Allsworth 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. — View Citation

Krings 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. Ep — View Citation

Kuroki 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. — View Citation

Matteson 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. — View Citation

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. Epub 2007 Feb 7. — View Citation

Peipert 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. — View Citation

Peipert 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. Epub 2007 Aug 21. — View Citation

Peipert 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 infecti — View Citation

Peipert 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral: reported use of dual methods of contraception	Outcome: ANY use of dual methods of contraception.; Also evaluated consistent condom use.	24 months	No
Primary	Biological: incident sexually transmitted infection or unintended pregnancy	ANY sexually transmitted infection OR unintended pregnancy.	24 months	No
Secondary	Secondary outcomes will include intermediate outcomes variables such as	Secondary outcomes: ANY sexually transmitted infection; unplanned pregnancy; incident infection with Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, or pelvic inflammatory disease.	24 months	No
Secondary	changes in stage of change, processes of change, decisional balance, and self-efficacy.	Advancement through the stages of change, and changes in the processes of change, decisional balance, and self-efficacy.	24 months	No