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Stage Matched Intervention to Increase Dual Method Use (PROTECT)

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ClinicalTrials.gov Identifier: NCT00436306
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Jeffrey Peipert, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Condition or disease Intervention/treatment Phase
Contraception Sexually Transmitted Diseases Pregnancy Behavioral: Individualized Intervention Behavioral: Computer-based contraceptive information Phase 4

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Stage Matched Intervention to Increase Dual Method Use
Study Start Date : October 1999
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Individualized Intervention: stage-matched/tailored counseling
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: 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.
Placebo Comparator: Control: Enhanced usual care counseling
The 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.
Behavioral: Computer-based contraceptive information
Contraceptive method information is provided on a computer.



Primary Outcome Measures :
  1. Behavioral: reported use of dual methods of contraception [ Time Frame: 24 months ]

    Outcome: ANY use of dual methods of contraception.

    Also evaluated consistent condom use.


  2. Biological: incident sexually transmitted infection or unintended pregnancy [ Time Frame: 24 months ]
    ANY sexually transmitted infection OR unintended pregnancy.


Secondary Outcome Measures :
  1. Secondary outcomes will include intermediate outcomes variables such as [ Time Frame: 24 months ]
    Secondary outcomes: ANY sexually transmitted infection; unplanned pregnancy; incident infection with Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, or pelvic inflammatory disease.

  2. changes in stage of change, processes of change, decisional balance, and self-efficacy. [ Time Frame: 24 months ]
    Advancement through the stages of change, and changes in the processes of change, decisional balance, and self-efficacy.



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Ages Eligible for Study:   13 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436306


Locations
United States, Rhode Island
Women & Infants Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Jeffrey F Peipert, MD, MPH Washington University School of Medicine

Publications of Results:

Other Publications:
Responsible Party: Jeffrey Peipert, Robert J. Terry Professor, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00436306     History of Changes
Other Study ID Numbers: R01HD036663 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015

Keywords provided by Jeffrey Peipert, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
prevention
behavior
risk reduction behavior

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs