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Completed

NCT Number: NCT00436306

Stage Matched Intervention to Increase Dual Method Use

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.

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Key information

Age range

13 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Individualized Intervention

Behavioral

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

Behavioral

Contraceptive method information is provided on a computer.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Acronym: PROTECT

Important dates

Study start
1999
Primary completion
2005
Study completion
2005
First posted
Feb 19, 2007
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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