Stage Matched Intervention to Increase Dual Method Use
Condition: Contraception; Sexually Transmitted Diseases; Pregnancy
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Individualized Intervention; Computer-based contraceptive information
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Intervention MeSH terms: Contraceptive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prevention; behavior; risk reduction behavior