Stage Matched Intervention to Increase Dual Method Use

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stage Matched Intervention to Increase Dual Method Use

Conditions
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Contraception, Sexually Transmitted Diseases, Pregnancy

Intervention / Treatment
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* Behavioral: Individualized Intervention
* Behavioral: Computer-based contraceptive information


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized Intervention: stage-matched/tailored counseling<br>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<br>* 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.<br>Behavioral: Computer-based contraceptive information<br>* Contraceptive method information is provided on a computer.<br>|
| Placebo Comparator: Control: Enhanced usual care counseling<br>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<br>* Contraceptive method information is provided on a computer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, behavior, risk reduction behavior