STAGE MATCHED INTERVENTION TO INCREASE DUAL METHOD USE

Women And Infants Hospital-Rhode Island, Providence RI

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Abstract

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 is designed to develop, implement, and evaluate the impact of an innovative, computer-assisted stage-based individualized interactive intervention (Individualized Intervention) based on the transtheoretical model compared to enhanced standard care counseling on the use of dual methods of contraception. This randomized clinical trial of 400 high- risk women will assess behavioral and biological primary outcomes. Women will be 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 will assess biological outcomes including incident or recurrent cases of STI and unintended pregnancy. Secondary outcomes will include intermediate outcomes variables such as changes in stage of change, processes of change, decisional balance, and self- efficacy. The primary hypotheses of this study are: 1. the Individualized Intervention will result in increased dual contraceptive use; 2. the Individualized Intervention will result in protection against new cases of STIs, reinfection with sexually transmitted organisms, and unplanned pregnancies; and 3. the Individualized Intervention will lead to the greatest changes in secondary outcome measures. Comparisons among the primary outcomes will be made according to the intention-to-treat principle using time to event (survival) curve analysis with the Kaplan-Meier nonparametric estimator and the log rank statistic. 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.