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.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Research Project (R01)
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Study Section
Special Emphasis Panel (ZHD1-DRG-A (05))
Program Officer
Newcomer, Susan
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Women and Infants Hospital-Rhode Island
United States
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Allsworth, Jenifer E; Peipert, Jeffrey F (2011) Severity of bacterial vaginosis and the risk of sexually transmitted infection. Am J Obstet Gynecol 205:113.e1-6
Peipert, Jeffrey F; Zhao, Qiuhong; Meints, Laura et al. (2011) Adherence to dual-method contraceptive use. Contraception 84:252-8
Allsworth, Jenifer E; Anand, Mallika; Redding, Colleen A et al. (2009) Physical and sexual violence and incident sexually transmitted infections. J Womens Health (Larchmt) 18:529-34
Peipert, Jeffrey F; Redding, Colleen A; Blume, Jeffrey D et al. (2008) Tailored intervention to increase dual-contraceptive method use: a randomized trial to reduce unintended pregnancies and sexually transmitted infections. Am J Obstet Gynecol 198:630.e1-8
Kuroki, Lindsay M; Allsworth, Jenifer E; Redding, Colleen A et al. (2008) Is a previous unplanned pregnancy a risk factor for a subsequent unplanned pregnancy? Am J Obstet Gynecol 199:517.e1-7
Peipert, Jeffrey F; Lapane, Kate L; Allsworth, Jenifer E et al. (2008) Bacterial vaginosis, race, and sexually transmitted infections: does race modify the association? Sex Transm Dis 35:363-7
Krings, Katherine M; Matteson, Kristen A; Allsworth, Jenifer E et al. (2008) Contraceptive choice: how do oral contraceptive users differ from condom users and women who use no contraception? Am J Obstet Gynecol 198:e46-7
Peipert, Jeffrey F; Lapane, Kate L; Allsworth, Jenifer E et al. (2007) Women at risk for sexually transmitted diseases: correlates of intercourse without barrier contraception. Am J Obstet Gynecol 197:474.e1-8
Peipert, Jeffrey; Redding, Colleen A; Blume, Jeffrey et al. (2007) Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT). Contemp Clin Trials 28:626-37