Reducing sexual health risks and substance use in the prenatal setting: A study protocol for a randomized controlled trial.

Journal: Contemporary clinical trials

Volume: 84

Issue: 

Year of Publication: 2020

Affiliated Institutions:  Department of Family Medicine, University of Michigan, Ann Arbor, MI , United States of America. Electronic address: gtzilos@med.umich.edu. Department of Family Medicine, University of Michigan, Ann Arbor, MI , United States of America. Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI , United States of America. Department of Emergency Medicine, University of Michigan, Ann Arbor, MI , United States of America. Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor, MI , United States of America. Department of Psychiatry and Human Behavior, Brown University, Providence, RI , United States of America; Women and Infants Hospital, Providence, RI , United States of America; Department of Psychiatry and Mental Health, University of Cape Town, South Africa.

Abstract summary 

Sexually transmitted infections (STIs) are at a record high in the United States, and STI risk is a critical and costly public health concern for childbearing women. STIs can lead to a number of serious health risks including premature birth, low birth weight, ectopic pregnancy, and fetal death. Similarly, there has been a dramatic increase in substance use during pregnancy, leading to complications during pregnancy and poorer birth outcomes. Women who misuse substances are disproportionately more likely to engage in risky sexual behaviors that can result in STIs. The proposed study will test whether the Health Check-Up for Expectant Moms (HCEM), a computer-delivered brief intervention that simultaneously targets STI risk and alcohol/illicit drug use during pregnancy, reduces antenatal and postpartum risk more than an attention, time, and information matched control condition among pregnant women seeking prenatal care. The study is a two-group, randomized controlled trial in which a diverse sample of 250 pregnant women will be recruited from prenatal care clinics and assigned to either (a) a computer-delivered, single-session brief intervention plus two booster sessions); or (b) a computer-delivered control condition. Follow-up assessments will occur at 2 and 6 months from baseline, and at 6 weeks postpartum. Our objective measures include STI incidence and birth outcomes. The results of this trial will fill a critical gap and provide much-needed data on the efficacy, costs, and resource utilization of a practical computer-delivered, brief motivational intervention tailored to reach high-risk women during pregnancy and extending impact to postpartum.

Authors & Co-authors:  Tzilos Wernette Golfo G Plegue Melissa M Mmeje Okeoma O Sen Ananda A Countryman Kristina K Ngo Quyen Q Prosser Lisa L Zlotnick Caron C

Study Outcome 

Source Link: Visit source

Statistics
Citations :  Centers for Disease Control and Prevention, STDs at Record High, Indicating Urgent Need for Prevention. Sexually Transmitted Disease Surveillance Report, 2017.
Authors :  8
Identifiers
Doi : 10.1016/j.cct.2019.105827
SSN : 1559-2030
Study Population
Women
Mesh Terms
Adolescent
Other Terms
Alcohol;Computer delivered brief intervention;Drug use;Pregnancy;Sexual health
Study Design
Randomized Control Trial,Case Control Trial,Cross Sectional Study
Study Approach
Country of Study
Publication Country
United States