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


Journal

Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342

Informations de publication

Date de publication:
09 2019
Historique:
received: 20 05 2019
revised: 06 08 2019
accepted: 11 08 2019
pubmed: 17 8 2019
medline: 24 10 2020
entrez: 17 8 2019
Statut: ppublish

Résumé

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.

Identifiants

pubmed: 31419607
pii: S1551-7144(19)30542-7
doi: 10.1016/j.cct.2019.105827
pmc: PMC6721968
mid: NIHMS1537698
pii:
doi:

Types de publication

Clinical Trial Protocol Journal Article Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

105827

Subventions

Organisme : NICHD NIH HHS
ID : R01 HD093611
Pays : United States

Informations de copyright

Copyright © 2019 Elsevier Inc. All rights reserved.

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Auteurs

Golfo Tzilos Wernette (G)

Department of Family Medicine, University of Michigan, Ann Arbor, MI 48104, United States of America. Electronic address: gtzilos@med.umich.edu.

Melissa Plegue (M)

Department of Family Medicine, University of Michigan, Ann Arbor, MI 48104, United States of America.

Okeoma Mmeje (O)

Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI 48104, United States of America.

Ananda Sen (A)

Department of Family Medicine, University of Michigan, Ann Arbor, MI 48104, United States of America.

Kristina Countryman (K)

Department of Family Medicine, University of Michigan, Ann Arbor, MI 48104, United States of America.

Quyen Ngo (Q)

Department of Emergency Medicine, University of Michigan, Ann Arbor, MI 48109, United States of America.

Lisa Prosser (L)

Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor, MI 48104, United States of America.

Caron Zlotnick (C)

Department of Psychiatry and Human Behavior, Brown University, Providence, RI 02906, United States of America; Women and Infants Hospital, Providence, RI 02906, United States of America; Department of Psychiatry and Mental Health, University of Cape Town, South Africa.

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