Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy

NCT ID: NCT03826342

Last Updated: 2025-05-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-16

Study Completion Date

2024-07-03

Brief Summary

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This proposed study is to test whether Health Check-up for Expectant Moms (HCEM), a computer-delivered screening and brief intervention (SBI) that simultaneously targets sexually transmitted infection (STI) risk and alcohol/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.

Detailed Description

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Conditions

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Sexually Transmitted Infection Alcohol Use Complicating the Puerperium Alcohol Use Complicating Pregnancy, Unspecified Trimester Drug Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Health Check-up for Expectant Moms

Theory-driven and derived from empirical support

Group Type EXPERIMENTAL

Health Check-up for Expectant Moms

Intervention Type BEHAVIORAL

A brief intervention (one session plus two booster sessions)

Time, attention, and information-matched control

Well-validated

Group Type ACTIVE_COMPARATOR

Time, attention, and information-matched control

Intervention Type BEHAVIORAL

We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity.

Interventions

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Health Check-up for Expectant Moms

A brief intervention (one session plus two booster sessions)

Intervention Type BEHAVIORAL

Time, attention, and information-matched control

We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* At least one unprotected vaginal (or anal) sex occasion in the past 30 days
* Having more than one male sex partner in the last 6 months and/or having uncertainty about current partner's monogamy.
* Pregnant
* Current alcohol/drug use risk.

Exclusion Criteria

* Unable to understand English
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Golfo Tzilos

Assistant Professor of Family Medicine and Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Golfo Tzilos Wernette

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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West Ann Arbor Health Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Tzilos Wernette G, Countryman K, Mmeje O, Ngo QM, Zlotnick C. Adapting to the Pandemic: Protocol of a Web-Based Perinatal Health Study to Improve Maternal and Infant Outcomes. JMIR Res Protoc. 2021 Sep 10;10(9):e30367. doi: 10.2196/30367.

Reference Type DERIVED
PMID: 34351867 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01HD093611-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00143896

Identifier Type: -

Identifier Source: org_study_id

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