Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Unprotected Sexual Occasions (USOs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •Current alcohol/drug use risk.
排除标准
- •Unable to understand English
结局指标
主要结局
Unprotected Sexual Occasions (USOs)
时间窗: Up to 6 months
USOs were instances of sexual intercourse where neither partner utilized any form of contraception. Participants were assessed using Timeline Follow-Back (TLFB), a calendar assisted structured interview that provided a way to cue memory so that accurate recall was enhanced for event-level data. TLFB has been used to assess sexual risk-taking. Participants were asked to provide the number of USOs experienced 90 days prior to baseline assessment, between baseline assessment and 2-month follow up, and from 2-month follow up to 6-month follow up.
Alcohol Use Measured by Timeline Follow-Back (TLFB)
时间窗: Up to 6 months
Alcohol use was measured by the TLFB. Participants were asked if they had consumed any standard alcoholic drinks 90 days prior to baseline assessment, between baseline assessment and 2-month follow up, and from 2-month follow up to 6-month follow up. Participants' responses could only be Yes or No. Results reflect the participants who responded Yes.
Cannabis Use Measured by Timeline Follow-Back (TLFB)
时间窗: Up to 6 months
Cannabis use was measured by the TLFB. Participants were asked if they had used or consumed any cannabis 90 days prior to baseline assessment, between baseline assessment and 2-month follow up, and from 2-month follow up to 6-month follow up. Participants' responses could only be Yes or No. Results reflect the participants who responded Yes.
次要结局
- Sexually Transmitted Infections (STIs)(Baseline to 6 weeks postpartum (up to 11 months))
- Unprotected Sexual Occasions (USOs) Postpartum(6 weeks postpartum (up to 11 months))
- Birth Weight of Baby(6 weeks postpartum (up to 11 months))
- Baby Head Circumference(6 weeks postpartum (up to 11 months))
- Baby Birth Length(6 weeks postpartum (up to 11 months))
- Heavy Episodic Drinking(6 weeks postpartum (up to 11 months))
- Estimated Cost-effectiveness of Health Check-up for Expectant Moms (HCEM)(6 weeks post-partum (up to 11 months))
研究者
Golfo Tzilos
Assistant Professor of Family Medicine and Assistant Professor of Psychiatry
University of Michigan