Alcohol Use Complicating Pregnancy, Unspecified Trimester, Alcohol Use Complicating the Puerperium, Drug Use, Sexually Transmitted Infection
Conditions
Brief summary
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.
Interventions
BEHAVIORALHealth Check-up for Expectant Moms
A brief intervention (one session plus two booster sessions)
BEHAVIORALTime, 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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unprotected Sexual Occasions (USOs) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baby Head Circumference | 6 weeks postpartum (up to 11 months) | Head circumference of participants' babies was measured in centimeters. |
| Baby Birth Length | 6 weeks postpartum (up to 11 months) | Birth length of participants' babies was measured in centimeters. |
| Sexually Transmitted Infections (STIs) | Baseline to 6 weeks postpartum (up to 11 months) | STIs were measured using urine samples or home vaginal swabs testing kits, which were collected at the baseline assessment and 6 weeks postpartum. Results reflect participants whose results came back with positive results for any STI. |
| Estimated Cost-effectiveness of Health Check-up for Expectant Moms (HCEM) | 6 weeks post-partum (up to 11 months) | Cost-effectiveness was measured in US dollars (USD) and was evaluated as the incremental cost-effectiveness ratio (ICER) that considers the difference in the mean total costs and the difference in health outcomes and events between the two arms. Results reflect the cost-effectiveness evaluation based on estimated costs per case of unprotected sexual occasion averted, alcohol or illicit drug use averted, and sexually transmitted infection (STI) event averted. To develop a plausible full range, a 25% variation of the estimated mean in each arm was used. All participants who were randomized were included in the analysis for this outcome measure. |
| Heavy Episodic Drinking | 6 weeks postpartum (up to 11 months) | Heavy episodic drinking was defined as consumption of 4 or more standard alcoholic drinks during a single day. Participants were asked if they had engaged in any heavy episodic drinking 90 days prior to baseline assessment and from the period from birth to 6 weeks postpartum. Participants' responses could only be Yes or No. Results reflect the participants who responded Yes. |
| Unprotected Sexual Occasions (USOs) Postpartum | 6 weeks postpartum (up to 11 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 from the period of birth up to 6 weeks postpartum. |
| Birth Weight of Baby | 6 weeks postpartum (up to 11 months) | Birth weight of participants' babies was measured in grams. |
Countries
United States
Participant flow
Pre-assignment details
180 participants were consented. 4 withdrew from the trial prior to randomization. Since the primary study outcome included measures at the baseline, 2-month follow-up, and 6-month follow-up assessments, a participant was deemed as completing the study if they completed the baseline visit and the 2-month follow-up visit or the 6-month follow-up visit.
Participants by arm
| Arm | Count |
|---|---|
| Health Check-up for Expectant Moms Theory-driven and derived from empirical support
Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions) | 88 |
| Time, Attention, and Information-matched Control Well-validated
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. | 88 |
| Total | 176 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 7 |
| Overall Study | Miscarriage - Loss of Eligibility to Participate | 1 | 3 |
| Overall Study | Withdrawal by Subject | 8 | 1 |
Baseline characteristics
| Characteristic | Health Check-up for Expectant Moms | Total | Time, Attention, and Information-matched Control |
|---|---|---|---|
| Age, Continuous | 30.26 years STANDARD_DEVIATION 4.94 | 30.17 years STANDARD_DEVIATION 5.02 | 30.08 years STANDARD_DEVIATION 5.13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 17 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants | 159 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 45 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) White | 61 Participants | 112 Participants | 51 Participants |
| Region of Enrollment United States | 88 Participants | 176 Participants | 88 Participants |
| Sex: Female, Male Female | 88 Participants | 176 Participants | 88 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 0 / 88 |
| other Total, other adverse events | 0 / 88 | 0 / 88 |
| serious Total, serious adverse events | 0 / 88 | 0 / 88 |
Outcome results
Primary
Alcohol Use Measured by Timeline Follow-Back (TLFB)
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.
Time frame: Up to 6 months
Population: Some participants did not attend the 2-month or 6-month assessments.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Check-up for Expectant Moms | Alcohol Use Measured by Timeline Follow-Back (TLFB) | Baseline (past 90 days) | 61 Participants |
| Health Check-up for Expectant Moms | Alcohol Use Measured by Timeline Follow-Back (TLFB) | Baseline to 2-month assessment | 7 Participants |
| Health Check-up for Expectant Moms | Alcohol Use Measured by Timeline Follow-Back (TLFB) | 2-month to 6-month assessment | 7 Participants |
| Time, Attention, and Information-matched Control | Alcohol Use Measured by Timeline Follow-Back (TLFB) | Baseline (past 90 days) | 55 Participants |
| Time, Attention, and Information-matched Control | Alcohol Use Measured by Timeline Follow-Back (TLFB) | Baseline to 2-month assessment | 5 Participants |
| Time, Attention, and Information-matched Control | Alcohol Use Measured by Timeline Follow-Back (TLFB) | 2-month to 6-month assessment | 2 Participants |
Comparison: Baseline to 2-month assessmentp-value: 0.7915Generalized linear mixed model analysis
Comparison: 2-month assessment to 6-month assessmentp-value: 0.2131generalized linear mixed model analysis
Primary
Cannabis Use Measured by Timeline Follow-Back (TLFB)
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.
Time frame: Up to 6 months
Population: Some participants did not attend the 2-month or 6-month assessments.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Check-up for Expectant Moms | Cannabis Use Measured by Timeline Follow-Back (TLFB) | Baseline | 25 Participants |
| Health Check-up for Expectant Moms | Cannabis Use Measured by Timeline Follow-Back (TLFB) | 2 month | 7 Participants |
| Health Check-up for Expectant Moms | Cannabis Use Measured by Timeline Follow-Back (TLFB) | 6 month | 6 Participants |
| Time, Attention, and Information-matched Control | Cannabis Use Measured by Timeline Follow-Back (TLFB) | Baseline | 37 Participants |
| Time, Attention, and Information-matched Control | Cannabis Use Measured by Timeline Follow-Back (TLFB) | 2 month | 12 Participants |
| Time, Attention, and Information-matched Control | Cannabis Use Measured by Timeline Follow-Back (TLFB) | 6 month | 3 Participants |
Comparison: Baseline to 2-month assessmentp-value: 0.8357Generalized linear mixed model analysis
Comparison: 2-month assessment to 6-month assessmentp-value: 0.095generalized linear mixed model analysis
Primary
Unprotected Sexual Occasions (USOs)
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.
Time frame: Up to 6 months
Population: Some participants did not attend the 2-month or 6-month assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Check-up for Expectant Moms | Unprotected Sexual Occasions (USOs) | Baseline to 2-month assessment | 8.68 USOs per participant | Standard Deviation 8.46 |
| Health Check-up for Expectant Moms | Unprotected Sexual Occasions (USOs) | 2-month assessment to 6-month assessment | 11.02 USOs per participant | Standard Deviation 16.09 |
| Health Check-up for Expectant Moms | Unprotected Sexual Occasions (USOs) | Baseline (past 90 days) | 27.73 USOs per participant | Standard Deviation 37.17 |
| Time, Attention, and Information-matched Control | Unprotected Sexual Occasions (USOs) | Baseline (past 90 days) | 41.50 USOs per participant | Standard Deviation 64.15 |
| Time, Attention, and Information-matched Control | Unprotected Sexual Occasions (USOs) | Baseline to 2-month assessment | 14.70 USOs per participant | Standard Deviation 17.61 |
| Time, Attention, and Information-matched Control | Unprotected Sexual Occasions (USOs) | 2-month assessment to 6-month assessment | 19.78 USOs per participant | Standard Deviation 27.89 |
Comparison: Baseline to 2-month assessmentp-value: 0.2964Generalized linear mixed model analysis
Comparison: 2-month assessment to 6-month assessmentp-value: 0.3404generalized linear mixed model analysis
Secondary
Baby Birth Length
Birth length of participants' babies was measured in centimeters.
Time frame: 6 weeks postpartum (up to 11 months)
Population: Birth length data was collected from EMRs and paper records, regardless of whether the participant completed the 6 Weeks Post Partum visit or not, which is why the Overall Number of Participants Analyzed is different than the Participant Flow. Data from some participants could not be collected because it was missing from the EMR or the participant did not consent to the release of the information. Additionally, data from twins was not included to avoid confounding the results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Check-up for Expectant Moms | Baby Birth Length | 50.38 Centimeters | Standard Deviation 3.21 |
| Time, Attention, and Information-matched Control | Baby Birth Length | 49.94 Centimeters | Standard Deviation 3.51 |
p-value: 0.4302t-test, 2 sided
Secondary
Baby Head Circumference
Head circumference of participants' babies was measured in centimeters.
Time frame: 6 weeks postpartum (up to 11 months)
Population: Birth head circumference data was collected from EMRs and paper records, regardless of whether the participant completed the 6 Weeks Post Partum visit or not, which is why the Overall Number of Participants Analyzed is different than the Participant Flow. Data from some participants could not be collected because it was missing from the EMR or the participant did not consent to the release of the information. Additionally, data from twins was not included to avoid confounding the results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Check-up for Expectant Moms | Baby Head Circumference | 34.41 Centimeters | Standard Deviation 1.8 |
| Time, Attention, and Information-matched Control | Baby Head Circumference | 34.20 Centimeters | Standard Deviation 2.13 |
p-value: 0.535t-test, 2 sided
Secondary
Birth Weight of Baby
Birth weight of participants' babies was measured in grams.
Time frame: 6 weeks postpartum (up to 11 months)
Population: Birth weight data was collected from EMRs at the participating sites, regardless of whether the participant completed the 6 Weeks Post Partum visit or not, which is why the Overall Number of Participants Analyzed is different than the Participant Flow. Data from some participants could not be collected because it was missing from the EMR or the participant did not consent to the release of the information. Additionally, data from twins was not included to avoid confounding the results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Check-up for Expectant Moms | Birth Weight of Baby | 3412.31 grams | Standard Deviation 558.32 |
| Time, Attention, and Information-matched Control | Birth Weight of Baby | 3244.86 grams | Standard Deviation 605.82 |
p-value: 0.0765t-test, 2 sided
Secondary
Estimated Cost-effectiveness of Health Check-up for Expectant Moms (HCEM)
Cost-effectiveness was measured in US dollars (USD) and was evaluated as the incremental cost-effectiveness ratio (ICER) that considers the difference in the mean total costs and the difference in health outcomes and events between the two arms. Results reflect the cost-effectiveness evaluation based on estimated costs per case of unprotected sexual occasion averted, alcohol or illicit drug use averted, and sexually transmitted infection (STI) event averted. To develop a plausible full range, a 25% variation of the estimated mean in each arm was used. All participants who were randomized were included in the analysis for this outcome measure.
Time frame: 6 weeks post-partum (up to 11 months)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Health Check-up for Expectant Moms | Estimated Cost-effectiveness of Health Check-up for Expectant Moms (HCEM) | 3558 dollars per averted event |
| Time, Attention, and Information-matched Control | Estimated Cost-effectiveness of Health Check-up for Expectant Moms (HCEM) | 3380 dollars per averted event |
Secondary
Heavy Episodic Drinking
Heavy episodic drinking was defined as consumption of 4 or more standard alcoholic drinks during a single day. Participants were asked if they had engaged in any heavy episodic drinking 90 days prior to baseline assessment and from the period from birth to 6 weeks postpartum. Participants' responses could only be Yes or No. Results reflect the participants who responded Yes.
Time frame: 6 weeks postpartum (up to 11 months)
Population: Not all participants participated in the postpartum follow-up assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Check-up for Expectant Moms | Heavy Episodic Drinking | Baseline (90 days prior) | 14 Participants |
| Health Check-up for Expectant Moms | Heavy Episodic Drinking | Birth to 6 weeks postpartum | 2 Participants |
| Time, Attention, and Information-matched Control | Heavy Episodic Drinking | Baseline (90 days prior) | 14 Participants |
| Time, Attention, and Information-matched Control | Heavy Episodic Drinking | Birth to 6 weeks postpartum | 3 Participants |
p-value: 0.807generalized linear mixed model analysis
Secondary
Sexually Transmitted Infections (STIs)
STIs were measured using urine samples or home vaginal swabs testing kits, which were collected at the baseline assessment and 6 weeks postpartum. Results reflect participants whose results came back with positive results for any STI.
Time frame: Baseline to 6 weeks postpartum (up to 11 months)
Population: Not all participants provided a urine sample or home vaginal swab for testing due to a national shortage on STI tests during the COVID-19 pandemic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Check-up for Expectant Moms | Sexually Transmitted Infections (STIs) | Baseline | 3 Participants |
| Health Check-up for Expectant Moms | Sexually Transmitted Infections (STIs) | Up to 6 weeks postpartum | 1 Participants |
| Time, Attention, and Information-matched Control | Sexually Transmitted Infections (STIs) | Up to 6 weeks postpartum | 3 Participants |
| Time, Attention, and Information-matched Control | Sexually Transmitted Infections (STIs) | Baseline | 5 Participants |
p-value: 0.7496generalized linear mixed model analysis
Secondary
Unprotected Sexual Occasions (USOs) Postpartum
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 from the period of birth up to 6 weeks postpartum.
Time frame: 6 weeks postpartum (up to 11 months)
Population: Not all participants participated in the postpartum follow-up assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Check-up for Expectant Moms | Unprotected Sexual Occasions (USOs) Postpartum | 2.24 USOs per participant | Standard Deviation 7.83 |
| Time, Attention, and Information-matched Control | Unprotected Sexual Occasions (USOs) Postpartum | 2.14 USOs per participant | Standard Deviation 5.67 |
p-value: 0.4492generalized linear mixed model analysis