Trial Outcomes & Findings for Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy (NCT NCT03826342)

NCT ID: NCT03826342

Last Updated: 2025-05-20

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 180 participants
• Primary outcome timeframe: Up to 6 months
• Results posted on: 2025-05-20

Participant Flow

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.

Participant milestones

Measure	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.	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)
Overall Study STARTED	88	88
Overall Study 2 Months	76	71
Overall Study 6 Month	59	54
Overall Study 6 Weeks Post Partum	77	68
Overall Study COMPLETED	77	72
Overall Study NOT COMPLETED	11	16

Reasons for withdrawal

Measure	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.	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)
Overall Study Withdrawal by Subject	1	8
Overall Study Lost to Follow-up	7	7
Overall Study Miscarriage - Loss of Eligibility to Participate	3	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Health Check-up for Expectant Moms n=88 Participants Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions)	Time, Attention, and Information-matched Control n=88 Participants 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.	Total n=176 Participants Total of all reporting groups
Age, Continuous	30.26 years STANDARD_DEVIATION 4.94 • n=5 Participants	30.08 years STANDARD_DEVIATION 5.13 • n=7 Participants	30.17 years STANDARD_DEVIATION 5.02 • n=5 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	88 Participants n=7 Participants	176 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants n=5 Participants	76 Participants n=7 Participants	159 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	27 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) White	61 Participants n=5 Participants	51 Participants n=7 Participants	112 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	88 Participants n=5 Participants	88 Participants n=7 Participants	176 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months

Population: Some participants did not attend the 2-month or 6-month assessments.

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.

Outcome measures

Measure	Health Check-up for Expectant Moms n=88 Participants Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions)	Time, Attention, and Information-matched Control n=88 Participants 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.
Unprotected Sexual Occasions (USOs) Baseline (past 90 days)	27.73 USOs per participant Standard Deviation 37.17	41.50 USOs per participant Standard Deviation 64.15
Unprotected Sexual Occasions (USOs) Baseline to 2-month assessment	8.68 USOs per participant Standard Deviation 8.46	14.70 USOs per participant Standard Deviation 17.61
Unprotected Sexual Occasions (USOs) 2-month assessment to 6-month assessment	11.02 USOs per participant Standard Deviation 16.09	19.78 USOs per participant Standard Deviation 27.89

PRIMARY outcome

Timeframe: Up to 6 months

Population: Some participants did not attend the 2-month or 6-month assessments.

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.

Outcome measures

Measure	Health Check-up for Expectant Moms n=88 Participants Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions)	Time, Attention, and Information-matched Control n=88 Participants 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.
Alcohol Use Measured by Timeline Follow-Back (TLFB) Baseline (past 90 days)	61 Participants	55 Participants
Alcohol Use Measured by Timeline Follow-Back (TLFB) Baseline to 2-month assessment	7 Participants	5 Participants
Alcohol Use Measured by Timeline Follow-Back (TLFB) 2-month to 6-month assessment	7 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to 6 months

Population: Some participants did not attend the 2-month or 6-month assessments.

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.

Outcome measures

Measure	Health Check-up for Expectant Moms n=88 Participants Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions)	Time, Attention, and Information-matched Control n=88 Participants 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.
Cannabis Use Measured by Timeline Follow-Back (TLFB) Baseline	25 Participants	37 Participants
Cannabis Use Measured by Timeline Follow-Back (TLFB) 2 month	7 Participants	12 Participants
Cannabis Use Measured by Timeline Follow-Back (TLFB) 6 month	6 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Health Check-up for Expectant Moms n=84 Participants Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions)	Time, Attention, and Information-matched Control n=78 Participants 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.
Sexually Transmitted Infections (STIs) Baseline	3 Participants	5 Participants
Sexually Transmitted Infections (STIs) Up to 6 weeks postpartum	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 6 weeks postpartum (up to 11 months)

Population: Not all participants participated in the postpartum follow-up assessment.

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.

Outcome measures

Measure	Health Check-up for Expectant Moms n=68 Participants Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions)	Time, Attention, and Information-matched Control n=77 Participants 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.
Unprotected Sexual Occasions (USOs) Postpartum	2.24 USOs per participant Standard Deviation 7.83	2.14 USOs per participant Standard Deviation 5.67

SECONDARY outcome

Timeframe: 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.

Birth weight of participants' babies was measured in grams.

Outcome measures

Measure	Health Check-up for Expectant Moms n=77 Participants Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions)	Time, Attention, and Information-matched Control n=77 Participants 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.
Birth Weight of Baby	3412.31 grams Standard Deviation 558.32	3244.86 grams Standard Deviation 605.82

SECONDARY outcome

Timeframe: 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.

Head circumference of participants' babies was measured in centimeters.

Outcome measures

Measure	Health Check-up for Expectant Moms n=77 Participants Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions)	Time, Attention, and Information-matched Control n=77 Participants 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.
Baby Head Circumference	34.41 Centimeters Standard Deviation 1.80	34.20 Centimeters Standard Deviation 2.13

SECONDARY outcome

Timeframe: 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.

Birth length of participants' babies was measured in centimeters.

Outcome measures

Measure	Health Check-up for Expectant Moms n=77 Participants Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions)	Time, Attention, and Information-matched Control n=77 Participants 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.
Baby Birth Length	50.38 Centimeters Standard Deviation 3.21	49.94 Centimeters Standard Deviation 3.51

SECONDARY outcome

Timeframe: 6 weeks postpartum (up to 11 months)

Population: Not all participants participated in the postpartum follow-up assessment.

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.

Outcome measures

Measure	Health Check-up for Expectant Moms n=88 Participants Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions)	Time, Attention, and Information-matched Control n=88 Participants 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.
Heavy Episodic Drinking Birth to 6 weeks postpartum	2 Participants	3 Participants
Heavy Episodic Drinking Baseline (90 days prior)	14 Participants	14 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Health Check-up for Expectant Moms n=88 Participants Theory-driven and derived from empirical support Health Check-up for Expectant Moms: A brief intervention (one session plus two booster sessions)	Time, Attention, and Information-matched Control n=88 Participants 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.
Estimated Cost-effectiveness of Health Check-up for Expectant Moms (HCEM)	3558 dollars per averted event Interval 2669.0 to 4448.0	3380 dollars per averted event Interval 2535.0 to 4225.0

Adverse Events

Health Check-up for Expectant Moms

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Time, Attention, and Information-matched Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Golfo Tzilos Wernette

University of Michigan

Phone: 734-988-3424

Email: gtzilos@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place