Sexually Transmitted InfectionNCT03826342

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

A study testing Health Check-up for Expectant Moms in people with Sexually Transmitted Infection and Alcohol Use Complicating the Puerperium, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Sexually Transmitted Infection, Alcohol Use Complicating the Puerperium, Alcohol Use Complicating Pregnancy, Unspecified Trimester
What is being tested?: Health Check-up for Expectant Moms
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteUnited States
Study dates: 16 Apr 2019to 3 Jul 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Unable to understand English

Trial locations and contacts

1 site in 1 country.

United States1 site

West Ann Arbor Health Center
Ann Arbor, Michigan, 48104

Other trials in United States

About this study

Conditions: Sexually Transmitted Infection, Alcohol Use Complicating the Puerperium, Alcohol Use Complicating Pregnancy, Unspecified Trimester, Drug Use
Being tested: Health Check-up for Expectant Moms, Time, attention, and information-matched control
Medical subject headings: Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Health Check-up for Expectant MomsBehavioural
A brief intervention (one session plus two booster sessions)
Time, attention, and information-matched controlBehavioural
We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity.

Study groups in NCT03826342
Study group	Role	What they receive
Health Check-up for Expectant Moms	Experimental	Theory-driven and derived from empirical support Receives: Behavioral: Health Check-up for Expectant Moms
Time, attention, and information-matched control	Active comparator	Well-validated Receives: Behavioral: Time, attention, and information-matched control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months

Secondary outcomes (7)

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.
Measured: Baseline to 6 weeks postpartum (up to 11 months)
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.
Measured: 6 weeks postpartum (up to 11 months)
Birth Weight of Baby
Birth weight of participants' babies was measured in grams.
Measured: 6 weeks postpartum (up to 11 months)
Baby Head Circumference
Head circumference of participants' babies was measured in centimeters.
Measured: 6 weeks postpartum (up to 11 months)
Baby Birth Length
Birth length of participants' babies was measured in centimeters.
Measured: 6 weeks postpartum (up to 11 months)
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.
Measured: 6 weeks postpartum (up to 11 months)
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.
Measured: 6 weeks post-partum (up to 11 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Apr 20193 Jul 2024

First posted1 Feb 2019
Study start16 Apr 2019
Primary completion8 Mar 2024
Study completion3 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Sexually Transmitted InfectionStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03826342
Sponsor's protocol ID: HUM00143896
Other IDs: 1R01HD093611-01A1
Status last verified: May 2025
First submitted: 30 Jan 2019
Last updated: 20 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The study team does not currently have a plan to share data. However, the team is currently in discussion about sharing data and will update the registration as needed.

Publications

Tzilos Wernette G, Sen A, Chen D, Countryman K, Mmeje O, Ngo QM, Gold KJ, Kahler CW, Zlotnick C. A Web-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy: Randomized Controlled Trial. J Med Internet Res. 2026 Jul 8;28:e95944. doi: 10.2196/95944.
PubMed 42418232
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.
PubMed 34351867

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sexually Transmitted Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy
ClinicalTrials.gov ID: NCT03826342
Acronym / sponsor ID: HUM00143896
Conditions: Sexually Transmitted Infection, Alcohol Use Complicating the Puerperium, Alcohol Use Complicating Pregnancy, Unspecified Trimester, Drug Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 16 Apr 2019 (actual)
Primary completion: 8 Mar 2024 (actual)
Study completion: 3 Jul 2024 (actual)
First posted: 1 Feb 2019 (actual)
Results: Posted 20 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Health Check-up for Expectant Moms	Experimental	Behavioral: Health Check-up for Expectant MomsTheory-driven and derived from empirical support
Time, attention, and information-matched control	Active comparator	Behavioral: Time, attention, and information-matched controlWell-validated

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (1 listed)

Unable to understand English

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Health Check-up for Expectant MomsA brief intervention (one session plus two booster sessions)	Behavioural	Health Check-up for Expectant Moms
Time, attention, and information-matched controlWe will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity.	Behavioural	Time, attention, and information-matched control

Primary outcome

Unprotected Sexual Occasions (USOs)
Time frame: 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)
Time frame: 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)
Time frame: 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.

7 secondary outcomes

Sexually Transmitted Infections (STIs)
Time frame: Baseline to 6 weeks postpartum (up to 11 months)
Unprotected Sexual Occasions (USOs) Postpartum
Time frame: 6 weeks postpartum (up to 11 months)
Birth Weight of Baby
Time frame: 6 weeks postpartum (up to 11 months)
Baby Head Circumference
Time frame: 6 weeks postpartum (up to 11 months)
Baby Birth Length
Time frame: 6 weeks postpartum (up to 11 months)
Heavy Episodic Drinking
Time frame: 6 weeks postpartum (up to 11 months)
Estimated Cost-effectiveness of Health Check-up for Expectant Moms (HCEM)
Time frame: 6 weeks post-partum (up to 11 months)

Results and safety

Results posted to the registry on 20 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Health Check-up for Expectant Moms	88	72
Time, Attention, and Information-matched Control	88	77

Primary outcome: Unprotected Sexual Occasions (USOs)

Time frame: Up to 6 months. Mean (Standard Deviation). Unit: USOs per participant

Measure	Health Check-up for Expectant Moms n = 88	Time, Attention, and Information-matched Control n = 88
Baseline (past 90 days)	27.73 (37.17)	41.50 (64.15)
Baseline to 2-month assessment	8.68 (8.46)	14.70 (17.61)
2-month assessment to 6-month assessment	11.02 (16.09)	19.78 (27.89)

Health Check-up for Expectant Moms vs Time, Attention, and Information-matched Control: p = 0.2964, Generalized linear mixed model analysis
Health Check-up for Expectant Moms vs Time, Attention, and Information-matched Control: p = 0.3404, generalized linear mixed model analysis

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

Primary outcome: Alcohol Use Measured by Timeline Follow-Back (TLFB)

Time frame: Up to 6 months. Count of participants. Unit: Participants

Measure	Health Check-up for Expectant Moms n = 88	Time, Attention, and Information-matched Control n = 88
Baseline (past 90 days)	61	55
Baseline to 2-month assessment	7	5
2-month to 6-month assessment	7	2

Health Check-up for Expectant Moms vs Time, Attention, and Information-matched Control: p = 0.7915, Generalized linear mixed model analysis
Health Check-up for Expectant Moms vs Time, Attention, and Information-matched Control: p = 0.2131, generalized linear mixed model analysis

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

Primary outcome: Cannabis Use Measured by Timeline Follow-Back (TLFB)

Time frame: Up to 6 months. Count of participants. Unit: Participants

Measure	Health Check-up for Expectant Moms n = 88	Time, Attention, and Information-matched Control n = 88
Baseline	25	37
2 month	7	12
6 month	6	3

Health Check-up for Expectant Moms vs Time, Attention, and Information-matched Control: p = 0.8357, Generalized linear mixed model analysis
Health Check-up for Expectant Moms vs Time, Attention, and Information-matched Control: p = 0.0950, generalized linear mixed model analysis

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

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Health Check-up for Expectant Moms	0 of 88 (0%)	0 of 88 (0%)	0 of 88
Time, Attention, and Information-matched Control	0 of 88 (0%)	0 of 88 (0%)	0 of 88

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42418232Tzilos Wernette G, Sen A, Chen D, Countryman K, Mmeje O, Ngo QM, Gold KJ, Kahler CW, Zlotnick C. A Web-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy: Randomized Controlled Trial. J Med Internet Res. 2026 Jul 8;28:e95944. doi: 10.2196/95944.
Derived from this study: PubMed 34351867Tzilos 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.
Individual participant dataSharing planned: No. The study team does not currently have a plan to share data. However, the team is currently in discussion about sharing data and will update the registration as needed.

Related trials for Sexually Transmitted Infection

Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Golfo Tzilos Wernette principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Health Check-up for Expectant Moms in people with Sexually Transmitted Infection and Alcohol Use Complicating the Puerperium, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unprotected Sexual Occasions (USOs) (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03826342, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.