NCT06438549 · Loma Linda University
Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation
(SFHOPE)
What this study is about
This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County.
View original scientific description
This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County.
Interventions
BEHAVIORAL
HCP-CHW Integration into Prenatal Care for Smoking Cessation
CHWs will be integrated into primary care, and subjects will receive CHW home visits (up to 8) that will provide brief behavioral smoking cessation interventions before, during, and after a quit date. This brief behavioral intervention will include watching a video and reviewing self-help materials.
OTHER
Control Arm
Standard of Care which provides referrals to community-based smoking cessation resources.
Primary outcome measures
Self-Report Tobacco Abstinence
Time frame: Change between baseline enrollment and 1 month postpartum visit, typically ten months
The 7 Day Point Prevalence Abstinence (PPA) questionnaire will be administered to subjects to assess the following: Tobacco use within past seven days
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \< 24 weeks pregnant
- age \> 18 years,
- current smokers (100 cigarettes in their lifetime and \>3 cigarettes per day in the last 7 days; including poly-tobacco use, combining cigarettes with non-combustible products) confirmed by expired carbon monoxide (CO)
- willing to quit smoking and set a quit date in the next 2 weeks upon enrolling
- enrolled in prenatal care at Loma Linda University Health (LLUH) or Riverside University Health System (RUHS)
Exclusion criteria
- severe mental health problems that prevent informed consent and/or CHW intervention
- women who were on Nicotine Replacement Therapy (NRT) or enrolled in a cessation program within 30 days
- unwillingness to participate in audio-recorded key informant interviews or focus groups
Where
- Loma Linda, California
- Moreno Valley, California
Collaborators
University of California, San Francisco, Riverside University Health System Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations