Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation (SFHOPE)

Loma Linda University (LLU)

Status: Enrolling

Conditions: Tobacco Use Cessation; Tobacco Use in Childbirth; Tobacco Use

Treatments: Behavioral: HCP-CHW Integration into Prenatal Care for Smoking Cessation; Other: Control Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT06438549

T32KT4784 (Other Grant/Funding Number)

5220112

Details and patient eligibility

About

This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County.

Full description

This study seeks to address the disparities in the maternal smoking cessation outcomes of previous research by developing an innovative maternal tobacco cessation program that expands the outreach by integrating home visits by community health workers (CHW) into the prenatal healthcare model. The overall aim is to conduct a pilot randomized control trial to test the feasibility, acceptability, and efficacy of a Healthcare Provider-Community Health Worker (HCP-CHW) intervention model that expands outreach by adding eight home visits by CHWs to provide tobacco cessation support services before and after the quit date.

Enrollment: 105 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Integrated HCP-CHW Intervention Arm

Experimental group

Description:

CHW visit with brief tobacco cessation intervention.

Treatment:

Behavioral: HCP-CHW Integration into Prenatal Care for Smoking Cessation

Control arm

Other group

Description:

Standard of Care

Treatment:

Other: Control Arm