Community Health Worker Navigation to Support Mental Health
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, Riverside
- Study ID
- NCT07387146
- Status
- Recruiting
Conditions
- Service Utilization
- Stress
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 120 Years
- Healthy Volunteers
- Not accepted
Interventions
- Protocolized Promotora-Led Navigation — BEHAVIORALParticipants in this group will receive the CAPAZ protocolized navigation intervention, in which trained promotoras-supported by the Lead Study Navigator and the Principal Investigator (PI)-deliver structured, individualized health navigation. The intervention will follow a defined protocol that includes behavioral health screening, care coordination, and facilitated referrals to mental health services, primary care, and social-cultural or community resources as needed. The model also allows participants to integrate cultural and traditional healing practices into their care plan. Each participant will receive up to six promotora sessions over 12 weeks, focusing on improving access to care, stress reduction, and overall wellbeing.
Study Details
This pilot study tests the feasibility and preliminary impact of a protocolized promotora-led navigation intervention to improve behavioral health access among Latinx and Native American underserved adults. The study is embedded within a community cultural center, leveraging a trusted and culturally grounded environment for recruitment and intervention delivery. Participants will be randomized 1:1 to receive either the promotora navigation intervention or a treatment-as-usual (TAU) condition consisting of cultural resources and promotora-supported wait-list control. The TAU group will continue to receive any usual care during the study period and will be offered the protocolized navigation intervention after completing follow-up assessments. Primary outcomes include feasibility, acceptability, and preliminary changes in behavioral health access, stress reduction, self-efficacy, and wellbeing.
Key Dates
- Start date
- Apr 16, 2026
- Status verified
- Apr 2026
- Primary completion
- Feb 28, 2027
- Completion
- Sep 19, 2028
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- No Intervention: Wait-List Control Arm - Treatment as UsualPromotora Support for Cultural Healing Practices: Participants assigned to the wait-list control condition will receive standard promotora support as typically provided through CANA's Indigenous Peoples Cultural Arts Healing Center and the Native American Health Center (NAHC), which may include general health promotion, wellness education, and linkage to cultural healing resources. After completing the 12-week wait-list period and follow-up assessment, participants in this group will be offered the full CAPAZ protocolized navigation intervention.
- Experimental: Protocolized Promotora-Led Navigation
Primary Outcome Measure
Perceived Stress Scale (PSS-10) [ Time Frame: Baseline, Week 12, Week 24 ]
Central Contacts
- Jaime Smith951-827-0741
- Lisa Fortuna
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cultura Y Arte Nativa De Las Americas | San Francisco | California | 94110 |
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