Recruiting

Promotora Navigation

Sponsor:

UCLA

Code:

NCT07387146

Conditions

Stress

Service Utilization

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Protocolized Promotora-Led Navigation

Study Details

Brief summary:

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.

Conditions

Stress

Service Utilization

Study ID

NCT07387146

Start date

Apr 16, 2026

Status verified date

Apr, 2026

Completion date

Sep 19, 2028

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Are 18 years of age or older

  • Speak either English or Spanish
  • Report moderate or higher perceived stress, defined as scoring 14 or above on the Perceived Stress Scale (PSS)

Exclusion Criteria:

  • Score below 14 on the Perceived Stress Scale (PSS), indicating low perceived stress and ineligibility for enrollment.

Endorse suicidal ideation on PHQ-9 item 9 (any score > 0) and score at moderate to high risk on the Columbia Suicide Severity Rating Scale (C-SSRS) as assessed by the study psychiatrist/PI.

Report verbal or written suicidal ideation to any study team member. Exhibit any indication of suicidality or threats of harm to others reported or observed by research staff.

Score 16 or higher on the AUDIT, indicating severe alcohol use. Score 6 or higher on the DAST-10, indicating severe drug use. Arrive at screening intoxicated, impairing informed consent capacity or ability to participate.

Present to the screening or interview space with any of the following concerning clinical signs:

  • Marked emotional dysregulation such that engagement is not feasible
  • Significant physical dishevelment suggesting acute impairment
  • Apparent intoxication from alcohol or other substances
  • Possible hallucinations or other signs of psychosis
  • Any indication that psychological status may compromise safe participation Are unable to complete the screening process due to any of the above concerns (screening will be halted and the participant will be referred for appropriate support).

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Wait-List Control Arm - Treatment as Usual

Promotora 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

Interventions

Protocolized Promotora-Led Navigation

Participants 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.

Primary outcome measure

  • Perceived Stress Scale (PSS-10) [ Time Frame: Baseline, Week 12, Week 24 ]
  • Depression Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline, Week 12, Week 24 ]

Central Contacts and Locations

Central contacts

Jaime Smith

951-827-0741jaime.smith@medsch.ucr.edu

Lisa Fortuna

lisa.fortuna@medsch.ucr.edu

Locations

Cultura Y Arte Nativa De Las Americas

Recruiting

San Francisco, California, United States, 94110

Contacts

Jaime Smith

951-827-0741jaime.smith@medsch.ucr.edu

More Information

Sponsor

University of California, Riverside

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Riverside on 2026-05-04.