Motivate Vaccinate Activate: An Effectiveness-Implementation Trial to Assess the Impact of a Multi-Component Community-Based Intervention to Increase RSV Vaccine Uptake Among Latino Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Motivate Aim Primary Outcome - RSV Vaccine Uptake
研究概览
简要总结
In collaboration with community-based organizations, this study will focus on increasing RSV vaccine use among Latinos. The study will determine how effective community health worker counseling and text-message approaches are to (1) increase RSV vaccine use among older adults (Motivate phase) and (2) encourage younger adults to discuss RSV vaccination with their older friends and family members (Activate phase).
详细描述
In this type 1 hybrid-implementation study, the investigators will utilize a well-established community-academic partnership to achieve multiple aims. In the Motivate phase, the study will randomize 400 Latino older adults to community health worker (CHW) counseling and text message nudges vs. CHW delivered RSV vaccine vs. text-message nudges alone. The primary outcome in the Motivate phase is RSV vaccine uptake. In the Activate phase, using a parallel design, investigators will randomize 350 Latino adults (18-49 years) to CHW 'activation' counseling to encourage them to discuss RSV vaccine with people over 50 and older in their network plus text-message nudges, vs. text-message nudges alone. The primary outcome for the Activate phase is the average proportion of older adults in participants' social network with whom they discussed RSV vaccination. Interventions in both phases will be adapted using community-based participatory research principles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Motivate Aim Inclusion Criteria:
- •Age 50 years or older
- •Self-identify as Latino/a/x and/or indigenous groups from Latin America
- •Eligible for RSV vaccination per current CDC/ACIP recommendations
- •Fluent in Spanish or English
- •Has not received the RSV vaccine
- •Has a cell phone
- •Lives or works in San Francisco or Daly City
- •Able to provide informed consent
- •Motivate Aim
排除标准
- •Intent to move outside of San Francisco or Daly City in the next year
- •Nursing home resident
- •Household member participating in Aim 1 or 2
- •Unable to provide consent
- •Motivate Aim Inclusion Criteria:
- •Age 18-49 years
- •Self-identify as Latino/a/x and/or indigenous groups from Latin America
- •Fluent in English or Spanish
- •Has >1 family member or friend 50 years or older who they have seen or spoken to for >15 minutes in the last 6 months and who lives in the United States
- •Activate Trial Exclusion Criteria:
- •Household member enrolled in Aim 1 or 2
- •Unable to provide consent
研究组 & 干预措施
Motivate Aim: CHW text message reminders and counseling
干预措施: Motivate Aim: CHW text message reminders and counseling (Behavioral)
Motivate Aim: CHW text message reminders only
干预措施: Motivate Aim: CHW text message reminders only (Behavioral)
Activate Aim: CHW text message reminders and counseling
干预措施: Activate Aim: CHW text message reminders and counseling (Behavioral)
Activate Aim: CHW text message reminders only
干预措施: Activate Aim: CHW text message reminders only (Behavioral)
结局指标
主要结局
Motivate Aim Primary Outcome - RSV Vaccine Uptake
时间窗: 60 days from study enrollment
RSV vaccine uptake at 60 days per California Immunization Registry (CAIR) or per medical record
Activate Aim Primary Outcome - Proportion of Contacts with whom RSV Vaccination Discussed
时间窗: 60 days after study enrollment
Self-reported average proportion of social network contacts 50 years or older with whom participant discussed RSV vaccination at 60 days
次要结局
未报告次要终点