NCT04421586已完成不适用
VISTA: Vaccinator-Initiated Screening and TAilored Counseling for Reducing Vaccine Hesitancy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm
研究概览
简要总结
The purpose of this study is to understand why parents do or do not vaccinate their children and explore what information parents need to vaccinate their children. The study will test whether information about vaccinations provided during pregnancy by a health provider (VISTA intervention) may improve the possibility that a child is vaccinated on time.
详细描述
The study will be implemented in 10 health facility catchment areas in Mtwara region, Tanzania. The study sites will be non-randomly assigned to receive VISTA or usual care.
Only core messages were developed and evaluated in this study. Tailored messages will be developed and evaluated in a follow-up study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study outcomes will be measured for health providers implementing the intervention and pregnant women receiving the intervention. Up to 10 health workers (including community health workers (CHW) from each of the intervention sites will participate in the study.
- •To participate in the study,
- •Health workers must be:
- •18 years of age or older
- •Work in one of the study intervention sites
- •Women must be:
- •In the third trimester of pregnancy
- •Residing in a study site (intervention or control)
- •At least 15 years of age
- •Planning to reside in the study site for the duration of their participation in the study (until approximately 6 months after delivery to enable follow up).
- •Have at least 1 concern about childhood vaccines
排除标准
- •There are no exclusion criteria.
结局指标
主要结局
Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm
时间窗: Post-counseling (Baseline visit)
次要结局
- Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm(Follow-up (up to 6 months post-birth; up to 9 months post-baseline))
- Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) is Helpful(Baseline)
- Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Was Respectful(Baseline)
- Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Explained Things in Terms They Could Understand(Baseline)
- Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm(Follow-up (up to 6 months post-birth; up to 9 months post-baseline))
- Mean Number of Minutes Spent Delivering Counseling Per Woman in VISTA Intervention Arm(Baseline)
- Number of Women in the VISTA Intervention Arm Who Were Satisfied With Their Conversation With the Community Health Worker (CHW)(Baseline)
- Percentage of Checklist Items Completed During Counseling in VISTA Intervention Arm(Baseline)
- Percentage of Women With Reduced Number of Concerns in Intervention Versus Control Arms at Follow up.(Follow-up (up to 6 months post-birth; up to 9 months post-baseline))
- Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Helped Them Understand Why Children Needed Vaccines(Baseline)
- Number of Women in the VISTA Intervention Arm Who Say They Would Refer the CHW to Their Friends and Family(Baseline)
- Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) Reduced Their Concerns About Vaccinations(Baseline)
- Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Answered Most of Their Questions(Baseline)
- Number of Women in the VISTA Intervention Arm Who Say They Are Comfortable Vaccinating Their Child(Baseline)
- Number of Women in the VISTA Intervention Arm Who Say They Will Speak With the CHW Again(Baseline)
研究者
研究点 (1)
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