Effectiveness of a Mobile-based HIV Prevention Intervention Involving Incentive Policy for Doctors in Liangshan, China
2022年6月6日 更新者：Yu Sun、Peking University
Effectiveness of a Mobile-based HIV Prevention Intervention for Rural and Low-income Population Involving Incentive Policy for Doctors in Liangshan, China: a Randomized Controlled Trial Protocol
This study will be carried out in Liangshan Yi Autonomous Prefecture, Sichuan province, China, using a single-blinded randomized controlled trial design to measure the effects of a mobile-based HIV-related information intervention on group HIV/AIDS prevention.
Village doctors will be responsible for sending the HIV-related health education information to the participants.
The aim of this study is to develop a generalizable, effective, acceptable, and convenient mobile-based information intervention model to improve HIV-related knowledge, attitudes, practices, and health outcomes in poverty-stricken areas in China and measure the impact of incentive policies on the work of village doctors in Liangshan, China.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (预期的)
4000
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Guoen Liu
- 电话号码：13901359157
- 邮箱：gordonliu@nsd.pku.edu.cn
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- aged 18 years or older
- has mobile phone with internet service
- has and use WeChat and TikTok account regularly
- willing to provide informed consent
- speak Mandarin Chinese or Yi ethnic group's language
Exclusion Criteria:
- diagnosed with psychiatric disorders
- diagnosed with severe cognitive impairment
- diagnosed with severe physical disabilities
- has already attended or is currently attending another intervention program
- plan on moving out of Liangshan in the 18-month study period
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Mobile-based intervention with standardized incentive
Participants will receive biweekly messages containing HIV-related educational modules from village doctors who will receive standardized compensation for performing the work.
|
HIV/AIDS awareness-raising and behavior-related cyclic messages will be delivered by the village doctors on a biweekly basis for 18 months.
|
|
实验性的：Mobile-based intervention with performance-based incentive
Participants will receive biweekly messages containing HIV-related educational modules from village doctors who will receive performance-based compensation for performing the work.
|
HIV/AIDS awareness-raising and behavior-related cyclic messages will be delivered by the village doctors on a biweekly basis for 18 months.
village doctors in Intervention A and B will receive different types of monetary compensation.
Doctors in Intervention A will receive standardized compensation for completing their assigned tasks.
Doctors in Intervention B will receive performance-based compensation whose amount depends on how well the participants perform on the follow-up questionnaires.
|
|
无干预：Control without intervention
Participants will not receive the mobile-based intervention
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HIV-related knowledge improvement
大体时间：18 months
|
Result will be obtained by calculating weighted scores for the indicators in the HIV Knowledge Questionnaire 18 (HIV-KQ-18) to represent the participants' and their family members' level of knowledge measured by the baseline and follow-up questionnaires.
The HIV-KQ-18 is a self-administered 18-item questionnaire; the possible scores range from 0 to 18, with 0-9 representing low HIV-related knowledge and 10-18 representing high HIV-related knowledge.
|
18 months
|
|
Comparison of the effectiveness of different financial compensations
大体时间：18 months
|
The research team will compare the two interventions to determine what type of financial reward, standardized compensation or participant performance-based compensation, is more effective at incentivizing village doctors to deliver and promote the intervention content.
|
18 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Effectiveness of secondary knowledge transmission: HIV-related knowledge improvement of the participants' family members
大体时间：18 months
|
The research team will examine the path of secondary knowledge transmission to the participants' family members by having the family members complete the HIV Knowledge Questionnaire 18 (HIV-KQ-18).
The HIV-KQ-18 is a self-administered 18-item questionnaire; the possible scores range from 0 to 18, with 0-9 representing low HIV-related knowledge and 10-18 representing high HIV-related knowledge.
|
18 months
|
|
Behavioral changes: condom use
大体时间：18 months
|
Assess the changes in participants' condom use via the Condoms Use Self-Efficacy Scale (CUSES), a 28-item self-reporting questionnaire using a 5-point scale scoring system in which 0 represents strongly disagree and 4 represents strongly agree.
|
18 months
|
|
Behavioral changes: substance use
大体时间：18 months
|
Assess the severity, frequency and change of participants' substance use via the Drug and Abuse Screening Test (DAST), a 10-item questionnaire with scores range from 0 to 10; 0-2 representing low substance use and 9-10 representing severe substance use.
|
18 months
|
|
Health outcomes: HIV prevalence
大体时间：18 months
|
Will be collecting regional data on HIV prevalence through collaboration with local departments.
|
18 months
|
|
Health outcomes: mental health
大体时间：18 months
|
Assessed via the use of the Primary Care Evaluation of Mental Disorders (PRIME-MD) patient questionnaire, a self-reporting questionnaire consisting of 26 yes/no questions about the presence of various symptoms of different mental disorders.
|
18 months
|
|
Health outcomes: all-cause mortality
大体时间：18 months
|
Will be collecting regional data on all-cause mortality through collaboration with local departments.
|
18 months
|
|
Social factors: quality of life
大体时间：18 months
|
Measured via the use of EQ-5D-3L, a questionnaire comprised of 5 questions and a visual analogue scale to assess the participants' health-related quality of life.
Each question has three possible answers corresponding to three levels of perceived problems.
Level 1 indicates no problem and level 3 indicates extreme problems.
The visual analogue scale is numbered from 0 to 100, with 0 representing "the worst health you can imagine" and 100 representing "the best health you can imagine"
|
18 months
|
|
Social factors: stigma towards HIV
大体时间：18 months
|
Assessed via the use of the Internalized AIDS-Related Stigma Scale, a 6-item scale that offers a binary (yes/no) response to every item and the scores is computed as the sums of the items with 6 representing high stigmatization and 0 representing low stigmatization.
|
18 months
|
|
Social factors: perception of social support
大体时间：18 months
|
Assess participants' social support in the community via the use of the Medical Outcomes Study Social Support Survey (MOS-SS), a self-reporting 19-item survey.
The mean score of the 19 items will be calculated and transferred onto a 0-100 scale with higher scores indicating more support.
|
18 months
|
|
Retention of HIV-related knowledge
大体时间：18 months
|
Measured by the HIV Knowledge Questionnaire 18 (HIV-KQ-18).
The research team will ask all participants to complete the questionnaire every six months after the intervention period and compare their new scores with their previous score to examine their ability to recall information from the educational modules.
The HIV-KQ-18 is a self-administered 18-item questionnaire; the possible scores range from 0 to 18, with 0-9 representing low HIV-related knowledge and 10-18 representing high HIV-related knowledge.
|
18 months
|
|
Feasibility: participants' use of social media applications
大体时间：18 months
|
Feasibility of the intervention will be calculated by dividing the number of people who can use WeChat and TikTok by the total number of people living in the area.
|
18 months
|
|
Level of engagement
大体时间：18 months
|
Measured by an original engagement and attendance scale.
Participants will choose from a range 1 to 6, with 1 representing non-engaging and 6 representing highly engaging.
|
18 months
|
|
Study's acceptability and satisfaction
大体时间：18 months
|
Assessed via an original 15-item questionnaire with rating scales (6 is Highly Satisfied and 1 is Highly Unsatisfied).
Participants will be asked to rate and provide feedback on the intervention's content and method, including the effectiveness of the HIV-related knowledge modules, the time and method of information delivery, village doctors' attitude and competence, the design of the entire experimental intervention process, and more.
|
18 months
|
|
Cost-effectiveness of the intervention:
大体时间：18 months
|
Data on the intervention's direct and indirect costs will be collected.
Direct cost involves labor costs, research-related travel expenses, and village doctors' and participants' financial compensations.
Indirect cost consists of the expenses on cell phone internet data.
The date will then be used to evaluate the cost-effectiveness of both interventions.
|
18 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Guoen Liu、Peking University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2023年1月1日
初级完成 (预期的)
2024年12月1日
研究完成 (预期的)
2025年12月1日
研究注册日期
首次提交
2021年7月24日
首先提交符合 QC 标准的
2021年8月14日
首次发布 (实际的)
2021年8月20日
研究记录更新
最后更新发布 (实际的)
2022年6月9日
上次提交的符合 QC 标准的更新
2022年6月6日
最后验证
2022年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
HIV爱滋病的临床试验
-
Duke UniversityThe University of Hong Kong; Oxford University Clinical Research Unit, Vietnam; National Hospital... 和其他合作者主动，不招人
-
Shanghai Pharmaceuticals Holding Co., Ltd完全的
-
VA Eastern Colorado Health Care SystemPublic Health Grant Program, Veterans Health Administration Office of Public Health完全的
-
Hospital Clinic of Barcelona完全的
-
Rajavithi Hospital未知研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的免疫状态 | 研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的 HIV 病毒载量泰国
-
National Institute of Allergy and Infectious Diseases...完全的HIV-1 感染 | HIV抗体 | 中和抗体 | 病毒载量 | 单克隆抗体美国
-
AIDS Healthcare FoundationUniversity of California, Los Angeles完全的
-
ANRS, Emerging Infectious DiseasesInstitut National de la Santé Et de la Recherche Médicale, France; University of Bergen; Centre... 和其他合作者完全的