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Effectiveness of a Mobile-based HIV Prevention Intervention Involving Incentive Policy for Doctors in Liangshan, China

Primary Purpose

HIV/AIDS

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile-based HIV-related educational message delivery
Incentive policies evaluation
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Mobile-based intervention with standardized incentive

    Mobile-based intervention with performance-based incentive

    Control without intervention

    Arm Description

    Participants will receive biweekly messages containing HIV-related educational modules from village doctors who will receive standardized compensation for performing the work.

    Participants will receive biweekly messages containing HIV-related educational modules from village doctors who will receive performance-based compensation for performing the work.

    Participants will not receive the mobile-based intervention

    Outcomes

    Primary Outcome Measures

    HIV-related knowledge improvement
    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.
    Comparison of the effectiveness of different financial compensations
    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.

    Secondary Outcome Measures

    Effectiveness of secondary knowledge transmission: HIV-related knowledge improvement of the participants' family members
    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.
    Behavioral changes: condom use
    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.
    Behavioral changes: substance use
    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.
    Health outcomes: HIV prevalence
    Will be collecting regional data on HIV prevalence through collaboration with local departments.
    Health outcomes: mental health
    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.
    Health outcomes: all-cause mortality
    Will be collecting regional data on all-cause mortality through collaboration with local departments.
    Social factors: quality of life
    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"
    Social factors: stigma towards HIV
    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.
    Social factors: perception of social support
    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.
    Retention of HIV-related knowledge
    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.
    Feasibility: participants' use of social media applications
    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.
    Level of engagement
    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.
    Study's acceptability and satisfaction
    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.
    Cost-effectiveness of the intervention:
    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.

    Full Information

    First Posted
    July 24, 2021
    Last Updated
    June 6, 2022
    Sponsor
    Peking University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05015062
    Brief Title
    Effectiveness of a Mobile-based HIV Prevention Intervention Involving Incentive Policy for Doctors in Liangshan, China
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV/AIDS

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    4000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mobile-based intervention with standardized incentive
    Arm Type
    Experimental
    Arm Description
    Participants will receive biweekly messages containing HIV-related educational modules from village doctors who will receive standardized compensation for performing the work.
    Arm Title
    Mobile-based intervention with performance-based incentive
    Arm Type
    Experimental
    Arm Description
    Participants will receive biweekly messages containing HIV-related educational modules from village doctors who will receive performance-based compensation for performing the work.
    Arm Title
    Control without intervention
    Arm Type
    No Intervention
    Arm Description
    Participants will not receive the mobile-based intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mobile-based HIV-related educational message delivery
    Intervention Description
    HIV/AIDS awareness-raising and behavior-related cyclic messages will be delivered by the village doctors on a biweekly basis for 18 months.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Incentive policies evaluation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    HIV-related knowledge improvement
    Description
    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.
    Time Frame
    18 months
    Title
    Comparison of the effectiveness of different financial compensations
    Description
    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.
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Effectiveness of secondary knowledge transmission: HIV-related knowledge improvement of the participants' family members
    Description
    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.
    Time Frame
    18 months
    Title
    Behavioral changes: condom use
    Description
    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.
    Time Frame
    18 months
    Title
    Behavioral changes: substance use
    Description
    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.
    Time Frame
    18 months
    Title
    Health outcomes: HIV prevalence
    Description
    Will be collecting regional data on HIV prevalence through collaboration with local departments.
    Time Frame
    18 months
    Title
    Health outcomes: mental health
    Description
    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.
    Time Frame
    18 months
    Title
    Health outcomes: all-cause mortality
    Description
    Will be collecting regional data on all-cause mortality through collaboration with local departments.
    Time Frame
    18 months
    Title
    Social factors: quality of life
    Description
    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"
    Time Frame
    18 months
    Title
    Social factors: stigma towards HIV
    Description
    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.
    Time Frame
    18 months
    Title
    Social factors: perception of social support
    Description
    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.
    Time Frame
    18 months
    Title
    Retention of HIV-related knowledge
    Description
    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.
    Time Frame
    18 months
    Title
    Feasibility: participants' use of social media applications
    Description
    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.
    Time Frame
    18 months
    Title
    Level of engagement
    Description
    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.
    Time Frame
    18 months
    Title
    Study's acceptability and satisfaction
    Description
    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.
    Time Frame
    18 months
    Title
    Cost-effectiveness of the intervention:
    Description
    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.
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guoen Liu
    Phone
    13901359157
    Email
    gordonliu@nsd.pku.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guoen Liu
    Organizational Affiliation
    Peking University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36064390
    Citation
    Wang M, Liu G, Chen X, Ma S, Chen C. Effectiveness of a mobile-based HIV prevention intervention for the rural and low-income population involving incentive policy to doctors in Liangshan, China: a randomized controlled trial protocol. BMC Public Health. 2022 Sep 5;22(1):1682. doi: 10.1186/s12889-022-13930-2.
    Results Reference
    derived

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    Effectiveness of a Mobile-based HIV Prevention Intervention Involving Incentive Policy for Doctors in Liangshan, China

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