HIV/AIDSNCT05015062
Effectiveness of a Mobile-based HIV Prevention Intervention Involving Incentive Policy for Doctors in Liangshan, China
A study testing Mobile-based HIV-related educational message delivery and Incentive policies evaluation in people with HIV/AIDS, run by Peking University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Mobile-based HIV-related educational message delivery and Incentive policies evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- HIV/AIDS
- Being tested
- Mobile-based HIV-related educational message delivery, Incentive policies evaluation
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile-based HIV-related educational message deliveryBehavioural
HIV/AIDS awareness-raising and behavior-related cyclic messages will be delivered by the village doctors on a biweekly basis for 18 months.
Incentive policies evaluationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile-based intervention with standardized incentive | Experimental | Participants will receive biweekly messages containing HIV-related educational modules from village doctors who will receive standardized compensation for performing the work. Receives: Behavioral: Mobile-based HIV-related educational message delivery |
| Mobile-based intervention with performance-based incentive | Experimental | Participants will receive biweekly messages containing HIV-related educational modules from village doctors who will receive performance-based compensation for performing the work. Receives: Behavioral: Mobile-based HIV-related educational message delivery; Behavioral: Incentive policies evaluation |
| Control without intervention | No intervention | Participants will not receive the mobile-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
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.
Measured: 18 months
Secondary outcomes (14)
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.
Measured: 18 months
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.
Measured: 18 months
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.
Measured: 18 months
Health outcomes: HIV prevalence
Will be collecting regional data on HIV prevalence through collaboration with local departments.
Measured: 18 months
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.
Measured: 18 months
Health outcomes: all-cause mortality
Will be collecting regional data on all-cause mortality through collaboration with local departments.
Measured: 18 months
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"
Measured: 18 months
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.
Measured: 18 months
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.
Measured: 18 months
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.
Measured: 18 months
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.
Measured: 18 months
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.
Measured: 18 months
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.
Measured: 18 months
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study startJan 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Sun, Peking University
- Investigators
- Guoen Liu, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015062
- Sponsor's protocol ID
- 71833001
- Status last verified
- Jun 2022
- First submitted
- 24 Jul 2021
- Last updated
- 9 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36064390
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05015062
- Acronym / sponsor ID
- 71833001
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mobile-based intervention with standardized incentive | Experimental | Behavioral: Mobile-based HIV-related educational message deliveryParticipants will receive biweekly messages containing HIV-related educational modules from village doctors who will receive standardized compensation for performing the work. |
| Mobile-based intervention with performance-based incentive | Experimental | Behavioral: Mobile-based HIV-related educational message delivery, Behavioral: Incentive policies evaluationParticipants will receive biweekly messages containing HIV-related educational modules from village doctors who will receive performance-based compensation for performing the work. |
| Control without intervention | No intervention | –Participants will not receive the mobile-based intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile-based HIV-related educational message deliveryHIV/AIDS awareness-raising and behavior-related cyclic messages will be delivered by the village doctors on a biweekly basis for 18 months. | Behavioural | Mobile-based intervention with performance-based incentive, Mobile-based intervention with standardized incentive |
| Incentive policies evaluationvillage 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. | Behavioural | Mobile-based intervention with performance-based incentive |
Primary outcome
HIV-related knowledge improvement
Time frame: 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.
Comparison of the effectiveness of different financial compensations
Time frame: 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.
14 secondary outcomes
Effectiveness of secondary knowledge transmission: HIV-related knowledge improvement of the participants' family members
Time frame: 18 months
Behavioral changes: condom use
Time frame: 18 months
Behavioral changes: substance use
Time frame: 18 months
Health outcomes: HIV prevalence
Time frame: 18 months
Health outcomes: mental health
Time frame: 18 months
Health outcomes: all-cause mortality
Time frame: 18 months
Social factors: quality of life
Time frame: 18 months
Social factors: stigma towards HIV
Time frame: 18 months
Social factors: perception of social support
Time frame: 18 months
Retention of HIV-related knowledge
Time frame: 18 months
Feasibility: participants' use of social media applications
Time frame: 18 months
Level of engagement
Time frame: 18 months
Study's acceptability and satisfaction
Time frame: 18 months
Cost-effectiveness of the intervention:
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Derived from this study: PubMed 36064390Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoen Liu principal investigator
Peking University
Questions about this trial
What is this clinical trial studying?
A study testing Mobile-based HIV-related educational message delivery and Incentive policies evaluation in people with HIV/AIDS, run by Peking University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guoen Liu (13901359157, gordonliu@nsd.pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV-related knowledge improvement (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05015062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.