- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05015062
Effectiveness of a Mobile-based HIV Prevention Intervention Involving Incentive Policy for Doctors in Liangshan, China
2022년 6월 6일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (예상)
4000
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Guoen Liu
- 전화번호: 13901359157
- 이메일: gordonliu@nsd.pku.edu.cn
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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.
|
실험적: 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.
|
간섭 없음: Control without intervention
Participants will not receive the mobile-based intervention
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
HIV-related knowledge improvement
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Effectiveness of secondary knowledge transmission: HIV-related knowledge improvement of the participants' family members
기간: 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
기간: 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
기간: 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
기간: 18 months
|
Will be collecting regional data on HIV prevalence through collaboration with local departments.
|
18 months
|
Health outcomes: mental health
기간: 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
기간: 18 months
|
Will be collecting regional data on all-cause mortality through collaboration with local departments.
|
18 months
|
Social factors: quality of life
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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:
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Guoen Liu, Peking University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2023년 1월 1일
기본 완료 (예상)
2024년 12월 1일
연구 완료 (예상)
2025년 12월 1일
연구 등록 날짜
최초 제출
2021년 7월 24일
QC 기준을 충족하는 최초 제출
2021년 8월 14일
처음 게시됨 (실제)
2021년 8월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 6월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 6월 6일
마지막으로 확인됨
2022년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 71833001
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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