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

6 juin 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

4000

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: Mobile-based HIV-related educational message delivery
HIV/AIDS awareness-raising and behavior-related cyclic messages will be delivered by the village doctors on a biweekly basis for 18 months.
Expérimental: 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.
Comportemental: Mobile-based HIV-related educational message delivery
HIV/AIDS awareness-raising and behavior-related cyclic messages will be delivered by the village doctors on a biweekly basis for 18 months.
Comportemental: Incentive policies evaluation
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.
Aucune intervention: Control without intervention
Participants will not receive the mobile-based intervention

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
HIV-related knowledge improvement
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Effectiveness of secondary knowledge transmission: HIV-related knowledge improvement of the participants' family members
Délai: 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
Délai: 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
Délai: 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
Délai: 18 months
Will be collecting regional data on HIV prevalence through collaboration with local departments.
18 months
Health outcomes: mental health
Délai: 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
Délai: 18 months
Will be collecting regional data on all-cause mortality through collaboration with local departments.
18 months
Social factors: quality of life
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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:
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Peking University

Les enquêteurs

  • Chercheur principal: Guoen Liu, Peking University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Anticipé)

1 janvier 2023

Achèvement primaire (Anticipé)

1 décembre 2024

Achèvement de l'étude (Anticipé)

1 décembre 2025

Dates d'inscription aux études

Première soumission

24 juillet 2021

Première soumission répondant aux critères de contrôle qualité

14 août 2021

Première publication (Réel)

20 août 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juin 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 juin 2022

Dernière vérification

1 juin 2022

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 71833001

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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