NCT05015062

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

1.9 years

First QC Date

July 24, 2021

Last Update Submit

June 6, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    18 months

Secondary Outcomes (14)

  • Effectiveness of secondary knowledge transmission: HIV-related knowledge improvement of the participants' family members

    18 months

  • Behavioral changes: condom use

    18 months

  • Behavioral changes: substance use

    18 months

  • Health outcomes: HIV prevalence

    18 months

  • Health outcomes: mental health

    18 months

  • +9 more secondary outcomes

Study Arms (3)

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.

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.

Behavioral: Mobile-based HIV-related educational message deliveryBehavioral: Incentive policies evaluation

Control without intervention

NO INTERVENTION

Participants will not receive the mobile-based intervention

Interventions

HIV/AIDS awareness-raising and behavior-related cyclic messages will be delivered by the village doctors on a biweekly basis for 18 months.

Mobile-based intervention with performance-based incentiveMobile-based intervention with standardized incentive

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.

Mobile-based intervention with performance-based incentive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Guoen Liu

    Peking University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D., Assistant Director, PKU China Center for Health Economic Research (CCHER)

Study Record Dates

First Submitted

July 24, 2021

First Posted

August 20, 2021

Study Start

January 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

June 9, 2022

Record last verified: 2022-06