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MHealth Intervention of HIV and STDs Partner Notification for MSM

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ClinicalTrials.gov Identifier: NCT04349748
Recruitment Status : Not yet recruiting
First Posted : April 16, 2020
Last Update Posted : May 27, 2020
Sponsor:
Collaborator:
Man Wellness Center, Beijing, China
Information provided by (Responsible Party):
ZhongweiJia, National Institute on Drug Dependence, China

Tracking Information
First Submitted Date  ICMJE April 10, 2020
First Posted Date  ICMJE April 16, 2020
Last Update Posted Date May 27, 2020
Estimated Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • HIV positive seroconversion rate (HIV incidence) [ Time Frame: through study completion, an average of six months ]
    The number of HIV positive seroconversions divided by the total number of person-years.
  • Additional cost of the intervention [ Time Frame: through study completion, an average of six months ]
    The total cost and average cost for per participant of the integrated intervention model and each additional intervention/service based on the existing HIV prevention measures provided as before.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • Syphilis positive seroconversion rate (Syphilis incidence) [ Time Frame: through study completion, an average of six months ]
    The number of syphilis seroconversions divided by the total number of person-years.
  • Hepatitis B positive seroconversion rate (Hepatitis B incidence) [ Time Frame: through study completion, an average of six months ]
    The number of hepatitis B seroconversions divided by the total number of person-years.
  • Hepatitis C positive seroconversion rate (Hepatitis C incidence) [ Time Frame: through study completion, an average of six months ]
    The number of hepatitis C seroconversions divided by the total number of person-years.
  • HIV and related diseases transmission among social networks [ Time Frame: through study completion, an average of 1 year ]
    Based on the partner notification information, we will construct the transmission networks of HIV and other STDs (syphilis, hepatitis B, and hepatitis C) among participants, and analyze the characteristics of these networks and factors associated with transmission of these diseases.
  • Testing adherence [ Time Frame: through study completion, an average of 1 year ]
    The proportion of participants whose every adjacent testing interval is no more than 3 months as recommended by China CDC.
  • Additional cost for finding per seroconversion [ Time Frame: through study completion, an average of six months ]
    The total additional cost of the integrated intervention model based on the existing HIV prevention measures provided as before divided by the total number of the HIV and STDs seroconversions.
  • Frequency of utilization for each intervention/service [ Time Frame: through study completion, an average of six months ]
    The total frequency and average frequency for per participant of utilization for each intervention/service, such as health education, partner notification, HIV and STDs testing and so on.
  • Satisfaction of the interventions and services [ Time Frame: through study completion, an average of six months ]
    This indicator is measured by the follow-up questionnaires as the degree of satisfaction for participants of HIV and STDs testing service, health education, partner notification and other app's functions.
  • Knowledge of HIV and related STDs [ Time Frame: through study completion, an average of six months ]
    This indicator is measured by the baseline and follow-up questionnaires, and we use the score of knowledge questions in the questionnaires to represent participants' level of knowledge.
  • Attitudes of HIV and STDs testing, safe sexual behaviors and partner notification [ Time Frame: through study completion, an average of six months ]
    The attitudes are collected by these questions in the baseline and follow-up questionnaires.
  • Sexual behaviors [ Time Frame: through study completion, an average of six months ]
    They are measured by questionnaires, including questions about the number of different kinds of sexual partners, frequency of anal sex, condom use, and partner notification implementation.
  • Substance use behaviors [ Time Frame: through study completion, an average of six months ]
    This indicator is measured by questionnaires about participants' usage about methamphetamine, heroin, ecstasy, and some other sex-promoting drugs.
  • Psychological status [ Time Frame: through study completion, an average of six months ]
    SAS (self-rating anxiety) scale and SDS (self-rating depression) scale are used to measure participants' psychological status through questionnaires. The higher scores of the two scares mean the worse outcomes.
  • Referral rate of HIV and related STDs [ Time Frame: through study completion, an average of six months ]
    The proportion of new HIV and STDs infections who have received treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MHealth Intervention of HIV and STDs Partner Notification for MSM
Official Title  ICMJE The Effect of Providing mHealth Intervention of Partner Notification to Protect MSM From HIV and Sexually Transmitted Diseases Infection: a Pragmatic Stepped Wedge Cluster Randomized Controlled Trial
Brief Summary Men who have sex with men (MSM) have become a focus of HIV and other sexually transmitted diseases (STD) control in China. Most of MSM who seek causal partners through online dating platforms do not know their sexual partners' real HIV and STDs infection status, which leads to more high risk status, especially for sexual behaviors. Effective Internet-based partner notification is urgently warranted to increase their risk awareness and prevent HIV and STDs transmission. This study developed an app which can help MSM to query recent HIV and other STDs statuses each other from the testing platform in order that they can find a relatively safety sexual partners and reduce risk of HIV infection.
Detailed Description Because most of the recent "Partner Notification" methods are a kind of afterwards remedial measures and will fail to find some of the infected MSM, researchers propose a preventive measures before they meet together. For MSM who are seeking potential sexual partners through Internet, researchers will encourage them to query health status before they decide to meet each other in order to promote their healthy self-responsibility consciousnes including avoiding HIV and other STDs infection, which will form a real ,digital MSM cohort. Researchers designed a pragmatic stepped wedge cluster randomized controlled trial to evaluate the effect of an intervention paradigm that provides HIV, syphilis, hepatitis B, and hepatitis C status partner notification based on the existing HIV and STDs control methods through an mHealth application (app), to reduce HIV and STDs incidences among MSM in China. More than 6000 MSM of 16 districts in Beijing, China will be grouped into four arms, each arm will cover four indepednent districts of Beijing randomly. The four arms will be randomized to sequentially initiate partner notification intervention through the app at 6-month intervals. All participants will be provided informed consent in the app after a full explanation of the protocol design. Researchers expect that the HIV incidence will be significantly lower and the secondary outcomes will also be better after partner notification intervention. The feasible and affordable public health management paradigm will have implications for HIV and STDs prevention and control among MSM and other key populations.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
This study is not a conventional crossover design,we use a pragmatic stepped-wedge cluster-randomised design.The study lasts for 2.5 years, which is divided to five continuous observation periods (every six months).The sixteen districts are assigned to four arms randomly.Four arms began recruiting participants at the same time,and at the first observation period,all groups were given health education and regular HIV and STDs testing prompting service,the two services above are given continuously for five observation periods.At the second observation period,the first group is given permission to query health status (partner notification) through app,but the other three groups do not.At every observation period after that (the third to fifth observation period),the three groups will be given permission to query health status one by one.Once a group is given the permission,it is retained until the end of study.
Masking: Single (Outcomes Assessor)
Masking Description:
Because partner notification is a kind of behavioral intervention, participants know what intervention they receive. However, we take efforts to reduce the bias caused by the non-blind design. At the beginning of the research, participants, care providers, and researchers who participate in participants management will not know the randomized scheme. The partner notification will be opened to participants sequentially by the predetermined computer program, and does not need care providers and researchers to implement the intervention manually. The care providers and researchers do not know the implementation of partner notification unless the participants tell them whether they can use the function on their own initiative. Even the care providers know that, the operation and results of the HIV and STDs testing will not be affected. At last, the outcomes assessors do not know the randomized scheme in data analysis.
Primary Purpose: Prevention
Condition  ICMJE
  • HIV/AIDS
  • Sexually Transmitted Diseases
  • Prevention
Intervention  ICMJE
  • Behavioral: Health education, and regular HIV and STDs testing prompting service
    Health education through app for once a week, and regular HIV and STDs testing prompting service (every month through app) are given to the participants at the beginning of the study and last for the whole five observation periods.
  • Behavioral: Health status inquiry through app (partner notification)
    The permission to query health status through app (partner notification) is given to participants (participants can query their potential sexual partner's status of HIV, syphilis, hepatitis B, and hepatitis C respectively through app) at the specific observation period,and the permission is retained until the end of study.
Study Arms  ICMJE
  • Experimental: Group 1
    The group is given health education, regular HIV and STDs testing prompting service in the whole study, and permission to query health status (partner notification) through app from the second observation period. HIV and STDs testing and questionnaire are given to the participants when they receive the testing service.
    Interventions:
    • Behavioral: Health education, and regular HIV and STDs testing prompting service
    • Behavioral: Health status inquiry through app (partner notification)
  • Experimental: Group 2
    The group is given health education, regular HIV and STDs testing prompting service in the whole study, and permission to query health status (partner notification) through app from the third observation period. HIV and STDs testing and questionnaire are given to the participants when they receive the testing service.
    Interventions:
    • Behavioral: Health education, and regular HIV and STDs testing prompting service
    • Behavioral: Health status inquiry through app (partner notification)
  • Experimental: Group 3
    The group is given health education, regular HIV and STDs testing prompting service in the whole study, and permission to query health status (partner notification) through app from the fourth observation period. HIV and STDs testing and questionnaire are given to the participants when they receive the testing service.
    Interventions:
    • Behavioral: Health education, and regular HIV and STDs testing prompting service
    • Behavioral: Health status inquiry through app (partner notification)
  • Experimental: Group 4
    The group is given health education, regular HIV and STDs testing prompting service in the whole study, and permission to query health status (partner notification) through app from the fifth observation period. HIV and STDs testing and questionnaire are given to the participants when they receive the testing service.
    Interventions:
    • Behavioral: Health education, and regular HIV and STDs testing prompting service
    • Behavioral: Health status inquiry through app (partner notification)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2020)
6172
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. biologically male,
  2. had oral or anal sex with men at least once during their lifetime,
  3. 15 years of age or older,
  4. had no difficulty using a mobile phone,
  5. willing to provide their mobile phone numbers to serve as the unique identification numbers of the app's self-query and partner notification functions,
  6. willing to use the app's function modules,
  7. willing to complete the questionnaire for the research,
  8. willing to continuously receive HIV and STDs testing and consulting services provided by the CBO our research setting at,
  9. willing to complete the informed consent document.

Exclusion criteria:

1.had serious physical disabilities or mental diseases.

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Zhongwei Jia, Prof. PhD +86-10-82802457 urchinjj@163.com
Contact: Xiangyu Yan, PhD +86-18380205261 yanxiangyu@bjmu.edu.cn
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04349748
Other Study ID Numbers  ICMJE NIDD-HIV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:
  1. Study Protocol,part of study report and data will be published in journals;
  2. Researchers can contact the principal investigator(PI:ZhongweiJia) for IPD through email two years after the end of the trial.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Two years after the end of the trial
Access Criteria: Data applicants should send email to PI. Real personal basic information (name, unit, title, etc.), detailed description of required data (required variables,etc.), and research plan should be included in the email. Our team will discuss the research proposal and reply as soon as possible
Responsible Party ZhongweiJia, National Institute on Drug Dependence, China
Study Sponsor  ICMJE National Institute on Drug Dependence, China
Collaborators  ICMJE Man Wellness Center, Beijing, China
Investigators  ICMJE
Principal Investigator: Zhongwei Jia, Prof. PhD National Institute on Drug Dependence, Peking University,China
PRS Account National Institute on Drug Dependence, China
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP