MHealth Intervention of HIV and STDs Partner Notification for MSM
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
1 other identifier
interventional
6,172
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Typical duration for not_applicable
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
April 10, 2020
CompletedFirst Posted
Study publicly available on registry
April 16, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedMay 27, 2020
May 1, 2020
2.5 years
April 10, 2020
May 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
HIV positive seroconversion rate (HIV incidence)
The number of HIV positive seroconversions divided by the total number of person-years.
through study completion, an average of six months
Additional cost of the intervention
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.
through study completion, an average of six months
Secondary Outcomes (14)
Syphilis positive seroconversion rate (Syphilis incidence)
through study completion, an average of six months
Hepatitis B positive seroconversion rate (Hepatitis B incidence)
through study completion, an average of six months
Hepatitis C positive seroconversion rate (Hepatitis C incidence)
through study completion, an average of six months
HIV and related diseases transmission among social networks
through study completion, an average of 1 year
Testing adherence
through study completion, an average of 1 year
- +9 more secondary outcomes
Study Arms (4)
Group 1
EXPERIMENTALThe 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.
Group 2
EXPERIMENTALThe 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.
Group 3
EXPERIMENTALThe 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.
Group 4
EXPERIMENTALThe 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
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.
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.
Eligibility Criteria
You may qualify if:
- biologically male,
- had oral or anal sex with men at least once during their lifetime,
- years of age or older,
- had no difficulty using a mobile phone,
- willing to provide their mobile phone numbers to serve as the unique identification numbers of the app's self-query and partner notification functions,
- willing to use the app's function modules,
- willing to complete the questionnaire for the research,
- willing to continuously receive HIV and STDs testing and consulting services provided by the CBO our research setting at,
- willing to complete the informed consent document.
You may not qualify if:
- had serious physical disabilities or mental diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
Brown LB, Miller WC, Kamanga G, Nyirenda N, Mmodzi P, Pettifor A, Dominik RC, Kaufman JS, Mapanje C, Martinson F, Cohen MS, Hoffman IF. HIV partner notification is effective and feasible in sub-Saharan Africa: opportunities for HIV treatment and prevention. J Acquir Immune Defic Syndr. 2011 Apr 15;56(5):437-42. doi: 10.1097/qai.0b013e318202bf7d.
PMID: 22046601BACKGROUNDTsega A, Udeagu CC, Begier EM. A comparison of partner notification effectiveness in African-, Caribbean-, and United States-born HIV-infected Blacks in New York City. AIDS Patient Care STDS. 2012 Jul;26(7):406-10. doi: 10.1089/apc.2011.0313. Epub 2012 Jun 4.
PMID: 22663166BACKGROUNDRosenberg NE, Mtande TK, Saidi F, Stanley C, Jere E, Paile L, Kumwenda K, Mofolo I, Ng'ambi W, Miller WC, Hoffman I, Hosseinipour M. Recruiting male partners for couple HIV testing and counselling in Malawi's option B+ programme: an unblinded randomised controlled trial. Lancet HIV. 2015 Nov;2(11):e483-91. doi: 10.1016/S2352-3018(15)00182-4. Epub 2015 Oct 22.
PMID: 26520928BACKGROUNDYan X, Lu Z, Zhang B, Li Y, Tang W, Zhang L, Jia Z. Protecting Men Who Have Sex With Men From HIV Infection With an mHealth App for Partner Notification: Observational Study. JMIR Mhealth Uhealth. 2020 Feb 19;8(2):e14457. doi: 10.2196/14457.
PMID: 32130147BACKGROUNDYan X, Li Y, Su H, Xing Y, Zhang B, Lu Z, Jia Z. Protect MSM from HIV and other sexually transmitted diseases by providing mobile health services of partner notification: protocol for a pragmatic stepped wedge cluster randomized controlled trial. BMC Public Health. 2020 Jul 14;20(1):1107. doi: 10.1186/s12889-020-09162-x.
PMID: 32664934DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhongwei Jia, Prof. PhD
National Institute on Drug Dependence, Peking University,China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director of Center for Drug Abuse Control and Prevention
Study Record Dates
First Submitted
April 10, 2020
First Posted
April 16, 2020
Study Start
July 1, 2020
Primary Completion
December 31, 2022
Study Completion
June 30, 2023
Last Updated
May 27, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, 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
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.