MHealth Intervention of HIV and STDs Partner Notification for MSM
25. května 2020 aktualizováno: ZhongweiJia, National Institute on Drug Dependence, China
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
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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Očekávaný)
6172
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Zhongwei Jia, Prof. PhD
- Telefonní číslo: +86-10-82802457
- E-mail: urchinjj@163.com
Studijní záloha kontaktů
- Jméno: Xiangyu Yan, PhD
- Telefonní číslo: +86-18380205261
- E-mail: yanxiangyu@bjmu.edu.cn
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
15 let a starší (Dítě, Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Mužský
Popis
Inclusion criteria:
- biologically male,
- had oral or anal sex with men at least once during their lifetime,
- 15 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.
Exclusion criteria:
1.had serious physical disabilities or mental diseases.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
|
|
Experimentální: 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.
|
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.
|
|
Experimentální: 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.
|
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.
|
|
Experimentální: 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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
HIV positive seroconversion rate (HIV incidence)
Časové okno: through study completion, an average of six months
|
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
Časové okno: 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.
|
through study completion, an average of six months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Syphilis positive seroconversion rate (Syphilis incidence)
Časové okno: through study completion, an average of six months
|
The number of syphilis seroconversions divided by the total number of person-years.
|
through study completion, an average of six months
|
|
Hepatitis B positive seroconversion rate (Hepatitis B incidence)
Časové okno: through study completion, an average of six months
|
The number of hepatitis B seroconversions divided by the total number of person-years.
|
through study completion, an average of six months
|
|
Hepatitis C positive seroconversion rate (Hepatitis C incidence)
Časové okno: through study completion, an average of six months
|
The number of hepatitis C seroconversions divided by the total number of person-years.
|
through study completion, an average of six months
|
|
HIV and related diseases transmission among social networks
Časové okno: 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.
|
through study completion, an average of 1 year
|
|
Testing adherence
Časové okno: 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.
|
through study completion, an average of 1 year
|
|
Additional cost for finding per seroconversion
Časové okno: 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.
|
through study completion, an average of six months
|
|
Frequency of utilization for each intervention/service
Časové okno: 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.
|
through study completion, an average of six months
|
|
Satisfaction of the interventions and services
Časové okno: 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.
|
through study completion, an average of six months
|
|
Knowledge of HIV and related STDs
Časové okno: 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.
|
through study completion, an average of six months
|
|
Attitudes of HIV and STDs testing, safe sexual behaviors and partner notification
Časové okno: through study completion, an average of six months
|
The attitudes are collected by these questions in the baseline and follow-up questionnaires.
|
through study completion, an average of six months
|
|
Sexual behaviors
Časové okno: 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.
|
through study completion, an average of six months
|
|
Substance use behaviors
Časové okno: 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.
|
through study completion, an average of six months
|
|
Psychological status
Časové okno: 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.
|
through study completion, an average of six months
|
|
Referral rate of HIV and related STDs
Časové okno: through study completion, an average of six months
|
The proportion of new HIV and STDs infections who have received treatment.
|
through study completion, an average of six months
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Zhongwei Jia, Prof. PhD, National Institute on Drug Dependence, Peking University,China
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
- Tsega 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.
- Rosenberg 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.
- Yan 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.
- Yan 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Očekávaný)
1. července 2020
Primární dokončení (Očekávaný)
31. prosince 2022
Dokončení studie (Očekávaný)
30. června 2023
Termíny zápisu do studia
První předloženo
10. dubna 2020
První předloženo, které splnilo kritéria kontroly kvality
14. dubna 2020
První zveřejněno (Aktuální)
16. dubna 2020
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
27. května 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. května 2020
Naposledy ověřeno
1. května 2020
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Patologické procesy
- RNA virové infekce
- Virová onemocnění
- Infekce
- Infekce přenášené krví
- Přenosné nemoci
- Pohlavně přenosné choroby, virové
- Lentivirové infekce
- Retroviridae infekce
- Syndromy imunologické nedostatečnosti
- Onemocnění imunitního systému
- Atributy nemoci
- Pomalá virová onemocnění
- HIV infekce
- Syndrom získané immunití nedostatečnisti
- Pohlavně přenosné nemoci
Další identifikační čísla studie
- NIDD-HIV
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
- Study Protocol,part of study report and data will be published in journals;
- Researchers can contact the principal investigator(PI:ZhongweiJia) for IPD through email two years after the end of the trial.
Časový rámec sdílení IPD
Two years after the end of the trial
Kritéria přístupu pro sdílení IPD
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
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .