MHealth Intervention of HIV and STDs Partner Notification for MSM
25 maggio 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Anticipato)
6172
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Zhongwei Jia, Prof. PhD
- Numero di telefono: +86-10-82802457
- Email: urchinjj@163.com
Backup dei contatti dello studio
- Nome: Xiangyu Yan, PhD
- Numero di telefono: +86-18380205261
- Email: yanxiangyu@bjmu.edu.cn
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
15 anni e precedenti (Bambino, Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Maschio
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
HIV positive seroconversion rate (HIV incidence)
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Syphilis positive seroconversion rate (Syphilis incidence)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Zhongwei Jia, Prof. PhD, National Institute on Drug Dependence, Peking University,China
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Anticipato)
1 luglio 2020
Completamento primario (Anticipato)
31 dicembre 2022
Completamento dello studio (Anticipato)
30 giugno 2023
Date di iscrizione allo studio
Primo inviato
10 aprile 2020
Primo inviato che soddisfa i criteri di controllo qualità
14 aprile 2020
Primo Inserito (Effettivo)
16 aprile 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
27 maggio 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 maggio 2020
Ultimo verificato
1 maggio 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie del sistema immunitario
- Attributi della malattia
- Malattie da virus lenti
- Infezioni da HIV
- Sindrome da immunodeficienza acquisita
- Malattie trasmesse sessualmente
Altri numeri di identificazione dello studio
- NIDD-HIV
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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.
Periodo di condivisione IPD
Two years after the end of the trial
Criteri di accesso alla condivisione 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
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .