MHealth Intervention of HIV and STDs Partner Notification for MSM
25 de mayo de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Anticipado)
6172
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Zhongwei Jia, Prof. PhD
- Número de teléfono: +86-10-82802457
- Correo electrónico: urchinjj@163.com
Copia de seguridad de contactos de estudio
- Nombre: Xiangyu Yan, PhD
- Número de teléfono: +86-18380205261
- Correo electrónico: yanxiangyu@bjmu.edu.cn
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
15 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
|
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.
|
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.
|
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
HIV positive seroconversion rate (HIV incidence)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Syphilis positive seroconversion rate (Syphilis incidence)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Zhongwei Jia, Prof. PhD, National Institute on Drug Dependence, Peking University,China
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de julio de 2020
Finalización primaria (Anticipado)
31 de diciembre de 2022
Finalización del estudio (Anticipado)
30 de junio de 2023
Fechas de registro del estudio
Enviado por primera vez
10 de abril de 2020
Primero enviado que cumplió con los criterios de control de calidad
14 de abril de 2020
Publicado por primera vez (Actual)
16 de abril de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de mayo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
25 de mayo de 2020
Última verificación
1 de mayo de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Atributos de la enfermedad
- Enfermedades de virus lentos
- Infecciones por VIH
- Síndrome de inmunodeficiencia adquirida
- Enfermedades de transmisión sexual
Otros números de identificación del estudio
- NIDD-HIV
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
Two years after the end of the trial
Criterios de acceso compartido de 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 de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .