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
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Odotettu)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Zhongwei Jia, Prof. PhD
- Puhelinnumero: +86-10-82802457
- Sähköposti: urchinjj@163.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Xiangyu Yan, PhD
- Puhelinnumero: +86-18380205261
- Sähköposti: yanxiangyu@bjmu.edu.cn
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Yksittäinen
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
HIV positive seroconversion rate (HIV incidence)
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Syphilis positive seroconversion rate (Syphilis incidence)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Yhteistyökumppanit
Yhteistyökumppanit
Tutkijat
Tutkijat
- Päätutkija: Zhongwei Jia, Prof. PhD, National Institute on Drug Dependence, Peking University,China
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Odotettu)
Opiskelun aloitus
Ensisijainen valmistuminen (Odotettu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Odotettu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Patologiset prosessit
- RNA-virusinfektiot
- Virussairaudet
- Infektiot
- Veren välityksellä leviävät infektiot
- Tartuntataudit
- Sukupuolitaudit, virus
- Lentivirus-infektiot
- Retroviridae-infektiot
- Immunologiset puutosoireyhtymät
- Immuunijärjestelmän sairaudet
- Sairauden ominaisuudet
- Hitaat virustaudit
- HIV-infektiot
- Immuunikato
- Sukupuolitaudit
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- NIDD-HIV
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
- 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.
IPD-jaon aikakehys
IPD-jaon käyttöoikeuskriteerit
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
- ANALYTIC_CODE
- CSR
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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