MHealth Intervention of HIV and STDs Partner Notification for MSM
2020年5月25日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (予想される)
6172
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Zhongwei Jia, Prof. PhD
- 電話番号：+86-10-82802457
- メール：urchinjj@163.com
研究連絡先のバックアップ
- 名前：Xiangyu Yan, PhD
- 電話番号：+86-18380205261
- メール：yanxiangyu@bjmu.edu.cn
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
15年歳以上 (子、大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
男
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
HIV positive seroconversion rate (HIV incidence)
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Syphilis positive seroconversion rate (Syphilis incidence)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Zhongwei Jia, Prof. PhD、National Institute on Drug Dependence, Peking University,China
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2020年7月1日
一次修了 (予想される)
2022年12月31日
研究の完了 (予想される)
2023年6月30日
試験登録日
最初に提出
2020年4月10日
QC基準を満たした最初の提出物
2020年4月14日
最初の投稿 (実際)
2020年4月16日
学習記録の更新
投稿された最後の更新 (実際)
2020年5月27日
QC基準を満たした最後の更新が送信されました
2020年5月25日
最終確認日
2020年5月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- NIDD-HIV
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
- 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 共有時間枠
Two years after the end of the trial
IPD 共有アクセス基準
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
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。