MHealth Intervention of HIV and STDs Partner Notification for MSM

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
HIV/AIDS, Sexually Transmitted Diseases, Prevention

Intervention / Treatment
-----------------
* Behavioral: Health education, and regular HIV and STDs testing prompting service
* Behavioral: Health status inquiry through app (partner notification)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study is not a conventional crossover design,we use a pragmatic stepped-wedge cluster-randomised design.The study lasts for 2.5 years, which is divided to five continuous observation periods (every six months).The sixteen districts are assigned to four arms randomly.Four arms began recruiting participants at the same time,and at the first observation period,all groups were given health education and regular HIV and STDs testing prompting service,the two services above are given continuously for five observation periods.At the second observation period,the first group is given permission to query health status (partner notification) through app,but the other three groups do not.At every observation period after that (the third to fifth observation period),the three groups will be given permission to query health status one by one.Once a group is given the permission,it is retained until the end of study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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. | Behavioral: Health education, and regular HIV and STDs testing prompting service<br>* 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.<br>Behavioral: Health status inquiry through app (partner notification)<br>* 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.<br>|
| Experimental: Group 2<br>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. | Behavioral: Health education, and regular HIV and STDs testing prompting service<br>* 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.<br>Behavioral: Health status inquiry through app (partner notification)<br>* 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.<br>|
| Experimental: Group 3<br>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. | Behavioral: Health education, and regular HIV and STDs testing prompting service<br>* 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.<br>Behavioral: Health status inquiry through app (partner notification)<br>* 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.<br>|
| Experimental: Group 4<br>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. | Behavioral: Health education, and regular HIV and STDs testing prompting service<br>* 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.<br>Behavioral: Health status inquiry through app (partner notification)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV positive seroconversion rate (HIV incidence) | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Syphilis positive seroconversion rate (Syphilis incidence) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | The attitudes are collected by these questions in the baseline and follow-up questionnaires. | through study completion, an average of six months | 
| Sexual behaviors | 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 | 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 | 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 | The proportion of new HIV and STDs infections who have received treatment. | through study completion, an average of six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mHealth application, HIV/AIDS, sexually transmitted disease (STD), men who have sex with men (MSM), partner notification, stepped wedge cluster randomized controlled trial