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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
6,172
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.
HIV positive seroconversion rate (HIV incidence)
The number of HIV positive seroconversions divided by the total number of person-years.
Time frame: 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.
Time frame: through study completion, an average of six months
Syphilis positive seroconversion rate (Syphilis incidence)
The number of syphilis seroconversions divided by the total number of person-years.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of six months
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