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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 6,172
- Primary Endpoint
- Additional cost of the intervention
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Because partner notification is a kind of behavioral intervention, participants know what intervention they receive. However, we take efforts to reduce the bias caused by the non-blind design. At the beginning of the research, participants, care providers, and researchers who participate in participants management will not know the randomized scheme. The partner notification will be opened to participants sequentially by the predetermined computer program, and does not need care providers and researchers to implement the intervention manually. The care providers and researchers do not know the implementation of partner notification unless the participants tell them whether they can use the function on their own initiative. Even the care providers know that, the operation and results of the HIV and STDs testing will not be affected. At last, the outcomes assessors do not know the randomized scheme in data analysis.
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Additional cost of the intervention
Time Frame: 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.
HIV positive seroconversion rate (HIV incidence)
Time Frame: through study completion, an average of six months
The number of HIV positive seroconversions divided by the total number of person-years.
Secondary Outcomes
- Psychological status(through study completion, an average of six months)
- Hepatitis C positive seroconversion rate (Hepatitis C incidence)(through study completion, an average of six months)
- Syphilis positive seroconversion rate (Syphilis incidence)(through study completion, an average of six months)
- Hepatitis B positive seroconversion rate (Hepatitis B incidence)(through study completion, an average of six months)
- HIV and related diseases transmission among social networks(through study completion, an average of 1 year)
- Frequency of utilization for each intervention/service(through study completion, an average of six months)
- Testing adherence(through study completion, an average of 1 year)
- Additional cost for finding per seroconversion(through study completion, an average of six months)
- Satisfaction of the interventions and services(through study completion, an average of six months)
- Sexual behaviors(through study completion, an average of six months)
- Knowledge of HIV and related STDs(through study completion, an average of six months)
- Referral rate of HIV and related STDs(through study completion, an average of six months)
- Attitudes of HIV and STDs testing, safe sexual behaviors and partner notification(through study completion, an average of six months)
- Substance use behaviors(through study completion, an average of six months)
Investigators
ZhongweiJia
Professor, Director of Center for Drug Abuse Control and Prevention
National Institute on Drug Dependence, China