MHealth Intervention of HIV and STDs Partner Notification for MSM

National Institute on Drug Dependence, China

Status: Unknown

Conditions: Prevention; Sexually Transmitted Diseases; HIV/AIDS

Treatments: Behavioral: Health education, and regular HIV and STDs testing prompting service; Behavioral: Health status inquiry through app (partner notification)

Study type: Interventional

Funder types: Other

Identifiers

NCT04349748

NIDD-HIV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,172 estimated patients

Sex: Male

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. biologically male,
2. had oral or anal sex with men at least once during their lifetime,
3. 15 years of age or older,
4. had no difficulty using a mobile phone,
5. willing to provide their mobile phone numbers to serve as the unique identification numbers of the app's self-query and partner notification functions,
6. willing to use the app's function modules,
7. willing to complete the questionnaire for the research,
8. willing to continuously receive HIV and STDs testing and consulting services provided by the CBO our research setting at,
9. willing to complete the informed consent document.

Exclusion criteria

1.had serious physical disabilities or mental diseases.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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6,172 participants in 4 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

Behavioral: Health education, and regular HIV and STDs testing prompting service

Behavioral: Health status inquiry through app (partner notification)

Group 2

Experimental group

Description:

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.

Treatment:

Behavioral: Health education, and regular HIV and STDs testing prompting service

Behavioral: Health status inquiry through app (partner notification)

Group 3

Experimental group

Description:

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.

Treatment:

Behavioral: Health education, and regular HIV and STDs testing prompting service

Behavioral: Health status inquiry through app (partner notification)

Group 4

Experimental group

Description:

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.

Treatment:

Behavioral: Health education, and regular HIV and STDs testing prompting service

Behavioral: Health status inquiry through app (partner notification)