mHealth and HIV Self-testing

Study Overview
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Brief Summary
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The investigators will pilot test an intervention to use a mobile application (app) to improve HIV self-testing (HST) with high-risk men in China. Sixty participants will be randomly assigned to an intervention group - which involves access to a mobile app-based HIV testing health promotion and risk reduction program - versus control. Participants will be evaluated at baseline and at 6-month follow up with respect to HST and changes in sexual risk behaviors.

Detailed Description
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Men who have sex with men (MSM) have emerged as one of the fastest growing HIV risk populations in China, the world's most populous country. Studies in China report that MSM have low rates of HIV testing, low use of HIV prevention services, and high levels of unprotected sex with both male and female partners. Stigma presents one of the critical barriers to engaging MSM in HIV testing and prevention interventions, as many MSM in China avoid health service facilities that require face-to-face disclosure of their same-sex behaviors. Because HIV testing is a crucial opportunity for HIV prevention and represents the first step on the continuum of care, efforts to improve rates of HIV testing among MSM in China can contribute to reduced risk for HIV transmission and enhanced public health outcomes in this population. For high-risk MSM in China, HIV self-testing (HST) offers a compelling strategy for achieving higher levels of HIV testing, due to the removal of barriers associated with traditional forms of in-person, clinic-based HIV testing. HST allows individuals to self-administer the HIV rapid diagnostic test in a private setting, which can detect for the presence of HIV-1/2 antibodies. The overarching goal of this research investigation is to improve the implementation science of HIV self-testing (HST) as a public health strategy to increase HIV testing among populations with low testing rates. The investigators propose using a mHealth approach to support the implementation of HST. Specifically, the investigators hypothesize that incorporating mobile application- or app-based behavioral risk reduction messages with HST can preserve the privacy and comfort associated with self-administered testing, while also allowing for individuals to receive timely information and motivational cues to take the crucial next steps following their HST results - i.e., to test repeatedly, to reduce their behavioral risks for HIV transmission, and to seek appropriate referral services as needed. This research will examine the acceptability and preliminary effects of HST linked with app-based behavioral risk reduction messages in a sample of high-risk MSM in China. In this pilot study, the investigators will test the primary hypothesis that the combination of HST plus mobile app-based risk reduction messaging compared to HST alone will increase HST re-testing and reduce sexual risk behavior in the next 6 months.

Official Title
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mHealth and HIV Self-testing for High-risk Men in China

Conditions
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Mobile Health Intervention to Promote HIV Self-testing

Intervention / Treatment
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* Behavioral: Mobile WeChat intervention
* Behavioral: Control condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Biological male Unprotected anal sex during the past 6 months Current resident in Hefei (city), China HIV-negative or HIV-status unknown Possess a mobile smart phone Not planning to relocate from study location Exclusion Criteria: HIV positive at enrollment Self-report coercion to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention involves demonstration of HIV self-testing and access to a mobile health application to promote HIV self-testing and HIV behavioral risk reduction
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile WeChat intervention<br>Participants will watch a demonstration of HIV self-testing, receive HIV self-testing kits, and receive access to a mobile health application that delivers content to promote HIV-self testing and reduce HIV-related risk behavior. | Behavioral: Mobile WeChat intervention<br>* Participants watch a demonstration of HIV self-testing, receive HIV self-testing kits, and receive access to a mobile application that delivers content to promote HIV self-testing and reduce HIV risk behavior<br>|
| Active Comparator: Control condition<br>Participants will watch a demonstration of HIV self-testing and receive HIV self-testing kits. | Behavioral: Control condition<br>* Participants watch a demonstration of HIV self-testing and receive HIV self-testing kits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV self-testing, picture | Picture of HIV self-test result submitted via mobile app | 6 months | 
| HIV self-testing, self-reported | Self-reported use of HIV self-test kit | 6 months | 
| HIV risk behavior | Condomless sex acts | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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China, Men who have sex with men, HIV self-testing, Mobile Health