mHealth and HIV Self-testing
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|ClinicalTrials.gov Identifier: NCT03569462|
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : July 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mobile Health Intervention to Promote HIV Self-testing||Behavioral: Mobile "WeChat" intervention Behavioral: Control condition||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Outcomes Assessor)|
|Official Title:||mHealth and HIV Self-testing for High-risk Men in China|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||June 30, 2018|
|Actual Study Completion Date :||December 30, 2018|
Experimental: Mobile "WeChat" intervention
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
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
Active Comparator: Control condition
Participants will watch a demonstration of HIV self-testing and receive HIV self-testing kits.
Behavioral: Control condition
Participants watch a demonstration of HIV self-testing and receive HIV self-testing kits.
- HIV self-testing, picture [ Time Frame: 6 months ]Picture of HIV self-test result submitted via mobile app
- HIV self-testing, self-reported [ Time Frame: 6 months ]Self-reported use of HIV self-test kit
- HIV risk behavior [ Time Frame: 6 months ]Condomless sex acts
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569462
|Anhui Medical University|
|Hefei, Anhui, China|
|Principal Investigator:||Don Operario, PhD||Brown University|