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Completed

NCT Number: NCT03569462

mHealth and HIV Self-testing

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Anhui Medical University

Hefei, Anhui, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile "WeChat" intervention

Behavioral

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

Control condition

Behavioral

Participants watch a demonstration of HIV self-testing and receive HIV self-testing kits.

Primary outcomes

  1. HIV self-testing, picture

    Time frame: 6 months

    Picture of HIV self-test result submitted via mobile app

  2. HIV self-testing, self-reported

    Time frame: 6 months

    Self-reported use of HIV self-test kit

  3. HIV risk behavior

    Time frame: 6 months

    Condomless sex acts

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • Anhui Medical University
  • Johns Hopkins University
  • University of Arkansas

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 26, 2018
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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