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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
Sponsor:
Collaborators:
Anhui Medical University
University of Arkansas
Johns Hopkins University
Information provided by (Responsible Party):
Don Operario, Brown University

Tracking Information
First Submitted Date  ICMJE June 15, 2018
First Posted Date  ICMJE June 26, 2018
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE September 1, 2017
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03569462 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE mHealth and HIV Self-testing
Official Title  ICMJE mHealth and HIV Self-testing for High-risk Men in China
Brief Summary 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

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
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)
Primary Purpose: Prevention
Condition  ICMJE Mobile Health Intervention to Promote HIV Self-testing
Intervention  ICMJE
  • 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
  • Behavioral: Control condition
    Participants watch a demonstration of HIV self-testing and receive HIV self-testing kits.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Mobile "WeChat" intervention
  • Active Comparator: Control condition
    Participants will watch a demonstration of HIV self-testing and receive HIV self-testing kits.
    Intervention: Behavioral: Control condition
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2018)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03569462
Other Study ID Numbers  ICMJE R34MH106349( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Don Operario, Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE
  • Anhui Medical University
  • University of Arkansas
  • Johns Hopkins University
Investigators  ICMJE
Principal Investigator: Don Operario, PhD Brown University
PRS Account Brown University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP