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mHealth and HIV Self-testing

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ClinicalTrials.gov Identifier: NCT03569462
Recruitment Status : Active, not recruiting
First Posted : June 26, 2018
Last Update Posted : June 27, 2018
Sponsor:
Collaborators:
Anhui Medical University
University of Arkansas
Johns Hopkins University
Information provided by (Responsible Party):
Don Operario, Brown University

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.

Condition or disease Intervention/treatment Phase
Mobile Health Intervention to Promote HIV Self-testing Behavioral: Mobile "WeChat" intervention Behavioral: Control condition Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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
Official Title: mHealth and HIV Self-testing for High-risk Men in China
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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China, Anhui
Anhui Medical University
Hefei, Anhui, China
Sponsors and Collaborators
Brown University
Anhui Medical University
University of Arkansas
Johns Hopkins University
Investigators
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Principal Investigator: Don Operario, PhD Brown University

Publications:
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Responsible Party: Don Operario, Professor, Brown University
ClinicalTrials.gov Identifier: NCT03569462     History of Changes
Other Study ID Numbers: R34MH106349 ( U.S. NIH Grant/Contract )
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Don Operario, Brown University:
HIV self-testing
Mobile Health
Men who have sex with men
China