mHealth and HIV Self-testing

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

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.

Study Overview

• Status: Completed
• Conditions: Mobile Health Intervention to Promote HIV Self-testing
• Intervention / Treatment: Behavioral: Mobile "WeChat" intervention; Behavioral: Control condition

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: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: Johns Hopkins University; University of Arkansas; Anhui Medical University
• Investigators: Principal Investigator: Don Operario, PhD, Brown University

Publications and helpful links

General Publications

• Han L, Bien CH, Wei C, Muessig KE, Yang M, Liu F, Yang L, Meng G, Emch ME, Tucker JD. HIV self-testing among online MSM in China: implications for expanding HIV testing among key populations. J Acquir Immune Defic Syndr. 2014 Oct 1;67(2):216-21. doi: 10.1097/QAI.0000000000000278.
• Tao J, Li MY, Qian HZ, Wang LJ, Zhang Z, Ding HF, Ji YC, Li DL, Xiao D, Hazlitt M, Vermund SH, Xiu X, Bao Y. Home-based HIV testing for men who have sex with men in China: a novel community-based partnership to complement government programs. PLoS One. 2014 Jul 22;9(7):e102812. doi: 10.1371/journal.pone.0102812. eCollection 2014.
• Zhang C, Li X, Brecht ML, Koniak-Griffin D. Can self-testing increase HIV testing among men who have sex with men: A systematic review and meta-analysis. PLoS One. 2017 Nov 30;12(11):e0188890. doi: 10.1371/journal.pone.0188890. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: June 15, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: China; Mobile Health; Men who have sex with men; HIV self-testing
• Other Study ID Numbers: R34MH106349 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No