mHealth and HIV Self-testing

NCT ID: NCT03569462

Last Updated: 2019-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-12-30

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.

Conditions

Mobile Health Intervention to Promote HIV Self-testing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mobile "WeChat" intervention

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Control condition

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Control condition

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Anhui Medical University

OTHER

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Don Operario

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Don Operario, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Anhui Medical University

Hefei, Anhui, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 24991972 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25051160 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29190791 (View on PubMed)

Other Identifiers

R34MH106349

Identifier Type: NIH

Identifier Source: org_study_id

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