Mobile Health Intervention to Promote HIV Self-testingNCT03569462
mHealth and HIV Self-testing
A study testing Mobile "WeChat" intervention in people with Mobile Health Intervention to Promote HIV Self-testing, run by Brown University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mobile Health Intervention to Promote HIV Self-testing
- What is being tested?
- Mobile "WeChat" intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- HIV positive at enrollment
- Self-report coercion to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Mobile "WeChat" intervention, Control condition
- Keywords
- HIV self-testing, Mobile Health, Men who have sex with men, China
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile "WeChat" interventionBehavioural
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 conditionBehavioural
Participants watch a demonstration of HIV self-testing and receive HIV self-testing kits.
| Study group | Role | What they receive |
|---|---|---|
| Mobile "WeChat" intervention | Experimental | 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. Receives: Behavioral: Mobile "WeChat" intervention |
| Control condition | Active comparator | Participants will watch a demonstration of HIV self-testing and receive HIV self-testing kits. Receives: Behavioral: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV self-testing, picture
Picture of HIV self-test result submitted via mobile app
Measured: 6 months
HIV self-testing, self-reported
Self-reported use of HIV self-test kit
Measured: 6 months
HIV risk behavior
Condomless sex acts
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Sep 2017
- Primary completion30 Jun 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mobile Health Intervention to Promote HIV Self-testingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Anhui Medical University, University of Arkansas, Johns Hopkins University
- Responsible party
- Principal investigator, Don Operario, Brown University
- Investigators
- Don Operario, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569462
- Sponsor's protocol ID
- R34MH106349
- Status last verified
- Jun 2018
- First submitted
- 15 Jun 2018
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24991972Tao 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.
PubMed 25051160Zhang 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.
PubMed 29190791
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth and HIV Self-testing for High-risk Men in China
- ClinicalTrials.gov ID
- NCT03569462
- Acronym / sponsor ID
- R34MH106349
- Keywords
- HIV self-testing, Mobile Health, Men who have sex with men, China
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Anhui Medical University, University of Arkansas, Johns Hopkins University
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Mobile "WeChat" intervention | Experimental | Behavioral: Mobile "WeChat" interventionParticipants 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. |
| Control condition | Active comparator | Behavioral: Control conditionParticipants will watch a demonstration of HIV self-testing and receive HIV self-testing kits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- HIV positive at enrollment
- Self-report coercion to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile "WeChat" interventionParticipants 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 | Behavioural | Mobile "WeChat" intervention |
| Control conditionParticipants watch a demonstration of HIV self-testing and receive HIV self-testing kits. | Behavioural | Control condition |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Background: PubMed 24991972Han 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.
- Background: PubMed 25051160Tao 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.
- Background: PubMed 29190791Zhang 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don Operario, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile "WeChat" intervention in people with Mobile Health Intervention to Promote HIV Self-testing, run by Brown University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV self-testing, picture (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569462, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.