HIVNCT02248558
Spurring Innovation to Promote HIV Testing: An RCT Evaluating Crowdsourcing
A study testing Conventional Video and Crowdsourced Video in people with HIV, run by University of North Carolina, Chapel Hill at 1 site in China.
Trial summary
Crowdsourcing may be a powerful tool to spur the development of innovative videos to promote HIV testing among key populations such as men who have sex with men (MSM) and transgender (TG) individuals. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Conventional Video and Crowdsourced Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 721 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Born biologically male or identify as transgender
- 16 years or older
- Lifetime anal sex with another man
- Providing informed consent and active mobile phone number
Who cannot join
- HIV-infected
- HIV-tested ever in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Crowdsourcing Versus Conventional HIV Testing Promotion: A Noninferiority Randomized Controlled Trial to Evaluate Promoting First-Time HIV Testing Among MSM and Transgender Individuals in China
Crowdsourcing may be a powerful tool to spur the development of innovative videos to promote HIV testing among key populations such as men who have sex with men (MSM) and transgender (TG) individuals. The purpose of this randomized controlled trial is to compare the effect of a crowdsourced video and a conventional video on first-time HIV testing among MSM and TG in China. The crowdsourced video was developed using an open contest, formal transparent judging, and an incentive of marketing promotion. The hypothesis is that a crowdsourced video will be equivalent (within a margin of 3%) to a conventional video in terms of self-reported first-time HIV testing within 3-4 weeks of watching the video.
- Conditions
- HIV
- Being tested
- Conventional Video, Crowdsourced Video
- Keywords
- Contest, Crowdsourcing, Innovation, Randomized controlled trial, China, Social entrepreneurship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional VideoBehavioural
Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.
Crowdsourced VideoBehavioural
Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.
| Study group | Role | What they receive |
|---|---|---|
| Conventional video | Active comparator | This arm will receive a one-minute conventional video promoting HIV test uptake. Receives: Behavioral: Conventional Video |
| Crowdsourced video | Experimental | This arm will receive a one-minute crowdsourced video promoting HIV test uptake. Receives: Behavioral: Crowdsourced Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-Time HIV Testing
All individuals enrolled in the study will receive a cell phone text message three weeks later asking if they have received an HIV test. Among those individuals who do not respond to the text message, another text will be sent at four weeks after the video. We anticipate the median duration of follow-up to be approximately 3.5 weeks following the video intervention.
Measured: Up to 4 weeks following the video intervention
Secondary outcomes (2)
Likelihood of HIV Testing
All individuals will be asked how likely they are to test for HIV soon immediately before and after watching the videos (during enrollment). Likelihood of HIV testing will be measured on a 4-point numerical Likert scale rating scale. 0 will be "very unlikely", 1 will be "unlikely", 2 will be likely, and 3 will be very likely. The percentage of individuals who report increased likelihood of HIV testing will be reported.
Measured: Up to one day
Cost-effectiveness of Developing HIV Testing Promotional Videos
Cost-effectiveness of developing the crowdsourced video compared to the conventional video
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 721 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Social Entrepreneurship to Spur Health, University of California, San Francisco, London School of Hygiene and Tropical Medicine, Guangdong Provincial Centers for Skin Diseases and STI Control
- Responsible party
- Principal investigator, Joseph Tucker, MD, PhD, MA, University of North Carolina, Chapel Hill
- Investigators
- Joseph Tucker, Principal investigator, UNC Project-China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248558
- Sponsor's protocol ID
- 14-1865
- Status last verified
- Dec 2016
- First submitted
- 17 Sep 2014
- Last updated
- 10 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wang C, Mollan KR, Hudgens MG, Tucker JD, Zheng H, Tang W, Ling L. Generalisability of an online randomised controlled trial: an empirical analysis. J Epidemiol Community Health. 2018 Feb;72(2):173-178. doi: 10.1136/jech-2017-209976. Epub 2017 Nov 28.
PubMed 29183956Tang W, Han L, Best J, Zhang Y, Mollan K, Kim J, Liu F, Hudgens M, Bayus B, Terris-Prestholt F, Galler S, Yang L, Peeling R, Volberding P, Ma B, Xu H, Yang B, Huang S, Fenton K, Wei C, Tucker JD. Crowdsourcing HIV Test Promotion Videos: A Noninferiority Randomized Controlled Trial in China. Clin Infect Dis. 2016 Jun 1;62(11):1436-1442. doi: 10.1093/cid/ciw171. Epub 2016 Apr 29.
PubMed 27129465
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crowdsourcing Versus Conventional HIV Testing Promotion: A Noninferiority Randomized Controlled Trial to Evaluate Promoting First-Time HIV Testing Among MSM and Transgender Individuals in China
- ClinicalTrials.gov ID
- NCT02248558
- Acronym / sponsor ID
- 14-1865
- Conditions
- HIV
- Keywords
- Contest, Crowdsourcing, Innovation, Randomized controlled trial, China, Social entrepreneurship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 721 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Social Entrepreneurship to Spur Health, University of California, San Francisco, London School of Hygiene and Tropical Medicine, Guangdong Provincial Centers for Skin Diseases and STI Control
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Posted 20 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Crowdsourcing may be a powerful tool to spur the development of innovative videos to promote HIV testing among key populations such as men who have sex with men (MSM) and transgender (TG) individuals. The purpose of this randomized controlled trial is to compare the effect of a crowdsourced video and a conventional video on first-time HIV testing among MSM and TG in China. The crowdsourced video was developed using an open contest, formal transparent judging, and an incentive of marketing promotion. The hypothesis is that a crowdsourced video will be equivalent (within a margin of 3%) to a conventional video in terms of self-reported first-time HIV testing within 3-4 weeks of watching the video.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional video | Active comparator | Behavioral: Conventional VideoThis arm will receive a one-minute conventional video promoting HIV test uptake. |
| Crowdsourced video | Experimental | Behavioral: Crowdsourced VideoThis arm will receive a one-minute crowdsourced video promoting HIV test uptake. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Born biologically male or identify as transgender
- 16 years or older
- Lifetime anal sex with another man
- Providing informed consent and active mobile phone number
Key exclusion criteria (2 listed)
- HIV-infected
- HIV-tested ever in the past
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 |
|---|---|---|
| Conventional VideoParticipants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development. | Behavioural | Conventional video |
| Crowdsourced VideoParticipants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos. | Behavioural | Crowdsourced video |
Primary outcome
First-Time HIV Testing
Time frame: Up to 4 weeks following the video intervention
All individuals enrolled in the study will receive a cell phone text message three weeks later asking if they have received an HIV test. Among those individuals who do not respond to the text message, another text will be sent at four weeks after the video. We anticipate the median duration of follow-up to be approximately 3.5 weeks following the video intervention.
2 secondary outcomes
Likelihood of HIV Testing
Time frame: Up to one day
Cost-effectiveness of Developing HIV Testing Promotional Videos
Time frame: Up to one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29183956Wang C, Mollan KR, Hudgens MG, Tucker JD, Zheng H, Tang W, Ling L. Generalisability of an online randomised controlled trial: an empirical analysis. J Epidemiol Community Health. 2018 Feb;72(2):173-178. doi: 10.1136/jech-2017-209976. Epub 2017 Nov 28.
- Derived from this study: PubMed 27129465Tang W, Han L, Best J, Zhang Y, Mollan K, Kim J, Liu F, Hudgens M, Bayus B, Terris-Prestholt F, Galler S, Yang L, Peeling R, Volberding P, Ma B, Xu H, Yang B, Huang S, Fenton K, Wei C, Tucker JD. Crowdsourcing HIV Test Promotion Videos: A Noninferiority Randomized Controlled Trial in China. Clin Infect Dis. 2016 Jun 1;62(11):1436-1442. doi: 10.1093/cid/ciw171. Epub 2016 Apr 29.
- Social Entrepreneurship for Sexual HealthLink provided by the sponsor.
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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.
Joseph Tucker principal investigator
UNC Project-China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Video and Crowdsourced Video in people with HIV, run by University of North Carolina, Chapel Hill 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 4 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 10 Feb 2017. 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?
Yes. Results are posted in the registry (first posted 20 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
First-Time HIV Testing (time frame: Up to 4 weeks following the video intervention). 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 NCT02248558, which also lists 2 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 10 Feb 2017.