HIVNCT02796963
Crowdsourcing A Public Health Campaign
A study testing Crowdsourced intervention and Traditional intervention campaign in people with HIV, run by University of North Carolina, Chapel Hill.
Trial summary
The purpose of this stepped wedge randomized controlled trial is to evaluate the effectiveness of a crowdsourced intervention on promoting HIV testing among young Chinese men who have sex with men (MSM). Read more about this study
- Who is it for?
- Ages 16 years and older, men only
- Conditions the study is for
- HIV
- What is being tested?
- Crowdsourced intervention and Traditional intervention campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,381 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Aug 2017
- 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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Currently living and planning to live in one of the eight cities used in the study in the next 12 months.
- Not living with HIV
- No HIV test in the past three months
- Born biologically male and identify as either male or transgender female
- Had anal or oral sex with men at least once during their lifetime
- 16 years or older
- Willing to provide cell phone number
- Complete the informed consent document
Who cannot join
- Women are excluded from this study
About this study
Official title: Institute for Global Health & Infectious Diseases (IGHID) 11604 - Crowdsourcing to Promote HIV Testing: A Stepped Wedge Randomized Controlled Trial to Evaluate Promoting HIV Testing in China
The purpose of this stepped wedge randomized controlled trial is to evaluate the effectiveness of a crowdsourced intervention on promoting HIV testing among young Chinese men who have sex with men (MSM). The crowdsourced intervention will include an open contest, judging to determine finalists and prizes, a designathon, and contest-based MSM engagement. The hypothesis is that a crowdsourced intervention will be superior to conventional HIV test uptake campaigns in eliciting HIV test uptake.
Read the detailed description
This study will use an adaptation of the stepped wedge randomized controlled trial design. A total of eight major metropolitan cities will implement the crowdsourced intervention. These cities will be chosen based on the following criteria: 1) previous Centers for Disease Control and Prevention (CDC) MSM sentinel surveillance site; 2) capacity for campaign implementation; 3) capacity for intervention implementation at the community level. Four cities will implement more intensive in-person events to promote engagement (Guangzhou, Shenzhen in Guangdong Province, Qingdao, and Jinan in Shandong Province) during survey intervention stage. The Randomized controlled trial (RCT) will be evaluated using two different sources of data: 1) online survey data from MSM in the eight cities prior to and after the intervention; 2) CDC routine surveillance data in the eight cities prior to and after the intervention.
- Conditions
- HIV
- Being tested
- Crowdsourced intervention, Traditional intervention campaign
- Keywords
- HIV, MSM, test uptake, crowdsourcing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crowdsourced interventionBehavioural
The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities.
Traditional intervention campaignBehavioural
Also called Conventional HIV testing campaign
The pre-intervention period will include conventional HIV testing campaigns organized by local CDC, Community-Based Organization (CBO), and partners. These are typically designed by experts and social marketing companies.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | Men will be exposed immediately to a comprehensive intervention promoting HIV testing. Receives: Behavioral: Crowdsourced intervention |
| Delayed Intervention | Experimental | Men will be exposed to a comprehensive intervention promoting HIV testing after a delay period. Receives: Behavioral: Crowdsourced intervention; Behavioral: Traditional intervention campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months
This will be assessed by self-report during a follow-up survey
Measured: From implementation roll-out to three months after implementation of crowdsourced intervention
Secondary outcomes (13)
Number of Men Reporting Condomless Sex at 3 Months Post-intervention
Measured: From implementation roll-out to three months after implementation of crowdsourced intervention
HIV Testing Social Norms
HIV testing social norms will be measured using six survey items that are each on a five-point Likert scale. Increased HIV testing social norms will be defined as having an increase from baseline in any two of these six survey items and dichotomized accordingly. Number of men who report higher score of social norms when comparing their pre-intervention and post-intervention values
Measured: From implementation roll-out to three months after implementation of crowdsourced intervention
Change in HIV Testing Self-efficacy
Number of men who report higher levels of self-efficacy when comparing their pre-intervention and post-intervention HIV testing norms
Measured: From implementation roll-out to three months after implementation of crowdsourced intervention
Community Engagement/ MSM Community Affiliation
Number of men, defined as an increase in closer affiliation with the MSM community (i.e., tongzhi circle, gay online networks or groups) when comparing their pre-intervention and post-intervention periods.
Measured: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Engaged in HIV Testing Community Campaign in the Past 3 Months
Measured: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Being Self-tested for HIV in the Last 3 Months Post-intervention
Measured: From implementation roll-out to three months after implementation of crowdsourced intervention
Mean Score of Anticipated HIV Stigma
Measured by a 7-item version of the anticipated HIV stigma scale, designed to measure the extent to which participants anticipated negative intrapersonal and interpersonal consequences were they to contract HIV in the future. All seven items were rated on a Likert-type scale (1=Strongly Disagree; 4=Strongly Agree). The mean score is reported, ranged from 1 to 4. Higher values indicate greater anticipated stigma.
Measured: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Being Tested for Syphilis in the Last 3 Months Post-intervention
Measured: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Using Weibo in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Measured: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Using Wechat in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Measured: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Using Tencent QQ (QQ) in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Measured: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Using Mobile Apps in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Frequency of men, defined as the number of men who reported using mobile apps in the past three months to give or receive information about HIV testing comparing their pre-intervention and post-intervention engagement
Measured: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Received HIV Self-testing Kits in the Last 3 Months Post-intervention
Measured: From implementation roll-out to three months after implementation of crowdsourced intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2017
- Study completionAug 2017
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 (5)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,381 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), UNC-South China STD Research Training Center, UNC Center for AIDS Research, SESH Global, Guangdong Provincial Center for Skin Diseases and STI Control, London School of Hygiene and Tropical Medicine, University of Bristol, Shandong University, Shandong Province Centers for Disease Control and Prevention, Guangdong Center for Disease Prevention and Control
- Responsible party
- Sponsor
- Investigators
- Joseph D Tucker, MD, PhD, Principal investigator, jdtucker@med.unc.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796963
- Sponsor's protocol ID
- 16-0851
- Other IDs
- R01AI114310
- Status last verified
- Feb 2018
- First submitted
- 23 May 2016
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Tang 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 27129465Zhang Y, Kim JA, Liu F, Tso LS, Tang W, Wei C, Bayus BL, Tucker JD. Creative Contributory Contests to Spur Innovation in Sexual Health: 2 Cases and a Guide for Implementation. Sex Transm Dis. 2015 Nov;42(11):625-8. doi: 10.1097/OLQ.0000000000000349.
PubMed 26462186Ong JJ, Booton RD, Tucker JD, Tang W, Vickerman P, Zhang L, Mitchell KM. Economic evaluation of improving HIV self-testing among MSM in China using a crowdsourced intervention: a cost-effectiveness analysis. AIDS. 2023 Mar 15;37(4):671-678. doi: 10.1097/QAD.0000000000003457. Epub 2022 Dec 9.
PubMed 36729711Tang W, Wei C, Cao B, Wu D, Li KT, Lu H, Ma W, Kang D, Li H, Liao M, Mollan KR, Hudgens MG, Liu C, Huang W, Liu A, Zhang Y, Smith MK, Mitchell KM, Ong JJ, Fu H, Vickerman P, Yang L, Wang C, Zheng H, Yang B, Tucker JD. Crowdsourcing to expand HIV testing among men who have sex with men in China: A closed cohort stepped wedge cluster randomized controlled trial. PLoS Med. 2018 Aug 28;15(8):e1002645. doi: 10.1371/journal.pmed.1002645. eCollection 2018 Aug.
PubMed 30153265SESH Study Group; Tucker JD. Crowdsourcing to promote HIV testing among MSM in China: study protocol for a stepped wedge randomized controlled trial. Trials. 2017 Oct 2;18(1):447. doi: 10.1186/s13063-017-2183-1.
PubMed 28969702
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institute for Global Health & Infectious Diseases (IGHID) 11604 - Crowdsourcing to Promote HIV Testing: A Stepped Wedge Randomized Controlled Trial to Evaluate Promoting HIV Testing in China
- ClinicalTrials.gov ID
- NCT02796963
- Acronym / sponsor ID
- 16-0851
- Conditions
- HIV
- Keywords
- HIV, MSM, test uptake, crowdsourcing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,381 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), UNC-South China STD Research Training Center, UNC Center for AIDS Research, SESH Global, Guangdong Provincial Center for Skin Diseases and STI Control, London School of Hygiene and Tropical Medicine, University of Bristol, Shandong University, Shandong Province Centers for Disease Control and Prevention, Guangdong Center for Disease Prevention and Control
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Posted 11 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this stepped wedge randomized controlled trial is to evaluate the effectiveness of a crowdsourced intervention on promoting HIV testing among young Chinese men who have sex with men (MSM). The crowdsourced intervention will include an open contest, judging to determine finalists and prizes, a designathon, and contest-based MSM engagement. The hypothesis is that a crowdsourced intervention will be superior to conventional HIV test uptake campaigns in eliciting HIV test uptake.
Detailed description
This study will use an adaptation of the stepped wedge randomized controlled trial design. A total of eight major metropolitan cities will implement the crowdsourced intervention. These cities will be chosen based on the following criteria: 1) previous Centers for Disease Control and Prevention (CDC) MSM sentinel surveillance site; 2) capacity for campaign implementation; 3) capacity for intervention implementation at the community level. Four cities will implement more intensive in-person events to promote engagement (Guangzhou, Shenzhen in Guangdong Province, Qingdao, and Jinan in Shandong Province) during survey intervention stage. The Randomized controlled trial (RCT) will be evaluated using two different sources of data: 1) online survey data from MSM in the eight cities prior to and after the intervention; 2) CDC routine surveillance data in the eight cities prior to and after the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Crowdsourced interventionMen will be exposed immediately to a comprehensive intervention promoting HIV testing. |
| Delayed Intervention | Experimental | Behavioral: Crowdsourced intervention, Behavioral: Traditional intervention campaignMen will be exposed to a comprehensive intervention promoting HIV testing after a delay period. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Currently living and planning to live in one of the eight cities used in the study in the next 12 months.
- Not living with HIV
- No HIV test in the past three months
- Born biologically male and identify as either male or transgender female
- Had anal or oral sex with men at least once during their lifetime
Key exclusion criteria (1 listed)
- Women are excluded from this study
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 |
|---|---|---|
| Crowdsourced interventionThe crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities. | Behavioural | Delayed Intervention, Immediate Intervention |
| Traditional intervention campaignAlso: Conventional HIV testing campaignThe pre-intervention period will include conventional HIV testing campaigns organized by local CDC, Community-Based Organization (CBO), and partners. These are typically designed by experts and social marketing companies. | Behavioural | Delayed Intervention |
Primary outcome
Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
This will be assessed by self-report during a follow-up survey
13 secondary outcomes
Number of Men Reporting Condomless Sex at 3 Months Post-intervention
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
HIV Testing Social Norms
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Change in HIV Testing Self-efficacy
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Community Engagement/ MSM Community Affiliation
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Engaged in HIV Testing Community Campaign in the Past 3 Months
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Being Self-tested for HIV in the Last 3 Months Post-intervention
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Mean Score of Anticipated HIV Stigma
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Being Tested for Syphilis in the Last 3 Months Post-intervention
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Using Weibo in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Using Wechat in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Using Tencent QQ (QQ) in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Using Mobile Apps in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Received HIV Self-testing Kits in the Last 3 Months Post-intervention
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: 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.
- Background: PubMed 26462186Zhang Y, Kim JA, Liu F, Tso LS, Tang W, Wei C, Bayus BL, Tucker JD. Creative Contributory Contests to Spur Innovation in Sexual Health: 2 Cases and a Guide for Implementation. Sex Transm Dis. 2015 Nov;42(11):625-8. doi: 10.1097/OLQ.0000000000000349.
- Derived from this study: PubMed 36729711Ong JJ, Booton RD, Tucker JD, Tang W, Vickerman P, Zhang L, Mitchell KM. Economic evaluation of improving HIV self-testing among MSM in China using a crowdsourced intervention: a cost-effectiveness analysis. AIDS. 2023 Mar 15;37(4):671-678. doi: 10.1097/QAD.0000000000003457. Epub 2022 Dec 9.
- Derived from this study: PubMed 30153265Tang W, Wei C, Cao B, Wu D, Li KT, Lu H, Ma W, Kang D, Li H, Liao M, Mollan KR, Hudgens MG, Liu C, Huang W, Liu A, Zhang Y, Smith MK, Mitchell KM, Ong JJ, Fu H, Vickerman P, Yang L, Wang C, Zheng H, Yang B, Tucker JD. Crowdsourcing to expand HIV testing among men who have sex with men in China: A closed cohort stepped wedge cluster randomized controlled trial. PLoS Med. 2018 Aug 28;15(8):e1002645. doi: 10.1371/journal.pmed.1002645. eCollection 2018 Aug.
- Derived from this study: PubMed 28969702SESH Study Group; Tucker JD. Crowdsourcing to promote HIV testing among MSM in China: study protocol for a stepped wedge randomized controlled trial. Trials. 2017 Oct 2;18(1):447. doi: 10.1186/s13063-017-2183-1.
- University of North Carolina websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 D Tucker, MD, PhD principal investigator
jdtucker@med.unc.edu
Questions about this trial
What is this clinical trial studying?
A study testing Crowdsourced intervention and Traditional intervention campaign in people with HIV, run by University of North Carolina, Chapel Hill.
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 8 inclusion and 1 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 11 May 2018). 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?
Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months (time frame: From implementation roll-out to three months after implementation of crowdsourced 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 NCT02796963, which also lists 5 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 28 Aug 2019.