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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI114310 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| UNC-South China STD Research Training Center | UNKNOWN |
| UNC Center for AIDS Research | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention | Experimental | Men will be exposed immediately to a comprehensive intervention promoting HIV testing. |
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| Delayed Intervention | Experimental | Men will be exposed to a comprehensive intervention promoting HIV testing after a delay period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crowdsourced intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From implementation roll-out to three months after implementation of crowdsourced intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Men Reporting Condomless Sex at 3 Months Post-intervention | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph D Tucker, MD, PhD | jdtucker@med.unc.edu | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27129465 | Background | 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. | |
| 26462186 | Background | Zhang 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. |
| Label | URL |
|---|---|
| University of North Carolina website | View source |
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Overall, the survey link was clicked 36,863 times from 25,141 independent Internet Protocol (IP) addresses, and a total of 2,112 eligible participants finished the questionnaire (many people clicked the survey link but withdrew before the eligible screening). Among these 2,112 participants, 1381 were eligible for the study.
Participants were recruited from July 28, 2016, and followed until August 21, 2017. A total of 1,381 participants were enrolled. Of these, 203, 139, 134 and 203 were recruited from Guangzhou, Jiangmen, Zhuhai and Shenzhen, respectively, while 180, 189, 182 and 151 were recruited from Yantai, Jinan, Qingdao and Jining, respectively.
| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Intervention | Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3. Crowdsourced intervention: 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. |
| FG001 | Delayed Intervention 1 | Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6. Crowdsourced intervention: 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. |
| FG002 | Delayed Intervention 2 | Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9. Crowdsourced intervention: 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. |
| FG003 | Delayed Intervention 3 | Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12. Crowdsourced intervention: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Intervention | Guangzhou and Yantai city. Intervention in months 1-3: A crowdsourcing contest to solicit optimal images/concepts/taglines; a designathon to formulate optimal HIV testing campaigns; a process of localization unique to each of the eight cities. |
| BG001 | Delayed Intervention 1 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | From implementation roll-out to three months after implementation of crowdsourced intervention |
|
1 year (July 28, 2016- August 20, 2017)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Intervention | Based on the pre-determined randomization schedule, 383 participants from Guangzhou and Yantai were assigned to the first intervention group to receive a crowdsourced intervention in months 1-3. Crowdsourced intervention: 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. No adverse outcome was reported. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Weiming Tang | UNC Project-China | +86-21-83755824 | weimingtangscience@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2017 | Feb 7, 2018 | Prot_SAP_000.pdf |
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| SESH Global |
| UNKNOWN |
| Guangdong Provincial Center for Skin Diseases and STI Control | UNKNOWN |
| London School of Hygiene and Tropical Medicine | OTHER |
| University of Bristol | OTHER |
| Shandong University | OTHER |
| Shandong Province Centers for Disease Control and Prevention | OTHER |
| Guangdong Center for Disease Prevention and Control | OTHER_GOV |
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|
| Traditional intervention campaign | Behavioral | 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. |
|
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| 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 | 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. | 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 | 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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 | From implementation roll-out to three months after implementation of crowdsourced intervention |
| 36729711 | Derived | Ong 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. |
| 30153265 | Derived | Tang 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. |
| 28969702 | Derived | SESH 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. |
Jiangmen and Jinan city. Intervention in months 4-6: A crowdsourcing contest to solicit optimal images/concepts/taglines; a designathon to formulate optimal HIV testing campaigns; a process of localization unique to each of the eight cities. |
| BG002 | Delayed Intervention 2 | Zhuhai and Qingdao city. Intervention in months 7-9: A crowdsourcing contest to solicit optimal images/concepts/taglines; a designathon to formulate optimal HIV testing campaigns; a process of localization unique to each of the eight cities. |
| BG003 | Delayed Intervention 3 | Shenzhen and Jining city. Intervention in months 10-12: A crowdsourcing contest to solicit optimal images/concepts/taglines; a designathon to formulate optimal HIV testing campaigns; a process of localization unique to each of the eight cities. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Annual income, US$ | Count of Participants | Participants |
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| Highest education | Count of Participants | Participants |
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| Sexual orientation | Count of Participants | Participants |
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| Disclosure of sexual orientation | Count of Participants | Participants |
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| Condomless sex | Ever had condomless sex in the past three months | Count of Participants | Participants |
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| Syphilis testing | Had syphilis test in the past three months | Count of Participants | Participants |
|
| OG001 |
| Delayed Intervention 1 |
Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6. Crowdsourced intervention: 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. |
| OG002 | Delayed Intervention 2 | Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9. Crowdsourced intervention: 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. |
| OG003 | Delayed Intervention 3 | Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12. Crowdsourced intervention: 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. |
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| Secondary | Number of Men Reporting Condomless Sex at 3 Months Post-intervention | Posted | Count of Participants | Participants | From implementation roll-out to three months after implementation of crowdsourced intervention |
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| Secondary | 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 | Posted | Count of Participants | Participants | From implementation roll-out to three months after implementation of crowdsourced intervention |
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| Secondary | 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 | Posted | Count of Participants | Participants | From implementation roll-out to three months after implementation of crowdsourced intervention |
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| Secondary | 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. | Posted | Count of Participants | Participants | From implementation roll-out to three months after implementation of crowdsourced intervention |
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| Secondary | Number of Men Reporting Engaged in HIV Testing Community Campaign in the Past 3 Months | Posted | Count of Participants | Participants | From implementation roll-out to three months after implementation of crowdsourced intervention |
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| Secondary | Number of Men Reporting Being Self-tested for HIV in the Last 3 Months Post-intervention | Posted | Count of Participants | Participants | From implementation roll-out to three months after implementation of crowdsourced intervention |
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|
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| Secondary | 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. | Posted | Mean | Standard Deviation | Scores on a scale | From implementation roll-out to three months after implementation of crowdsourced intervention |
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| Secondary | Number of Men Reporting Being Tested for Syphilis in the Last 3 Months Post-intervention | Posted | Count of Participants | Participants | From implementation roll-out to three months after implementation of crowdsourced intervention |
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| Secondary | Number of Men Reporting Using Weibo in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | Posted | Count of Participants | Participants | From implementation roll-out to three months after implementation of crowdsourced intervention |
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| Secondary | Number of Men Reporting Using Wechat in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | Posted | Count of Participants | Participants | From implementation roll-out to three months after implementation of crowdsourced intervention |
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| Secondary | Number of Men Reporting Using Tencent QQ (QQ) in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | Posted | Count of Participants | Participants | From implementation roll-out to three months after implementation of crowdsourced intervention |
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| Secondary | 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 | Posted | Count of Participants | Participants | From implementation roll-out to three months after implementation of crowdsourced intervention |
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| Secondary | Number of Men Reporting Received HIV Self-testing Kits in the Last 3 Months Post-intervention | Posted | Count of Participants | Participants | From implementation roll-out to three months after implementation of crowdsourced intervention |
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| 0 |
| 383 |
| 0 |
| 383 |
| 0 |
| 383 |
| EG001 | Delayed Intervention 1 | Based on the pre-determined randomization schedule, 328 participants from Jiangmen and Jinan were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 4-6. Crowdsourced intervention: 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. No adverse outcome was reported. | 0 | 328 | 0 | 328 | 0 | 328 |
| EG002 | Delayed Intervention 2 | Based on the pre-determined randomization schedule, 316 participants from Zhuhai and Qingdao were assigned to the delayed intervention group 2 to receive a crowdsourced intervention in months 7-9. Crowdsourced intervention: 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. No adverse outcome was reported. | 0 | 316 | 0 | 316 | 0 | 316 |
| EG003 | Delayed Intervention 3 | Based on the pre-determined randomization schedule, 354 participants from Shenzhen and Jining were assigned to delayed intervention group 3 to receive a crowdsourced intervention in months 10-12. Crowdsourced intervention: 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. No adverse outcome was reported. | 0 | 354 | 0 | 354 | 0 | 354 |
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