HIV
Conditions
Keywords
HIV, MSM, test uptake, crowdsourcing
Brief 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). 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.
Interventions
BEHAVIORALCrowdsourced 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.
BEHAVIORALTraditional intervention 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.
Sponsors
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
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Women are excluded from this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months | From implementation roll-out to three months after implementation of crowdsourced intervention | This will be assessed by self-report during a follow-up survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV Testing Social Norms | From implementation roll-out to three months after implementation of crowdsourced intervention | 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 |
| Change in HIV Testing Self-efficacy | From implementation roll-out to three months after implementation of crowdsourced intervention | Number of men who report higher levels of self-efficacy when comparing their pre-intervention and post-intervention HIV testing norms |
| Community Engagement/ MSM Community Affiliation | From implementation roll-out to three months after implementation of crowdsourced intervention | 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. |
| 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 | From implementation roll-out to three months after implementation of crowdsourced intervention | 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. |
| Number of Men Reporting Condomless Sex at 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 | From implementation roll-out to three months after implementation of crowdsourced intervention | 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 |
| 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 | — |
| 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 | — |
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 383 |
| Delayed Intervention 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. | 328 |
| 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. | 316 |
| 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. | 354 |
| Total | 1,381 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 89 | 76 | 69 | 72 |
Baseline characteristics
| Characteristic | Immediate Intervention | Delayed Intervention 3 | Delayed Intervention 1 | Delayed Intervention 2 | Total |
|---|---|---|---|---|---|
| Age, Customized 16-20 years | 65 Participants | 87 Participants | 78 Participants | 81 Participants | 311 Participants |
| Age, Customized 21-25 years | 146 Participants | 111 Participants | 118 Participants | 94 Participants | 469 Participants |
| Age, Customized 26-30 years | 100 Participants | 95 Participants | 80 Participants | 80 Participants | 355 Participants |
| Age, Customized >30 years | 72 Participants | 61 Participants | 52 Participants | 61 Participants | 246 Participants |
| Annual income, US$ >12500 | 35 Participants | 36 Participants | 22 Participants | 36 Participants | 129 Participants |
| Annual income, US$ <3000 | 75 Participants | 64 Participants | 82 Participants | 64 Participants | 285 Participants |
| Annual income, US$ 3000-6000 | 75 Participants | 67 Participants | 86 Participants | 71 Participants | 299 Participants |
| Annual income, US$ 6001-9500 | 133 Participants | 120 Participants | 88 Participants | 93 Participants | 434 Participants |
| Annual income, US$ 9501-12500 | 65 Participants | 67 Participants | 50 Participants | 52 Participants | 234 Participants |
| Condomless sex No | 101 Participants | 98 Participants | 92 Participants | 85 Participants | 376 Participants |
| Condomless sex Yes | 282 Participants | 256 Participants | 236 Participants | 231 Participants | 1005 Participants |
| Disclosure of sexual orientation Disclosed to others | 262 Participants | 222 Participants | 205 Participants | 209 Participants | 898 Participants |
| Disclosure of sexual orientation Not disclosed to others | 121 Participants | 132 Participants | 123 Participants | 107 Participants | 483 Participants |
| Highest education College or beyond | 251 Participants | 227 Participants | 222 Participants | 198 Participants | 898 Participants |
| Highest education High school or below | 132 Participants | 127 Participants | 106 Participants | 118 Participants | 483 Participants |
| Marital Status Married | 46 Participants | 55 Participants | 38 Participants | 48 Participants | 187 Participants |
| Marital Status Never married | 337 Participants | 299 Participants | 290 Participants | 268 Participants | 1194 Participants |
| Race/Ethnicity, Customized Asian | 383 Participants | 354 Participants | 328 Participants | 316 Participants | 1381 Participants |
| Region of Enrollment China | 383 Participants | 354 Participants | 328 Participants | 316 Participants | 1381 Participants |
| Sex/Gender, Customized Male | 364 Participants | 334 Participants | 314 Participants | 301 Participants | 1313 Participants |
| Sex/Gender, Customized Transgender individuals | 19 Participants | 20 Participants | 14 Participants | 15 Participants | 68 Participants |
| Sexual orientation Bisexual | 87 Participants | 125 Participants | 103 Participants | 86 Participants | 401 Participants |
| Sexual orientation Gay | 296 Participants | 229 Participants | 225 Participants | 230 Participants | 980 Participants |
| Syphilis testing No | 360 Participants | 335 Participants | 317 Participants | 301 Participants | 1313 Participants |
| Syphilis testing Yes | 23 Participants | 19 Participants | 11 Participants | 15 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 383 | 0 / 328 | 0 / 316 | 0 / 354 |
| other Total, other adverse events | 0 / 383 | 0 / 328 | 0 / 316 | 0 / 354 |
| serious Total, serious adverse events | 0 / 383 | 0 / 328 | 0 / 316 | 0 / 354 |
Outcome results
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
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Intervention | Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months | 56 Participants |
| Delayed Intervention 1 | Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months | 85 Participants |
| Delayed Intervention 2 | Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months | 122 Participants |
| Delayed Intervention 3 | Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months | 128 Participants |
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
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Intervention | Change in HIV Testing Self-efficacy | 200 Participants |
| Delayed Intervention 1 | Change in HIV Testing Self-efficacy | 173 Participants |
| Delayed Intervention 2 | Change in HIV Testing Self-efficacy | 153 Participants |
| Delayed Intervention 3 | Change in HIV Testing Self-efficacy | 181 Participants |
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.
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Intervention | Community Engagement/ MSM Community Affiliation | 190 Participants |
| Delayed Intervention 1 | Community Engagement/ MSM Community Affiliation | 148 Participants |
| Delayed Intervention 2 | Community Engagement/ MSM Community Affiliation | 157 Participants |
| Delayed Intervention 3 | Community Engagement/ MSM Community Affiliation | 176 Participants |
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
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Intervention | HIV Testing Social Norms | 214 Participants |
| Delayed Intervention 1 | HIV Testing Social Norms | 181 Participants |
| Delayed Intervention 2 | HIV Testing Social Norms | 175 Participants |
| Delayed Intervention 3 | HIV Testing Social Norms | 190 Participants |
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.
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention | Mean Score of Anticipated HIV Stigma | 2.06 Scores on a scale | Standard Deviation 0.65 |
| Delayed Intervention 1 | Mean Score of Anticipated HIV Stigma | 2.06 Scores on a scale | Standard Deviation 0.7 |
| Delayed Intervention 2 | Mean Score of Anticipated HIV Stigma | 2.11 Scores on a scale | Standard Deviation 0.66 |
| Delayed Intervention 3 | Mean Score of Anticipated HIV Stigma | 2.08 Scores on a scale | Standard Deviation 0.69 |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Intervention | Number of Men Reporting Being Self-tested for HIV in the Last 3 Months Post-intervention | 32 Participants |
| Delayed Intervention 1 | Number of Men Reporting Being Self-tested for HIV in the Last 3 Months Post-intervention | 68 Participants |
| Delayed Intervention 2 | Number of Men Reporting Being Self-tested for HIV in the Last 3 Months Post-intervention | 94 Participants |
| Delayed Intervention 3 | Number of Men Reporting Being Self-tested for HIV in the Last 3 Months Post-intervention | 107 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Intervention | Number of Men Reporting Being Tested for Syphilis in the Last 3 Months Post-intervention | 22 Participants |
| Delayed Intervention 1 | Number of Men Reporting Being Tested for Syphilis in the Last 3 Months Post-intervention | 29 Participants |
| Delayed Intervention 2 | Number of Men Reporting Being Tested for Syphilis in the Last 3 Months Post-intervention | 37 Participants |
| Delayed Intervention 3 | Number of Men Reporting Being Tested for Syphilis in the Last 3 Months Post-intervention | 50 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Intervention | Number of Men Reporting Condomless Sex at 3 Months Post-intervention | 74 Participants |
| Delayed Intervention 1 | Number of Men Reporting Condomless Sex at 3 Months Post-intervention | 52 Participants |
| Delayed Intervention 2 | Number of Men Reporting Condomless Sex at 3 Months Post-intervention | 62 Participants |
| Delayed Intervention 3 | Number of Men Reporting Condomless Sex at 3 Months Post-intervention | 60 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Intervention | Number of Men Reporting Engaged in HIV Testing Community Campaign in the Past 3 Months | 269 Participants |
| Delayed Intervention 1 | Number of Men Reporting Engaged in HIV Testing Community Campaign in the Past 3 Months | 246 Participants |
| Delayed Intervention 2 | Number of Men Reporting Engaged in HIV Testing Community Campaign in the Past 3 Months | 226 Participants |
| Delayed Intervention 3 | Number of Men Reporting Engaged in HIV Testing Community Campaign in the Past 3 Months | 236 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Intervention | Number of Men Reporting Received HIV Self-testing Kits in the Last 3 Months Post-intervention | 91 Participants |
| Delayed Intervention 1 | Number of Men Reporting Received HIV Self-testing Kits in the Last 3 Months Post-intervention | 73 Participants |
| Delayed Intervention 2 | Number of Men Reporting Received HIV Self-testing Kits in the Last 3 Months Post-intervention | 89 Participants |
| Delayed Intervention 3 | Number of Men Reporting Received HIV Self-testing Kits in the Last 3 Months Post-intervention | 120 Participants |
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
Time frame: From implementation roll-out to three months after implementation of crowdsourced intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Intervention | Number of Men Reporting Using Mobile Apps in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 71 Participants |
| Delayed Intervention 1 | Number of Men Reporting Using Mobile Apps in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 54 Participants |
| Delayed Intervention 2 | Number of Men Reporting Using Mobile Apps in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 63 Participants |
| Delayed Intervention 3 | Number of Men Reporting Using Mobile Apps in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 81 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Intervention | Number of Men Reporting Using Tencent QQ (QQ) in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 47 Participants |
| Delayed Intervention 1 | Number of Men Reporting Using Tencent QQ (QQ) in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 71 Participants |
| Delayed Intervention 2 | Number of Men Reporting Using Tencent QQ (QQ) in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 44 Participants |
| Delayed Intervention 3 | Number of Men Reporting Using Tencent QQ (QQ) in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 49 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Intervention | Number of Men Reporting Using Wechat in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 117 Participants |
| Delayed Intervention 1 | Number of Men Reporting Using Wechat in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 101 Participants |
| Delayed Intervention 2 | Number of Men Reporting Using Wechat in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 97 Participants |
| Delayed Intervention 3 | Number of Men Reporting Using Wechat in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 102 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Intervention | Number of Men Reporting Using Weibo in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 49 Participants |
| Delayed Intervention 1 | Number of Men Reporting Using Weibo in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 56 Participants |
| Delayed Intervention 2 | Number of Men Reporting Using Weibo in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 44 Participants |
| Delayed Intervention 3 | Number of Men Reporting Using Weibo in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing | 46 Participants |