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| Name | Class |
|---|---|
| Doris Duke Charitable Foundation | OTHER |
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This is an online randomized controlled trial (RCT) comparing men who have sex with men (MSM) exposed to a crowdsourced intervention to MSM who did not receive the intervention to determine the effect on Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) testing. Participants will be randomly assigned in a 1:1 ratio to intervention or control using a computer-based allocation system. Participants will be assessed for primary and secondary outcomes four weeks after randomization.
700 MSM will be recruited through social media operated by gay organizations in China. Eligible participants will be born biologically male, age 16 years or older, report previous anal sex with another man, and reside in China. Men self-reporting previous HBV vaccination, HBV testing, or HCV testing will be excluded. After completing a baseline online survey, participants will be randomly assigned to intervention or control arms with a 1:1 allocation ratio. The intervention will include two components: (1) a multimedia component will deliver two videos and two images promoting HBV and HCV testing developed through a crowdsourcing contest in China. (2) A participatory component will invite men to submit suggestions for how to improve crowdsourced videos and images. The control arm will not view any images or videos and will not be invited to submit suggestions. All participants will be offered reimbursement for HBV and HCV testing costs. The primary outcome is HBV and HCV test uptake confirmed through electronic submission of test report photos within four weeks of enrollment. Secondary outcomes include self-reported HBV and HCV test uptake, HBV vaccination uptake, and change in stigma toward people living with HBV measured through a follow-up survey after four weeks. Men with primary and secondary outcomes will be calculated using intention to treat and as-exposed analyses and compared using two-sided 95% confidence intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crowdsourced intervention | Experimental | A multimedia component will deliver two videos and two images promoting HBV and HCV testing developed through a crowdsourcing contest in China. A participatory component will invite men to submit suggestions for how to improve crowdsourced videos and images. |
|
| Control | Other | No images or videos will be viewed, and suggestions for improving hepatitis testing materials will not be collected. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crowdsourced materials | Behavioral | Among participants randomized to the intervention arm, intervention images and videos promoting HBV and HCV testing will be delivered through the WeChat platform. Men will also be invited to submit suggestions for how to improve intervention videos and images. |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed HBV and HCV test uptake | Defined as frequency of men who had both HBsAg test uptake and anti-HCV IgG test uptake confirmed through electronic submission of a test report photo showing serology results, age of tester, sex of tester, and date of test | enrollment - 4 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed HBV test uptake | Defined as frequency of men who had HBsAg test uptake through electronic submission of a test report photo showing serology results, age of tester, sex of tester, and date of test | enrollment - 4 weeks after enrollment |
| Confirmed HCV test uptake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Tucker, MD, PhD, MA | University of North Carolina, Chapel Hill | Study Director |
| Thomas Fitzpatrick | Institute for Global Health and Infectious Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Project-China | Guangzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32779730 | Derived | Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680. | |
| 30268114 | Derived |
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All de-identified data generated or analyzed during this study will be included in published articles and supplementary information files.
They will be shared upon publication of the main manuscript.
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| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D006509 | Hepatitis B |
| D006526 | Hepatitis C |
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
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Participants will be randomly assigned in a 1:1 ratio to the study intervention or control
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|
| Control | Other | Participants will not view any images or videos promoting HBV and HCV testing. |
|
Defined as frequency of men who had anti-HCV IgG test uptake confirmed through electronic submission of a test report photo showing serology results, age of tester, sex of tester, and date of test |
| enrollment - 4 weeks after enrollment |
| Self-reported HBV test uptake | Defined as frequency of men who had HBsAg uptake within four weeks of enrollment, self-reported in follow-up survey | enrollment - 4 weeks after enrollment |
| Self-reported HCV test uptake | Defined as frequency of men who had anti-HCV IgG uptake within four weeks of enrollment, self-reported in follow-up survey | enrollment - 4 weeks after enrollment |
| HBV vaccination uptake | Defined as frequency of men who had receipt of at least a one dose of the HBV vaccine within four weeks of enrollment, self-reported in follow-up survey | enrollment - 4 weeks after enrollment |
| HBV vaccination uptake among men with confirmed susceptibility to HBV infection | Defined as frequency of men with negative HBsAg and negative anti-HBs results confirmed through electronic submission of a test report photo showing serology results, who had receipt of at least a one dose of the HBV vaccine within four weeks of enrollment, self-reported in follow-up survey | enrollment - 4 weeks after enrollment |
| HIV test uptake | Defined as frequency of men who had HIV test uptake within four weeks of enrollment, self-reported in follow-up survey | enrollment - 4 weeks after enrollment |
| Chlamydia test uptake | Defined as frequency of men who had chlamydia test uptake within four weeks of enrollment, self-reported in follow-up survey | baseline - 4 weeks after enrollment |
| Gonorrhea test uptake | Defined as frequency of men who had gonorrhea test uptake within four weeks of enrollment, self-reported in follow-up survey | enrollment - 4 weeks after enrollment |
| Syphilis test uptake | Defined as frequency of men who had syphilis test uptake within four weeks of enrollment, self-reported in follow-up survey | enrollment - 4 weeks after enrollment |
| Change in stigma toward people living with HBV | Continuous variable, defined as difference between Toronto Chinese HBV Stigma Scale score assessed at follow-up and baseline. Stigma toward people living with HBV will be measured at baseline and follow-up using 20 survey items that are each on a five point Likert scale. The 20 items were originally developed as the Toronto Chinese HBV Stigma Scale (potential range of 20 - 100), which has been previously validated and correlated to HBV testing behaviors among Chinese populations. Decreased stigma toward people living with HBV will be defined as a mean composite score that is less at follow-up compared to baseline. | enrollment - 4 weeks after enrollment |
| Visit with a physician after hepatitis test uptake | Defined as frequency of men who had HBV and/or HCV test uptake and saw a physician to discuss hepatitis test results within four weeks of enrollment, self-reported in follow-up survey | enrollment - 4 weeks after enrollment |
| Fitzpatrick T, Zhou K, Cheng Y, Chan PL, Cui F, Tang W, Mollan KR, Guo W, Tucker JD. A crowdsourced intervention to promote hepatitis B and C testing among men who have sex with men in China: study protocol for a nationwide online randomized controlled trial. BMC Infect Dis. 2018 Sep 29;18(1):489. doi: 10.1186/s12879-018-3403-3. |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |