Crowdsourcing HIV Test Promotion Videos: A Noninferiority Randomized Controlled Trial in China.
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ABSTRACT: Background
Crowdsourcing, the process of shifting individual tasks to a large group, may enhance human immunodeficiency virus (HIV) testing interventions. We conducted a noninferiority, randomized controlled trial to compare first-time HIV testing rates among men who have sex with men (MSM) and transgender individuals who received a crowdsourced or a health marketing HIV test promotion video.Methods
Seven hundred twenty-one MSM and transgender participants (≥16 years old, never before tested for HIV) were recruited through 3 Chinese MSM Web portals and randomly assigned to 1 of 2 videos. The crowdsourced video was developed using an open contest and formal transparent judging while the evidence-based health marketing video was designed by experts. Study objectives were to measure HIV test uptake within 3 weeks of watching either HIV test promotion video and cost per new HIV test and diagnosis.Results
Overall, 624 of 721 (87%) participants from 31 provinces in 217 Chinese cities completed the study. HIV test uptake was similar between the crowdsourced arm (37% [114/307]) and the health marketing arm (35% [111/317]). The estimated difference between the interventions was 2.1% (95% confidence interval, -5.4% to 9.7%). Among those tested, 31% (69/225) reported a new HIV diagnosis. The crowdsourced intervention cost substantially less than the health marketing intervention per first-time HIV test (US$131 vs US$238 per person) and per new HIV diagnosis (US$415 vs US$799 per person).Conclusions
Our nationwide study demonstrates that crowdsourcing may be an effective tool for improving HIV testing messaging campaigns and could increase community engagement in health campaigns.Clinical trials registration
NCT02248558.
SUBMITTER: Tang W
PROVIDER: S-EPMC4872295 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundHIV testing for marginalized populations is critical to controlling the HIV epidemic. However, the HIV testing rate among men who have sex with men (MSM) in China remains low. Crowdsourcing, the process of shifting individual tasks to a group, has been increasingly adopted in public health programs and may be a useful tool for spurring innovation in HIV testing campaigns. We designed a multi-site study to develop a crowdsourced HIV test promotion campaign and evaluate its effectiveness against conventional campaigns among MSM in China.MethodsThis study will use an adaptation of the stepped wedge, randomized controlled trial design. A total of eight major metropolitan cities in China will be randomized to sequentially initiate interventions at 3-month intervals. The intervention uses crowdsourcing at multiple steps to sustain crowd contribution. Approximately 1280 MSM, who are 16 years of age or over, live in the intervention city, have not been tested for HIV in the past 3 months, and are not living with HIV, will be recruited. Recruitment will take place through banner advertisements on a large gay dating app along with other social media platforms. Participants will complete one follow-up survey every 3 months for 12 months to evaluate their HIV testing uptake in the past 3 months and secondary outcomes including syphilis testing, sex without condoms, community engagement, testing stigma, and other related outcomes.DiscussionMSM HIV testing rates remain poor in China. Innovative methods to promote HIV testing are urgently needed. With a large-scale, stepped wedge, randomized controlled trial our study can improve understanding of crowdsourcing's long-term effectiveness in public health campaigns, expand HIV testing coverage among a key population, and inform intervention design in related public health fields.Trial registrationClinicalTrials.gov, NCT02796963 . Registered on 23 May 2016.
| S-EPMC5625620 | biostudies-literature
Project description:BACKGROUND:Crowdsourcing, the process of shifting individual tasks to a large group, may be useful for health communication, making it more people-centered. We aimed to evaluate whether a crowdsourced video is noninferior to a social marketing video in promoting condom use. METHODS:Men who have sex with men (?16 years old, had condomless sex within 3 months) were recruited and randomly assigned to watch 1 of the 2 videos in 2015. The crowdsourced video was developed through an open contest, and the social marketing video was designed by using social marketing principles. Participants completed a baseline survey and follow-up surveys at 3 weeks and 3 months postintervention. The outcome was compared with a noninferiority margin of +10%. RESULTS:Among the 1173 participants, 907 (77%) and 791 (67%) completed the 3-week and 3-month follow-ups. At 3 weeks, condomless sex was reported by 146 (33.6%) of 434 participants and 153 (32.3%) 473 participants in the crowdsourced and social marketing arms, respectively. The crowdsourced intervention achieved noninferiority (estimated difference, +1.3%; 95% confidence interval, -4.8% to 7.4%). At 3 months, 196 (52.1%) of 376 individuals and 206 (49.6%) of 415 individuals reported condomless sex in the crowdsourced and social-marketing arms (estimated difference: +2.5%, 95% confidence interval, -4.5 to 9.5%). The 2 arms also had similar human immunodeficiency virus testing rates and other condom-related secondary outcomes. CONCLUSIONS:Our study demonstrates that crowdsourced message is noninferior to a social marketing intervention in promoting condom use among Chinese men who have sex with men. Crowdsourcing contests could have a wider reach than other approaches and create more people-centered intervention tools for human immunodeficiency virus control.
| S-EPMC6380681 | biostudies-literature
Project description:BACKGROUND:HIV testing rates are suboptimal among at-risk men. Crowdsourcing may be a useful tool for designing innovative, community-based HIV testing strategies to increase HIV testing. The purpose of this study was to use a stepped wedge cluster randomized controlled trial (RCT) to evaluate the effect of a crowdsourced HIV intervention on HIV testing uptake among men who have sex with men (MSM) in eight Chinese cities. METHODS AND FINDINGS:An HIV testing intervention was developed through a national image contest, a regional strategy designathon, and local message contests. The final intervention included a multimedia HIV testing campaign, an online HIV testing service, and local testing promotion campaigns tailored for MSM. This intervention was evaluated using a closed cohort stepped wedge cluster RCT in eight Chinese cities (Guangzhou, Shenzhen, Zhuhai, and Jiangmen in Guangdong province; Jinan, Qingdao, Yantai, and Jining in Shandong province) from August 2016 to August 2017. MSM were recruited through Blued, a social networking mobile application for MSM, from July 29 to August 21 of 2016. The primary outcome was self-reported HIV testing in the past 3 months. Secondary outcomes included HIV self-testing, facility-based HIV testing, condom use, and syphilis testing. Generalized linear mixed models (GLMMs) were used to analyze primary and secondary outcomes. We enrolled a total of 1,381 MSM. Most were ?30 years old (82%), unmarried (86%), and had a college degree or higher (65%). The proportion of individuals receiving an HIV test during the intervention periods within a city was 8.9% (95% confidence interval [CI] 2.2-15.5) greater than during the control periods. In addition, the intention-to-treat analysis showed a higher probability of receiving an HIV test during the intervention periods as compared to the control periods (estimated risk ratio [RR] = 1.43, 95% CI 1.19-1.73). The intervention also increased HIV self-testing (RR = 1.89, 95% CI 1.50-2.38). There was no effect on facility-based HIV testing (RR = 1.00, 95% CI 0.79-1.26), condom use (RR = 1.00, 95% CI 0.86-1.17), or syphilis testing (RR = 0.92, 95% CI 0.70-1.21). A total of 48.6% (593/1,219) of participants reported that they received HIV self-testing. Among men who received two HIV tests, 32 individuals seroconverted during the 1-year study period. Study limitations include the use of self-reported HIV testing data among a subset of men and non-completion of the final survey by 23% of participants. Our study population was a young online group in urban China and the relevance of our findings to other populations will require further investigation. CONCLUSIONS:In this setting, crowdsourcing was effective for developing and strengthening community-based HIV testing services for MSM. Crowdsourced interventions may be an important tool for the scale-up of HIV testing services among MSM in low- and middle-income countries (LMIC). TRIAL REGISTRATION:ClinicalTrials.gov NCT02796963.
| S-EPMC6112627 | biostudies-literature
Project description:Background and objectivesMineralocorticoid receptor antagonism reduces morbidity and mortality in patients with heart failure, but the safety of these drugs in patients receiving dialysis is unclear. This study evaluated whether hyperkalemia and/or hypotension limited the use of eplerenone, a selective mineralocorticoid receptor antagonist, in hemodialysis patients.Design, setting, participants, & measurementsThis was a randomized controlled trial of prevalent patients receiving hemodialysis at five Canadian centers. Participants were randomly allocated to 13 weeks of eplerenone titrated to 50 mg daily (n=77) or a matching placebo (n=77). The primary outcome was permanent discontinuation of the drug because of hyperkalemia or hypotension. Secondary outcomes included hyperkalemia, hypotension, and cardiovascular events.ResultsSeventy-five eplerenone-treated patients and 71 placebo-treated patients were included in the per protocol population. The primary outcome occurred in three patients (4.0%) in the eplerenone group and two (2.8%) in the placebo group, for an absolute risk difference of 1.2 percentage points (95% confidence interval, -4.7 to 7.1 percentage points). Eplerenone was interpreted as noninferior to placebo with respect to the primary outcome (i.e., a discontinuation rate for these reasons >10% was excluded). In the eplerenone group, nine patients (11.7%) developed hyperkalemia (potassium level >6.5 mEq/L), compared with two patients (2.6%) in the placebo group (relative risk, 4.5; 95% confidence interval, 1.0 to 20.2). There was no significant effect on predialysis or postdialysis BP.ConclusionEplerenone increased the risk of hyperkalemia but did not result in an excess need to permanently discontinue the drug. Further trials are required to determine whether mineralocorticoid receptor antagonism improves cardiovascular outcomes in patients receiving long-term dialysis.
| S-EPMC4559523 | biostudies-literature
Project description:BackgroundChildren affected by HIV are at risk for poor mental health. We conducted a pilot randomized controlled trial (RCT) of the Family Strengthening Intervention (FSI-HIV), a family home-visiting intervention to promote mental health and improve parent-child relationships in families with caregivers living with HIV, hypothesizing that child and family outcomes would be superior to usual care social work services.MethodsEighty two families (N = 170 children, 48.24% female; N = 123 caregivers, 68.29% female) with at least one HIV-positive caregiver (n = 103, 83.74%) and school-aged child (ages 7-17) (HIV+ n = 21, 12.35%) were randomized to receive FSI-HIV or treatment-as-usual (TAU). Local research assistants blind to treatment conducted assessments of child mental health, parenting practices, and family functioning at baseline, post-intervention, and 3-month follow-up. Multilevel modeling assessed effects of FSI-HIV on outcomes across three time points.Trial registrationNCT01509573, 'Pilot Feasibility Trial of the Family Strengthening Intervention in Rwanda (FSI-HIV-R).' https://clinicaltrials.gov/ct2/show/;NCT01509573?term=Pilot+Feasibility+Trial+of+the+Family+Strengthening+Intervention+in+Rwanda+%28FSI-HIV-R%29&rank=1.ResultsAt 3-month follow-up, children in FSI-HIV showed fewer symptoms of depression compared to TAU by both self-report (β = -.246; p = .009) and parent report (β = -.174; p = .035) but there were no significant differences by group on conduct problems, functional impairment, family connectedness, or parenting.ConclusionsFamily-based prevention has promise for reducing depression symptoms in children affected by HIV. Future trials should examine the effects of FSI-HIV over time in trials powered to examine treatment mediators.
| S-EPMC5730278 | biostudies-literature
Project description:Background:Germline genetic testing is standard practice in oncology. Outcomes of telephone disclosure of a wide range of cancer genetic test results, including multigene panel testing (MGPT) are unknown. Methods:Patients undergoing cancer genetic testing were recruited to a multicenter, randomized, noninferiority trial (NCT01736345) comparing telephone disclosure (TD) of genetic test results with usual care, in-person disclosure (IPD) after tiered-binned in-person pretest counseling. Primary noninferiority outcomes included change in knowledge, state anxiety, and general anxiety. Secondary outcomes included cancer-specific distress, depression, uncertainty, satisfaction, and screening and risk-reducing surgery intentions. To declare noninferiority, we calculated the 98.3% one-sided confidence interval of the standardized effect; t tests were used for secondary subgroup analyses. Only noninferiority tests were one-sided, others were two-sided. Results:A total of 1178 patients enrolled in the study. Two hundred eight (17.7%) participants declined random assignment due to a preference for in-person disclosure; 473 participants were randomly assigned to TD and 497 to IPD; 291 (30.0%) had MGPT. TD was noninferior to IPD for general and state anxiety and all secondary outcomes immediately postdisclosure. TD did not meet the noninferiority threshold for knowledge in the primary analysis, but it did meet the threshold in the multiple imputation analysis. In secondary analyses, there were no statistically significant differences between arms in screening and risk-reducing surgery intentions, and no statistically significant differences in outcomes by arm among those who had MGPT. In subgroup analyses, patients with a positive result had statistically significantly greater decreases in general anxiety with telephone disclosure (TD -0.37 vs IPD +0.87, P = .02). Conclusions:Even in the era of multigene panel testing, these data suggest that telephone disclosure of cancer genetic test results is as an alternative to in-person disclosure for interested patients after in-person pretest counseling with a genetic counselor.
| S-EPMC6136932 | biostudies-literature
Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.
2024-06-13 | PXD046061 | Pride
Project description:BACKGROUND:HCV (Hepatitis C virus) is a prevalent chronic disease with potentially deadly consequences, especially for drug users. However, there are no special HCV or HIV (human immunodeficiency virus)-related intervention programs that are tailored for drug users in China; to fill this gap, the purpose of this study was to explore HCV and HIV-related knowledge among drug users in MMT (methadone maintenance treatment) sites of China and to investigate the effectiveness of HCV and HIV-related education for improving the knowledge of IDUs (injection drug users) and their awareness of infection. METHODS:The study was a randomized cluster controlled trial that compared a usual care group to a usual care plus HCV/HIV-REP (HCV/HIV-Reduction Education Program) group with a 24-week follow-up. The self-designed questionnaires, the HCV- and HIV-related knowledge questionnaire and the HIV/HCV infection awareness questionnaire, were used to collect the data. Four MMT clinics were selected for this project; two MMT clinics were randomly assigned to the research group, with subjects receiving their usual care plus HCV/HIV-REP, and the remaining two MMT clinics were the control group, with subjects receiving their usual care over 12?weeks. Sixty patients were recruited from each MMT clinic. A total of 240 patients were recruited. Follow-up studies were conducted at the end of the 12th week and the 24th week after the intervention. RESULTS:At baseline, the mean score (out of 20 possible correct answers) for HCV knowledge among the patients in the group receiving the intervention was 6.51 (SD?=?3.5), and it was 20.57 (SD?=?6.54) for HIV knowledge (out of 45 correct answers) and 8.35 (SD?=?2.8) for HIV/HCV infection awareness (out of 20 correct answers). At the 12-week and 24-week follow-up assessments, the research group showed a greater increase in HCV-/HIV-related knowledge (group × time effect, F?=?37.444/11.281, P?<?0.05) but no difference in their HIV/HCV infection awareness (group × time effect, F?=?2.056, P?>?0.05). CONCLUSION:An MMT-based HCV/HIV intervention program could be used to improve patient knowledge of HCV and HIV prevention, but more effort should be devoted to HIV/HCV infection awareness. TRIAL REGISTRATION:Protocols for this study were approved by institution review board (IRB) of Shanghai Mental Health Center (IRB:2009036), and registered in U.S national institutes of health (http://www.clinicaltrials.gov, NCT01647191 ). Registered 23 July 2012.
| S-EPMC6727322 | biostudies-literature
Project description: Not available
| S-EPMC7501164 | biostudies-literature
Project description:BackgroundThe diagnostic accuracy of the Gaxilose test (GT) for hypolactasia diagnosis has already been proved. The objectives of this clinical trial were to demonstrate the noninferiority of the GT compared to the hydrogen breath test (HBT) on the impact on diagnostic thinking and patient management, to evaluate the GT reproducibility with urine accumulated from 0 to 4 hours and from 0 to 5 hours and to assess test safety.MethodsWe conducted a randomized, parallel, noninferiority clinical trial. Patients with clinical symptoms suggestive of lactose intolerance were screened for inclusion and randomly assigned to the GT arm or the HBT arm of the study. The impact on diagnostic thinking and patient management was analyzed with pretest and posttest questionnaires in which the investigators indicated their estimated probability of hypolactasia diagnosis and the intended management before and after the GT or the HBT (noninferiority margin: -10%). The primary outcome of the study was the impact on diagnostic thinking, expressed as the mean of the absolute values of the differences between the pretest and posttest probabilities of hypolactasia diagnosis. Patients randomized to the GT arm performed also the retest to evaluate the reproducibility of the GT.ResultsA total of 147 patients were included in the intend-to-treat (ITT) population. Among them, 74 performed the HBT and 73 performed the GT. The results proved the noninferiority of the GT compared to the HBT on the impact on diagnostic thinking (ImpactGT = 31.74 ± 23.30%; ImpactHBT = 24.28 ± 19.87%; ΔGT-HBT = 7.46%; 95% confidence interval of ΔGT-HBT: 1.55%, infinite) and on patient management. The test-retest reproducibility was better for the GT with urine accumulated from 0 to 5 h: the intraclass correlation coefficient (ICC) was 0.5761, and the Kappa coefficient was 0.7548, indicative of substantial agreement between both tests. No serious adverse events were reported during the study.ConclusionsThe GT has an impact on diagnostic thinking and patient management noninferior to that of the HBT, is reproducible and well tolerated. These results prove the clinical benefit of its use in the clinical practice (ClinicalTrials.gov identifier: NCT02636413).
| S-EPMC6257416 | biostudies-literature