BACKGROUND Gay, bisexual and other men who have sex with men (GBMSM) are at disproportionately hi... more BACKGROUND Gay, bisexual and other men who have sex with men (GBMSM) are at disproportionately higher risk of acquiring HIV and other sexually transmitted infections (STI). While HIV/STI testing rates among GBMSM are increasing worldwide, they remain suboptimal in a variety of settings. While many studies have attempted to evaluate the efficacy of a variety of community-based campaigns, including peer and reminder-based interventions on HIV/STI testing, however few have attempted to do so for a web drama series. OBJECTIVE This study evaluates the effectiveness of a popular web drama video series developed by a community-based organization in Singapore for GBMSM on HIV and other STI testing behaviors. METHODS The study is a pragmatic, randomized controlled trial to evaluate a popular web drama video series developed by a community-based organization in Singapore for GBMSM. A total of 300 HIV-negative, GBMSM men in Singapore aged 18 to 29 years old were recruited and block-randomized into the intervention (n=150) and control arms (n=150). Primary outcomes included changes in self-reported intention to test for, actual testing for, and regularity of testing for HIV, Syphilis, Chlamydia or Gonorrhoea, while secondary outcomes include changes in a variety of other knowledge-based and psychosocial measures at the end of the study period. RESULTS Overall, 125 out of 150 participants (83.3%) in the intervention arm completed the proof of completion survey, compared to 133 out of 150 participants (88.7%) in the control arm. We found statistically significant differences in self-reporting as a regular (at least yearly) tester for HIV (15.9% difference, 95%CI [3.2%, 28.6%]), as well as chlamydia or gonorrhoea (15.5% difference, 95%CI [4.2%, 26.9%]), indicating that the intervention had positively impacted these outcomes compared to the control condition. We also found statistically significant differences in participants’ intentions to test for HIV (16.6% difference, 95%CI [4.3%, 28.9%]), syphilis (14.8% difference, 95%CI [3.2%, 26.4%]), as well as chlamydia or gonorrhoea (15.4% difference, 95%CI [4.2%, 26.6%]), in the next three months, indicating that the intervention was effective in positively impacting intention for HIV and other STI testing among participants. CONCLUSIONS There are clear benefits for promoting intentions to test regularly and prospectively on a broad scale through this intervention. This intervention also has potential to reach GBMSM who may not have access to conventional HIV and other STI prevention messaging, which have typically been implemented at sex-on-premises venues, bars, clubs, and in sexual health settings frequented by GBMSM. When coupled with community or population-wide structural interventions, the overall impact on testing will likely be significant. CLINICALTRIAL Clinicaltrials.gov, NCT04021953 INTERNATIONAL REGISTERED REPORT RR2-http://dx.doi.org/10.1136/bmjopen-2019-033855
We assessed the efficacy of a multicomponent culturally tailored HIV/STI prevention intervention ... more We assessed the efficacy of a multicomponent culturally tailored HIV/STI prevention intervention programme on consistent condom use and STI incidence among foreign Thai and Vietnamese female entertainment workers (FEWs) in Singapore. We conducted a quasi-experimental pretest and post-test intervention trial with a comparison group. We recruited 220 participants (115 Vietnamese and 105 Thai) for the comparison group, followed by the intervention group (same number) from the same sites which were purposively selected after a 3-month interval period. Both groups completed a self-administered anonymous questionnaire and STI testing for cervical gonorrhoea and Chlamydia, as well as pharyngeal gonorrhoea at baseline and 6-week follow-up. The peer-led intervention consisted of behavioural (HIV/STI education and condom negotiation skills), biomedical (STI screening and treatment services) and structural components (access to free condoms). We used the mixed effects Poisson regression model accounting for clustering by establishment venue to compute the adjusted risk ratio (aRR) of the outcomes at follow-up. At follow-up, the intervention group was more likely than the comparison group to report consistent condom use for vaginal sex with paid (aRR 1.77; 95% CI 1.71 to 1.83) and casual (aRR 1.81; 95% CI 1.71 to 1.91) partners. For consistent condom use for oral sex, this was aRR 1.50; 95% CI 1.23 to 1.82 with paid and aRR 1.54; 95% CI 1.22 to 1.95 with casual partners. STI incidence at follow-up was significantly lower in the intervention (6.8 per 100 FEWs) than the comparison (14.8 per 100 FEWs) group (aRR 0.42; 95% CI 0.32 to 0.55). This trial was effective in promoting consistent condom use for vaginal and oral sex as well as reducing STI incidence among the foreign Thai and Vietnamese FEWs in Singapore. The feasibility of scaling up the interventions to all entertainment establishments in Singapore should be assessed.
Objective: To determine the extent to which conduit artery stiffness is associated with plasma N-... more Objective: To determine the extent to which conduit artery stiffness is associated with plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) in patients with atrial fibrillation (AF). Design: Cross-sectional study. Setting: National University Hospital, Singapore. Patients: Cases (n=117) were patients with AF onset <65 years of age without heart failure or structural heart disease. Controls (n=274) were patients without AF who were seen at the general cardiology clinic. Interventions: Transthoracic echocardiography, carotid-femoral pulse wave velocity (CFPWV) measured using applanation tonometry and blood draw for plasma NT-proBNP at enrolment for all patients. Main outcome measures: Plasma NT-proBNP. Results: In patients with AF, CFPWV was associated with NT-proBNP after adjusting for hypertension and factors that were univariately associated with NT-proBNP: age at enrolment, type of AF, body mass index, left ventricular mass index, left atrial volume index, mitral E/E', mitral deceleration time and use of β-blockers (β=0.234; 95% CI 0.100 to 0.367; p=0.001). In contrast, CFPWV was not associated with NT-proBNP in controls. In patients with AF, the adjusted mean NT-proBNP level in the highest quartile of CFPWV (350 pg/ml; 95% CI 237 to 517 pg/ml) was fivefold higher than the lowest quartile (69 pg/ml; 95% CI 47 to 103 pg/ml) (p=0.001). Conclusions: CFPWV is associated with NT-proBNP level in AF. Since elevated NT-proBNP is a marker of adverse cardiovascular outcomes, arterial stiffness may be associated with worse prognosis in patients with AF.
The use of the bootstrap test lends both elegance and simplicity to the analysis of complicated s... more The use of the bootstrap test lends both elegance and simplicity to the analysis of complicated statistical problems. Such a numerical approach yields an estimated P-value as a binomial proportion. The purpose of this article is to recommend that confidence intervals for the bootstrap P-value be calculated routinely. In constructing these intervals, due consideration needs to be given to the
1099 Background: Fluoropyrimidines are commonly used in the treatment of patients (pts) with meta... more 1099 Background: Fluoropyrimidines are commonly used in the treatment of patients (pts) with metastatic breast cancers (MBC). FTD/TPI is an oral drug combination of trifluridine with tipiracil, a thymidine phosphorylase inhibitor preventing rapid degradation of trifluridine, thus allowing for increased exposure to active agent, and has showed activity in pts with colorectal and gastric cancers despite prior exposure to fluoropyrimidines. We investigate the role of FTD/TPI in MBC pts with (Cohort A) or without (Cohort B) prior exposure to fluoropyridines in a single arm phase II study. Methods: Pts were treated with FTD/TPI, and enrolled first into a lead-in dose confirmation phase, followed by two parallel cohorts based on prior exposure to fluoropyrimidines. Primary objectives for each cohort included determination of progression-free survivals (PFS), and secondary objectives included determination of objective response rates (ORR), safety and tolerability. Results: A total of 74 pts were recruited (42 for Cohort A, 32 for Cohort B), of whom 4 belonged to lead-in phase. Dosing was confirmed at FTD/TPI 35mg/m2 days 1-5 and 8-12 of 4-weekly cycles based on lead-in phase with no dose-limiting toxicities observed, and recruitment then proceeded in 2 parallel cohorts. All pts were evaluable for toxicity and survival analyses, and 72 were evaluable for ORR. Median age at enrolment was 62 years (range 32-85), with median of 4 (range 0-14) prior lines therapy in the metastatic setting, and 47% had de novo metastatic disease. Median PFS was 5.7 months (95% CI 3.8 to 8.3) and 9.4 months (95% CI 5.5 to 14.0) respectively in Cohorts A and B. Similar response rates were observed regardless of prior exposure to fluoropyrimidine, with ORR of 19.5% (95% CI 8.8 to 34.9) and 16.1% (95% CI 5.5 to 33.7) in Cohorts A and B, with 6-month clinical benefit rates of 56.1% (95% CI 39.7 to 71.5) and 61.3% (95% CI 42.2 to 78.2) respectively. Safety profile was consistent with known toxicities of FTD/TPI, with most common treatment-related adverse events of neutropenia, fatigue, nausea and anorexia. 64% of pts required dose modifications during study treatment, most commonly due to neutropenia, that could be overcome by dose reduction or prolongation from 4- to 5-weekly cycles. Only 1 pt required discontinuation due to toxicity from therapy. Conclusions: FTD/TPI showed promising anti-tumor activity with meaningful clinical benefit even among pts with prior exposure to fluoropyrimidines, and has a reasonable toxicity profile with appropriate dose modification. An oral chemotherapy option with good disease control provides an attractive treatment alternative to pts with MBC where quality of life is paramount, warranting further investigation in randomised studies. Clinical trial information: NCT04280536 .
BACKGROUND Gay, bisexual and other men who have sex with men (GBMSM) are at disproportionately hi... more BACKGROUND Gay, bisexual and other men who have sex with men (GBMSM) are at disproportionately higher risk of acquiring HIV and other sexually transmitted infections (STI). While HIV/STI testing rates among GBMSM are increasing worldwide, they remain suboptimal in a variety of settings. While many studies have attempted to evaluate the efficacy of a variety of community-based campaigns, including peer and reminder-based interventions on HIV/STI testing, however few have attempted to do so for a web drama series. OBJECTIVE This study evaluates the effectiveness of a popular web drama video series developed by a community-based organization in Singapore for GBMSM on HIV and other STI testing behaviors. METHODS The study is a pragmatic, randomized controlled trial to evaluate a popular web drama video series developed by a community-based organization in Singapore for GBMSM. A total of 300 HIV-negative, GBMSM men in Singapore aged 18 to 29 years old were recruited and block-randomized into the intervention (n=150) and control arms (n=150). Primary outcomes included changes in self-reported intention to test for, actual testing for, and regularity of testing for HIV, Syphilis, Chlamydia or Gonorrhoea, while secondary outcomes include changes in a variety of other knowledge-based and psychosocial measures at the end of the study period. RESULTS Overall, 125 out of 150 participants (83.3%) in the intervention arm completed the proof of completion survey, compared to 133 out of 150 participants (88.7%) in the control arm. We found statistically significant differences in self-reporting as a regular (at least yearly) tester for HIV (15.9% difference, 95%CI [3.2%, 28.6%]), as well as chlamydia or gonorrhoea (15.5% difference, 95%CI [4.2%, 26.9%]), indicating that the intervention had positively impacted these outcomes compared to the control condition. We also found statistically significant differences in participants’ intentions to test for HIV (16.6% difference, 95%CI [4.3%, 28.9%]), syphilis (14.8% difference, 95%CI [3.2%, 26.4%]), as well as chlamydia or gonorrhoea (15.4% difference, 95%CI [4.2%, 26.6%]), in the next three months, indicating that the intervention was effective in positively impacting intention for HIV and other STI testing among participants. CONCLUSIONS There are clear benefits for promoting intentions to test regularly and prospectively on a broad scale through this intervention. This intervention also has potential to reach GBMSM who may not have access to conventional HIV and other STI prevention messaging, which have typically been implemented at sex-on-premises venues, bars, clubs, and in sexual health settings frequented by GBMSM. When coupled with community or population-wide structural interventions, the overall impact on testing will likely be significant. CLINICALTRIAL Clinicaltrials.gov, NCT04021953 INTERNATIONAL REGISTERED REPORT RR2-http://dx.doi.org/10.1136/bmjopen-2019-033855
We assessed the efficacy of a multicomponent culturally tailored HIV/STI prevention intervention ... more We assessed the efficacy of a multicomponent culturally tailored HIV/STI prevention intervention programme on consistent condom use and STI incidence among foreign Thai and Vietnamese female entertainment workers (FEWs) in Singapore. We conducted a quasi-experimental pretest and post-test intervention trial with a comparison group. We recruited 220 participants (115 Vietnamese and 105 Thai) for the comparison group, followed by the intervention group (same number) from the same sites which were purposively selected after a 3-month interval period. Both groups completed a self-administered anonymous questionnaire and STI testing for cervical gonorrhoea and Chlamydia, as well as pharyngeal gonorrhoea at baseline and 6-week follow-up. The peer-led intervention consisted of behavioural (HIV/STI education and condom negotiation skills), biomedical (STI screening and treatment services) and structural components (access to free condoms). We used the mixed effects Poisson regression model accounting for clustering by establishment venue to compute the adjusted risk ratio (aRR) of the outcomes at follow-up. At follow-up, the intervention group was more likely than the comparison group to report consistent condom use for vaginal sex with paid (aRR 1.77; 95% CI 1.71 to 1.83) and casual (aRR 1.81; 95% CI 1.71 to 1.91) partners. For consistent condom use for oral sex, this was aRR 1.50; 95% CI 1.23 to 1.82 with paid and aRR 1.54; 95% CI 1.22 to 1.95 with casual partners. STI incidence at follow-up was significantly lower in the intervention (6.8 per 100 FEWs) than the comparison (14.8 per 100 FEWs) group (aRR 0.42; 95% CI 0.32 to 0.55). This trial was effective in promoting consistent condom use for vaginal and oral sex as well as reducing STI incidence among the foreign Thai and Vietnamese FEWs in Singapore. The feasibility of scaling up the interventions to all entertainment establishments in Singapore should be assessed.
Objective: To determine the extent to which conduit artery stiffness is associated with plasma N-... more Objective: To determine the extent to which conduit artery stiffness is associated with plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) in patients with atrial fibrillation (AF). Design: Cross-sectional study. Setting: National University Hospital, Singapore. Patients: Cases (n=117) were patients with AF onset <65 years of age without heart failure or structural heart disease. Controls (n=274) were patients without AF who were seen at the general cardiology clinic. Interventions: Transthoracic echocardiography, carotid-femoral pulse wave velocity (CFPWV) measured using applanation tonometry and blood draw for plasma NT-proBNP at enrolment for all patients. Main outcome measures: Plasma NT-proBNP. Results: In patients with AF, CFPWV was associated with NT-proBNP after adjusting for hypertension and factors that were univariately associated with NT-proBNP: age at enrolment, type of AF, body mass index, left ventricular mass index, left atrial volume index, mitral E/E', mitral deceleration time and use of β-blockers (β=0.234; 95% CI 0.100 to 0.367; p=0.001). In contrast, CFPWV was not associated with NT-proBNP in controls. In patients with AF, the adjusted mean NT-proBNP level in the highest quartile of CFPWV (350 pg/ml; 95% CI 237 to 517 pg/ml) was fivefold higher than the lowest quartile (69 pg/ml; 95% CI 47 to 103 pg/ml) (p=0.001). Conclusions: CFPWV is associated with NT-proBNP level in AF. Since elevated NT-proBNP is a marker of adverse cardiovascular outcomes, arterial stiffness may be associated with worse prognosis in patients with AF.
The use of the bootstrap test lends both elegance and simplicity to the analysis of complicated s... more The use of the bootstrap test lends both elegance and simplicity to the analysis of complicated statistical problems. Such a numerical approach yields an estimated P-value as a binomial proportion. The purpose of this article is to recommend that confidence intervals for the bootstrap P-value be calculated routinely. In constructing these intervals, due consideration needs to be given to the
1099 Background: Fluoropyrimidines are commonly used in the treatment of patients (pts) with meta... more 1099 Background: Fluoropyrimidines are commonly used in the treatment of patients (pts) with metastatic breast cancers (MBC). FTD/TPI is an oral drug combination of trifluridine with tipiracil, a thymidine phosphorylase inhibitor preventing rapid degradation of trifluridine, thus allowing for increased exposure to active agent, and has showed activity in pts with colorectal and gastric cancers despite prior exposure to fluoropyrimidines. We investigate the role of FTD/TPI in MBC pts with (Cohort A) or without (Cohort B) prior exposure to fluoropyridines in a single arm phase II study. Methods: Pts were treated with FTD/TPI, and enrolled first into a lead-in dose confirmation phase, followed by two parallel cohorts based on prior exposure to fluoropyrimidines. Primary objectives for each cohort included determination of progression-free survivals (PFS), and secondary objectives included determination of objective response rates (ORR), safety and tolerability. Results: A total of 74 pts were recruited (42 for Cohort A, 32 for Cohort B), of whom 4 belonged to lead-in phase. Dosing was confirmed at FTD/TPI 35mg/m2 days 1-5 and 8-12 of 4-weekly cycles based on lead-in phase with no dose-limiting toxicities observed, and recruitment then proceeded in 2 parallel cohorts. All pts were evaluable for toxicity and survival analyses, and 72 were evaluable for ORR. Median age at enrolment was 62 years (range 32-85), with median of 4 (range 0-14) prior lines therapy in the metastatic setting, and 47% had de novo metastatic disease. Median PFS was 5.7 months (95% CI 3.8 to 8.3) and 9.4 months (95% CI 5.5 to 14.0) respectively in Cohorts A and B. Similar response rates were observed regardless of prior exposure to fluoropyrimidine, with ORR of 19.5% (95% CI 8.8 to 34.9) and 16.1% (95% CI 5.5 to 33.7) in Cohorts A and B, with 6-month clinical benefit rates of 56.1% (95% CI 39.7 to 71.5) and 61.3% (95% CI 42.2 to 78.2) respectively. Safety profile was consistent with known toxicities of FTD/TPI, with most common treatment-related adverse events of neutropenia, fatigue, nausea and anorexia. 64% of pts required dose modifications during study treatment, most commonly due to neutropenia, that could be overcome by dose reduction or prolongation from 4- to 5-weekly cycles. Only 1 pt required discontinuation due to toxicity from therapy. Conclusions: FTD/TPI showed promising anti-tumor activity with meaningful clinical benefit even among pts with prior exposure to fluoropyrimidines, and has a reasonable toxicity profile with appropriate dose modification. An oral chemotherapy option with good disease control provides an attractive treatment alternative to pts with MBC where quality of life is paramount, warranting further investigation in randomised studies. Clinical trial information: NCT04280536 .
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