scholarly journals Impact of a Scalable Intervention Package, Including a Point-of-Care Molecular Diagnostic Tool, on Community-Based Active Case Finding for Tuberculosis: A Pragmatic Randomized Controlled Trial

2020 ◽  
Author(s):  
A. Esmail ◽  
P. Randall ◽  
A. Pooran ◽  
S. Oelofse ◽  
G.L. Calligaro ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Point Of Care ◽  
Controlled Trial ◽  
Case Finding ◽  
Molecular Diagnostic ◽  
Active Case Finding ◽  
Intervention Package ◽  
Community Based ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled

Effect of a popular web drama video series on HIV and other sexually transmitted infection testing among gay, bisexual and other men who have sex with men in Singapore: a community-based, pragmatic, randomized controlled trial amidst the COVID-19 pandemic (Preprint)

2021 ◽  
Author(s):  
Rayner Kay Jin Tan ◽  
Wee Ling Koh ◽  
Daniel Le ◽  
Sumita Banerjee ◽  
Martin Tze-Wei Chio ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Community Based ◽  
Transmitted Infection ◽  
Sexually Transmitted ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Sti Testing ◽  
Community Based Organization ◽  
Sex With Men

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

scholarly journals Effect of community active case-finding strategies for detection of tuberculosis in Cambodia: study protocol for a pragmatic cluster randomized controlled trial

2020 ◽  
Author(s):  
Alvin Kuo Jing Teo ◽  
Kiesha Prem ◽  
Konstantin Evdokimov ◽  
Chetra Ork ◽  
Sothearith Eng ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Controlled Trial ◽  
Case Finding ◽  
Cluster Randomized Controlled Trial ◽  
Active Case Finding ◽  
Active Case ◽  
Randomized Controlled ◽  
Secondary Endpoints ◽  
Cluster Randomized

Abstract • Background: Cambodia has made notable progress in the fight against tuberculosis (TB). However, these gains are impeded by a significant proportion of undiagnosed cases. To effectively reach people with TB, active case finding (ACF) strategies have been adopted by countries affected by the epidemic, including Cambodia, alongside passive case finding (PCF). Despite increased efforts to improve case detection, approximately 40% of TB cases in Cambodia remained undiagnosed in 2018. In Cambodia, several community-based TB ACF modalities have been implemented, but their effectiveness has yet to be systematically assessed.• Methods: This pragmatic cluster randomized controlled trial will be conducted between December 2019 and June 2021. We will randomize eight operational districts (cluster) in seven provinces (Kampong Cham, Kampong Thom, Prey Veng, Thbong Khmum, Kampong Chhnang, Kandal, and Kampong Speu) to either the control group (PCF) or the intervention groups (ACF using a seed-and-recruit model, ACF targeting household and neighborhood contacts, and ACF targeting persons aged ≥55 using mobile screening units). The primary endpoints will be TB case notification rates, additionality, and cumulative yield of TB cases. The secondary endpoints include treatment outcomes, the number needed to screen to find one TB case, and cost-effectiveness outcome measures. We will analyze the primary and secondary endpoints by intention-to-treat. We will compare cluster and individual-level characteristics using student’s t-test and hierarchical or mixed-effect models to estimate the ratio of these means. Incremental cost-effectiveness ratio per disability-adjusted life year averted will also be considered as a benchmark to determine if the interventions are cost-effective.• Discussion: This study will build an evidence base to inform future scale-up, implementation, and sustainability of ACF strategies in Cambodia and other similar settings. Implementation of this study will also complement TB control strategies in Cambodia by conducting ACF in operational districts without active interventions to find TB cases currently. Those who are ill and might have TB will be promptly screened, diagnosed, and linked to care. Early diagnosis and treatment initiation will also benefit their community by interrupting transmission and prevent further infections. The experience gained from this project will inform future attempts in conducting pragmatic trials in low-resource settings.• Trial registration: This trial is registered at ClinicalTrials.gov, NCT04094350. Registered 18 September 2019.

scholarly journals Effect of community active case-finding strategies for detection of tuberculosis in Cambodia: study protocol for a pragmatic cluster randomized controlled trial

2020 ◽  
Author(s):  
Alvin Kuo Jing Teo ◽  
Kiesha Prem ◽  
Konstantin Evdokimov ◽  
Chetra Ork ◽  
Sothearith Eng ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Controlled Trial ◽  
Case Finding ◽  
Cluster Randomized Controlled Trial ◽  
Active Case Finding ◽  
Active Case ◽  
Randomized Controlled ◽  
Secondary Endpoints ◽  
Cluster Randomized

Abstract Background: Cambodia has made notable progress in the fight against tuberculosis (TB). However, these gains are impeded by a significant proportion of undiagnosed cases. To effectively reach people with TB, active case finding (ACF) strategies have been adopted by countries affected by the epidemic, including Cambodia, alongside passive case finding (PCF). Despite increased efforts to improve case detection, approximately 40% of TB cases in Cambodia remained undiagnosed in 2017. In Cambodia, several community-based TB ACF modalities have been implemented, but their effectiveness has yet to be systematically assessed. Methods: This pragmatic cluster randomized controlled trial will be conducted between December 2019 and June 2021. We will randomize eight operational districts (cluster) in 7 provinces (Kampong Cham, Kampong Thom, Prey Veng, Thbong Khmum, Kampong Chhnang, Kandal, and Kampong Speu) to either the control group (PCF) or the intervention groups (ACF using a seed-and-recruit model, ACF targeting household and neighborhood contacts, and ACF targeting persons aged ≥55 using mobile screening units). The primary endpoints will be TB case notification rates, additionality, and cumulative yield of TB cases. The secondary endpoints include treatment outcomes, the number needed to screen to find one TB case, and cost-effectiveness outcome measures. We will analyze the primary and secondary endpoints by intention-to-treat. We will compare cluster and individual-level characteristics using student’s t-test and hierarchical or mixed-effect models to estimate the ratio of these means. Incremental cost-effectiveness ratio per disability-adjusted life year averted will also be considered as a benchmark to determine if the interventions are cost-effective. Discussion: This study will build an evidence base to inform future scale-up, implementation, and sustainability of ACF strategies in Cambodia and other similar settings. Implementation of this study will also complement TB control strategies in Cambodia by conducting ACF in operational districts without active interventions to find TB cases currently. Those who are ill and might have TB will be promptly screened, diagnosed, and linked to care. Early diagnosis and treatment initiation will also benefit their community by interrupting transmission and prevent further infections. The experience gained from this project will inform future attempts in conducting pragmatic trials in low-resource settings. Trial registration: This trial is registered at ClinicalTrials.gov, NCT04094350. Registered 18 September 2019.

A Community-based Addiction Rehabilitation Electronic System to Improve Recovery Outcomes in Patients with Drug Use Disorder: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Zhe WANG ◽  
Shujuan CHEN ◽  
Junning CHEN ◽  
Chunfeng XU ◽  
Zhikang CHEN ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Drug Use ◽  
Illicit Drug ◽  
Service Providers ◽  
Controlled Trial ◽  
Electronic System ◽  
Community Based ◽  
Randomized Controlled ◽  
Community Rehabilitation ◽  
Drug Use Disorder

BACKGROUND Relapse is very common in patients with illicit drug use disorder and contributes to a series of bad consequences that substantially impact their physical and social functions. Due to the limited existence of effective addiction treatment, the majority of patients with drug use disorder could not access help when needing. Mobile health (mHealth) offers a potential solution to improving recovery outcome for patients in community. OBJECTIVE This paper is a protocol for a randomized controlled trial (RCT) of a smart phone application called community-based addiction rehabilitation electronic system (CAREs). This interactive system consists of an APP for clients and a webpage for service providers, with the aim of teaching clients craving and emergency coping skills and helping service providers to improve their work efficiency and effectiveness in community. METHODS A randomized controlled trial (RCT) will be conducted. Sixty drug illicit users who are newly ordered to undergo community rehabilitation will be recruited from the community in Shanghai. Participants will be 1:1 randomly assigned to receive integrated community rehabilitation by using CAREs or only receiving routine community rehabilitation for 6 months. Corresponding anti-drug social workers will provide service and monitor their drug use behavior in accordance with the routine work-flow. Outcomes will be assessed at baseline and in the 6th month. The primary study outcome is the performance on illicit drug urine test which will be carried on regularly twice per week during the study period. Secondary study outcomes include longest duration of sustained abstinence, days that participants interact with anti-drug social workers, and the decrease rate of addiction-related issues severity index. RESULTS Recruitment is currently underway with the aim of recruiting 60 subjects with drug use disorder. Recruitment will continue until the end of 2018. CONCLUSIONS This is the first known trial of a smartphone-based psychotherapy program for improving recovery outcomes in illicit drug users in community. The study provides evidence for the feasibility and effectiveness of the "CAREs" system through comparing the results of the intervention group with the control group. This paper describes the design and methodology of the study. CLINICALTRIAL ClinicalTrials.gov NCT03451344, https://clinicaltrials.gov/ct2/show/NCT03451344

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