Effectiveness and implementation of evriMED with short messages service (SMS) reminders and tailored feedback compared to standard care on adherence to treatment among tuberculosis patients in Kilimanjaro, Tanzania: proposal for a cluster Randomized Controlled Trial SMS reminders and tailored feedback through evriMED and adherence to TB treatment

Abstract Background Adherence to TB treatment is challenging because of many factors. WHO has recommended the use of digital adherence monitoring technologies in its End-TB-strategy. However, there is paucity on its evidence in improving adherence. EvriMED a real time medication monitoring (RTMM) which was found feasible and acceptable in few studies in Asia. However, in Tanzania, there may be challenges in implementing evriMED due to stigmatization, network and power access, accuracy and cost effectiveness which may have an implication for treatment outcomes. We propose a pragmatic cluster randomized trial, to investigate the effectiveness of evriMED with reminder cues and tailored feedback on adherence to TB treatment in Kilimanjaro, Tanzania. Methods We will create clusters in Kilimanjaro based on level of health care facility. Clusters will be randomized in an intervention arm, where evriMED will be implemented or a control arm, where standard practice DOTs will be followed. TB patients in intervention clusters will take their medication from the evriMED pillbox and receive tailored feedback. We will use the ‘Stagesof-change’model, which assumes that a person has to go through the stages of pre-contemplation, contemplation, preparation, action and evaluation to change behaviour for tailored feedback on adherence reports from the device. Discussion If the intervention shows a significant effect on adherence and the devices are accepted, accurate and sustainable, the intervention can be scaled up within the National Tuberculosis Programmes.

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Effectiveness and implementation of evriMED with short messages service (SMS) reminders and tailored feedback compared to standard care on adherence to treatment among tuberculosis patients in Kilimanjaro, Tanzania: proposal for a cluster Randomized Controlled Trial SMS reminders and tailored feedback through evriMED and adherence to TB treatment

10.21203/rs.2.399/v2 ◽

2019 ◽

Author(s):

I. Marion Sumari-de Boer ◽

Francis M Pima ◽

Kennedy M Ngowi ◽

Geoffrey M Chelangwa ◽

Linda Minja ◽

...

Keyword(s):

Controlled Trial ◽

Care Facility ◽

Health Care Facility ◽

Cluster Randomized Trial ◽

World Health ◽

Tb Treatment ◽

Sms Reminders ◽

Cluster Randomized ◽

Health Organization ◽

Monitoring Technologies

Abstract Background: Adherence to Tuberculosis (TB) treatment is challenging because of many factors. The World Health Organization (WHO) has recommended the use of digital adherence monitoring technologies in its End-TB-strategy. However, there is paucity on its evidence in improving adherence. EvriMED is a real time medication monitoring (RTMM) device which was found feasible and acceptable in few studies in Asia. However, in Tanzania, there may be challenges in implementing evriMED due to stigmatization, network and power access, accuracy and cost effectiveness which may have an implication for treatment outcomes. We propose a pragmatic cluster randomized trial, to investigate the effectiveness of evriMED with reminder cues and tailored feedback on adherence to TB treatment in Kilimanjaro, Tanzania. Methods: We will create clusters in Kilimanjaro based on level of health care facility. Clusters will be randomized in an intervention arm, where evriMED will be implemented or a control arm, where standard practice Directly Observed Treatment (DOT) will be followed. TB patients in intervention clusters will take their medication from the evriMED pillbox and receive tailored feedback. We will use the ‘Stagesof-change’model, which assumes that a person has to go through the stages of pre-contemplation, contemplation, preparation, action and evaluation to change behaviour for tailored feedback on adherence reports from the device. Discussion: If the intervention shows a significant effect on adherence and the devices are accepted, accurate and sustainable, the intervention can be scaled up within the National Tuberculosis Programmes. Trial registration: PACTR201811755733759 at 8 November 2018 at https://pactr.samrc.ac.za/

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Does #Tamojunto alter the dynamic between drug use and school violence among youth? Secondary analysis from a large cluster-randomized trial

European Child & Adolescent Psychiatry ◽

10.1007/s00787-021-01863-x ◽

2021 ◽

Author(s):

Hugo Cogo-Moreira ◽

Julia D. Gusmões ◽

Juliana Y. Valente ◽

Michael Eid ◽

Zila M. Sanchez

Keyword(s):

Drug Use ◽

School Violence ◽

Causal Effect ◽

Controlled Trial ◽

Secondary Analysis ◽

Cluster Randomized Trial ◽

Random Intercept ◽

Carry Over ◽

Cluster Randomized ◽

Use Behavior

AbstractThe present study investigated how intervention might alter the relationship between perpetrating violence and later drug use. A cluster-randomized controlled trial design involving 72 schools (38 intervention, 34 control) and 6390 students attending grades 7 and 8 was employed in Brazil. Drug use and violence were assessed at three points. A random-intercept cross-lagged panel model examined the reciprocal association between drug use and school violence domains across the three data collection waves. For both groups, we found that the cross-lagged effect of perpetration on further drug use in adolescents was stronger than the reverse, but the interrelationship was not statistically significant between #Tamojunto and control schools. The carry-over effects of drug use and violence were also not significantly different between groups. There is a lack of evidence showing that #Tamojunto can modify the dynamics between drug use and school violence across the 21-month period. The direction of the causal effect (i.e., the more perpetration behavior, the more subsequent drug use behavior) is present, but weak in both groups. The trial registration protocol at the national Brazilian Register of Clinical Trials (REBEC) is #RBR-4mnv5g.

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Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma

BMC Ophthalmology ◽

10.1186/s12886-020-01776-4 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Abdou Amza ◽

Boubacar Kadri ◽

Beido Nassirou ◽

Ahmed M. Arzika ◽

Ariana Austin ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Clinical Signs ◽

Cluster Randomized Trial ◽

World Health ◽

Baseline Assessment ◽

Randomized Controlled ◽

Registration Number ◽

Cluster Randomized ◽

Health Organization

Abstract Background The World Health Organization (WHO) recommends annual mass azithromycin distribution until districts drop below 5% prevalence of trachomatous inflammation—follicular (TF). Districts with very low TF prevalence may have little or no transmission of the ocular strains of Chlamydia trachomatis that cause trachoma, and additional rounds of mass azithromycin distribution may not be useful. Here, we describe the protocol for a randomized controlled trial designed to evaluate whether mass azithromycin distribution can be stopped prior to the current WHO guidelines. Methods The Azithromycin Reduction to Reach Elimination of Trachoma (ARRET) study is a 1:1 community randomized non-inferiority trial designed to evaluate whether mass azithromycin distribution can be stopped in districts with baseline prevalence of TF under 20%. Communities in Maradi, Niger are randomized after baseline assessment either to continued annual mass azithromycin distribution or stopping annual azithromycin distribution over a 3-year period. We will compare the prevalence of ocular C. trachomatis (primary outcome), TF and other clinical signs of trachoma, and serologic markers of trachoma after 3 years. We hypothesize that stopping annual azithromycin distribution will be non-inferior to continued annual azithromycin distributions for all markers of trachoma prevalence and transmission. Discussion The results of this trial are anticipated to provide potentially guideline-changing evidence for when mass azithromycin distributions can be stopped in low TF prevalence areas. Trial registration number This study is registered at clinicaltrials.gov (NCT04185402). Registered December 4, 2019; prospectively registered pre-results.

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Effectiveness of upgraded maternity waiting homes and local leader training on improving institutional births: a cluster-randomized controlled trial in Jimma, Ethiopia

BMC Public Health ◽

10.1186/s12889-020-09692-4 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Jaameeta Kurji ◽

Lakew Abebe Gebretsadik ◽

Muluemebet Abera Wordofa ◽

Sudhakar Morankar ◽

Kunuz Haji Bedru ◽

...

Keyword(s):

Usual Care ◽

Randomized Trial ◽

Controlled Trial ◽

Cluster Randomized Trial ◽

Safe Motherhood ◽

Link Type ◽

Local Leader ◽

Maternity Waiting Homes ◽

Leader Training ◽

Cluster Randomized

Abstract Background Maternity waiting homes (MWHs), residential spaces for pregnant women close to obstetric care facilities, are being used to tackle physical barriers to access. However, their effectiveness has not been rigorously assessed. The objective of this cluster randomized trial was to evaluate the effectiveness of functional MWHs combined with community mobilization by trained local leaders in improving institutional births in Jimma Zone, Ethiopia. Methods A pragmatic, parallel arm cluster-randomized trial was conducted in three districts. Twenty-four primary health care units (PHCUs) were randomly assigned to either (i) upgraded MWHs combined with local leader training on safe motherhood strategies, (ii) local leader training only, or (iii) usual care. Data were collected using repeat cross-sectional surveys at baseline and 21 months after intervention to assess the effect of intervention on the primary outcome, defined as institutional births, at the individual level. Women who had a pregnancy outcome (livebirth, stillbirth or abortion) 12 months prior to being surveyed were eligible for interview. Random effects logistic regression was used to evaluate the effect of the interventions. Results Data from 24 PHCUs and 7593 women were analysed using intention-to-treat. The proportion of institutional births was comparable at baseline between the three arms. At endline, institutional births were slightly higher in the MWH + training (54% [n = 671/1239]) and training only arms (65% [n = 821/1263]) compared to usual care (51% [n = 646/1271]). MWH use at baseline was 6.7% (n = 256/3784) and 5.8% at endline (n = 219/3809). Both intervention groups exhibited a non-statistically significant higher odds of institutional births compared to usual care (MWH+ & leader training odds ratio [OR] = 1.09, 97.5% confidence interval [CI] 0.67 to 1.75; leader training OR = 1.37, 97.5% CI 0.85 to 2.22). Conclusions Both the combined MWH+ & leader training and the leader training alone intervention led to a small but non-significant increase in institutional births when compared to usual care. Implementation challenges and short intervention duration may have hindered intervention effectiveness. Nevertheless, the observed increases suggest the interventions have potential to improve women’s use of maternal healthcare services. Optimal distances at which MWHs are most beneficial to women need to be investigated. Trial registration The trial was retrospectively registered on the Clinical Trials website (https://clinicaltrials.gov) on 3rd October 2017. The trial identifier is NCT03299491.

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Impact of group-based dietary education on the dietary habits of female adolescents: a cluster randomized trial

Public Health Nutrition ◽

10.1017/s1368980010002405 ◽

2010 ◽

Vol 14 (4) ◽

pp. 702-708 ◽

Cited By ~ 9

Author(s):

Kazue Yamaoka ◽

Mariko Watanabe ◽

Eisuke Hida ◽

Toshiro Tango

Keyword(s):

Dietary Intake ◽

Energy Intake ◽

Young Women ◽

Dietary Habits ◽

Controlled Trial ◽

Cluster Randomized Trial ◽

Female Adolescents ◽

Control Group ◽

Dietary Education ◽

Cluster Randomized

AbstractObjectiveThe number of extremely thin young women has increased and education at school on maintaining an optimal weight has become important. The aim of the present study was to assess the effectiveness of a group-based home-collaborative dietary education (HCDE) programme to maintain appropriate dietary intake compared to conventional school classroom education.DesignTwo-arm cluster randomized controlled trial. Twelve classes were randomly assigned as clusters to either the HCDE group or the control group. Each participant in the HCDE group received twelve sessions of group counselling aimed at increasing energy intake at breakfast by modifying dietary intake and adopting appropriate habits. The hypothesis underlying the study was that after 6 months of HCDE the total energy intake would be increased by 627 kJ from baseline (primary endpoint). Secondary outcomes were differences in intake of various nutrients from baseline. Outcome measures after log transformation were examined by t tests and linear mixed models (crude and baseline-adjusted).SettingYoung women among Japanese female adolescents in Tokyo.SubjectsFour hundred and seventy-four participants aged 13–15 years.ResultsStudents in twelve classes were used for analysis (n 459). Energy intake was decreased in many of the classes during the 6-month period, especially for those in the control group. After adjustment for the baseline value, significant increases in energy intake and protein, calcium, magnesium and iron intakes at breakfast were observed (P < 0·05)ConclusionsAlthough energy intake was increased in the HCDE group compared to the control group, further study of the HCDE is warranted.

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Cluster randomized trial of an antibiotic time-out led by a team-based pharmacist

Infection Control and Hospital Epidemiology ◽

10.1017/ice.2020.347 ◽

2020 ◽

Vol 41 (11) ◽

pp. 1266-1271

Author(s):

Trevor C. Van Schooneveld ◽

Mark E. Rupp ◽

R. Jenifer Cavaleiri ◽

Elizabeth Lyden ◽

Kiri Rolek

Keyword(s):

Controlled Trial ◽

Early Period ◽

Cluster Randomized Trial ◽

Antibiotic Use ◽

Effective Strategies ◽

Randomized Controlled ◽

Time Out ◽

Academic Medical ◽

Cluster Randomized ◽

Medicine Team

AbstractObjective:Antibiotic time-outs (ATOs) have been advocated to improve antibiotic use without dedicated stewardship resources, but their utility is poorly defined. We sought to evaluate the effectiveness of an ATO led by a team-based pharmacist.Design:Cluster randomized controlled trial.Setting:Six medicine teams at an academic medical facility.Patients:Inpatients who received antibiotics and were cared for by a medicine team.Intervention:In phase A (2 months) pharmacist-led ATOs were implemented on 3 medicine teams (ATO-A) while 3 teams maintained usual care (UC-A). In phase B (2 months), ATOs were continued in the ATO group (ATO-B) and ATOs were initiated in the UC group (UC ATO-B). We targeted 2 ATO points: early (<72 hours after antibiotics were initiated) and late (after the early period but ≤5 days after antibiotic initiation).Results:In total, 290 ATOs were documented (181 early, 87 late, and 22 subsequent) among 538 admissions. The most common ATO recommendations were narrow therapy (148 of 290), no change (124 of 290), and change to oral (30 of 290). ATO initiation was lower in the UC ATO-B group than in either ATO group (21.8% UC ATO-B vs 69.2% ATO-A and -B). Overall antibiotic use was not different between the groups (P = .51), although intravenous (IV) levofloxacin use decreased in the UC group after ATO implementation (49 DOT/1,000 PD vs 20 DOT/1,000 PD; P = .022). The ratio of oral (PO) to intravenous (IV) DOT was lower in the UC group than in any of the ATO groups (P = .032). We detected no differences in mortality, length of stay, readmission, C. difficile infection, or antibiotic adverse events.Conclusions:Implementation of a pharmacist-led ATO was feasible and well accepted but did not change overall antibiotic use. An ATO may promote increased use of oral antibiotics, but more effective strategies for self-stewardship are needed.

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Barriers and facilitators to facility HIV self-testing in outpatient settings in Malawi: a qualitative study

BMC Public Health ◽

10.1186/s12889-021-12213-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Misheck Mphande ◽

Paula Campbell ◽

Risa M. Hoffman ◽

Khumbo Phiri ◽

Mike Nyirenda ◽

...

Keyword(s):

Care Facility ◽

Cluster Randomized Trial ◽

Routine Care ◽

Barriers And Facilitators ◽

Easy Access ◽

Link Type ◽

Self Testing ◽

Study Staff ◽

Post Test ◽

Cluster Randomized

Abstract Background Facility HIV self-testing (HIVST) within outpatient departments can increase HIV testing coverage by facilitating HIVST use in outpatient waiting spaces while clients wait for routine care. Facility HIVST allows for the majority of outpatients to test with minimal health care worker time requirements. However, barriers and facilitators to outpatients’ use of facility HIVST are still unknown. Methods As part of a cluster randomized trial on facility HIVST in Malawi, we conducted in-depth interviews with 57 adult outpatients (> 15 years) who were exposed to the HIVST intervention and collected observational journals that documented study staff observations from facility waiting spaces where HIVST was implemented. Translated and transcribed data were analyzed using constant comparison analysis in Atlas.ti. Results Facility HIVST was convenient, fast, and provided autonomy to outpatients. The strategy also had novel facilitators for testing, such as increased motivation to test due to seeing others test, immediate support for HIVST use, and easy access to additional HIV services in the health facility. Barriers to facility HIVST included fear of judgment from others and unwanted status disclosure due to lack of privacy. Desired changes to the intervention included private, separate spaces for kit use and interpretation and increased opportunity for disclosure and post-test counseling. Conclusions Facility HIVST was largely acceptable to outpatients in Malawi with novel facilitators that are unique to facility HIVST in OPD waiting spaces. Trial registration The parent trial is registered with ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316.

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Can individual and integrated water, sanitation, and handwashing interventions reduce fecal contamination in the household environment? Evidence from the WASH Benefits cluster-randomized trial in rural Kenya

10.1101/731992 ◽

2019 ◽

Cited By ~ 1

Author(s):

Amy J. Pickering ◽

Jenna Swarthout ◽

MaryAnne Mureithi ◽

John Mboya ◽

Benjamin F. Arnold ◽

...

Keyword(s):

Drinking Water ◽

Controlled Trial ◽

Fecal Contamination ◽

Cluster Randomized Trial ◽

Child Growth ◽

Fecal Indicator ◽

Child Exposure ◽

E Coli ◽

Household Environment ◽

Cluster Randomized

AbstractCombined water, sanitation, and handwashing (WSH) interventions have the potential to reduce fecal pathogens along more transmission pathways than single interventions alone. We measured Escherichia coli levels in 3909 drinking water samples, 2691 child hand rinses, and 2422 toy ball rinses collected from households enrolled in a two-year cluster-randomized controlled trial evaluating single and combined WSH interventions. Water treatment alone reduced E. coli in drinking water, while a combined WSH intervention improved water quality by the same magnitude but did not affect levels of fecal indicator bacteria on child hands or toy balls. The failure of the WSH interventions to reduce E. coli along important child exposure pathways is consistent with the lack of a protective effect from the interventions on child diarrhea or child growth during the trial. Our results have important implications for WSH program design; the sanitation and handwashing interventions implemented in this trial should not be expected to reduce child exposure to fecal contamination in other similar settings.

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Impact of a tuberculosis treatment adherence intervention versus usual care on treatment completion rates: results of a pragmatic cluster randomized controlled trial

Implementation Science ◽

10.1186/s13012-020-01067-y ◽

2020 ◽

Vol 15 (1) ◽

Author(s):

Lisa M. Puchalski Ritchie ◽

Monique van Lettow ◽

Austine Makwakwa ◽

Ester C. Kip ◽

Sharon E. Straus ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Treatment Adherence ◽

Health Workers ◽

Controlled Trial ◽

Demographic Data ◽

Treatment Success ◽

Randomized Controlled ◽

Tb Treatment ◽

Adherence Intervention ◽

Cluster Randomized

Abstract Background With the global shortage of skilled health workers estimated at 7.2 million, outpatient tuberculosis (TB) care is commonly task-shifted to lay health workers (LHWs) in many low- and middle-income countries where the shortages are greatest. While shown to improve access to care and some health outcomes including TB treatment outcomes, lack of training and supervision limit the effectiveness of LHW programs. Our objective was to refine and evaluate an intervention designed to address common causes of non-adherence to TB treatment and LHW knowledge and skills training needs. Methods We employed a pragmatic cluster randomized controlled trial. Participants included 103 health centres (HCs) providing TB care in four districts in Malawi, randomized 1:1 stratified by district and HC funding (Ministry of Health, non-Ministry funded). At intervention HCs, a TB treatment adherence intervention was implemented using educational outreach, a point-of-care reminder tool, and a peer support network. Clusters in the control arm provided usual care. The primary outcome was the proportion of patients with successful TB treatment (i.e., cure or treatment completion). We used a generalized linear mixed model, with district as a fixed effect and HC as a random effect, to compare proportions of patients with treatment success, among the trial arms, with adjustment for baseline differences. Results We randomized 51 HCs to the intervention group and 52 HCs to the control group. Four intervention and six control HCs accrued no eligible patients, and 371 of 1169 patients had missing outcome, HC, or demographic data, which left 74 HCs and 798 patients for analysis. Randomization group was not related to missing outcome, however, district, age, and TB type were significantly related and included in the primary analysis model. Among the 1153 patients with HC and demographic data, 297/605 (49%) and 348/548 (64%) in the intervention and control arms, respectively, had treatment success. The intervention had no significant effect on treatment success (adjusted odds ratio 1.35 [95% confidence interval 0.93–1.98]). Conclusion We found no significant effect of the intervention on TB treatment outcomes with high variability in implementation quality, highlighting important challenges to both scale-up and sustainability. Trial registration ClinicalTrials.gov NCT02533089. Registered August 20, 2015.

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