Latrine promotion for trachoma: assessment of mortality from a cluster-randomized trial in Ethiopia.
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SUBMITTER: Gebre T
PROVIDER: S-EPMC3163877 | biostudies-literature | 2011 Sep
REPOSITORIES: biostudies-literature
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Latrine promotion for trachoma: assessment of mortality from a cluster-randomized trial in Ethiopia.
Gebre Teshome T Ayele Berhan B Zerihun Mulat M House Jenafir I JI Stoller Nicole E NE Zhou Zhaoxia Z Ray Kathryn J KJ Gaynor Bruce D BD Porco Travis C TC Emerson Paul M PM Lietman Thomas M TM Keenan Jeremy D JD
The American journal of tropical medicine and hygiene 20110901 3
Trachoma control strategies, including latrine construction and antibiotic distribution, are directed at reducing ocular chlamydia, but may have additional benefits. In a cluster-randomized clinical trial, 24 subkebeles (administrative geographic units) in Ethiopia were offered a single mass azithromycin treatment, and half were randomized to receive an intensive latrine promotion. At a follow-up census 26 months after the baseline treatment, 320 persons had died. The mortality rate of children ...[more]
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Project description:The World Health Organization (WHO) recommends environmental improvements such as latrine construction in the integrated trachoma control strategy, SAFE. We report a cluster-randomized trial assessing the effect of intensive latrine promotion on emergence of infection with ocular Chlamydia trachomatis after mass treatment with antibiotics.Twenty-four communities in Goncha Seso Enesie woreda, Amhara Regional State, Ethiopia, were enumerated, and a random selection of 60 children aged 0- 9 years in each was monitored for clinical signs of trachoma and ocular chlamydial infection at baseline, 12 and 24 months. All community members were offered treatment with a single dose of oral azithromycin or topical tetracycline. After treatment, 12 subkebeles were randomized to receive intensive latrine promotion. Mean cluster ocular infection in the latrine and the non-latrine arms were reduced from 45.5% (95% CI 34.1-56.8%) and 43.0% (95% CI 31.1-54.8%) respectively at baseline to 14.6% (95% CI 7.4-21.8%) and 14.8% (95% CI 8.9-20.8%) respectively at 24 months (P=0.93). Clinical signs fell from 72.0% (95% CI 58.2-85.5%) and 61.3% (95% CI 44.0-78.5%) at baseline to 45.8% (36.0-55.6%) and 48.5% (34.0-62.9%) respectively at 24 months (P=0.69). At 24 months, estimated household latrine coverage and use were 80.8% and 61.7% respectively where there had been intensive latrine promotion and 30.0% and 25.0% respectively in the single treatment only arm. We were unable to detect a difference in the prevalence of ocular chlamydial infection in children due to latrine construction.
| S-EPMC3139980 | biostudies-literature
Project description:Trial designTrachoma is targeted for global elimination. Infection rates with Chlamydia trachomatis are higher in new arrivals to a community and in travelers who leave for extended periods, suggesting they are sources of re-infection. This community-randomized, clinical trial was designed to determine if a surveillance program that targeted newcomers and travelers, identified weekly, would result in more communities achieving levels of infection of ?1%.Methods52 communities were randomly allocated 1:1 to the control (annual MDA alone if warranted) or intervention arm (annual MDA if warranted, plus a surveillance program to identify and treat newcomers and travelers). In each community, surveys were completed every six months on a random sample of 100 children ages 1-9 years for trachoma and infection. The primary outcome was the proportion of communities in the intervention arm, compared to the control arm, which had a prevalence of infection at ?1% by 24 months. Registered: clinicaltrials.gov(NCT01767506).ResultsIntervention communities experienced an average of 110 surveillance events per month. At 24 months, 7 (27%) of 26 intervention communities achieved a prevalence of infection ?1% compared to 4 (15%) of the 26 control communities (odds ratio = 2·6, 95%CI = 0·56-11·9). At 24 months, the average infection prevalence in the intervention communities was 4·8, compared to 6·9 in the control communities (p = ·06).ConclusionDespite surveillance programs for community newcomers and travelers, the proportion of intervention communities with a level of infection ?1% was lower than expected and not significantly different from control communities.
| S-EPMC5490954 | biostudies-literature
Project description:Repeated oral azithromycin distribution targeted only to children has proven effective in reducing the ocular Chlamydia that causes trachoma. Here, we assess whether an enhanced coverage target of at least 90% of children is superior to the World Health Organization recommendation of at least 80%. Twenty-four trachoma-endemic communities in Matamèye, Niger, were randomized to a single day of azithromycin distribution aiming for at least 80% coverage or up to 4 days of treatment and > 90% coverage of children under age 12. All distributions were biannual. Children < 5 years of age and adults > 15 years were monitored for ocular Chlamydia infection by polymerase chain reaction every 6 months for 36 months in children and at baseline and 36 months in adults. Ocular Chlamydia prevalence in children decreased from 24.9% (95% confidence interval [CI] 15.9-33.8%) to 4.4% (95% CI 0.6-8.2%, P < 0.001) at 36 months in the standard coverage arm and from 15.6% (95% CI 10.0-21.2%) to 3.3% (95% CI 1.0-5.5%; P < 0.001) in the enhanced coverage arm. Enhanced coverage reduced ocular Chlamydia prevalence in children more quickly over time compared with standard (P = 0.04). There was no difference between arms at 36 months in children (2.4% lower with enhanced coverage, 95% CI 7.7-12.5%; P = 0.60). No infection was detected in adults at 36 months. Increasing antibiotic coverage among children from 80% to 90% may yield only short term improvements for trachoma control programs. Targeting treatment to children alone may be sufficient for trachoma control in this setting.
| S-EPMC5929194 | biostudies-literature
Project description:BackgroundThe 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.MethodsThe 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.DiscussionThe 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.
| S-EPMC7789605 | biostudies-literature
Project description:BackgroundWHO promotes the SAFE strategy for the elimination of trachoma as a public health programme, which promotes surgery for trichiasis (ie, the S component), antibiotics to clear the ocular strains of chlamydia that cause trachoma (the A component), facial cleanliness to prevent transmission of secretions (the F component), and environmental improvements to provide water for washing and sanitation facilities (the E component). However, little evidence is available from randomised trials to support the efficacy of interventions targeting the F and E components of the strategy. We aimed to determine whether an integrated water, sanitation, and hygiene (WASH) intervention prevents the transmission of trachoma.MethodsThe WASH Upgrades for Health in Amhara (WUHA) was a two-arm, parallel-group, cluster-randomised trial in 40 rural communities in Wag Hemra Zone (Amhara Region, Ethiopia) that had been treated with 7 years of annual mass azithromycin distributions. The randomisation unit was the school catchment area. All households within a 1·5 km radius of a potential water point within the catchment area (as determined by the investigators) were eligible for inclusion. Clusters were randomly assigned (at a 1:1 ratio) to receive a WASH intervention either immediately (intervention) or delayed until the conclusion of the trial (control), in the absence of concurrent antibiotic distributions. Given the nature of the intervention, participants and field workers could not be masked, but laboratory personnel were masked to treatment allocation. The WASH intervention consisted of both hygiene infrastructure improvements (namely, construction of a community water point) and hygiene promotion by government, school, and community leaders, which were implemented at the household, school, and community levels. Hygiene promotion focused on two simple messages: to use soap and water to wash your or your child's face, and to always use a latrine for defecation. The primary outcome was the cluster-level prevalence of ocular chlamydia, measured annually using conjunctival swabs in a random sample of children aged 0-5 years from each cluster at 12, 24, and 36 month timepoints. Analyses were done in an intention-to-treat manner. This trial is ongoing and is registered at ClinicalTrials.gov, NCT02754583.FindingsBetween Nov 9, 2015, and March 5, 2019, 40 of 44 clusters assessed for eligibility were enrolled and randomly allocated to the trial groups (20 clusters each, with 7636 people from 1751 households in the intervention group and 9821 people from 2211 households in the control group at baseline). At baseline, ocular chlamydia prevalence among children aged 0-5 years was 11% (95% CI 6 to 16) in the WASH group and 11% (5 to 18) in the control group. At month 36, ocular chlamydia prevalence had increased in both groups, to 32% (24 to 41) in the WASH group and 31% (21 to 41) in the control group (risk difference across three annual monitoring visits, after adjustment for prevalence at baseline: 3·7 percentage points; 95% CI -4·9 to 12·4; p=0·40). No adverse events were reported in either group.InterpretationAn integrated WASH intervention addressing the F and E components of the SAFE strategy did not prevent an increase in prevalence of ocular chlamydia following cessation of antibiotics in an area with hyperendemic trachoma. The impact of WASH in the presence of annual mass azithromycin distributions is currently being studied in a follow-up trial of the 40 study clusters. Continued antibiotic distributions will probably be important in areas with persistent trachoma.FundingNational Institutes of Health-National Eye Institute.TranslationFor the Amharic translation of the abstract see Supplementary Materials section.
| S-EPMC9360557 | biostudies-literature
Project description:ImportanceSchool-based interventions offer an opportunity for health promotion in adolescence.ObjectiveTo assess the effect of 2 multicomponent educational health promotion strategies of differing duration and intensity on adolescents' cardiovascular health (CVH).Design, setting, and participantsThe SI! Program for Secondary Schools is a 4-year cluster randomized clinical intervention trial conducted in 24 secondary schools from Barcelona and Madrid, Spain, from September 7, 2017, to July 31, 2021. Eligible participants were adolescents enrolled in the first grade of secondary school.InterventionsSchools and their participants were randomized to receive a health promotion intervention (SI! Program) over 4 school years (long-term intervention [LTI], 8 schools, 412 adolescents) or 2 school years (short-term intervention [STI], 8 schools, 504 adolescents) or to receive the standard curriculum (control, 8 schools, 441 adolescents).Main outcome and measuresThe primary end point was the between-group difference at 2 and 4 years in the change from baseline of the overall CVH score, as defined by the American Heart Association (range, 0-14 points, with a higher score indicating a healthier CVH profile). Intervention effects were tested with multilevel mixed-effects models. A complete-case intention-to-treat analysis was performed as the primary analysis.ResultsOf the randomized students, the study enrolled 1326 adolescents (684 [51.6%] boys, mean [SD] age, 12.5 [0.4] years at recruitment) with a study completion rate of 86.0%. Baseline overall CVH scores were 10.3 points in the LTI group, 10.6 points in the STI group, and 10.5 points in the control group. After 2 years, at halfway through the LTI and at the end of the STI, the difference in the CVH score change was 0.44 points (95% CI, 0.01-0.87; P = .04) between the LTI group and the control group and 0.18 points (95% CI, -0.25 to 0.61; P = .39) between the STI group and the control group. At 4 years, differences for the LTI and STI groups vs control were 0.12 points (LTI: 95% CI, -0.19 to 0.43; P = .42) and 0.13 points (STI: 95% CI, -0.17 to 0.44; P = .38). No adverse events were reported.Conclusions and relevanceOverall, the tested school-based health promotion strategies in this randomized clinical trial had a neutral effect on the CVH of the adolescents. Although there was evidence of a marginal beneficial effect at a point halfway through implementation in the LTI group, such a benefit was not noted at 4 years. Further research is warranted into the efficacy of school-based health promotion programs.Trial registrationClinicalTrials.gov Identifier: NCT03504059.
| S-EPMC10398546 | biostudies-literature
Project description:BackgroundMass azithromycin distributions have been shown to reduce mortality among pre-school children in sub-Saharan Africa. It is unclear what mediates this mortality reduction, but one possibility is that antibiotics function as growth promoters for young children.Methods and findings24 rural Ethiopian communities that had received biannual mass azithromycin distributions over the previous four years were enrolled in a parallel-group, cluster-randomized trial. Communities were randomized in a 1:1 ratio to either continuation of biannual oral azithromycin (20mg/kg for children, 1 g for adults) or to no programmatic antibiotics over the 36 months of the study period. All community members 6 months and older were eligible for the intervention. The primary outcome was ocular chlamydia; height and weight were measured as secondary outcomes on children less than 60 months of age at months 12 and 36. Study participants were not masked; anthropometrists were not informed of the treatment allocation. Anthropometric measurements were collected for 282 children aged 0-36 months at the month 12 assessment and 455 children aged 0-59 months at the month 36 assessment, including 207 children who had measurements at both time points. After adjusting for age and sex, children were slightly but not significantly taller in the biannually treated communities (84.0 cm, 95%CI 83.2-84.8, in the azithromycin-treated communities vs. 83.7 cm, 95%CI 82.9-84.5, in the untreated communities; mean difference 0.31 cm, 95%CI -0.85 to 1.47, P = 0.60). No adverse events were reported.ConclusionsPeriodic mass azithromycin distributions for trachoma did not demonstrate a strong impact on childhood growth.Trial registrationThe TANA II trial was registered on clinicaltrials.gov #NCT01202331.
| S-EPMC6550377 | biostudies-literature
Project description:We conducted a cluster randomized trial of the effects of the integrated community case management of childhood illness (iCCM) strategy on careseeking for and coverage of correct treatment of suspected pneumonia, diarrhea, and malaria, and mortality among children aged 2-59 months in 31 districts of the Oromia region of Ethiopia. We conducted baseline and endline coverage and mortality surveys approximately 2 years apart, and assessed program strength after about 1 year of implementation. Results showed strong iCCM implementation, with iCCM-trained workers providing generally good quality of care. However, few sick children were taken to iCCM providers (average 16 per month). Difference in differences analyses revealed that careseeking for childhood illness was low and similar in both study arms at baseline and endline, and increased only marginally in intervention (22.9-25.7%) and comparison (23.3-29.3%) areas over the study period (P = 0.77). Mortality declined at similar rates in both study arms. Ethiopia's iCCM program did not generate levels of demand and utilization sufficient to achieve significant increases in intervention coverage and a resulting acceleration in reductions in child mortality. This evaluation has allowed Ethiopia to strengthen its strategic approaches to increasing population demand and use of iCCM services.
| S-EPMC4775896 | biostudies-literature
Project description:Trachoma control programs utilize mass azithromycin distributions to treat ocular Chlamydia trachomatis as part of an effort to eliminate this disease world-wide. But it remains unclear what the community-level risk factors are for infection.This cluster-randomized, controlled trial entered 48 randomly selected communities in a 2×2 factorial design evaluating the effect of different treatment frequencies and treatment coverage levels. A pretreatment census and examination established the prevalence of risk factors for clinical trachoma and ocular chlamydia infection including years of education of household head, distance to primary water source, presence of household latrine, and facial cleanliness (ocular discharge, nasal discharge, and presence of facial flies). Univariate and multivariate associations were tested using linear regression and Bayes model averaging.There were a total of 24,536 participants (4,484 children aged 0-5 years) in 6,235 households in the study. Before treatment in May to July 2010, the community-level prevalence of active trachoma (TF or TI utilizing the World Health Organization [WHO] grading system) was 26.0% (95% CI: 21.9% to 30.0%) and the mean community-level prevalence of chlamydia infection by Amplicor PCR was 20.7% (95% CI: 16.5% to 24.9%) in children aged 0-5 years. Univariate analysis showed that nasal discharge (0.29, 95% CI: 0.04 to 0.54; P?=?0.03), presence of flies on the face (0.40, 95% CI: 0.17 to 0.64; P?=?0.001), and years of formal education completed by the head of household (0.07, 95% CI: 0.07 to 0.13; P?=?0.03) were independent risk factors for chlamydia infection. In multivariate analysis, facial flies (0.26, 95% CI: 0.02 to 0.49; P?=?0.03) and years of formal education completed by the head of household (0.06, 95% CI: 0.008 to 0.11; P?=?0.02) were associated risk factors for ocular chlamydial infection.We have found that the presence of facial flies and years of education of the head of the household are risk factors for chlamydia infection when the analysis is done at the community level.ClinicalTrials.gov NCT00792922.
| S-EPMC3335874 | biostudies-literature
Project description:BACKGROUND:Unhealthy dietary behaviour-high intake of fat, sugar, and salt, and low intake of fruits and vegetables-is a major risk factor for chronic diseases. There is a lack of evidence-based interventions to promote healthy dietary intake among Indian populations. Therefore, we tested the effectiveness of an information technology-enabled 'SMART Eating' intervention to reduce the intake of fat, sugar and salt, and to increase the intake of fruits and vegetables. METHODS:In Chandigarh, a North Indian city, a cluster randomized controlled trial was implemented in twelve geographical clusters, based on the type of housing (i.e., LIG: Low-income group; MIG; Middle-income group, and HIG: High-income group-a proxy for socio-economic status). Computer-generated randomization was used to allocate clusters to intervention and comparison arms after pairing on the basis of socioeconomic status and geographical distance between clusters. The sample size was 366 families per arm (N = 732). One adult per family was randomly selected as an index case to measure the change in the outcomes. For behaviour change, a multi-channel communication approach was used, which included information technology-short message service (SMS), email, social networking app and 'SMART Eating' website, and interpersonal communication along with distribution of a 'SMART Eating' kit-kitchen calendar, dining table mat, and measuring spoons. The intervention was implemented at the family level over a period of six months. The comparison group received pamphlets on nutrition education. Outcome measurements were made at 0 and 6 months post-intervention at the individual level. Primary outcomes were changes in mean dietary intakes of fat, sugar, salt, and fruit and vegetables. Secondary outcomes included changes in body mass index (BMI), blood pressure, haemoglobin, fasting plasma glucose (FPG), and serum lipids. Mixed-effects linear regression models were used to determine the net change in the outcomes in the intervention group relative to the comparison group. RESULTS:Participants' mean age was 53 years, a majority were women (76%), most were married (90%) and 51% had completed a college degree. All families had mobile phones, and more than 90% of these families had access to Internet through mobile phones. The intervention group had significant net mean changes of -12.5 g/day (p<0.001), -11.4 g/day (p<0.001), -0.5 g/day (p<0.001), and +71.6 g/day (p<0.001) in the intake of fat, sugar, salt, and fruit and vegetables, respectively. Similarly, significant net changes occurred for secondary outcomes: BMI -0.25 kg/m2, diastolic blood pressure -2.77 mm Hg, FPG -5.7 mg/dl, and triglycerides -24.2mg/dl. The intervention had no effect on haemoglobin, systolic blood pressure, low-density lipoprotein cholesterol, or high-density lipoprotein cholesterol. CONCLUSION:The IT-enabled 'SMART Eating' intervention was found to be effective in reducing fat, sugar, and salt intake, and increasing fruit and vegetable consumption among urban adults from diverse socio-economic backgrounds. TRIAL REGISTRATION:Clinical Trial Registry of India CTRI/2016/11/007457.
| S-EPMC6953835 | biostudies-literature