scholarly journals Community case management of chest indrawing pneumonia in children aged 2 to 59 months by community health workers: study protocol for a multi-country cluster randomized open label non-inferiority trial

2020 ◽  
Vol 7 (2) ◽  
pp. 131
Author(s):  
Yasir Bin Nisar

<p class="abstract"><strong>Background:</strong> The World Health Organization (WHO) integrated management of childhood illness (IMCI) protocol recommends treatment of chest indrawing in 2-59 months old children with oral amoxicillin by trained health facility workers. Whereas, the WHO/UNICEF integrated community case management (iCCM) protocol recommends referral by community level health workers (CLHWs) to a health facility. This study aims to evaluate whether CLHWs can treat chest indrawing pneumonia effectively and safely.</p><p class="abstract"><strong>Methods:</strong> This<strong> </strong>multi-centre cluster randomized controlled open label, non-inferiority trial will be conducted in Bangladesh, Ethiopia, India and Malawi. All sites will use a common protocol with the same study design, participants, intervention, control and outcomes. CLHWs will identify 2-59 months old children with chest indrawing. Study supervisors, trained in the iCCM protocol, will confirm CLHWs’ findings. Pulse oximetry will be used to identify hypoxaemic children. In the intervention group, enrolled children will be treated with oral amoxicillin for 5 days, and in the control group they will be referred to a health facility, after providing first dose of oral amoxicillin. An independent outcome assessor will visit each enrolled child on days 6 and 14 of enrolment, to assess study outcomes.</p><p class="abstract"><strong>Conclusions:</strong> If CLHWs can effectively and safely treat chest indrawing pneumonia in 2-59 months old children, it will increase access to pneumonia treatment substantially, as in many settings, health facilities and trained health workers are not easily accessible. Moreover, this evidence will contribute towards the review of the current iCCM protocol and its harmonization with the IMCI protocol.</p><p class="abstract"><strong>Trial Registration:</strong> The trial is registered at AZNCTR International Trial Registry as ACTRN12617000857303.</p>

2020 ◽  
Vol 7 (2) ◽  
pp. 83 ◽  
Author(s):  
Yasir Bin Nisar

<p class="abstract"><strong>Background:</strong> WHO does not recommend community-level health workers (CLHWs) using integrated community case management (iCCM) to treat 7-59 days old infants with fast breathing with oral amoxicillin, whereas World Health Organization (WHO) integrated management of childhood illness (IMCI) recommends it. We want to collect evidence to help harmonization of both protocols.</p><p class="abstract"><strong>Methods:</strong> A cluster, randomized, open-label trial will be conducted in Africa and Asia (Ethiopia, Malawi, Bangladesh and India) using a common protocol with the same study design, inclusion criteria, intervention, comparison, and outcomes to contribute to the overall sample size. This trial will also identify hypoxaemia in young infants with fast breathing. CLHWs will assess infants for fast breathing, which will be confirmed by a study supervisor. Enrolled infants in the intervention clusters will be treated with oral amoxicillin, whereas in the control clusters they will be managed as per existing iCCM protocol. An independent outcome assessor will assess all enrolled infants on days 6 and 14 of enrolment for the study outcomes in both intervention and control clusters. Primary outcome will be clinical treatment failure by day 6. This trial will obtain approval from the WHO and site institutional ethics committees.</p><p class="abstract"><strong>Conclusions: </strong>If the research shows that CLHWs can effectively and safely treat fast breathing pneumonia in 7-59 days old young infants, it will increase access to pneumonia treatment substantially for infants living in communities with poor access to health facilities. Additionally, this evidence will contribute towards the review of the current iCCM protocol and its harmonization with IMCI protocol.</p><p class="abstract"><strong>Trial Registration:</strong> The trial is registered at AZNCTR International Trial Registry as ACTRN12617000857303.</p>


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Elizabeth Wambui Kimani-Murage ◽  
Hermann Pythagore ◽  
Elizabeth Mwaniki ◽  
Tewoldeberha Daniel ◽  
Betty Samburu ◽  
...  

Abstract Background In many low income countries, the majority of acutely malnourished children are either brought to the health facility late or never at all due to reasons related to distance and associated costs. Integrated community case management (iCCM) is an integrated approach addressing disease and malnutrition through use of community health volunteers (CHVs) in children under-5 years. Evidence on the potential impact and practical experiences on integrating community-based management of acute malnutrition as part of an iCCM package is not well documented. In this study, we aim to investigate the effectiveness and cost effectiveness of integrating management of acute malnutrition into iCCM. Methods This is a two arm parallel groups, non-inferiority cluster randomized community trial (CRT) employing mixed methods approach (both qualitative and quantitative approaches). Baseline and end line data will be collected from eligible (malnourished) mother/caregiver-child dyads. Ten community units (CUs) with a cluster size of 24 study subjects will be randomized to either an intervention (5 CUs) and a control arm (5 CUs). CHV in the control arm, will only screening and refer MAM/SAM cases to the nearby health facility for treatment by healthcare professionals. In the intervention arm, however; CHVs will be trained both to screen/diagnose and also treat moderate acute malnutrition (MAM) and severe acute malnutrition (SAM) without complication. A paired-matching design where each control group will be matched with intervention group with similar characteristics will be matched to ensure balance between the two groups with respect to baseline characteristics. Qualitative data will be collected using key informant and in-depth interviews (KIIs) and focused group discussions (FGDs) to capture the views and experiences of stakeholders. Discussion Our proposed intervention is based on an innovative approach of integrating and simplifying SAM and MAM management through CHWs bring the services closer to the community. The trial has received ethical approval from the Ethics Committee of AMREF Health Africa - Ethical and Scientific Review Committee (AMREF- ESRC), Nairobi, Kenya. The results will be disseminated through workshops, policy briefs, peer-reviewed publications, and presented to local and international conferences. Trial registration PACTR201811870943127; Pre-results. 26 November 2018.


2021 ◽  
Vol 6 (8) ◽  
pp. e006578
Author(s):  
◽  
Yasir B Nisar

IntroductionYoung infants 7–59 days old with fast breathing pneumonia presented to a primary level health facility receive a 7-day course of amoxicillin as per the WHO guideline. However, community-level health workers (CLHW) are not allowed to treat these infants. This trial evaluated the community level treatment of non-hypoxaemic young infants with fast breathing pneumonia by CLHWs.MethodsThis cluster-randomised, open-label, non-inferiority trial was conducted in rural areas of Bangladesh, Ethiopia, India and Malawi. We randomly allocated clusters (first-level health facility) 1:1, stratified by the population size, to an intervention group (enhanced community case management) or control group (standard community case management). Infants aged 7–59 days with a respiratory rate of ≥60 breaths/min and oxygen saturation (SpO2) ≥90% were enrolled. In the intervention clusters, these infants were treated with a 7-day course of oral amoxicillin (according to WHO weight bands) and were regularly followed up by CLHWs. In the control clusters, CLHWs continued the standard management (assess and refer after pre-referral antibiotic dose) and followed up according to the national programme guideline. The primary outcome of treatment failure was assessed in both groups by independent outcome assessors on days 6 and 14 after enrolment. Secondary outcomes (accuracy and impact of pulse oximetry) were also assessed.ResultsBetween September 2016 and December 2018, we enrolled 2334 infants (1168 in intervention and 1166 in control clusters) from 208 clusters (104 intervention and 104 control). Of 2334, 22 infants with fast breathing were excluded from analysis, leaving 2312 (1155 in intervention clusters and 1157 in control clusters) for intention-to-treat analysis. The proportion of treatment failure was 5.4% (63/1155) in intervention and 6.3% (73/1157) in the control clusters, including two deaths (0.2%) in each group. The adjusted risk difference for treatment failure between the two groups was −1.0% (95% CI −3.0% to 1.1%). The secondary outcome showed that CLHWs in the intervention clusters performed all recommended steps of pulse oximetry assessment in 94% (1050/1115) of enrolled patients.ConclusionsThe 7-day amoxicillin treatment for 7–59 days old non-hypoxaemic infants with fast breathing pneumonia by CLHWs was non-inferior to the currently recommended referral strategy.Trial registration numbersCTRI/2017/02/007761 and ACTRN12617000857303.


2018 ◽  
Vol 69 (3) ◽  
pp. 397-404
Author(s):  
Salim Sadruddin ◽  
Ibad ul Haque Khan ◽  
Matthew P Fox ◽  
Abdul Bari ◽  
Attaullah Khan ◽  
...  

Abstract Background Globally, most deaths due to childhood pneumonia occur at the community level. Some countries are still using oral co-trimoxazole, despite a World Health Organization recommendation of oral amoxicillin for the treatment of fast-breathing pneumonia in children at the community level. Methods We conducted an unblinded, cluster-randomized, controlled-equivalency trial in Haripur District, Pakistan. Children 2–59 months of age with fast-breathing pneumonia were treated with oral amoxicillin suspension (50 mg/kg/day) for 3 days in 14 intervention clusters and oral co-trimoxazole suspension (8 mg trimethoprim/kg and 40 mg sulfamethoxazole/kg/day) for 5 days in 14 control clusters by lady health workers (LHW). The primary outcome was treatment failure by day 4 for intervention clusters and by day 6 for control clusters. The analysis was per protocol. Results Out of the 15 749 cases enrolled in the study, 9153 cases in intervention and 6509 cases in control clusters were included in the analysis. Treatment failure rates were 3.6% (326) in intervention clusters and 9.1% (592) in control clusters. After adjusting for clustering, the risk of treatment failure was lower in intervention clusters (risk difference [RD] -5.5%, 95% confidence interval [CI] -7.4–-3.7%) than in control clusters. Children with incomplete adherence had a small increase in treatment failure versus those with complete adherence (RD 2.9%, 95% CI 1.6–4.1%). No deaths or serious adverse events occurred. Conclusions A 3-day course of oral amoxicillin, administered by LHWs, is an effective and safe treatment for fast-breathing pneumonia in children 2–59 months of age. A shorter course of amoxicillin improves adherence to therapy, is low in cost, and puts less pressure on antimicrobial resistance. Clinical Trials Registration ISRCTN10618300.


2021 ◽  
Vol 20 (1) ◽  
Author(s):  
James S. Miller ◽  
Palka Patel ◽  
Sara Mian-McCarthy ◽  
Andrew Christopher Wesuta ◽  
Michael Matte ◽  
...  

Abstract Background In some areas of Uganda, village health workers (VHW) deliver Integrated Community Case Management (iCCM) care, providing initial assessment of children under 5 years of age as well as protocol-based treatment of malaria, pneumonia, and diarrhoea for eligible patients. Little is known about community perspectives on or satisfaction with iCCM care. This study examines usage of and satisfaction with iCCM care as well as potential associations between these outcomes and time required to travel to the household’s preferred health facility. Methods A cross-sectional household survey was administered in a rural subcounty in western Uganda during December 2016, using a stratified random sampling approach in villages where iCCM care was available. Households were eligible if the household contained one or more children under 5 years of age. Results A total of 271 households across 8 villages were included in the final sample. Of these, 39% reported that it took over an hour to reach their preferred health facility, and 73% reported walking to the health facility; 92% stated they had seen a VHW for iCCM care in the past, and 55% had seen a VHW in the month prior to the survey. Of respondents whose households had sought iCCM care, 60% rated their overall experience as “very good” or “excellent,” 97% stated they would seek iCCM care in the future, and 92% stated they were “confident” or “very confident” in the VHW’s overall abilities. Longer travel time to the household’s preferred health facility did not appear to be associated with higher propensity to seek iCCM care or higher overall satisfaction with iCCM care. Conclusions In this setting, community usage of and satisfaction with iCCM care for malaria, pneumonia, and diarrhoea appears high overall. Ease of access to facility-based care did not appear to impact the choice to access iCCM care or satisfaction with iCCM care.


2020 ◽  
Author(s):  
Julie Gutman ◽  
Daniel K Stephens ◽  
Justin Tiendrebeogo ◽  
Ousmane Badolo ◽  
Mathurin Dodo ◽  
...  

Abstract Background: Malaria in pregnancy is responsible for 8–14% of low birth weight and 20% of stillbirths in sub-Saharan Africa. To prevent these adverse consequences, the World Health Organization recommends intermittent preventive treatment of pregnant women (IPTp) with sulfadoxine-pyrimethamine be administered at each ANC visit starting as early as possible in the second trimester. Global IPTp coverage in targeted countries remains unacceptably low. Community delivery of IPTp was explored as a means to improve coverage. Methods: A cluster randomized, controlled trial was conducted in 12 health facilities in a 1:1 ratio to either an intervention group (IPTp delivered by CHWs) or a control group (standard practice, with IPTp delivered at HFs) in three districts of Burkina Faso to assess the effect of IPTp administration by community health workers (CHWs) on the coverage of IPTp and antenatal care (ANC). The districts and facilities were purposively selected taking into account malaria epidemiology, IPTp coverage, and the presence of active CHWs. Pre- and post-intervention surveys were carried out in March 2017 and July–August 2018, respectively. A difference in differences (DiD) analysis was conducted to assess the change in coverage of IPTp and ANC over time, accounting for clustering at the health facility level. Results: Altogether 374 and 360 women were included in the baseline and endline surveys, respectively. At baseline, women received a median of 2.1 doses; by endline, women received a median of 1.8 doses in the control group and 2.8 doses in the intervention group (p-value <.0001). There was a non-statistically significant increase in the proportion of women attending four ANC visits in the intervention compared to control group (DiD= 12.6%, p-value= 0.16). By the endline, administration of IPTp was higher in the intervention than control, with a DiD of 17.6% for IPTp3 (95% confidence interval (CI) -16.3, 51.5; p-value 0.31) and 20.0% for IPTp4 (95% CI -7.2, 47.3; p-value= 0.15). Conclusions: Community delivery of IPTp could potentially lead to a greater number of IPTp doses delivered, with no apparent decrease in ANC coverage.


2020 ◽  
Vol 10 (2) ◽  
Author(s):  
Godfrey Biemba ◽  
Arnold Mulenga ◽  
Boniface Chiluba ◽  
Ulla K. Griffiths ◽  
Kojo Yeboah-Antwi ◽  
...  

Integrated community case management (iCCM) of malaria, diarrhea, and pneumonia is a comprehensive, equitybased strategy to improve treatment access for underserved children under five years old. This paper presents data on cost of iCCM and incremental costs of mHealth enhanced supervision and supply chain management in Zambia. We collected cost data using three questionnaires applied at national, district, health facility and community levels. We interviewed 40 health facility supervisors and 75 community health workers. A provider perspective and an ingredient costing method was used. We entered and analyzed data in a customized excel costing tool. The result shows that total iCCM cost per patient contact was USD 18.43. The incremental cost of using the mHealth intervention per child contact for all iCCM conditions was USD 11.35. The incremental cost per treatment of diarrhea, pneumonia, and malaria with mHealth intervention was USD 9.58, USD 10.37 and USD 12.82. Program costs accounted for 67% of the total, and the largest share was associated with supervision estimated at 36%, followed by supply chain management at 27%. This study has provided valuable information to policy makers on how much it costs to implement iCCM program using mHealth interventions.


2016 ◽  
Vol 23 (8) ◽  
pp. 725-732 ◽  
Author(s):  
Edouard Piette ◽  
Michel Nougairède ◽  
Valerie Vuong ◽  
Beatrice Crickx ◽  
Viet-Thi Tran

Introduction In France, 66% of patients forego getting specialized care by dermatologists because of difficulty obtaining appointments. Store-and-forward teledermatology could improve how promptly treatment begins by reducing the delay in obtaining a specialist’s opinion. In this study, we compared the delay before care between general practitioners (GPs) using a store-and-forward teledermatology intervention and GPs addressing their patients with a standard referral letter. Methods We performed an open-label, pragmatic cluster-randomized controlled trial with two parallel arms. GP clinics in Paris (France) were randomly assigned to use either teledermatology referral (use of electronics to send clinical images taken using a mobile phone) or conventional referral (using standard letters) to care for patients for whom a dermatologist’s advice was needed for the diagnosis or treatment of skin lesions. Dermatologists integrated responses to teledermatology requests in their usual schedule. Patients were followed up for three months. Primary outcome was the delay, in days, between the GP’s consultation and a reply by the specialist allowing treatment to begin. Analyses were adjusted for clustering of GPs and identities of dermatologists. Results Between February and June 2014, 103 patients were included in the study (53 patients of 20 GPs in the intervention group). The median delay between the initial GP’s consultation and the reply allowing for treatment to begin was four days in the intervention group and 40 days in the control group (adjusted hazard ratio = 2.55; p < 0.011). Discussion We showed that a simple store-and-forward teledermatology intervention significantly reduced the delay before beginning care (ClinicalTrials.gov identifier: NCT02122432).


2020 ◽  
Vol 6 (3) ◽  
pp. 383-387
Author(s):  
Bunga Tiara Carolin ◽  
Siti Syamsiah Syamsiah ◽  
Mita Mauliah Khasri

ABSTRACT  Background: Weight problems in babies are very sensitive, as evidenced by World Health Organization (WHO) data stating the incidence of infant weight in the world is still below the standard of more than 5% with the prevalence of underweigh in southeast asia 26.9% (WHO, 2017). One of the efforts to optimize weight gain in infants in addition to the nutrition provided by the women, one of which needs to be the stimulation of stimuli or commonly known as baby massage.  Puprose: This study aims to determine the effect of infant massage on infant weight in the Alanda Care working area of Pangkalpinang City, Bangka Belitung Province.  Methods: The study used the Quasy Experiment method with Two Group pretest and postest Design. The population in this study is infants aged 2-5 months. The sample in this study are 30 respondens. Data were analyzed using paired t-test and Independen T-Test. Results: The results showed that there were 793 grams of infant weight in the intervention group and 400 grams in the control group. There were differences in the results of the pretest and posttest in each of the intervention groups (p=0,000) and the control group (p=0,000) and there is an effect of baby massage on baby weight (p=0,000). Conclusion: Although both of them gained weight in the intervention group and the control group, the weight gain in the intervention group almost doubled compared to the control group and there was also the effect of massage on baby weight.  Suggestion: It is expected that health workers can provide education about baby massage and its benefits to parents, especially those who have babies, so that public participation in the health sector can be increased  Keywords: Baby, Massage, Weight   ABSTRAK  Latar Belakang: Permasalahan berat badan pada bayi sangatlah sensitif, terbukti dari data World Health Organization (WHO) tahun 2017 menyatakan angka kejadian berat badan bayi di dunia masih di bawah standar yaitu lebih dari 5% dengan prevalensi underweigh di asia tenggara 26,9%. Salah satu upaya untuk mengoptimalkan berat badan pada bayi di samping nutrisi yang diberikan oleh ibu, salah satunya perlu juga adanya rangsangan stimulus atau yang biasa di kenal dengan pijat bayi.  Tujuan: Untuk mengetahui pengaruh pijat bayi terhadap berat badan bayi di wilayah kerja Alanda Care Kota Pangkalpinang Provinsi Bangka Belitung.  Metode: Penelitian menggunakan metode Quasy Experimen dengan Two Group pretest and postest Design. Populasi dalam penelitian ini adalah seluruh bayi 2-5 bulan. Sampel dalam penelitian ini berjumlah 30 responden yang dibagi menjadi dari 2 kelompok. Data dianalisa dengan Paired t test dan Independen T-Test. Hasil: Hasil penelitian menunjukkan bahwa ada kenaikan berat badan bayi pada kelompok intervensi sebanyak 793 gram dan pada kelompok kontrol sebanyak 400 gram. Terdapat perbedaan hasil pretest dan posttest pada masing-masing kelompok intervensi (p=0,000) dan kontrol (p=0,000) dan terdapat pengaruh pemberian pijit bayi terhadap berat badan bayi (p=0,000). Kesimpulan: Walaupun sama-sama terdapat kenaikan berat badan bayi pada kelompok intervensi maupun kelompok kontrol, tetapi kenaikannya berat pada kelompok intervensi mencapai hampir dua kali lipat daripada kelompok control dan juga ada pengaruh pijat terhadap berat badan bayi.  Saran: Diharapkan bagi petugas kesehatan dapat memberikan pendidikan tentang pijat bayi dan manfaatnya kepada para orangtua terutama yang memiliki bayi agar peran serta masyarakat di bidang kesehatan dapat meningkat.  Kata Kunci: Bayi, Pijat, Berat Badan


2020 ◽  
Author(s):  
Julie Gutman ◽  
Daniel K Stephens ◽  
Justin Tiendrebeogo ◽  
Ousmane Badolo ◽  
Mathurin Dodo ◽  
...  

Abstract Background: Malaria in pregnancy is responsible for 8–14% of low birth weight and 20% of stillbirths in sub-Saharan Africa. To prevent these adverse consequences, the World Health Organization recommends intermittent preventive treatment of pregnant women (IPTp) with sulfadoxine-pyrimethamine be administered at each ANC visit starting as early as possible in the second trimester. Global IPTp coverage in targeted countries remains unacceptably low. Community delivery of IPTp was explored as a means to improve coverage. Methods: A cluster randomized, controlled trial was conducted in 12 health facilities in a 1:1 ratio to either an intervention group (IPTp delivered by CHWs) or a control group (standard practice, with IPTp delivered at HFs) in three districts of Burkina Faso to assess the effect of IPTp administration by community health workers (CHWs) on the coverage of IPTp and antenatal care (ANC). The districts and facilities were purposively selected taking into account malaria epidemiology, IPTp coverage, and the presence of active CHWs. Pre- and post-intervention surveys were carried out in March 2017 and July–August 2018, respectively. A difference in differences (DiD) analysis was conducted to assess the change in coverage of IPTp and ANC over time, accounting for clustering at the health facility level. Results: Altogether 374 and 360 women were included in the baseline and endline surveys, respectively. At baseline, women received a median of 2.1 doses; by endline, women received a median of 1.8 doses in the control group and 2.8 doses in the intervention group (p-value <.0001). There was a non-statistically significant increase in the proportion of women attending four ANC visits in the intervention compared to control group (DiD= 12.6%, p-value= 0.16). By the endline, administration of IPTp was higher in the intervention than control, with a DiD of 17.6% for IPTp3 (95% confidence interval (CI) -16.3, 51.5; p-value 0.31) and 20.0% for IPTp4 (95% CI -7.2, 47.3; p-value= 0.15). Conclusions: Community delivery of IPTp could potentially lead to a greater number of IPTp doses delivered, with no apparent decrease in ANC coverage.


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