mHealth intervention "ImTeCHO" to improve delivery of maternal, neonatal, and child care services-A cluster-randomized trial in tribal areas of Gujarat, India.

BACKGROUND: The coverage of community-based maternal, neonatal, and child health (MNCH) services remains low, especially in hard-to-reach areas. We evaluated the effectiveness of a mobile-phone-and web-based application, Innovative Mobile-phone Technology for Community Health Operations (ImTeCHO), as a job aid to the government's Accredited Social Health Activists (ASHAs) and Primary Health Center (PHC) staff to improve coverage of MNCH services in rural tribal communities of Gujarat, India. METHODS AND FINDINGS: This open cluster-randomized trial was conducted in 22 PHCs in six tribal blocks of Bharuch and Narmada districts in India. The ImTeCHO mobile-phone-and web-based application included various technology-based job aids to facilitate scheduling of home visits, screening for complications, counseling during home visits, and supportive supervision by PHC staff. Primary outcome indicators were a composite index calculated based on coverage of important MNCH services and coverage of at least two home visitations by ASHA within the first week of birth. Primary analysis was intention to treat (ITT). Generalized Estimating Equation (GEE) was used to account for clustering. Eleven PHCs each were randomly allocated to the intervention (280 ASHAs, population: 234,134) and control (281 ASHAs, population: 242,809) arms. The intervention was implemented from February, 2016 to January, 2017. At the end of the implementation, 6,493 mothers were surveyed. Most of the surveyed women were tribal (5,571, 85.8%), and reported having a government-issued certificate for living below poverty line (4,916, 75.7%). The coverage of at least two home visits within first week of birth was 32.4% in the intervention clusters compared to 22.9% in the control clusters (adjusted effect size 10.2 [95% CI: 6.4, 14.0], p < 0.001). Mean number of home visits within first week of birth was 1.11 and 0.80 for intervention and control clusters, respectively (adjusted effect size 0.34 [95% CI: 0.23, 0.45], p < 0.001). The composite coverage index was 43.0% in the intervention clusters compared to 38.5% (adjusted effect size 4.9 [95% CI: 0.2, 9.5], p = 0.03) in the control clusters. There were substantial improvements in coverage home visits by ASHAs during antenatal period (adjusted effect size 15.7 [95% CI: 11.0, 20.4], p < 0.001), postnatal period (adjusted effect size 6.4, [95% CI: 3.2, 9.6], p <0.001), early initiation of breastfeeding (adjusted effect size 7.8 [95% CI: 4.2, 11.4], p < 0.001), and exclusive breastfeeding (adjusted effect size 13.4 [95% CI: 8.9, 17.9], p < 0.001). Number of infant and neonatal deaths was similar in the two arms in the ITT analysis. The limitations of the study include potential risk of inaccuracies in reporting events that occurred during pregnancy by the mothers and the duration of intervention being 12 months, which might be considered short. CONCLUSIONS: In this study, we found that use of ImTeCHO mobile- and web-based application as a job aid by government ASHAs and PHC staff improved coverage and quality of MNCH services in hard-to-reach areas. Supportive supervision, change management, and timely resolution of technology-related issues were critical implementation considerations to ensure adherence to the intervention. TRIAL REGISTRATION: Study was registered at the Clinical Trial Registry of India (www.ctri.nic.in). Trial number: CTRI/2015/06/005847. The trial was registered (prospective) on 3 June, 2015. First enrollment was done on 26 August, 2015.

High uptake of an innovative mobile phone application among community health workers in rural India: An implementation study.

Background: We assessed the uptake, feasibility and effectiveness of an mHealth intervention in improving the performance of village-based frontline workers, called accredited social health activists (ASHAs), to increase the coverage of maternal, newborn and child health services in rural India. Methods: A new mobile phone application-Innovative Mobile-phone Technology for Community Health Operations (ImTeCHO)-was implemented in all the 45 villages of two primary health centres in Jhagadia, Gujarat (population ~45 000), between August 2013 and February 2014 after training 45 ASHAs. After 9 months of implementation, 99 mothers of young infants between the ages of 1 and 4 months and 187 mothers of infants between the ages of 6 and 9 months were interviewed during the household survey to assess the coverage of maternal, newborn and child health services in the project and similar control villages. Fifteen ASHAs were purposively selected and interviewed. Results: The coverage of home-based newborn care (56% v. 10%), exclusive breastfeeding (44% v. 23%), care-seeking for maternal (77% v. 57%) and neonatal complications (78% v. 27%) and pneumonia (41% v. 24%) improved in the interventional area compared to the control area. The ASHAs logged into the mobile phone application on 88% of working days. Of a total of 10 774 forms required to be completed, the ASHAs completed 7710 forms. During the interviews, all ASHAs demonstrated sufficient competency to use ImTeCHO and expressed a high level of acceptability and utility of all components of the intervention. Conclusion: A high degree of acceptability, feasibility and effectiveness for the mHealth intervention among ASHAs was supported by its widespread use.

Epidemiology of Infant Deaths in Predominant Tribal Areas of Two Districts of Gujarat: Results of Pregnancy and Mortality Surveillance Program.

OBJECTIVE: To understand epidemiology of the neonatal and infant deaths in predominant areas of two tribal districts of Gujarat. METHODS: A secondary analysis of pregnancy and mortality surveillance data was done to understand the causes and determinants of infant deaths in predominant tribal areas of two districts of Gujarat, India from 2015 to 2018. All pregnancies, their outcomes, and infant deaths were prospectively registered. A verbal autopsy tool was used to understand the cause of death. RESULT: A total of 25,130 live births were recorded; 20,994 (83.5%) deliveries occurred at the hospital. Total 1,309 infant deaths (IMR - 52.08/1,000 live births) and 879 neonatal deaths (NMR - 34.97/1,000 live births) occurred during the program duration. The odds of infant deaths was high among male child aOR - 1.5 (CI:1.3-1.7, p < 0.001), born to illiterate/primary educated mother aOR - 1.2 (1.03-1.4, 0.013), born at home or on the way aOR - 1.4 (1.1-1.8, 0.003), born with low birth weight (< 2.5 kg), aOR - 3.7 (3.2-4.3, < 0.001), born preterm (< 37 wk) aOR - 1.9 (1.7-2.2, < 0.001), and born twins aOR - 1.5 (1-2.1, 0.037) in comparison to female child, born to secondary/or above educated mother, born in hospital, born normal weight (>= 2.5 kg), born full-term (>= 37 wk), and born single, respectively. The asphyxia/respiratory distress syndrome (RDS) 282 (56%), sepsis/pneumonia and asphyxia/RDS 188 (63%), and sepsis/pneumonia 281 (65%) were leading cause of death among 0-3 d, 4-28 d, and 29-365 d infant deaths. CONCLUSION: There is a need to improve quality of intrapartum and postpartum care. Additionally, sepsis detection among infants and referral by community health workers also need to be improved to reduce infant mortality due to sepsis.

Newborn Screening and Clinical Profile of Children With Sickle Cell Disease in a Tribal Area of Gujarat.

OBJECTIVE: To present the result of newborn sickle cell disease (SCD) screening and clinical profile of SCD newborns in a tribal area of Gujarat. METHODS: We screened all newborns of sickle cell trait (SCT) and SCD mothers for SCD using high-performance liquid chromatography (HPLC) within two days of birth at a secondary care hospital in a tribal area in Gujarat from 2014 to 2019. Newborns with SCD were registered under an information technology based platform for hospital-based comprehensive care. Neonates were followed prospectively every 3 months. If they missed the clinic visit, a medical counsellor visited them at home to collect the required information. RESULTS: Out of 2492 newborns screened, 87 (3.5%) were diagnosed with SCD. Among the 67 newborns screened for alpha-thalassemia deletion, 64 (95.4%) of babies had alpha-thalassemia deletion. We recorded total 554 clinic visits over the period of 221.5 person-years. The rates of acute febrile illness, painful crisis, hospitalization and severe anemia were 42.9, 14.9, 14.9 and 4.5 per 100 person-year, respectively. Two deaths were recorded, and 5 babies (5.7%) had severe SCD. CONCLUSION: We found a high prevalence of alpha thalassemia deletion among newborn SCD cohort in tribal area of Gujarat, and 70% babies had atleast one clinical complication on follow-up.

Malaria and dengue in Hodeidah city, Yemen: High proportion of febrile outpatients with dengue or malaria, but low proportion co-infected.

BACKGROUND: The emergence of dengue in malaria-endemic countries with limited diagnostic resources, such as Yemen, can be problematic because presumptive treatment of febrile cases as being malaria is a common practice. Co-infections with dengue and malaria are often overlooked and misdiagnosed as being a mono-infection because of clinical similarities. In Hodeidah city, Yemen, the capacity to conduct the diagnosis can be aggravated by the war context. To assess the magnitude of the problem, we determined the proportions of malaria, dengue and co-infection in relation to clinical characteristics among febrile outpatients. METHODS: This cross-sectional study included 355 febrile outpatients from Hodeidah city during the malaria transmission season (September 2018 -February 2019). Sociodemographic and clinical characteristics were collected using a pre-designed, structured questionnaire. Malaria was confirmed using microscopy and rapid diagnostic tests (RDTs), while dengue was confirmed using RDTs. RESULTS: Mono-infection proportions of 32.4% for falciparum malaria and 35.2% for dengue were found, where about two-thirds of dengue patients had a recent probable infection. However, co-infection with falciparum malaria and dengue was detected among 4.8% of cases. There was no statistically significant difference between having co-infection and mono-infection with malaria or dengue in relation to the sociodemographic characteristics. On the other hand, the odds of co-infection were significantly lower than the odds of malaria among patients presenting with sweating (OR = 0.1, 95% CI: 0.05-0.45; p <0.001), while the odds of co-infection were 3.5 times significantly higher than the odds of dengue among patients presenting with vomiting (OR = 3.5, 95% CI: 1.20-10.04; p <0.021). However, there were no statistically significant differences between having co-infection and mono-infection (malaria or dengue) in relation to other clinical characteristics. CONCLUSIONS: Mono-infection with malaria or dengue can be detected among about one-third of febrile outpatients in Hodeidah, while almost 5.0% of cases can be co-infected. Sociodemographic and clinical characteristics cannot easily distinguish malaria patients from dengue-infected or co-infected ones, reinforcing the necessity of laboratory confirmation and avoidance of treating febrile patients as being presumed malaria cases.

Improving menstrual hygiene management among adolescent girls in tribal areas of Gujarat: an evaluation of an implementation model integrating the government service delivery system.

The majority of adolescent girls in rural India lack awareness regarding menstrual hygiene management (MHM), access to sanitary absorbents and necessary facilities in schools, homes, and workplaces. This study evaluated an intervention to strengthen a public health programme aimed to increase the use of safe, sanitary absorbents and knowledge of MHM among tribal adolescent girls. This project was implemented in 202 villages of two sub-districts of Narmada district in Gujarat, India, for one year (2018-2019). The intervention consisted of capacity building of 892 government frontline health workers and teachers, followed by supportive supervision. Convergence with concerned departments was achieved through meetings with stakeholders. "MHM-corners" and "MHM-Committees" were created at schools and Anganwadi-centres to improve access to menstrual absorbents and information. Household surveys of adolescent girls were conducted at baseline (n = 507) and end-line (n = 550) in 27 randomly selected villages to evaluate outcomes. Of 550 girls at the end-line, mean age 16.3 years, 487 (88.5%) were tribal, and 243 (44%) were out-of-school. The primary outcome of interest, the proportion of adolescent girls using safe, sanitary absorbents, increased from 69% to 90.5% (OR: 5.19, CI: 3.61-7.47). Their knowledge of the uterus as the origin of menstrual blood and hormonal changes as the cause for menstruation improved from 6.3% to 66% (p-value < 0.001) and 7.5% to 73% (p-value < 0.001), respectively. School absenteeism during menstruation reduced from 24% to 14% (p-value < 0.001). It is possible to improve MHM knowledge and practices among adolescent girls from tribal communities by utilising existing government systems. Awareness and access to safe absorbents can lead to safe and hygienic MHM practices.

Newborn Screening for Sickle Cell Disease Among Tribal Populations in the States of Gujarat and Madhya Pradesh in India: Evaluation and Outcome Over 6 Years.

Sickle cell disease (SCD) poses considerable public health problems in India. This study was undertaken to understand the clinical course of SCD among children identified during newborn screening programmes in Gujarat and Madhya Pradesh where the frequency of the HbS gene is high. A total of 8,916 newborn babies 8,411 from Gujarat and 505 from Madhya Pradesh were screened over 6 years (2010-2016) using HPLC and the diagnosis was confirmed by molecular analysis in a subset. A total of 128 babies (122 Gujarat, 6 Madhya Pradesh) were identified with sickle cell disease, of whom 87 (69 HbSS, 18 HbS-ß thalassemia) from Gujarat were followed for 0.5-6.6 years. Acute painful events, severe anemia and fever with infections were the major complications and 23 babies required hospitalization. Severe to moderate clinical presentation was found in 13.8% babies with SCD whereas, 86.2% babies had a milder presentation. Presence of ameliorating factors (α-thalassemia and Xmn 1 polymorphism) did not have a discernible effect on the clinical severity. Parents of babies with SCD were educated and counseled for home care. Distribution of mobile phones to 44 families having babies with SCD was beneficial as it allowed regular contact with patients and their families. Genetic counseling to the affected families has increased the awareness and acceptance for prenatal diagnosis and 18 couples opted for prenatal diagnosis in subsequent pregnancies. SCD is not always mild among tribal groups in India. Therefore, facilities for early diagnosis and prophylactic treatment in the tertiary care centers should be made available. The difficulties in regular follow up of the babies in remote rural areas have also been highlighted.

Costing and Cost-Effectiveness of a Mobile Health Intervention (ImTeCHO) in Improving Infant Mortality in Tribal Areas of Gujarat, India: Cluster Randomized Controlled Trial.

BACKGROUND: During 2013, a mobile health (mHealth) program, Innovative Mobile Technology for Community Health Operation (ImTeCHO), was launched in predominantly tribal and rural communities of Gujarat, India. ImTeCHO was developed as a job aid for Accredited Social Health Activists (ASHAs) and staff of primary health centers to increase coverage of maternal, neonatal, and child health care. OBJECTIVE: In this study, we assessed the incremental cost per life-years saved as a result of the ImTeCHO intervention as compared to routine maternal, neonatal, and child health care programs. METHODS: A two-arm, parallel, stratified cluster randomized trial with 11 clusters (primary health centers) randomly allocated to the intervention (280 ASHAs, n=2,34,134) and control (281 ASHAs, n=2,42,809) arms was initiated in 2015 in a predominantly tribal and rural community of Gujarat. A system of surveillance assessed all live births and infant deaths in the intervention and control areas. All costs, including those required during the start-up and implementation phases, were estimated from a program perspective. Incremental cost-effectiveness ratios were estimated by dividing the incremental cost of the intervention with the number of deaths averted to estimate the cost per infant death averted. This was further analyzed to estimate the cost per life-years saved for the purpose of comparability. Sensitivity analysis was undertaken to account for parameter uncertainties. RESULTS: Out of a total of 5754 live births (3014 in the intervention arm, 2740 in the control arm) reported in the study area, per protocol analysis showed that the implementation of ImTeCHO resulted in saving 11 infant deaths per 1000 live births in the study area at an annual incremental cost of US $163,841, which is equivalent to US $54,360 per 1000 live births. Overall, ImTeCHO is a cost-effective intervention from a program perspective at an incremental cost of US $74 per life-years saved or US $5057 per death averted. In a realistic environment with district scale-up, the program is expected to become even more cost-effective. CONCLUSIONS: Overall, the findings of our study strongly suggest that the mHealth intervention as part of the ImTeCHO program is cost-effective and should be considered for replication elsewhere in India. TRIAL REGISTRATION: Clinical Trials Registry of India CTRI/2015/06/005847; http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=11820&EncHid=&modid=&compid=%27,%2711820det%27.

Gaps in Hepatitis B Vaccination Completion and Sero-Protection for People Who Inject Drugs in Hpakant, Myanmar, 2015-2018.

Hepatitis B vaccination (HBV) is recommended for high-risk groups, such as people who inject drugs (PWIDs). As part of a harm reduction program by a non-governmental organization, hepatitis B screening, vaccination and antibody (HBAb) testing after completion of the vaccination schedule were offered to PWIDS in Myanmar. We determined the proportions of HBV non-completion and sero-unprotection among PWIDs enrolled in the program and their association with socio-demographic and clinical characteristics. We conducted a descriptive study based on routine program data in five selected clinics in Hpakant Township, Myanmar. PWIDs who were Hepatitis B antigen negative at screening during January 2015-December 2018 were included. Among 5386 participants eligible for HBV, 9% refused vaccination. Among those who accepted vaccination (n = 3177 individuals), 65% completed vaccination. Of those tested for HBsAb (n = 2202), 30% were sero-unprotected. Young-adults (aged 18-44 years) and migrant workers had a higher risk of incomplete vaccination. However, participants who used methadone had a lower risk of incomplete vaccination. Migrant workers had higher risk of not returning for HBsAb testing and HIV-positive participants had a higher risk of being HBV sero-unprotected. Efforts to increase HBV vaccination in PWIDs for young adults and clients during methadone and anti-retroviral services should be prioritized.

Multicenter Evaluation of HemoTypeSC as a Point-of-Care Sickle Cell Disease Rapid Diagnostic Test for Newborns and Adults Across India.

OBJECTIVES: Sickle cell anemia is the commonest genetic disorder in India, and the frequency of the sickle cell gene is very high in the remote tribal areas where facilities are generally limited. Therefore, a rapid and affordable point-of-care test for sickle cell disease is needed. METHODS: The diagnostic accuracy of HemoTypeSC was evaluated against automated high-performance liquid chromatography (HPLC) as the gold standard for its efficacy in a newborn screening program. RESULTS: A total of 1,559 individuals (980 newborns and 579 adults) from four participating centers were analyzed by both methods. HemoTypeSC correctly identified 209 of 211 total hemoglobin (Hb) SS cases, for a 99.1%/99.9% total HbSS sensitivity/specificity. Overall, HemoTypeSC exhibited sensitivity and specificity of 98.1% and 99.1% for all possible phenotypes (HbAA, HbAS, and HbSS) detected. HPLC is relatively expensive and not available in most laboratories in remote tribal areas. CONCLUSIONS: We conclude that the rapid, point-of-care testing device HemoTypeSC test is suitable for population and newborn screening for the HbS phenotype.

Attrition from Care and Clinical Outcomes in a Cohort of Sickle Cell Disease Patients in a Tribal Area of Western India.

In a tribal area of western India, a non-governmental organization implemented a comprehensive sickle cell disease (SCD) program at a secondary level hospital. In a cohort of SCD patients registered during December 2015 to June 2017, we assessed rates of lost to follow-up (LTFU) during the follow-up period using routinely collected data. We compared the uptake of proven interventions and indicators of disease severity from one year prior to registration until the end of the study (June 2018). Of 404 patients, the total follow-up duration was 534 person-years (PY). The rate (95% CI) of LTFU was 21 (17.5-25.3) per 100 PY. The proportion of people who received the pneumococcal vaccine improved from 10% to 93%, and coverage of hydroxyurea improved from 3.5% to 88%. There was a statistically significant decrease in rates (per 100 PY) of pain crisis (277 vs 53.4), hospitalization (49.8 vs 42.2), and blood transfusion (27.4 vs 17.8) after enrollment in the SCD program. Although clinical intervention uptake was high, one quarter of the patients were LTFU. The study demonstrated significant reductions in disease severity in SCD patients.

Cluster randomized trial of a mHealth intervention "ImTeCHO" to improve delivery of proven maternal, neonatal, and child care interventions through community-based Accredited Social Health Activists (ASHAs) by enhancing their motivation and strengthening supervision in tribal areas of Gujarat, India: study protocol for a randomized controlled trial.

BACKGROUND: To facilitate the delivery of proven maternal, neonatal, and child health (MNCH) services, a new cadre of village-based frontline workers, called the Accredited Social Health Activists (ASHAs), was created in 2005 under the aegis of the National Rural Health Mission in India. Evaluations have noted that coverage of selected MNCH services to be delivered by the ASHAs is low. Reasons for low coverage are inadequate supervision and support to ASHAs apart from insufficient skills, poor quality of training, and complexity of tasks to be performed. The proposed study aims to implement and evaluate an innovative intervention based on mobile phone technology (mHealth) to improve the performance of ASHAs through better supervision and support in predominantly tribal and rural communities of Gujarat, India. METHODS/DESIGN: This is a two-arm, stratified, cluster randomized trial of 36 months in which the units of randomization will be Primary Health Centers (PHCs). There are 11 PHCs in each arm. The intervention is a newly built mobile phone application used in the public health system and evaluated in three ways: (1) mobile phone as a job aid to ASHAs to increase coverage of MNCH services; (2) mobile phone as a job aid to ASHAs and Auxiliary Nurse Midwives (ANMs) to increase coverage of care among complicated cases by facilitating referrals, if indicated and home-based care; (3) web interface as a job aid for medical officers and PHC staff to improve supervision and support to the ASHA program. Participants of the study are pregnant women, mothers, infants, ASHAs, and PHC staff. Primary outcome measures are a composite index made of critical, proven MNCH services and the proportion of neonates who were visited by ASHAs at home within the first week of birth. Secondary outcomes include coverage of selected MNCH services and care sought by complicated cases. Outcomes will be measured by conducting household surveys at baseline and post-intervention which will be compared with usual practice in the control area, where the current level of services provided by the government will continue. The primary analysis will be intention to treat. DISCUSSION: This study will help answer some critical questions about the effectiveness and feasibility of implementing an mHealth solution in an area of MNCH services. TRIAL REGISTRATION: Clinical Trial Registry of India, CTRI/2015/06/005847 . Registered on 3 June 2015.

Sickle cell disease and pregnancy outcomes: a study of the community-based hospital in a tribal block of Gujarat, India.

BACKGROUND: Sickle cell disease (SCD) is a hereditary blood disorder prevalent in tribal regions of India. SCD can increase complications during pregnancy and in turn negatively influence pregnancy outcomes. This study reports the analysis of tribal maternal admissions in the community-based hospital of SEWA Rural (Kasturba Maternity Hospital) in Jhagadia block, Gujarat. The objective of the study is to compare the pregnancy outcomes among SCD, sickle cell trait and non-SCD admissions. This study also estimated the risk of adverse pregnancy outcomes for SCD admissions. METHODS: The data pertains to four and half years from March 2011 to September 2015. The total tribal maternal admissions were 14640, out of which 10519 admissions were deliveries. The admissions were classified as sickle cell disease, sickle cell trait and non-sickle cell disease. The selected pregnancy outcomes and maternal complications were abortion, stillbirth, Caesarean section, haemoglobin levels, blood transfusion, preterm pregnancy, newborn birth weight and other diagnosed morbidities (IUGR, PIH, eclampsia, preterm labour pain). The odds ratios for each risk factor were estimated for sickle cell patients. The odds ratios were adjusted for the respective years. RESULTS: Overall, 1.2% (131 out of 10519) of tribal delivery admissions was sickle cell admissions. Another 15.6% (1645 out of 10519) of tribal delivery admissions have sickle cell trait. The percentage of stillbirth was 9.9% among sickle cell delivery admission compared to 4.2% among non-sickle cell deliveries admissions. Among sickle cell deliveries, 70.2% were low birth weight compared to 43.8% of non-sickle cell patient. Similarly, almost half of the sickle cell deliveries needed the blood transfusion. The 45.0% of sickle cell delivery admissions were pre-term births, compared to 17.3% in non-SCD deliveries. The odds ratio of severe anaemia, stillbirth, blood transfusion, Caesarean section, and low birth weight was significantly higher for sickle cell admissions compared to non-sickle cell admissions. CONCLUSIONS: The study exhibited that there is a high risk of adverse pregnancy outcomes for women with SCD. It may also be associated with the poor maternal and neonatal health in these tribal regions. Thus, the study advocates the need for better management of SCD in tribal Gujarat.