The prioritisation of curable sexually transmitted infections among pregnant women in Zambia and Papua New Guinea: Qualitative insights.

Curable sexually transmitted infections (STIs) are neglected in public health policy, services and society at large. Effective interventions are available for some STI but seem not to be prioritised at global, regional or local levels. Zambia and Papua New Guinea (PNG) have a high burden of STIs among pregnant women but little is known about the prioritisation of STI treatment and care among this group. We undertook a qualitative study to explore how STIs are prioritised among pregnant women in local health systems in Zambia and PNG. Semi-structured interviews were conducted with 19 key informants-health care workers providing antenatal care, and policy and programme advisers across the two countries. Audio recordings were transcribed and translated into English and stored, managed, and coded in NVivo v12. Analysis used deductive and inductive thematic analysis. Findings were coded against the World Health Organization health system building blocks. Participants spoke about the stigma of STIs at the community level. They described a broad understanding of morbidity associated with undiagnosed and untreated STIs in pregnant women. The importance of testing and treating STIs in pregnancy was well recognised but many spoke of constraints in providing these services due to stock outs of test kits for HIV and syphilis and antibiotics. In both settings, syndromic management remains the mainstay for treating curable STIs. Clinical practice and treatment were not in alignment with current STI guidelines in either country, with participants recognising the need for mentorship and in-service training, as well as the availability of commodities to support their clinical practice. Local disruptions to screening and management of syphilis, HIV and other curable STIs were widely reported in both countries. There is a need to galvanise priority at national and regional levels to ensure ongoing access to supplies needed to undertake STI testing and treatment.

Acceptability of self-collected vaginal swabs and point-of-care testing for sexually transmitted and genital infections among pregnant women in Papua New Guinea.

The self-collection of vaginal swabs and point-of-care testing and treatment of sexually transmitted infections (STIs) is reported from several low-and middle-income countries. However, the reporting on women's experiences of self-collection and same-day testing and treatment of STIs is less well described. In this paper, we present the acceptability of self-collected vaginal swabs and point-of-care testing and treatment among pregnant women enrolled in a clinical trial (Women and Newborn Trial of Antenatal Intervention and Management - WANTAIM) in Papua New Guinea. Semi-structured interviews were conducted among 54 women enrolled into WANTAIM to identify the acceptability of the test and treat approach. Analysis of qualitative data used deductive and inductive thematic analysis applying Sekhon, Cartwright and Francis' acceptability theoretical framework. Most women reported that they understood that the vaginal swab was to identify infections that may affect their unborn baby; however, some were unsure about the specific infections they were being tested for. Among women who tested positive for an STI, some were unsure what they had been treated for. Overall, the self-collection of vaginal swabs for STI testing during pregnancy was highly acceptable.

Point-of-care testing and treatment of sexually transmitted and genital infections to improve birth outcomes in high-burden, low-resource settings (WANTAIM): a pragmatic cluster randomised crossover trial in Papua New Guinea.

BACKGROUND: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and bacterial vaginosis have been associated with adverse maternal and perinatal outcomes, but there is conflicting evidence on the benefits of antenatal screening and treatment for these conditions. We aimed to determine the effect of antenatal point-of-care testing and immediate treatment of C trachomatis, N gonorrhoeae, T vaginalis, and bacterial vaginosis on preterm birth, low birthweight, and other adverse maternal and perinatal outcomes compared with current standard of care, which included symptom-based treatment without laboratory confirmation. METHODS: In this pragmatic cluster randomised crossover trial, we enrolled women (aged ≥16 years) attending an antenatal clinic at 26 weeks' gestation or earlier (confirmed by obstetric ultrasound), living within approximately 1 h drive of a study clinic, and able to provide reliable contact details at ten primary health facilities and their catchment communities (clusters) in Papua New Guinea. Clusters were randomly allocated 1:1 to receive either the intervention or control (standard care) in the first phase of the trial. Following an interval (washout period) of 2-3 months at the end of the first phase, each cluster crossed over to the other group. Randomisation was stratified by province. Individual participants were informed about trial group allocation only after completing informed consent procedures. The primary outcome was a composite of preterm birth (livebirth before 37 weeks' gestation), low birthweight (<2500 g), or both, analysed according to the intention-to-treat population. This study is registered with ISRCTN Registry, ISRCTN37134032, and is completed. FINDINGS: Between July 26, 2017, and Aug 30, 2021, 4526 women were enrolled (2210 [63·3%] of 3492 women in the intervention group and 2316 [62·8%] of 3687 in the control group). Primary outcome data were available for 4297 (94·9%) newborn babies of 4526 women. The proportion of preterm birth, low birthweight, or both, in the intervention group, expressed as the mean of crude proportions across clusters, was 18·8% (SD 4·7%) compared with 17·8% in the control group (risk ratio [RR] 1·06, 95% CI 0·78-1·42; p=0·67). There were 1052 serious adverse events reported (566 in the intervention group and 486 in the control group) among 929 trial participants, and no differences by trial group. INTERPRETATION: Point-of-care testing and treatment of C trachomatis, N gonorrhoeae, T vaginalis, and bacterial vaginosis did not reduce preterm birth or low birthweight compared with standard care. Within the subgroup of women with N gonorrhoeae, there was a substantial reduction in the primary outcome. FUNDING: UK Department of Health and Social Care; UK Foreign, Commonwealth and Development Office; UK Medical Research Council; the Wellcome Trust; the Australian National Health and Medical Research Council; and Swiss National Science Foundation.

Risk factors for incident cardiovascular events and their population attributable fractions in rural India: The Rishi Valley Prospective Cohort Study.

OBJECTIVE: We prospectively determined incident cardiovascular events and their association with risk factors in rural India. METHODS: We followed up with 7935 adults from the Rishi Valley Prospective Cohort Study to identify incident cardiovascular events. Using Cox proportional hazards regression, we estimated hazard ratios (HRs) with 95% confidence intervals (95% CI) for associations between potential risk factors and cardiovascular events. Population attributable fractions (PAFs) for risk factors were estimated using R ('averisk' package). RESULTS: Of the 4809 participants without prior cardiovascular disease, 57.7% were women and baseline mean age was 45.3 years. At follow-up (median of 4.9 years, 23,180 person-years [PYs]), 202 participants developed cardiovascular events, equating to an incidence of 8.7 cardiovascular events/1000 PYs. Incidence was greater in those with hypertension (hazard ratio [HR] [95% CI] 1.73 [1.21-2.49], adjusted PAF 18%), diabetes (1.96 [1.15-3.36], 4%) or central obesity (1.77 [1.23, 2.54], 9%) which together accounted for 31% of the PAF. Non-traditional risk factors such as night sleeping hours and number of children accounted for 16% of the PAF. CONCLUSIONS: Both traditional and non-traditional cardiovascular risk factors are important contributors to incident cardiovascular events in rural India. Interventions targeted to these factors could assist in reducing the incidence of cardiovascular events.

Comparison of the performance of cardiovascular risk prediction tools in rural India: the Rishi Valley Prospective Cohort Study.

AIMS: We compared the performance of cardiovascular risk prediction tools in rural India. METHODS AND RESULTS: We applied the World Health Organization Risk Score (WHO-RS) tools, Australian Risk Score (ARS), and Global risk (Globorisk) prediction tools to participants aged 40-74 years, without prior cardiovascular disease, in the Rishi Valley Prospective Cohort Study, Andhra Pradesh, India. Cardiovascular events during the 5-year follow-up period were identified by verbal autopsy (fatal events) or self-report (non-fatal events). The predictive performance of each tool was assessed by discrimination and calibration. Sensitivity and specificity of each tool for identifying high-risk individuals were assessed using a risk score cut-off of 10% alone or this 10% cut-off plus clinical risk criteria of diabetes in those aged >60 years, high blood pressure, or high cholesterol. Among 2333 participants (10 731 person-years of follow-up), 102 participants developed a cardiovascular event. The 5-year observed risk was 4.4% (95% confidence interval: 3.6-5.3). The WHO-RS tools underestimated cardiovascular risk but the ARS overestimated risk, particularly in men. Both the laboratory-based (C-statistic: 0.68 and χ2: 26.5, P = 0.003) and non-laboratory-based (C-statistic: 0.69 and χ2: 20.29, P = 0.003) Globorisk tools showed relatively good discrimination and agreement. Addition of clinical criteria to a 10% risk score cut-off improved the diagnostic accuracy of all tools. CONCLUSION: Cardiovascular risk prediction tools performed disparately in a setting of disadvantage in rural India, with the Globorisk performing best. Addition of clinical criteria to a 10% risk score cut-off aids assessment of risk of a cardiovascular event in rural India. LAY SUMMARY: In a cohort of people without prior cardiovascular disease, tools used to predict the risk of cardiovascular events varied widely in their ability to accurately predict who would develop a cardiovascular event.The Globorisk, and to a lesser extent the ARS, tools could be appropriate for this setting in rural India.Adding clinical criteria, such as sustained high blood pressure, to a cut-off of 10% risk of a cardiovascular event within 5 years could improve identification of individuals who should be monitored closely and provided with appropriate preventive medications.

The use of newborn foot length to identify low birth weight and preterm babies in Papua New Guinea: A diagnostic accuracy study.

Low birth weight (LBW, <2.50 kg) and preterm birth (PTB, <37 completed weeks of gestation) are important contributors to neonatal death. Newborn foot length has been reported to identify LBW and PTB babies. The objectives of this study were to determine the diagnostic accuracy of foot length to identify LBW and PTB and to compare foot length measurements of a researcher with those of trained volunteers in Papua New Guinea. Newborn babies were enrolled prospectively with written informed consent from their mothers, who were participating in a clinical trial in Madang Province. The reference standards were birth weight, measured by electronic scales and gestational age at birth, based on ultrasound scan and last menstrual period at the first antenatal visit. Newborn foot length was measured within 72 hours of birth with a firm plastic ruler. Optimal foot length cut-off values for LBW and PTB were derived from receiver operating characteristic curve analysis. Bland-Altman analysis was used to assess inter-observer agreement. From 12 October 2019 to 6 January 2021, we enrolled 342 newborns (80% of those eligible); 21.1% (72/342) were LBW and 7.3% (25/342) were PTB. The area under the curve for LBW was 87.0% (95% confidence intervals 82.8-90.2) and for PTB 85.6% (81.5-89.2). The optimal foot length cut-off was <7.7 cm for both LBW (sensitivity 84.7%, 74.7-91.2, specificity 69.6%, 63.9-74.8) and PTB (sensitivity 88.0% (70.0-95.8), specificity 61.8% (56.4-67.0). In 123 babies with paired measurements, the mean difference between the researcher and volunteer measurements was 0.07 cm (95% limits of agreement -0.55 to +0.70) and 7.3% (9/123) of the pairs were outside the 95% limits of agreement. When birth at a health facility is not possible, foot length measurement can identify LBW and PTB in newborns but needs appropriate training for community volunteers and evaluation of its impact on healthcare outcomes.

Combining general and central measures of adiposity to identify risk of hypertension: a cross-sectional survey in rural India.

AIM: In three socioeconomically diverse regions of rural India, we determined the optimal cut-offs for definition of overweight, the prevalence of overweight, and the relationships between measures of overweight and risk of hypertension. SUBJECTS AND METHODS: Villages were randomly sampled within rural Trivandrum, West Godavari, and Rishi Valley. Sampling of individuals was stratified by age group and sex. Cut-offs for measures of adiposity were compared using area under the receiver operating characteristic curve. Associations between hypertension and definitions of overweight were assessed by logistic regression. RESULTS: Of 11 657 participants (50 % male; median age 45 years), 29.8 % had hypertension. Large proportions were overweight as defined by body mass index (BMI) ≥ 23 kg/m2 (47.7 %), waist circumference (WC) ≥ 90 cm for men or ≥ 80 cm for women (39.6 %), waist-hip ratio (WHR) ≥ 0.9 for men or ≥ 0.8 for women (65.6 %), waist-height ratio (WHtR) ≥ 0.5 (62.5 %), or by BMI plus either WHR, WC or WHtR (45.0 %). All definitions of overweight were associated with hypertension, with optimal cut-offs being at, or close to, the World Health Organization (WHO) Asia-Pacific standards. Having overweight according to both BMI and a measure of central adiposity was associated with approximately twice the risk of hypertension than overweight defined by only one measure. CONCLUSIONS: Overweight, as assessed by both general and central measures, is prevalent in rural southern India. WHO standard cut-offs are appropriate in this setting for assessing risk of hypertension. However, combining BMI with a measure of central adiposity identifies risk of hypertension better than any single measure. The risk of hypertension is significantly greater in those centrally and generally overweight than those overweight by a single measure.

Morbidity and utilisation of healthcare services among people with cardiometabolic disease in three diverse regions of rural India.

OBJECTIVES: To assess the prevalence and determinants of cardiometabolic disease (CMD), and the factors associated with healthcare utilisation, among people with CMD. METHODS: Using a cross-sectional design, 11,657 participants were recruited from randomly selected villages in 3 regions located in Kerala and Andhra Pradesh from 2014 to 2016. Multivariable logistic regression was used to identify factors independently associated with CMD and healthcare utilisation (public or private). RESULTS: Thirty-four per cent (n = 3629) of participants reported having ≥1 CMD, including hypertension (21.6%), diabetes (11.6%), heart disease (5.0%) or chronic kidney disease (CKD) (1.6%). The prevalence of CMD was progressively greater in regions of greater socio-economic position (SEP), ranging from 19.1% to 40.9%. Among those with CMD 41% had sought any medical advice in the last month, with only 19% utilising public health facilities. Among people with CMD, those with health insurance utilised more healthcare (age-gender adjusted odds ratio (AOR) (95% confidence interval (CI)): 1.31 (1.13, 1.51)) as did those who reported accessing private rather than public health services (1.43 (1.23, 1.66)). DISCUSSION: The prevalence of CMD is high in these regions of rural India and is positively associated with indices of SEP. The utilisation of outpatient health services, particularly public services, among those with CMD is low.

Association of hypertension with infection and inflammation in a setting of disadvantage in rural India.

We assessed the association of hypertension with markers of inflammation and infection in a rural and disadvantaged Indian population. In a case-control study, we age- and gender-matched 300 cases with hypertension to 300 controls without hypertension. Blood pressure was measured according to a strict protocol. We measured markers of inflammation and infection including serum high-sensitivity C-reactive protein (hs-CRP), blood lymphocyte count, serum homocysteine, tooth loss, overcrowding and exposure to fecal contamination. Multivariable conditional logistic regression was used to determine their association with hypertension. Median serum hs-CRP was 42% greater in cases than controls, while median serum homocysteine was 10% greater. In multivariable conditional logistic regression, elevated homocysteine (OR 1.75, 95% CI 1.09-2.82), greater lymphocyte count (OR 1.49, 95% CI 1.01-2.01) and exposure to fecal contamination, defined as a distance from the field used for toilet purposes to the household of ≤50 m (OR 2.38, 95% CI 1.07-5.29), were independently associated with hypertension in this rural population. In separate analyses for each gender, elevated hs-CRP (OR 2.62, 95% CI 1.04-6.58) was associated with hypertension in men, whereas edentulism (OR 4.75, 95% CI 1.62-13.96) was associated with greater odds of hypertension in women. Our findings demonstrate specific associations between hypertension and markers of inflammation and infection including hs-CRP, homocysteine, lymphocyte count, edentulism and exposure to fecal contamination. Thus, strategies aimed at reducing inflammation and infection may reduce the burden of hypertension in such settings of disadvantage in rural India.

ASHA-Led Community-Based Groups to Support Control of Hypertension in Rural India Are Feasible and Potentially Scalable.

Background: To improve the control of hypertension in low- and middle-income countries, we trialed a community-based group program co-designed with local policy makers to fit within the framework of India's health system. Trained accredited social health activists (ASHAs), delivered the program, in three economically and developmentally diverse settings in rural India. We evaluated the program's implementation and scalability. Methods: Our mixed methods process evaluation was guided by the United Kingdom Medical Research Council guidelines for complex interventions. Meeting attendance reports, as well as blood pressure and weight measures of attendees and adherence to meeting content and use of meeting tools were used to evaluate the implementation process. Thematic analysis of separate focus group discussions with participants and ASHAs as well as meeting reports and participant evaluation were used to investigate the mechanisms of impact. Results: Fifteen ASHAs led 32 community-based groups in three rural settings in the states of Kerala and Andhra Pradesh, Southern India. Overall, the fidelity of intervention delivery was high. Six meetings were delivered over a 3-month period to each of the intervention groups. The mean number of meetings attended by participants at each site varied significantly, with participants in Rishi Valley attending fewer meetings [mean (SD) = 2.83 (1.68)] than participants in West Godavari (Tukeys test, p = 0.009) and Trivandrum (Tukeys test, p < 0.001) and participants in West Godavari [mean (SD) = 3.48 (1.72)] attending significantly fewer meetings than participants in Trivandrum [mean (SD) = 4.29 (1.76), Tukeys test, p < 0.001]. Culturally appropriate intervention resources and the training of ASHAs, and supportive supervision of them during the program were critical enablers to program implementation. Although highly motivated during the implementation of the program ASHA reported historical issues with timely remuneration and lack of supportive supervision. Conclusions: Culturally appropriate community-based group programs run by trained and supported ASHAs are a successful and potentially scalable model for improving the control of hypertension in rural India. However, consideration of issues related to unreliable/insufficient remuneration for ASHAs, supportive supervision and their formal role in the wider health workforce in India will be important to address in future program scale up. Trial Registration: Clinical Trial Registry of India [CTRI/2016/02/006678, Registered prospectively].

Early neonatal death review from two provinces in Papua New Guinea: A retrospective analysis.

AIM: To determine the causes of early neonatal death and the avoidable factors associated with these deaths among women participating in a cluster-randomised crossover trial in Papua New Guinea. METHODS: Early neonatal deaths were identified by retrospective chart review of the Women and Newborn Trial of Antenatal Interventions and Management study participants between July 2017 and January 2020. Causes of death and avoidable factors were identified using the Perinatal Problem Identification Program system. RESULTS: There were 35 early neonatal deaths among 2499 livebirths (14 per 1000 births). Fifty-seven percent (20/35) of deaths occurred on the first day of life. Idiopathic preterm birth was the leading obstetric cause of perinatal death (29%; 10/35). Extreme multi-organ immaturity (23%; 8/35) and hypoxic ischaemic encephalopathy (17%; 6/35) were the most common final causes of neonatal death. Forty-six avoidable factors were identified among 26 deaths, including delays in care-seeking, insufficient resources at health facilities, poor intrapartum care and immediate care of the newborn, including neonatal resuscitation. CONCLUSION: In this study, potentially preventable causes and avoidable factors were identified in the majority of early neonatal deaths. Addressing these factors will require health system strengthening, particularly the upskilling of primary level health staff, as well as targeted health education of women and the community.

Additive association of knowledge and awareness on control of hypertension: a cross-sectional survey in rural India.

OBJECTIVE: To determine whether there is an interaction between knowledge about hypertension and awareness of hypertension on the treatment and control of hypertension in three regions of South India at different stages of epidemiological transition (see Video, Supplemental Digital Content 1, http://links.lww.com/HJH/B426). METHODS: Using a cross-sectional design, we randomly selected villages within each of rural Trivandrum, West Godavari, and Chittoor. Sampling was stratified by age group and sex. We measured blood pressure and administered a questionnaire to determine knowledge and awareness of hypertension. Logistic regression was used to assess associations of awareness and knowledge about hypertension with its treatment and control in participants with hypertension, while examining for statistical interaction. RESULTS: Among a total of 11 657 participants (50% male; median age 45 years), 3455 had hypertension. In analyses adjusted for age and sex, both knowledge score [adjusted odds ratio (aOR) 1.14 [95% confidence interval (CI) 1.12--1.17)] and awareness [aOR 104 (95% CI 82--134)] were associated with treatment for hypertension. Similarly, both knowledge score [aOR 1.10; 95% CI (1.08--1.12)] and awareness [aOR 13.4; 95% CI (10.7--16.7)], were positively associated with control of blood pressure in those with hypertension, independent of age and sex. There was an interaction between knowledge and awareness on both treatment and control of hypertension (P of attributable proportion <0.001 for each). CONCLUSION: Health education to improve knowledge about hypertension and screening programs to improve awareness of hypertension may act in an additive fashion to improve management of hypertension in rural Indian populations.

Perinatal death audit and classification of stillbirths in two provinces in Papua New Guinea: A retrospective analysis.

OBJECTIVE: To undertake a retrospective perinatal death audit and assessment of avoidable factors associated with stillbirths among a cohort of women in two provinces in Papua New Guinea. METHODS: We used data from an ongoing cluster-randomized crossover trial in 10 sites among 4600 women in Papua New Guinea (from 2017 to date). The overarching aim is to improve birth outcomes. All stillbirths from July 2017 to January 2020 were identified. The Perinatal Problem Identification Program was used to analyze each stillbirth and review associated avoidable factors. RESULTS: There were 59 stillbirths among 2558 births (23 per 1000 births); 68% (40/59) were classified "fresh" and 32% as "macerated". Perinatal cause of death was identified for 63% (37/59): 30% (11/37) were due to intrapartum asphyxia and traumatic breech birth and 19% (7/37) were the result of pre-eclampsia. At least one avoidable factor was identified for 95% (56/59) of stillbirths. Patient-associated factors included lack of response to reduced fetal movements and delay in seeking care during labor. Health personnel-associated factors included poor intrapartum care, late diagnosis of breech presentation, and prolonged second stage with no intervention. CONCLUSION: Factors associated with stillbirths in this setting could be avoided through a package of interventions at both the community and health-facility levels.

Hypertension in Rural India: The Contribution of Socioeconomic Position.

Background Various indicators of socioeconomic position (SEP) may have opposing effects on the risk of hypertension in disadvantaged settings. For example, high income may reflect sedentary employment, whereas greater education may promote healthy lifestyle choices. We assessed whether education modifies the association between income and hypertension in 3 regions of South India at different stages of epidemiological transition. Methods and Results Using a cross-sectional design, we randomly selected villages within each of rural Trivandrum, West Godavari, and Rishi Valley. Sampling was stratified by age group and sex. We measured blood pressure and anthropometry and administered a questionnaire to identify lifestyle factors and SEP, including education, literacy, and income. Logistic regression was used to assess associations between various components of SEP and hypertension, and interaction analyses were used to determine whether educational attainment modified the association between income and hypertension. Trivandrum, the region of highest SEP, had the greatest prevalence of hypertension, whereas Rishi Valley, the lowest SEP region, had the least. Overall, greater income was associated with greater risk of hypertension. In interaction analyses, there was no evidence that educational attainment modified the association between income and hypertension. Conclusions Education is widely considered to ameliorate the risk of hypertension in high-income countries. Why this effect is absent in rural India merits investigation.

Effectiveness of a scalable group-based education and monitoring program, delivered by health workers, to improve control of hypertension in rural India: A cluster randomised controlled trial.

BACKGROUND: New methods are required to manage hypertension in resource-poor settings. We hypothesised that a community health worker (CHW)-led group-based education and monitoring intervention would improve control of blood pressure (BP). METHODS AND FINDINGS: We conducted a baseline community-based survey followed by a cluster randomised controlled trial of people with hypertension in 3 rural regions of South India, each at differing stages of epidemiological transition. Participants with hypertension, defined as BP ≥ 140/90 mm Hg or taking antihypertensive medication, were advised to visit a doctor. In each region, villages were randomly assigned to intervention or usual care (UC) in a 1:2 ratio. In intervention clusters, trained CHWs delivered a group-based intervention to people with hypertension. The program, conducted fortnightly for 3 months, included monitoring of BP, education about hypertension, and support for healthy lifestyle change. Outcomes were assessed approximately 2 months after completion of the intervention. The primary outcome was control of BP (BP < 140/90 mm Hg), analysed using mixed effects regression, clustered by village within region and adjusted for baseline control of hypertension (using intention-to-treat principles). Of 2,382 potentially eligible people, 637 from 5 intervention clusters and 1,097 from 10 UC clusters were recruited between November 2015 and April 2016, with follow-up occurring in 459 in the intervention group and 1,012 in UC. Mean age was 56.9 years (SD 13.7). Baseline BP was similar between groups. Control of BP improved from baseline to follow-up more in the intervention group (from 227 [49.5%] to 320 [69.7%] individuals) than in the UC group (from 528 [52.2%] to 624 [61.7%] individuals) (odds ratio [OR] 1.6, 95% CI 1.2-2.1; P = 0.001). In secondary outcome analyses, there was a greater decline in systolic BP in the intervention than UC group (-5.0 mm Hg, 95% CI -7.1 to -3.0; P < 0.001) and a greater decline in diastolic BP (-2.1 mm Hg, 95% CI -3.6 to -0.6; P < 0.006), but no detectable difference in the use of BP-lowering medications between groups (OR 1.2, 95% CI 0.8-1.9; P = 0.34). Similar results were found when using imputation analyses that included those lost to follow-up. Limitations include a relatively short follow-up period and use of outcome assessors who were not blinded to the group allocation. CONCLUSIONS: While the durability of the effect is uncertain, this trial provides evidence that a low-cost program using CHWs to deliver an education and monitoring intervention is effective in controlling BP and is potentially scalable in resource-poor settings globally. TRIAL REGISTRATION: The trial was registered with the Clinical Trials Registry-India (CTRI/2016/02/006678).

Process evaluation in the field: global learnings from seven implementation research hypertension projects in low-and middle-income countries.

BACKGROUND: Process evaluation is increasingly recognized as an important component of effective implementation research and yet, there has been surprisingly little work to understand what constitutes best practice. Researchers use different methodologies describing causal pathways and understanding barriers and facilitators to implementation of interventions in diverse contexts and settings. We report on challenges and lessons learned from undertaking process evaluation of seven hypertension intervention trials funded through the Global Alliance of Chronic Diseases (GACD). METHODS: Preliminary data collected from the GACD hypertension teams in 2015 were used to inform a template for data collection. Case study themes included: (1) description of the intervention, (2) objectives of the process evaluation, (3) methods including theoretical basis, (4) main findings of the study and the process evaluation, (5) implications for the project, policy and research practice and (6) lessons for future process evaluations. The information was summarized and reported descriptively and narratively and key lessons were identified. RESULTS: The case studies were from low- and middle-income countries and Indigenous communities in Canada. They were implementation research projects with intervention arm. Six theoretical approaches were used but most comprised of mixed-methods approaches. Each of the process evaluations generated findings on whether interventions were implemented with fidelity, the extent of capacity building, contextual factors and the extent to which relationships between researchers and community impacted on intervention implementation. The most important learning was that although process evaluation is time consuming, it enhances understanding of factors affecting implementation of complex interventions. The research highlighted the need to initiate process evaluations early on in the project, to help guide design of the intervention; and the importance of effective communication between researchers responsible for trial implementation, process evaluation and outcome evaluation. CONCLUSION: This research demonstrates the important role of process evaluation in understanding implementation process of complex interventions. This can help to highlight a broad range of system requirements such as new policies and capacity building to support implementation. Process evaluation is crucial in understanding contextual factors that may impact intervention implementation which is important in considering whether or not the intervention can be translated to other contexts.

Knowledge of risk factors for hypertension in a rural Indian population.

OBJECTIVE: To study knowledge of risk factors and consequences of hypertension in a rural population in South India. METHODS: This is a community-based study conducted among adults of a rural population in the Rishi Valley, India. Residents of randomised rural villages were invited to participate in a study of hypertension. We obtained measures of blood pressure, height, weight, waist and hip circumferences and questionnaire-based information on knowledge about hypertension, sociodemographic characteristics and health behaviours. Multivariable logistic regression analyses were conducted to determine the factors associated with knowledge of risk factors for hypertension (knowledge of ≥2 risk factors). RESULTS: The study comprised 641 adults; 132 aware and 218 unaware of their hypertension, and 291 with normal blood pressure. Only 31% of participants knew that hypertension adversely affects an individual's health and 7% knew the benefits of treating hypertension. Almost a third (30%) of those aware of their hypertensive status, and 48% overall, did not know any of the risk factors for hypertension. Being aware of one's hypertensive status (OR 2.51, 95% CI 1.44 to 4.39), being treated for hypertension, male sex, younger age, having some schooling, abdominal obesity and physical inactivity were associated with better knowledge of risk factors for hypertension. CONCLUSION: Knowledge of risk factors and consequences of hypertension in this disadvantaged population was poor. There was better knowledge of risk factors in some, but not all, people who were aware of having hypertension. Screening and targeted educational programmes are warranted in this population to improve health behaviours and reduce the consequences of hypertension.

Task-shifting for cardiovascular risk factor management: lessons from the Global Alliance for Chronic Diseases.

Task-shifting to non-physician health workers (NPHWs) has been an effective model for managing infectious diseases and improving maternal and child health. There is inadequate evidence to show the effectiveness of NPHWs to manage cardiovascular diseases (CVDs). In 2012, the Global Alliance for Chronic Diseases funded eight studies which focused on task-shifting to NPHWs for the management of hypertension. We report the lessons learnt from the field. From each of the studies, we obtained information on the types of tasks shifted, the professional level from which the task was shifted, the training provided and the challenges faced. Additionally, we collected more granular data on 'lessons learnt ' throughout the implementation process and 'design to implementation' changes that emerged in each project. The tasks shifted to NPHWs included screening of individuals, referral to physicians for diagnosis and management, patient education for lifestyle improvement, follow-up and reminders for medication adherence and appointments. In four studies, tasks were shifted from physicians to NPHWs and in four studies tasks were shared between two different levels of NPHWs. Training programmes ranged between 3 and 7 days with regular refresher training. Two studies used clinical decision support tools and mobile health components. Challenges faced included system level barriers such as inability to prescribe medicines, varying skill sets of NPHWs, high workload and staff turnover. With the acute shortage of the health workforce in low-income and middle-income countries (LMICs), achieving better health outcomes for the prevention and control of CVD is a major challenge. Task-shifting or sharing provides a practical model for the management of CVD in LMICs.

Gaps in Guidelines for the Management of Diabetes in Low- and Middle-Income Versus High-Income Countries-A Systematic Review.

OBJECTIVE: The extent to which diabetes (DM) practice guidelines, often based on evidence from high-income countries (HIC), can be implemented to improve outcomes in low- and middle-income countries (LMIC) is a critical challenge. We carried out a systematic review to compare type 2 DM guidelines in individual LMIC versus HIC over the past decade to identify aspects that could be improved to facilitate implementation. RESEARCH DESIGN AND METHODS: Eligible guidelines were sought from online databases and websites of diabetes associations and ministries of health. Type 2 DM guidelines published between 2006 and 2016 with accessible full publications were included. Each of the 54 eligible guidelines was assessed for compliance with the Institute of Medicine (IOM) standards, coverage of the cardiovascular quadrangle (epidemiologic surveillance, prevention, acute care, and rehabilitation), translatability, and its target audiences. RESULTS: Most LMIC guidelines were inadequate in terms of applicability, clarity, and dissemination plan as well as socioeconomic and ethical-legal contextualization. LMIC guidelines targeted mainly health care providers, with only a few including patients (7%), payers (11%), and policy makers (18%) as their target audiences. Compared with HIC guidelines, the spectrum of DM clinical care addressed by LMIC guidelines was narrow. Most guidelines from the LMIC complied with less than half of the IOM standards, with 12% of the LMIC guidelines satisfying at least four IOM criteria as opposed to 60% of the HIC guidelines (P < 0.001). CONCLUSIONS: A new approach to the contextualization, content development, and delivery of LMIC guidelines is needed to improve outcomes.