Discovery, development, and deployment of a user-centered point-of-care digital information system to treat and track hypertension and diabetes patients under India Hypertension Control Initiative 2019-2022, India.

Background: Hypertension affects 28.5% of Indians aged 18-69. Real-time registration and follow-up of persons with hypertension are possible with point-of-care digital information systems. We intend to describe herein the experiences of discovering, developing, and deploying a point-of-care digital information system for public health facilities under the India Hypertension Control Initiative. Methods: We have adopted an agile and user-centered approach in each phase in selected states of India since 2017. A multidisciplinary team adopted a hybrid approach with quantitative and qualitative methods, such as contextual inquiries, usability testing, and semi-structured interviews with healthcare workers, to document and monitor utility and usability. Results: During the discovery phase, we adopted a storyboard technique to understand the requirement of a digital information system. The participatory approach in discovery phase co-designed the information system with the nurses and doctors at Punjab state of India. Simple, which is the developed information system, has a front-end Android mobile application for healthcare workers and a backend dashboard for program managers. As of October 2022, over 24,31,962 patients of hypertension and 8,99,829 diabetes were registered in the information system of 10,017 health facilities. The median duration of registering a new patient was 50 seconds, and for recording a follow-up visit was 14 seconds in the app. High satisfaction was reported in 100 app users' quarterly interviews. Conclusion: Simple was implemented by administering a user-centered approach and agile techniques. It demonstrated high utility and usability among users, highlighting the benefits of a user-centered approach for effective digital health solutions.

India Hypertension Control Initiative: Blood Pressure Control Using Drug and Dose-Specific Standard Treatment Protocol at Scale in Punjab and Maharashtra, India, 2022.

Background: Hypertension treatment coverage is low in India. A stepwise simple treatment protocol is one of the strategies to improve hypertension treatment in primary care. We estimated the effectiveness of various protocol steps to achieve blood pressure (BP) control in public sector health facilities in Punjab and Maharashtra, India, where the India Hypertension Control Initiative (IHCI) was implemented. Methods: We analyzed the records of people enrolled for hypertension treatment and follow-up under IHCI between January 2018 and December 2021 in public sector primary and secondary care facilities across 23 districts from two states. Each state followed a different treatment protocol. We calculated the proportion with controlled BP at each step of the protocol. We also estimated the mean decline in BP pre- and post-treatment. Results: Of 281,209 patients initiated on amlodipine 5 mg, 159,292 continued on protocol drugs and came for a follow-up visit during the first quarter of 2022. Of 33,450 individuals who came for the follow-up in Punjab and 125,842 in Maharashtra, 70% and 76% had controlled BP, respectively, at the first step with amlodipine 5 mg. In Punjab, at the second step with amlodipine 10 mg, the cumulative BP control increased to 75%. A similar 5% (76%-81%) increase was seen in the second step after adding telmisartan 40 mg in Maharashtra. Overall, the mean (SD) systolic blood pressure (SBP) decreased by 16 mmHg from 148 (15) mmHg at the baseline in Punjab. In Maharashtra, the decline in the mean (SD) SBP was about 15 mmHg from the 144 (18) mmHg baseline. Conclusion: Simple drug- and dose-specific protocols helped achieve a high control rate among patients retained in care under program conditions. We recommend treatment protocols starting with a single low-cost drug and escalating with the same or another antihypertensive drug depending on the cost and availability.

Financial implications of protocol-based hypertension treatment: an insight into medication costs in public and private health sectors in India.

Hypertension is a major public health challenge in low- and middle-income countries (LMICs) and calls for large-scale effective hypertension control programs. Adoption of drug and dose-specific treatment protocols recommended by the World Health Organization-HEARTS Initiative is key for hypertension control programs in LMICs. We estimated the annual medication cost per patient using three such protocols (protocol-1 and protocol-2 with Amlodipine, Telmisartan, using add-on doses and different drug orders, adding Chlorthalidone; protocol-3 with a single-pill combination (SPC) of Amlodipine/Telmisartan with dose up-titration, and addition of Chlorthalidone, if required) in India. The medication cost was simulated with different hypertension control assumptions for each protocol and calculated based on prices in the public and private sectors in India. The estimated annual medication cost per patient for protocol-1 and protocol-2 was $33.88-58.44 and $51.57-68.83 for protocol-3 in the private sector. The medication cost was lower in the generic stores ($5.78-9.57 for protocol-1 and protocol-2, and $7.35-9.89 for protocol-3). The medication cost for patients was the lowest ($2.05-3.89 for protocol-1 and protocol-2, and $2.94-3.98 for protocol-3) in the public sector. At less than $4 per patient per annum, scaling up a hypertension control program with specific treatment protocols is a potentially cost-effective public health intervention. Expanding low-cost generic retail networks would extend affordability in the private sector. The cost of treatment with SPC is comparable with non-SPC protocols and can be adopted in a public health program considering the advantage of simplified logistics, reduced pill burden, improved treatment adherence, and blood pressure control.

A simple six-step guide to National-Scale Hypertension Control Program implementation.

Hypertension is the leading single preventable risk factor for death worldwide, and most of the disease burden attributed to hypertension weighs on low-and middle-income countries. Effective large-scale public health hypertension control programs are needed to control hypertension globally. National programs can follow six important steps to launch a successful national-scale hypertension control program: establish an administrative structure and survey current resources, select a standard hypertension treatment protocol, ensure supply of medication and blood pressure devices, train health care workers to measure blood pressure and control hypertension, implement an information system for monitoring patients and the program overall, and enroll and monitor patients with phased program expansion. Resolve to Save Lives, an initiative of global public health organization Vital Strategies, and its partners organized these six key steps and materials into a structured, stepwise guide to establish best practices in hypertension program design, launch, maintenance, and scale-up.

Research Letter: Antihypertensive Drugs Market in India: An Insight on Size, Trends, and Prescribing Preferences in the Private Health Sector, 2016-2018.

Background: India has a high burden of hypertension. While the private sector provides 70% of out-patient care in the country, a significant proportion of patients seeking care from the public sector buy drugs from private markets. This study aimed to describe India's private sector antihypertensive drugs market at the national and state levels over 2016-2018. Methods: Antihypertensive drugs sales in India from 2016-2018 were analysed using a large nationally representative dataset for the private pharmaceuticals market. In addition, data for five states (Punjab, Madhya Pradesh, Kerala, Telangana, and Maharashtra) that were the foci of a large hypertension control program were studied. Results: The Indian hypertension drug market grew at a rate of 6.9% from 2016 to 2018 with a total of 21,066 million pills sales in 2018. Single-pill combinations (SPCs) contributed to 39.1% of total sale volumes. The market comprised of 182 different antihypertensive drugs including 134 SPCs. Total volume of sales covered a maximum of 26% of treatment need for the estimated population with hypertension. Two-drug SPCs had the highest market share (36%), followed by calcium channel blockers (18%), beta-blockers (16%) and angiotensin receptor blockers (14%). Among SPCs, amlodipine+atenolol had highest sales (9.8%). Twenty-five drugs, a mix of single drugs and SPCs, accounted for 80% of total sales. There were large state-to-state variations in sales per capita, preferred therapeutic classes and drugs. Conclusions: Despite the large antihypertensive drugs market, there exists a high unmet need for treatment in India. Inter-state differences in product sales indicate variable treatment practices, underscoring the need for private sector engagement to improve hypertension care practices aligned with national and international guidelines. SPCs contributed to a large share of the private market and inclusion of select antihypertensive SPCs in the national list of essential medications should be considered for the public health system.

Validation of a Practical Approach to Blood Pressure Measurement: Secondary Analysis of Data from a Nationally Representative Survey in India.

Background: Clinical guidelines differ on the recommended number of blood pressure (BP) measurements for hypertension diagnosis in primary health care settings. We assessed the accuracy in identifying high BP (≥140/90 mmHg) and efficiency (mean BP measures per person in one visit) of a practical BP measurement approach against the research standard. Methods: We analyzed data from a national survey in India with three BP measurements for each adult participant (N = 372,110). The research standard (referred to as 'standard approach') is measuring three BP and using the mean of the last two. In the practical approach, the first BP reading was used if the measure was <140/90 mmHg; the second BP was used if the first BP was ≥140/90 mmHg. If the difference between either the first two systolic or diastolic BPs was >5 mmHg, then we used the third reading. Results: Prevalence of high BP was 15.5% and 14.9% using standard and practical approaches, respectively. The sensitivity, specificity, false positive, and false negative rates of the practical approach were 85.4%, 98.0%, 11.3%, and 2.7% compared to the standard approach. The practical approach was more resource-efficient (mean BPs/person/visit 1.4 versus 3.0 for the standard approach). The practical approach had similar validity, but higher efficiency compared to other internationally recommended BP measurement protocols. Conclusion: The practical BP measurement approach has high validity, is simpler and involves a lower measurement burden on health care providers and can improve the utility of BP measurement, hypertension diagnosis, and management in busy primary health care settings.

Prices of combination medicines and single-molecule antihypertensive medicines in India's private health care sector.

More than half of patients with hypertension require two or more medicines to control blood pressure. Combinations of anti-hypertensive medicines are available as Single Pill Combinations (SPCs) or Single Agent Pills (SAPs). SPCs of two or more anti-hypertensive medicines facilitate simpler dosing schedules, decrease pill burden, increase adherence to medicine, and simplify procurement and distribution. Despite this, equivalent combinations of separate pills (SAPs) are often prescribed instead of SPCs under the assumption that SAPs are priced lower. This study compared prices of anti-hypertensive SPCs and equivalent SAPs in the private health care sector of India. High sales volume anti-hypertensive SPCs and SAPs were selected from 2018 private sector pharmaceutical sales data. SPCs and SAPs price information was collected from online pharmacy websites between November 2019 and January 2020. Anti-hypertensive SPCs represent approximately 39.1% of India's private sector anti-hypertensive drug market. Multiple manufacturers produce the same top-selling SPCs, suggesting a viable and competitive market. A comparison of SPCs and SAPs across different manufacturers showed that the lowest prices of both SPCs and the sum of component SAPs were nearly identical across different manufacturers. An analysis of dual-drug SPCs and SAPs by the same manufacturer showed that most manufacturers (five of six) had priced their SPCs higher than SAPs. These observations suggest that the price of SPCs could be lowered to match the combined price of the component SAPs, and manufacturing costs and market forces do not present a barrier to the implementation of anti-hypertensive SPCs.

High rates of reinfection and incidence of bacterial sexually transmitted infections in a cohort of female sex workers from two Indian cities: need for different STI control strategies?

BACKGROUND: Female sex workers (FSWs) in India are provided a standardised package of clinical interventions for management of sexually transmitted infections (STIs). A study was conducted among FSWs at known high STI prevalence sites to determine the effectiveness of the service package. METHODS: A cohort of FSW clinic attendees in two cities, Hyderabad and Mumbai, were enrolled and followed up from October 2008 to November 2009. At each visit, behavioural and clinical data were obtained and vaginal swabs collected for laboratory testing of cervical infections (gonorrhoea and chlamydia). RESULTS: 417 participants were enrolled, of whom 360 attended at least a follow-up visit. Prevalence of cervical infections did not change between the baseline and final visits (27.7% and 21.3% respectively, p=0.08) in spite of presumptive treatment at baseline and syndromic management at all visits. The proportion of asymptomatic cervical infections increased from 36% at baseline to 77% at the final visit. Incidence rate of cervical infections was high (85.6/100 person years) and associated with a prevalent cervical infection at baseline (HR=2.7, p<0.001) and inconsistent condom use with non-commercial partners (HR=2.5, p=0.014). CONCLUSIONS: High rates of STIs persisted despite the interventions due to poor condom use, minimal partner treatment, and high prevalence and incidence of STIs with a large proportion of asymptomatic infections. High-prevalence FSW sites in India need to design more effective partner treatment strategies and consider increasing the frequency of presumptive treatment as a temporary measure for quickly reducing STI prevalence, with renewed emphasis on consistent condom use with all partners.