Adolescents' Perspective Regarding a Community-Wide Mass Drug Administration Program for Soil-Transmitted Helminths in India.

This study was undertaken to understand the perspective of adolescents in endemic communities of India regarding soil-transmitted helminth (STH) infections and community-wide mass drug administration (cMDA). A multicountry community-based cluster-randomized trial, the Deworm3 trial, tested the feasibility of interrupting STH transmission with cMDA, where all individuals aged 1-99 are treated empirically with albendazole. Using a guideline based on the Consolidated Framework for Implementation Research, eight focus group discussions were conducted among 57 adolescents from the trial site in India and analyzed on ATLAS.ti 8.0 software using an a priori thematic codebook. Adolescents believed that adults could be a source of STH infection because they were not routinely dewormed like the children through the national deworming program. Perceived benefits of cMDA for all were better health and increased work efficiency. Perceived barriers to adults' participation in cMDA was their mistrust about the program, fear of side effects, perceived low risk of infection, and absence during drug distribution. To encourage adult participation in cMDAs, adolescents suggested community outreach activities, engaging village influencers and health workers, and tailoring drug distribution to when adults would be available. Adolescents were confident in their ability to be change agents within their households for treatment compliance. Adolescents provided insights into potential barriers and solutions to improve adult participation in cMDA, identified best practices of cMDA delivery, and suggested that they have unique roles as change agents to increase their household participation in cMDA.

"Our desire is to make this village intestinal worm free": Identifying determinants of high coverage of community-wide mass drug administration for soil transmitted helminths in Benin, India, and Malawi.

BACKGROUND: Soil-transmitted helminth infections (STH) are associated with substantial morbidity in low-and-middle-income countries, accounting for 2.7 million disability-adjusted life years annually. Current World Health Organization guidelines recommend controlling STH-associated morbidity through periodic deworming of at-risk populations, including children and women of reproductive age (15-49 years). However, there is increasing interest in community-wide mass drug administration (cMDA) which includes deworming adults who serve as infection reservoirs as a method to improve coverage and possibly to interrupt STH transmission. We investigated determinants of cMDA coverage by comparing high-coverage clusters (HCCs) and low-coverage clusters (LCCs) receiving STH cMDA in three countries. METHODS: A convergent mixed-methods design was used to analyze data from HCCs and LCCs in DeWorm3 trial sites in Benin, India, and Malawi following three rounds of cMDA. Qualitative data were collected via 48 community-level focus group discussions. Quantitative data were collected via routine activities nested within the DeWorm3 trial, including annual censuses and coverage surveys. The Consolidated Framework for Implementation Research (CFIR) guided coding, theme development and a rating process to determine the influence of each CFIR construct on cMDA coverage. RESULTS: Of 23 CFIR constructs evaluated, we identified 11 constructs that differentiated between HCCs and LCCs, indicating they are potential drivers of coverage. Determinants differentiating HCC and LCC include participant experiences with previous community-wide programs, communities' perceptions of directly observed therapy (DOT), perceptions about the treatment uptake behaviors of neighbors, and women's agency to make household-level treatment decisions. CONCLUSION: The convergent mixed-methods study identified barriers and facilitators that may be useful to NTD programs to improve cMDA implementation for STH, increase treatment coverage, and contribute to the successful control or elimination of STH. TRIAL REGISTRATION: The parent trial was registered at clinicaltrials.gov (NCT03014167).

Remote evaluation of STH program coverage: Experiences from the DeWorm3 study, India.

BACKGROUND: The DeWorm3 trial is a multi-country study testing the feasibility of interrupting transmission of soil-transmitted helminths by community-wide mass drug administration (cMDA). Treatment coverage during cMDA delivery was validated by in-person coverage evaluation surveys (CES) after each round of treatment. A mobile phone-based CES was carried out in India when access to households was restricted during the COVID-19 lockdown. METHODS: Two focus group discussions were conducted with the survey implementers to document their experiences of conducting phone-based CES via mobile-phone voice calls. PRINCIPAL FINDINGS: In the phone-based CES, only 56% of sampled households were reached compared to 89% during the in-person CES (89%). This was due to phone numbers being wrongly recorded, or calls being unanswered leading to a higher number of households that had to be sampled in order to achieve the sample size of 2,000 households in phone-based CES compared in-person CES (3,600 and 2,352 respectively). Although the phone-based CES took less time to complete than in person coverage evaluations, the surveyors highlighted the lack of gender representation among phone survey participants as it was mostly men who answered calls and were then interviewed. The surveyors also mentioned that eliciting responses to open-ended questions and confirming treatment compliance from every member of the household was challenging during phone based CES. These observations were confirmed by analysing the survey participation data which showed women's participation in CES was significantly lower in phone-based CES (66%) compared to in-person CES (94%) (Z = -22.38; p<0.01) and that a significantly higher proportion of households provided proxy responses in phone-based CES (51%) compared to in-person CES (21%) (Z = 20.23; p<0.01). CONCLUSIONS: The phone-based CES may be a viable option to evaluate treatment coverage but issues such as participation bias, gender inclusion, and quality of responses will need to be addressed to optimize this methodology.

Evaluation of opportunities to implement community-wide mass drug administration for interrupting transmission of soil-transmitted helminths infections in India.

BACKGROUND: The World Health Organization Neglected Tropical Disease (NTD) guidelines recommend control of soil transmitted helminth (STH)-associated morbidity with targeted deworming of preschool and school-aged children who are disproportionately affected by STH-associated morbidity. However, this strategy leaves many adults untreated and reinfection within communities perpetuates transmission even when mass drug administration (MDA) coverage of children is high. Evidence suggests that it may be possible to interrupt STH transmission by expanding MDA to a community-wide MDA (cMDA). METHODS: This multi-methods study of organizational readiness survey, key informant interviews, and program mapping, were conducted with government stakeholders in three Indian states, Goa, Sikkim, and Odisha, to assess readiness of the states for transitioning from school-based MDA to cMDA and identify opportunities to leverage existing infrastructure from other NTD programs like lymphatic filariasis (LF) for STH cMDA. PRINCIPAL FINDINGS: Overall, all three states indicated a highly favorable policy environment, effective leadership structure, adequate material resources, demonstrated technical capacity, and adequate community infrastructure needed to launch a STH cMDA program. The findings indicated a high-level of health system readiness to implement provided human resources and financial resources to deliver cMDA is strengthened. Areas with a significant overlap between LF and STH MDA platforms, particularly at the community-level, may be best primed for transitioning. Immunization, maternal child health, and non-communicable disease control programs were the other programs for possible integration of cMDA. States indicated having effective leadership structures in place at the state-level, however, engaging local leaders and community groups were considered crucial for successful implementation of cMDA. In-migration was a perceived challenge for estimating drug requirement and preventing possible stockouts. CONCLUSIONS: Findings from this study are intended to proactively support government decision making, prioritization, and program planning across heterogenous implementation contexts in India to speed the translation of research findings into practice. CLINICAL TRIAL REGISTRATION: NCT03014167; ClinicalTrials.gov.

Impact of adverse events during community-wide mass drug administration for soil-transmitted helminths on subsequent participation-a Theory of Planned Behaviour analysis.

BACKGROUND: Experiencing adverse events (AEs) during mass drug administration (MDA) could affect participation in future MDAs. This study aims to understand the potential influence of AEs during a community-wide MDA (cMDA) trial for soil-transmitted helminths (STH) in India on intention to participate in future cMDAs. METHODS: This study was conducted using a multi-method quantitative and qualitative approach among 74 participants who experienced an AE during STH cMDA and the 12 participants who subsequently refused cMDA treatment of the ongoing DeWorm3 trial. Path analysis and thematic analysis guided by the Theory of Planned Behaviour, was used. PRINCIPAL FINDINGS: Among 74 individuals who reported an AE, 12% refused treatment in the cMDA immediately subsequent to their AE and 4% refused in all subsequent cMDAs. Of these 74 individuals, 59 (80%) completed a survey and eight participated in in-depth interviews. A positive attitude towards deworming and perceived ability to participate in cMDA (perceived behavioural control) were significant predictors of intention to participate in cMDA (p<0.05). A positive attitude towards cMDA was associated with caste (χ2 = 3.83, P = 0.05), particularly among the scheduled caste/scheduled tribe (SC/ST) (62%). Perceived behavioural control in cMDA participation was associated with occupation (χ2 = 5.02, P<0.05), with higher perceived control among those engaged in skilled occupations (78%). Intention to participate in subsequent cMDAs was associated with caste and family type (χ2 = 3.83, P = 0.05 and χ2 = 7.50, P<0.05 respectively) and was higher among SC/ST (62%) and those with extended families (67%). In-depth interviews demonstrated that perceived severe AEs may lead to treatment refusal in future, particularly if children were affected. CONCLUSIONS: Intention to participate in future STH cMDAs was associated with caste (SC/ST) and family type (extended families). Therefore, community mobilization messages about potential AEs and their management may need to intentionally target non-SC/ST households, nuclear families, and those engaged in unskilled occupations to increase cMDA participation given the possibility of AEs occurring. TRIAL REGISTRATION: NCT03014167, ClinicalTrials.gov.

Policy stakeholder perspectives on barriers and facilitators to launching a community-wide mass drug administration program for soil-transmitted helminths.

BACKGROUND: Recent evidence suggests that soil-transmitted helminth (STH) transmission interruption may be feasible through community-wide mass drug administration (cMDA) that deworms community members of all ages. A change from school-based deworming to cMDA will require reconfiguring of STH programs in endemic countries. We conducted formative qualitative research in Benin, India, and Malawi to identify barriers and facilitators to successfully launching a cMDA program from the policy-stakeholder perspective. METHODS: We conducted 40 key informant interviews with policy stakeholders identified as critical change agents at national, state/district, and sub-district levels. Participants included World Health Organization country office staff, implementing partners, and national and sub-national government officials. We used the Consolidated Framework for Implementation Research to guide data collection, coding, and analysis. Heat maps were used to organize coded data and differentiate perceived facilitators and barriers to launching cMDA by stakeholder. RESULTS: Key facilitators to launching a cMDA program included availability of high-quality, tailored sensitization materials, and human and material resources that could be leveraged from previous MDA campaigns. Key barriers included the potential to overburden existing health workers, uncertainty of external funding to sustain a cMDA program, and concerns about weak intragovernmental coordination to implement cMDA. Cross-cutting themes included the need for rigorous trial evidence on STH transmission interruption to gain confidence in cMDA, and implementation evidence to effectively operationalize cMDA. Importantly, if policy stakeholders anticipate a cMDA program cannot be sustained due to cost and human resource barriers in the long term they may be less likely to support the launch of a program in the short term. CONCLUSIONS: Overall, policy stakeholders were optimistic about implementing cMDA primarily because they believe that the tools necessary to successfully implement cMDA are already available. Policy stakeholders in this study were cautiously optimistic about launching cMDA to achieve STH transmission interruption and believe that it is feasible to implement. However, launching cMDA as an alternative policy to school-based deworming will require addressing key resource and evidence barriers. Trial registration This study was registered in the U.S. National Library of Medicine Clinical Trials registry (NCT03014167).

Differential treatment in the provision of medication abortion at pharmacies in Uttar Pradesh, India.

BACKGROUND: Almost 3 quarters of India's roughly 16 million annual abortions are done through medication abortion purchased from pharmacists outside of healthcare facilities. The quality of information provided by pharmacists about medication abortion is often poor. OBJECTIVE: To determine whether pharmacists selling medication abortion provide different information or ask different, potentially stigmatizing questions to clients by gender and marital status. STUDY DESIGN: Mystery clients presenting as 4 profiles (unmarried woman, unmarried man, married woman, and married man) purchasing medication abortion interacted with 111 pharmacists in 3 districts around Lucknow, Uttar Pradesh in 2018. Data were collected immediately after the interaction. The differences in the information conveyed and the questions asked by the pharmacists by mystery client characteristics were analyzed using logistic regression in Stata 15 MP. RESULTS: Pharmacists very rarely asked intrusive, medically irrelevant questions and appeared willing to sell medication abortion to all the mystery clients regardless of gender, age, or marital status. However, the pharmacists were overall less likely to provide the female mystery clients with as comprehensive and correct information on medication abortion as they were to male mystery clients, particularly if female mystery clients presented as unmarried. CONCLUSION: Pharmacists are observed to provide differential and poorer quality information about medication abortion to women, especially if they seem unmarried, potentially putting women at risk of having a lower-quality and less supported experience of using the medication. However, the pharmacists' willingness to sell the medication to all mystery clients and the lack of intrusive questions and comments reinforces out-of-facility medication abortion as a way for individuals to access an often-stigmatized service. Interventions must find a way to either address this bias among pharmacists, or more practically, to provide high-quality information directly to the individuals seeking medication abortion.

An intervention to improve the quality of medication abortion knowledge among pharmacists in India.

OBJECTIVE: To test an infographic two-pager on medication abortions (MA) aimed to improve pharmacists counseling in India. METHODS: A quantitative baseline survey was conducted among 283 pharmacists in three districts around Lucknow, Uttar Pradesh in January 2018. The intervention (infographic) was given to 117 of these pharmacists a few weeks later and a follow-up survey was conducted 3 months later with 281 pharmacists. In addition, mystery clients were sent to 115 of the pharmacists. RESULTS: A statistically significant improvement in knowledge post-intervention was found, compared to pre-, for almost all quality items measured. Difference-in-difference estimators showed a difference in knowledge among indicators related to misoprostol in particular. However, mystery client reports showed few differences in pharmacist behaviors between intervention and control pharmacists. CONCLUSION: This simple, paper-based intervention, which required no training, showed a significant improvement in pharmacists' knowledge and was welcomed by the providers. Translating knowledge into behavior change, however, seems more difficult to impact. Adapting this simple intervention to motivate providers to change behaviors could improve the quality of care provided by pharmacists in India.

Knowledge, provision of information and barriers to high quality medication abortion provision by pharmacists in Uttar Pradesh, India.

BACKGROUND: The use of medication abortion is increasing rapidly in India, the majority of which is purchased through pharmacies. More information is needed about the quality of services provided by pharmacist about medication abortion, especially barriers to providing high quality information. The goal of this study was to explore the quality of pharmacist medication abortion provision using mixed methods to inform the developed of an intervention for this population. METHODS: Data was collected via convenience sampling using three methods: a quantitative survey of pharmacists (N = 283), mystery clients (N = 111), and in-depth qualitative interviews with pharmacist (N = 11). Quality indictors from the quantitative data from surveys and mystery clients were compared. Qualitative interviews were used to elucidate reasons behind findings from the quantitative survey. RESULTS: Quality of information provided to client purchasing medication abortion was low, especially related to timing and dosing of misoprostol (18% of pharmacists knew correct timing) and side effects (31% not telling any information on side effects). Mystery clients reported lower quality (less correct information) than pharmacists reported about their own behaviors. Qualitative interviews suggested that many barriers exist for pharmacists, including perceptions about what information clients can understand and desire, and also lack of comfort giving certain information to certain types of clients (young women). CONCLUSIONS: It is essential to improve the quality of information given to client purchasing medication abortion from pharmacists. Our findings highlight specific gaps in knowledge and reasons for poor quality information. Differences in guidelines available at that time from the Indian Government, World Health Organization, and the medication abortion boxes may lead to confusion amongst pharmacists and potentially clients. Interventions need to improve both knowledge about medication abortion and also biases in the provision of care.

Pathways to seeking medication abortion care: A qualitative research in Uttar Pradesh, India.

INTRODUCTION: Abortion is legal in India and medication abortion (MA) using a combined regimen of mifepristone and misoprostol is the preferred method. Users increasingly purchase MA kits directly from pharmacies, in some cases experiencing perceived complications and approaching a facility for care. We present findings of a qualitative research tracing the decision-making pathway(s) of MA users in Uttar Pradesh, India, to help understand knowledge and behaviour gaps, and recommend ways to improve the overall quality of care at these service delivery points. METHODS: Forty in-depth interviews were conducted with recent MA users (20 each of clinic and pharmacy clients) across three districts. Providers were purposively selected in collaboration with an international organization selling MA kits, using their list of pharmacies and clinics. MA users were identified from the clients of the selected providers, and additionally through the snow ball method. Interviews were conducted in Hindi with verbal informed consent in a private place convenient to the respondent. Transcripts were translated to English and analysed thematically. RESULTS: Users first sought MA kits at pharmacies out of convenience, low cost and customer anonymity. Men often purchased kits for their partners and trusted the chemist for guidance on dosage, progression and side effects. For side effects or other concerns after using an MA kit, users first visited their neighbourhood doctor or traditional practitioner. These providers either attempted to treat the issue and failed, or directly advised her to consult a gynaecologist. The final point of care was gynaecologists, preferably female private practitioners with their own clinics. They diagnosed most abortion-related cases as incomplete abortions, emptying the uterus using the dilation and curettage method. Comparatively low cost and convenience made users inclined towards repeat use of MA. CONCLUSION: There are information gaps at various stages in the MA pathway that need to be addressed. Large scale public information programmes are required on safe abortion care- when is it legal, where to obtain MA, dosage, side effects and signs of possible complications. Pharmacists could be trained or incentivized to improve their quality of care to facilitate adequate exchange of information on MA. Since, for most couples, the male partner purchases MA, information approaches or tools are needed that pharmacists can give men to share directly with the MA user.

Do women's perspectives of quality of care during childbirth match with those of providers? A qualitative study in Uttar Pradesh, India.

BACKGROUND: Persistently high maternal mortality levels are a concern in developing countries. In India, monetary incentive schemes have increased institutional delivery rates appreciably, but have not been equally successful in reducing maternal mortality. Maternal outcomes are affected by quality of obstetric care and socio-cultural norms. In this light there is need to examine the quality of care provided to women delivering in institutions. OBJECTIVE: This study aimed to examine pregnant women's expectations of high-quality care in public health facilities in Uttar Pradesh, India, and to contrast this with provider's perceptions of the same, as well as the barriers that limit their ability to provide high-quality care. METHODS: A qualitative descriptive analysis was conducted on data from two studies - focus group discussions with rural women in their last trimester of pregnancy (conducted in 2014) to understand women's experience and satisfaction with maternal care services, and in-depth interviews with care providers (conducted in 2016-17) to understand provision of person-centred care. Provider perspectives were matched with themes of women's perspectives on quality of childbirth care in facilities. RESULTS: Major themes of care prioritised by women included availability of doctors at the facility; availability of medicines; food; ambulance services; maintenance of cleanliness and hygiene; privacy; good and safe delivery with no complications; client-provider interaction; financial cost of care. Many women also voiced no expectation of care, indicating disillusionment from the existing system. Providers concurred with women on all themes of care except availability of doctors, as they felt that trained nurses were proficient in conducting deliveries. CONCLUSIONS: This study shows that women have clear expectations of quality care from facilities where they go to deliver. Understanding their expectations and matching them with providers' perspectives of care is critical for efforts to improve the quality of care and thereby impact maternal outcomes.

Is quality of care during childbirth consistent from admission to discharge? A qualitative study of delivery care in Uttar Pradesh, India.

BACKGROUND: Improving quality of maternal healthcare services is key to reducing maternal mortality across developing nations, including India. Expanding access to institutionalized care alone has failed to address critical quality barriers to safe, effective, patient-centred, timely and equitable care. Multi-dimensional quality improvement focusing on Person Centred Care(PCC) has an important role in expanding utilization of maternal health services and reducing maternal mortality. METHODS: Nine public health facilities were selected in two rural districts of Uttar Pradesh(UP), India, to understand women's experiences of childbirth and identify quality gaps in the process of maternity care. 23 direct, non-participant observations of uncomplicated vaginal deliveries were conducted using checklists with special reference to PCC, capturing quality of care provision at five stages-admission; pre-delivery; delivery; post-delivery and discharge. Data was thematically analysed using the framework approach. Case studies, good practices and gaps were noted at each stage of delivery care. RESULTS: Admission to maternity wards was generally prompt. All deliveries were conducted by skilled providers and at least one staff was available at all times. Study findings were discussed under two broad themes of care 'structure' and 'process'. While infrastructure, supplies and human resource were available across most facilities, gaps were observed in the process of care, particularly during delivery and post-delivery stages. Key areas of concern included compromised patient safety like poor hand hygiene, usage of unsterilized instruments; inadequate clinical care like lack of routine monitoring of labour progression, inadequate postpartum care; partially compromised privacy in the labour room and postnatal ward; and few incidents of abuse and demand for informal payments. CONCLUSIONS: The study findings reflect gaps in the quality of maternity care across public health facilities in the study area and support the argument for strengthening PCC as an important effort towards quality improvement across the continuum of delivery care.

Exploring the Barriers to and Facilitators of Using Evidence-Based Drugs in the Secondary Prevention of Cardiovascular Diseases: Findings From a Multistakeholder, Qualitative Analysis.

BACKGROUND: Health-system barriers and facilitators associated with cardiovascular medication adherence have seldom been studied, particularly in low- and middle-income countries where uptake rates are poorest. OBJECTIVES: This study sought to explore the major obstacles and facilitators to the use of evidence-supported medications for secondary prevention of cardiovascular disease using qualitative analysis in 2 diverse countries across multiple levels of their health care systems. METHODS: A qualitative descriptive study approach was implemented in Hamilton, Ontario, Canada, and Delhi, India. A purposeful sample (n = 69) of 23 patients, 10 physicians, 2 nurse practitioners, 5 Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy physicians, 11 pharmacists, 3 nurses, 4 hospital administrators, 1 social worker, 3 nongovernmental organization workers, 2 pharmaceutical company representatives, and 5 policy makers participated in interviews in Hamilton, Ontario, Canada (n = 21), and Delhi, India (n = 48). All interviews were digitally recorded and transcribed followed by directed content analysis to summarize and categorize the interviews. RESULTS: Themes that emerged across the stakeholder groups included: medication counseling; monitoring adherence; medication availability; medication affordability and drug coverage; time restrictions; and task shifting. The depth of verbal medication counseling provided varied substantially between countries, with prescribers in India unable to convey relevant information about drug treatments due to time constraint and high patient load. Canadian patients reported drug affordability as a common issue and very few patients were familiar with government subsidized drug programs. In India, patients purchased medications out-of-pocket from private, community pharmacies to avoid long commutes, lost wages, and unavailability of medications from hospitals formularies. Task shifting medication-refilling and titration to nonphysician health workers was accepted and supported by physicians in Canada but not in India, where many of the physicians considered a high level of clinical expertise a precondition to carry out these tasks skillfully. CONCLUSIONS: Our findings reveal context-specific, health system factors that affect the patient's choice or ability to initiate and/or continue cardiovascular medication. Strategies to optimize cardiovascular drug use should be targeted and relevant to the health care system.

Health system barriers and facilitators to medication adherence for the secondary prevention of cardiovascular disease: a systematic review.

BACKGROUND: Secondary prevention is cost-effective for cardiovascular disease (CVD), but uptake is suboptimal. Understanding barriers and facilitators to adherence to secondary prevention for CVD at multiple health system levels may inform policy. OBJECTIVES: To conduct a systematic review of barriers and facilitators to adherence/persistence to secondary CVD prevention medications at health system level. METHODS: Included studies reported effects of health system level factors on adherence/persistence to secondary prevention medications for CVD (coronary artery or cerebrovascular disease). Studies considered at least one of ß blockers, statins, angiotensin-renin system blockers and aspirin. Relevant databases were searched from 1 January 1966 until 1 October 2015. Full texts were screened for inclusion by 2 independent reviewers. RESULTS: Of 2246 screened articles, 25 studies were included (12 trials, 11 cohort studies, 1 cross-sectional study and 1 case-control study) with 132 140 individuals overall (smallest n=30, largest n=63 301). 3 studies included upper middle-income countries, 1 included a low middle-income country and 21 (84%) included high-income countries (9 in the USA). Studies concerned established CVD (n=4), cerebrovascular disease (n=7) and coronary heart disease (n=14). Three studies considered persistence and adherence. Quantity and quality of evidence was limited for adherence, persistence and across drug classes. Studies were concerned with governance and delivery (n=19, including 4 trials of fixed-dose combination therapy, FDC), intellectual resources (n=1), human resources (n=1) and health system financing (n=4). Full prescription coverage, reduced copayments, FDC and counselling were facilitators associated with higher adherence. CONCLUSIONS: High-quality evidence on health system barriers and facilitators to adherence to secondary prevention medications for CVD is lacking, especially for low-income settings. Full prescription coverage, reduced copayments, FDC and counselling may be effective in improving adherence and are priorities for further research.