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Browsing by Author "Pastakia, Sonak D."
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Item Community-based medication delivery program for antihypertensive medications improves adherence and reduces blood pressure(PLOS, 2022-09) Tran, Dan N.; Kangogo, Kibet; Amisi, James A.; Kamadi, James; Karwa, Rakhi; Kiragu, Benson; Laktabai, Jeremiah; Manji, Imran N.; Njuguna, Benson; Szkwarko, Daria; Qian, Kun; Vedanthan, Rajesh; Pastakia, Sonak D.; Medicine, School of MedicineNon-adherence to antihypertensive medications is a major cause of uncontrolled hypertension, leading to cardiovascular morbidity and mortality. Ensuring consistent medication possession is crucial in addressing non-adherence. Community-based medication delivery is a strategy that may improve medication possession, adherence, and blood pressure (BP) reduction. Our program in Kenya piloted a community medication delivery program, coupled with blood pressure monitoring and adherence evaluation. Between September 2019 and March 2020, patients who received hypertension care from our chronic disease management program also received community-based delivery of antihypertensive medications. We calculated number of days during which each patient had possession of medications and analyzed the relationship between successful medication delivery and self-reported medication adherence and BP. A total of 128 patient records (80.5% female) were reviewed. At baseline, mean systolic blood pressure (SBP) was 155.7 mmHg and mean self-reported adherence score was 2.7. Sixty-eight (53.1%) patients received at least 1 successful medication delivery. Our pharmacy dispensing records demonstrated that medication possession was greater among patients receiving medication deliveries. Change in self-reported medication adherence from baseline worsened in patients who did not receive any medication delivery (+0.5), but improved in patients receiving 1 delivery (-0.3) and 2 or more deliveries (-0.8). There was an SBP reduction of 1.9, 6.1, and 15.5 mmHg among patients who did not receive any deliveries, those who received 1 delivery, and those who received 2 or more medication deliveries, respectively. Adjusted mixed-effect model estimates revealed that mean SBP reduction and self-reported medication adherence were improved among individuals who successfully received medication deliveries, compared to those who did not. A community medication delivery program in western Kenya was shown to be implementable and enhanced medication possession, reduced SBP, and significantly improved self-reported adherence. This is a promising strategy to improve health outcomes for patients with uncontrolled hypertension that warrants further investigation.Item Compression Therapy for HIV-Associated Kaposi Sarcoma Leg Lymphedema: Results of the Kenyan Improvised Compression for Kaposi Sarcoma Randomized Controlled Trial(American Society of Clinical Oncology, 2022) Chang, Aileen Y.; Karwa, Rakhi; Odhiambo, Haji; Were, Phelix; Fletcher, Sara L.; Tonui, Edith C.; Kohn, Michael A.; Lee, Jeannette; Chang, Di; Lensing, Shelly; Namaemba, Diana Flora; Busakhala, Naftali; Kiprono, Samson K.; Maurer, Toby; Goodrich, Suzanne; Pastakia, Sonak D.; Dermatology, School of MedicinePurpose: Evaluate the effectiveness of compression while receiving chemotherapy compared with chemotherapy alone in the treatment of HIV-associated Kaposi sarcoma (KS) lymphedema. Methods: A randomized controlled trial was conducted in a single oncology clinic in western Kenya (NCT03404297). A computer-generated randomization schedule was used to allocate treatment arms. Randomized block design was used for stratification by lymphedema stage. Participants were HIV positive adults age ≥ 18 years on antiretroviral therapy with biopsy-proven KS associated with leg lymphedema and being initiated on chemotherapy. The intervention was 10 weeks of weekly clinic-based application of two-component paste compression bandages. The primary outcome was change in the Lower Extremity Lymphedema Index (LELI) score from week 0 to week 14. The secondary outcomes were change in the Lymphedema Quality of Life measure (LYMQOL) and change in the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 score from week 0 to week 14. Blinded outcome assessments were conducted. Results: Of 30 participants randomly assigned, 25 eligible patients (chemotherapy [control], n = 13; compression plus chemotherapy [intervention], n = 12) returned at week 14. Change in LELI, LYMQOL, and EORTC QLQ-C30 scores between week 14 and week 0 did not significantly differ by arm. The mean (standard deviation) change in LELI score was -25.9 (34.6) for the control arm compared with -13.3 (29.5) for the intervention arm, P = .340. The difference (95% CI) in the change in LELI score was -12.6 (-39.3 to 14.1). Conclusion: Future studies evaluating a 14-week change in LELI for KS lymphedema should assume a standard deviation of approximately 30. Lessons learned from this pilot trial should inform the development of a larger, multicenter trial to evaluate the effectiveness of compression for KS lymphedema.Item COVID-19 and clinical pharmacy worldwide—A wake up call and a call to action(Wiley, 2020-06-15) Cheong, Mark Wing Loong; Brock, Tina; Karwa, Rakhi; Pastakia, Sonak D.; Medicine, School of MedicineItem Implementing a Locally Made Low-Cost Intervention for Wound and Lymphedema Care in Western Kenya(Elsevier, 2021) Chang, Aileen Y.; Mungai, Margaret; Coates, Sarah J.; Chao, Tiffany; Odhiambo, Haji Philip; Were, Phelix M.; Fletcher, Sara L.; Maurer, Toby; Karwa, Rakhi; Pastakia, Sonak D.; Dermatology, School of MedicineIn Western Kenya, the burden of chronic wounds and lymphedema has a significant impact on functionality and quality of life. Major barriers to provision of care include availability, affordability, and accessibility of bandages. At the Academic Model Providing Access to Healthcare, dermatologists and pharmacists collaborated to develop a 2-component compression bandage modeled after the Unna boot, using locally available materials, that is distributed through a revolving fund pharmacy network. In partnership with nursing, use of these bandages at a national referral hospital and a few county facilities has increased, but increasing utilization to an expanded catchment area is needed.Item Integrating community-based HIV and non-communicable disease care with microfinance groups: a feasibility study in Western Kenya(BMC, 2022-12-28) Kafu, Catherine; Wachira, Juddy; Omodi, Victor; Said, Jamil; Pastakia, Sonak D.; Tran, Dan N.; Adongo Onyango, Jael; Aburi, Dan; Wilson‑Barthes, Marta; Galárraga, Omar; Genberg, Becky Lynn; Medicine, School of MedicineBackground: The Harambee study is a cluster randomized trial in Western Kenya that tests the effect, mechanisms, and cost-effectiveness of integrating community-based HIV and non-communicable disease care within microfinance groups on chronic disease treatment outcomes. This paper documents the stages of our feasibility study conducted in preparation for the Harambee trial, which include (1) characterizing the target population and gauging recruitment capacity, (2) determining community acceptability of the integrated intervention and study procedures, and (3) identifying key implementation considerations prior to study start. Methods: Feasibility research took place between November 2019 and February 2020 in Western Kenya. Mixed methods data collection included surveys administered to 115 leaders of 105 community-based microfinance groups, 7 in-person meetings and two workshops with stakeholders from multiple sectors of the health system, and ascertainment of field notes and geographic coordinates for group meeting locations and HIV healthcare facilities. Quantitative survey data were analyzed using STATA IC/13. Longitude and latitude coordinates were mapped to county boundaries using Esri ArcMap. Qualitative data obtained from stakeholder meetings and field notes were analyzed thematically. Results: Of the 105 surveyed microfinance groups, 77 met eligibility criteria. Eligible groups had been in existence from 6 months to 18 years and had an average of 22 members. The majority (64%) of groups had at least one member who owned a smartphone. The definition of "active" membership and model of saving and lending differed across groups. Stakeholders perceived the community-based intervention and trial procedures to be acceptable given the minimal risks to participants and the potential to improve HIV treatment outcomes while facilitating care integration. Potential challenges identified by stakeholders included possible conflicts between the trial and existing community-based interventions, fear of group disintegration prior to trial end, clinicians' inability to draw blood for viral load testing in the community, and deviations from standard care protocols. Conclusions: This study revealed that it was feasible to recruit the number of microfinance groups necessary to ensure that our clinical trial was sufficient powered. Elicitation of stakeholder feedback confirmed that the planned intervention was largely acceptable and was critical to identifying challenges prior to implementation.Item Meeting the Needs of Underserved Patients in Western Kenya by Creating the Next Generation of Global Health Pharmacists(American Journal of Pharmaceutical Education, 2016-03-25) Miller, Monica L.; Karwa, Rakhi; Schellhase, Ellen M.; Pastakia, Sonak D.; Crowe, Susie; Manji, Imran; Jakait, Beatrice; Maina, Mercy; Medicine Faculty Volunteers, IU School of MedicineObjective. To describe a novel training model used to create a sustainable public health-focused pharmacy residency based in Kenya and to describe the outcomes of this training program on underserved populations. Design. The postgraduate year 2 residency was designed to expose trainees to the unique public health facets of inpatient, outpatient, and community-based care delivery in low and middle-income countries. Public health areas of focus included supply chain management, reproductive health, pediatrics, HIV, chronic disease management, and teaching. Assessment. The outcomes of the residency were assessed based on the number of new clinical programs developed by residents, articles and abstracts written by residents, and resident participation in grant writing. To date, six residents from the United States and eight Kenyan residents have completed the residency. Eleven sustainable patient care services have been implemented as a result of the residency program. Conclusion. This pharmacy residency training model developed accomplished pharmacists in public health pharmacy, with each residency class expanding funding and clinical programming, contributing to curriculum development, and creating jobs.Item Observational assessment of the utilization of donated point of care tests and glycemic control at free and charitable clinics across the United States(Elsevier, 2025-01-10) Pastakia, Sonak D.; Schutz, Heidi; Tiruneh, Tena; De Vivero, Ariana Gordillo; Dodds, Lindsey; Medicine, School of MedicineIntroduction: Populations experiencing poverty often lack access to convenient lab tests. This analysis assesses trends observed from a national point of care (POC) lab donation program for free and charitable clinics across the United States. Methods: A total of 16 clinics were selected to receive a comprehensive package of POC lab tests. De-identified data on POC test utilization and results were assessed to descriptively identify trends in utilization (primary objective) and glycemic control (secondary objective). A paired t-test was utilized to identify statistically significant changes in HbA1c from baseline to predefined 90-day time intervals for all people living with diabetes (PLWD) and those with a baseline HbA1c ≥ 9.0 % (75 mmol/mol). The main comparison of interest was the change in HbA1c from baseline to 90-179 days. Results: A total of 17,563 POC tests were completed for 9658 patients with 3223 tests being HbA1c's. In the secondary analysis of PLWD with a baseline HbA1c ≥ 9.0 % (75 mmol/mol), patients who completed an HbA1c between 90 and 179 days (n = 188) demonstrated a statistically significant mean reduction from baseline of -1.2 % (95 % CI, -1.6 % to -0.9 %, p < 0.01, -10 mmol/mol [95 % CI, -6 mmol/mol - -14 mmol/mol]). Discussion: The provision of POC labs helped support the care populations experiencing poverty received at free and charitable clinics, especially for chronic diseases like diabetes.Item Risk of Dysglycemia in Pregnancy amongst Kenyan Women with HIV Infection: A Nested Case-Control Analysis from the STRiDE Study(Hindawi, 2021-04-05) Pastakia, Sonak D.; Kosgei, Wycliffe K.; Christoffersen-Deb, Astrid; Kiragu, Benson; Hector, John N.; Anusu, Gertrude; Saravanan, Ponnusamy; Medicine, School of MedicineIntroduction: Gestational diabetes is a common complication, whose incidence is growing globally. There is a pressing need to obtain more data on GDM in low- and middle-income countries, especially amongst high-risk populations, as most of the data on GDM comes from high-income countries. With the growing awareness of the role HIV plays in the progression of noncommunicable diseases and the disproportionate HIV burden African countries like Kenya face, investigating the potential role HIV plays in increasing dysglycemia amongst pregnant women with HIV is an important area of study. Methods: The STRiDE study is one of the largest ever conducted studies of GDM in Kenya. This study enrolled pregnant women aged between 16 and 50 who were receiving care from public and private sector facilities in Eldoret, Kenya. Within this study, women received venous testing for glycosylated hemoglobin (HbA1c) and fasting glucose between 8- and 20-week gestational age. At their 24-32-week visit, they received a venous 75 g oral glucose tolerance test (OGTT). Because of the pressing need to assess the burden of GDM within the population of pregnant women with HIV, a nested case-control study design was used. Pregnant women with HIV within the larger STRiDE cohort were matched to non-HIV-infected women within the STRiDE cohort at a 1 : 3 ratio based on body mass index, parity, family history of GDM, gestational age, and family history of hypertension. The measurements of glucose from the initial visit (fasting glucose and HbA1c) and follow-up visit (OGTT) were compared between the two groups of HIV+ cases and matched HIV- controls. Results: A total of 83 pregnant women with HIV were well matched to 249 non-HIV-infected women from the STRiDE cohort with marital status being the only characteristic that was statistically significantly different between the two groups. Statistically significant differences were not observed in the proportion of women who developed GDM, the fasting glucose values, the HbA1c, or OGTT measurements between the two groups. Discussion. Significant associations were not seen between the different measures of glycemic status between pregnant women with and without HIV. While significant differences were not seen in this cohort, additional investigation is needed to better describe the association of dysglycemia with HIV, especially in Kenyan populations with a higher prevalence of GDM.Item Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) in western Kenya: a study protocol of a cluster randomized trial(BioMed Central, 2019-09-09) Mercer, Tim; Njuguna, Benson; Bloomfield, Gerald S.; Dick, Jonathan; Finkelstein, Eric; Kamano, Jemima; Mwangi, Ann; Naanyu, Violet; Pastakia, Sonak D.; Valente, Thomas W.; Vedanthan, Rajesh; Akwanalo, Constantine; Medicine, School of MedicineBACKGROUND: Hypertension is a major risk factor for cardiovascular disease (CVD), yet treatment and control rates for hypertension are very low in low- and middle-income countries (LMICs). Lack of effective referral networks between different levels of the health system is one factor that threatens the ability to achieve adequate blood pressure control and prevent CVD-related morbidity. Health information technology and peer support are two strategies that have improved care coordination and clinical outcomes for other disease entities in other settings; however, their effectiveness and cost-effectiveness in strengthening referral networks to improve blood pressure control and reduce CVD risk in low-resource settings are unknown. METHODS/DESIGN: We will use the PRECEDE-PROCEED framework to conduct transdisciplinary implementation research, focused on strengthening referral networks for hypertension in western Kenya. We will conduct a baseline needs and contextual assessment using a mixed-methods approach, in order to inform a participatory, community-based design process to fully develop a contextually and culturally appropriate intervention model that combines health information technology and peer support. Subsequently, we will conduct a two-arm cluster randomized trial comparing 1) usual care for referrals vs 2) referral networks strengthened with our intervention. The primary outcome will be one-year change in systolic blood pressure. The key secondary clinical outcome will be CVD risk reduction, and the key secondary implementation outcomes will include referral process metrics such as referral appropriateness and completion rates. We will conduct a mediation analysis to evaluate the influence of changes in referral network characteristics on intervention outcomes, a moderation analysis to evaluate the influence of baseline referral network characteristics on the effectiveness of the intervention, as well as a process evaluation using the Saunders framework. Finally, we will analyze the incremental cost-effectiveness of the intervention relative to usual care, in terms of costs per unit decrease in systolic blood pressure, per percentage change in CVD risk score, and per disability-adjusted life year saved. DISCUSSION: This study will provide evidence for the implementation of innovative strategies for strengthening referral networks to improve hypertension control in LMICs. If effective, it has the potential to be a scalable model for health systems strengthening in other low-resource settings worldwide.Item Supply-chain strategies for essential medicines in rural western Kenya during COVID-19(WHO, 2021-05-01) Tran, Dan N.; Were, Phelix M.; Kangogo, Kibet; Amisi, James A.; Manji, Imran; Pastakia, Sonak D.; Vedanthan, Rajesh; Medicine, School of MedicineProblem: The coronavirus disease 2019 (COVID-19) pandemic has disrupted health systems worldwide and threatened the supply of essential medicines. Especially affected are vulnerable patients in low- and middle-income countries who can only afford access to public health systems. Approach: Soon after physical distancing and curfew orders began on 15 March 2020 in Kenya, we rapidly implemented three supply-chain strategies to ensure a continuous supply of essential medicines while minimizing patients' COVID-19 exposure risks. We redistributed central stocks of medicines to peripheral health facilities to ensure local availability for several months. We equipped smaller, remote health facilities with medicine tackle boxes. We also made deliveries of medicines to patients with difficulty reaching facilities. Local setting: Τo implement these strategies we leveraged our 30-year partnership with local health authorities in rural western Kenya and the existing revolving fund pharmacy scheme serving 85 peripheral health centres. Relevant changes: In April 2020, stocks of essential chronic and non-chronic disease medicines redistributed to peripheral health facilities increased to 835 140 units, as compared with 316 330 units in April 2019. We provided medicine tackle boxes to an additional 46 health facilities. Our team successfully delivered medications to 264 out of 311 patients (84.9%) with noncommunicable diseases whom we were able to reach. Lessons learnt: Our revolving fund pharmacy model has ensured that patients' access to essential medicines has not been interrupted during the pandemic. Success was built on a community approach to extend pharmaceutical services, adapting our current supply-chain infrastructure and working quickly in partnership with local health authorities.