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Designing an implementation science clinical trial to integrate hypertension and cardiovascular diseases care into existing HIV services package in Botswana (InterCARE)

Youssouf, Nabila; Mogaetsho, Gaone Edwin; Moshomo, Thato; Gaolathe, Tendani; Ponatshego, Ponego; Ramotsababa, Mareko; Molefe-Baikai, Onkabetse Julia; Dintwa, Evelyn; Kiki, Tsaone; Van Pelt, Amelia E; Steger-May, Karen; Bogart, Laura M; Jaffar, Shabbar; Gala, Pooja; Wang, Duolao; Seipone, Khumo; Bennett, Kara; Hurwitz, Kathleen Wirth; Kebotsamang, Kago; Hirschhorn, Lisa R; Mosepele, Mosepele
BACKGROUND:Despite success in HIV treatment, diagnosis and management of hypertension (HTN) and cardiovascular disease (CVD) remains suboptimal among people living with HIV (PLWH) in Botswana, with an overall HTN control of only 19% compared to 98% HIV viral suppressed. These gaps persist despite CVD primary care national guidelines and availability of free healthcare including antihypertensive medications. Our study aims to develop and test strategies to close the HTN care gap in PLWH, through integration into HIV care, leveraging the successful national HIV care and treatment program and strategies. METHODS:The InterCARE trial is a cluster randomized controlled hybrid type 2 effectiveness-implementation trial at 14 sites designed to enroll 4652 adults living with HIV and HTN plus up to 2326 treatment partners. Primary outcomes included effectiveness (HTN control) and implementation outcomes using the Reach Effectiveness Adoption Implementation and Maintenance framework, with explanatory mixed methods used to understand variability in outcomes. InterCARE trial's main strategies include healthcare worker HTN and CVD care training plus long-term practice facilitation, electronic health record (EHR) documentation of key indicators and use of reminders, and use of treatment partners to provide social support to people living with HIV and HTN. InterCARE started with formative research to identify contextual factors influencing care gaps using the Consolidated Framework for Implementation Research. Results were used to adapt initial and develop additional implementation strategies to address barriers and leverage facilitators. The package was pilot tested in two clinics, with findings used to further adapt or add strategies for the clinical trial. DISCUSSION/CONCLUSIONS:If successful, the InterCARE model can be scaled up to HIV clinics nationwide to improve diagnosis, management, and support in Botswana. The trial will provide insights for scale-up of HTN integration into HIV care in the region. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov reference NCT05414526. Registered 18 May 2022, https://clinicaltrials.gov/study/NCT05414526?term=NCT05414526.&rank=1 .
PMCID:11285256
PMID: 39075506
ISSN: 1745-6215
CID: 5696312

Quantitative outcomes of a type 2 single arm hybrid effectiveness implementation pilot study for hypertension-HIV integration in Botswana

Moshomo, Thato; Gaolathe, Tendani; Ramotsababa, Mareko; Molefe-Baikai, Onkabetse Julia; Mogaetsho, Edwin; Dintwa, Evelyn; Gala, Pooja; Ponatshego, Ponego; Bogart, Laura M; Youssouf, Nabila; Seipone, Khumo; Van Pelt, Amelia E; Bennett, Kara; Jaffar, Shabbar; Ilias, Maliha; Tonwe, Veronica; Hurwitz, Kathleen Wirth; Kebotsamang, Kago; Steger-May, Karen; Hirschhorn, Lisa R; Mosepele, Mosepele
BACKGROUND:Successful HIV treatment programs have turned HIV into a chronic condition, but noncommunicable diseases such as hypertension jeopardize this progress. Hypertension control rates among people with HIV (PWH) are low owing to gaps in patient awareness, diagnosis, effective treatment, and management of both conditions at separate clinic visits. Integrated management, such as in our study, InterCARE, can enhance HIV-hypertension integration and blood pressure (BP) control. METHODS:Our pilot study was conducted in two Botswana HIV clinics between October 2021 and November 2022. Based on our formative work, we adopted three main strategies; Health worker training on HTN/cardiovascular disease (CVD) management, adaptation of HIV Electronic Health Record (EHR) for HTN/CVD care, and use of treatment partners to support PWH with hypertension for implementation. We employed the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to assess implementation effectiveness and outcomes for BP control at baseline, 6 and 12 months. HIV viral load (VL) suppression was also measured to assess impact of integration on HIV care. RESULTS:We enrolled 290 participants; 35 (12.1%) were lost to follow-up, leaving 255 (87.9%) at 12-months. Median age was 54 years (IQR 46-62), and 77.2% were females. Our interventions significantly improved BP control to < 140/90 mmHg (or < 130/80 mmHg if diagnosis of diabetes or chronic kidney disease), from 137/290 participants, 47.2% at baseline to 206/290 participants, 71.0%, at 12 months (p < 0.001). Among targeted providers, 94.7% received training, with an associated significant increase in counseling on exercise, diet, and medication (all p < 0.001) but EHR use for BP medication prescribing and cardiovascular risk factor evaluation showed no adoption. In the intention-to-treat analysis, HIV VL suppression at 12 months decreased (85.5% vs 93.8%, p = 0.002) due to loss to follow-up but the per protocol analysis showed no difference in VL suppression between baseline and 12 months (97.3% vs 93.3%, p = 0.060). CONCLUSION/CONCLUSIONS:The InterCARE pilot study demonstrated that low-cost practical support measures involving the integration of HIV and hypertension/CVD management could lead to improvements in BP control. These results support the need for a large implementation and effectiveness trial. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT05414526. Registered 18th May 2022.
PMCID:11264446
PMID: 39039609
ISSN: 2662-2211
CID: 5723512

A mixed methods approach identifying facilitators and barriers to guide adaptations to InterCARE strategies: an integrated HIV and hypertension care model in Botswana

Gala, Pooja; Ponatshego, Ponego; Bogart, Laura M; Youssouf, Nabila; Ramotsababa, Mareko; Van Pelt, Amelia E; Moshomo, Thato; Dintwa, Evelyn; Seipone, Khumo; Ilias, Maliha; Tonwe, Veronica; Gaolathe, Tendani; Hirschhorn, Lisa R; Mosepele, Mosepele
BACKGROUND:Botswana serves as a model of success for HIV with 95% of people living with HIV (PLWH) virally suppressed. Yet, only 19% of PLWH and hypertension have controlled blood pressure. To address this gap, InterCARE, a care model that integrates HIV and hypertension care through a) provider training; b) adapted electronic health record; and c) treatment partners (peer support), was designed. This study presents results from our baseline assessment of the determinants and factors used to guide adaptations to InterCARE implementation strategies prior to a hybrid type 2 effectiveness-implementation study. METHODS:This study employed a convergent mixed methods design across two clinics (one rural, one urban) to collect quantitative and qualitative data through facility assessments, 100 stakeholder surveys (20 each PLWH and hypertension, existing HIV treatment partners, clinical healthcare providers (HCPs), and 40 community leaders) and ten stakeholder key informative interviews (KIIs). Data were analyzed using descriptive statistics and deductive qualitative analysis organized by the Consolidated Framework for Implementation Research (CFIR) and compared to identify areas of convergence and divergence. RESULTS:Although 90.3% of 290 PLWH and hypertension at the clinics were taking antihypertensive medications, 52.8% had uncontrolled blood pressure. Results from facility assessments, surveys, and KIIs identified key determinants in the CFIR innovation and inner setting domains. Most stakeholders (> 85%) agreed that InterCARE was adaptable, compatible and would be successful at improving blood pressure control in PLWH and hypertension. HCPs agreed that there were insufficient resources (40%), consistent with facility assessments and KIIs which identified limited staffing, inconsistent electricity, and a lack of supplies as key barriers. Adaptations to InterCARE included a task-sharing strategy and expanded treatment partner training and support. CONCLUSIONS:Integrating hypertension services into HIV clinics was perceived as more advantageous for PLWH than the current model of hypertension care delivered outside of HIV clinics. Identified barriers were used to adapt InterCARE implementation strategies for more effective intervention delivery. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT05414526 . Registered 18 May 2022 - Retrospectively registered.
PMCID:11188218
PMID: 38902846
ISSN: 2662-2211
CID: 5672352

Impact of the COVID-19 Public Health Crisis and a Structured COVID Unit on Physician Behaviors in Code Status Ordering

Molitch-Hou, Ethan; Zhang, Hui; Gala, Pooja; Tate, Alexandra
PMCID:10985045
PMID: 37786255
ISSN: 1938-2715
CID: 5673422

Cross-sectional analysis of factors associated with medication adherence in western Kenya

Gala, Pooja; Kamano, Jemima H; Vazquez Sanchez, Manuel; Mugo, Richard; Orango, Vitalis; Pastakia, Sonak; Horowitz, Carol; Hogan, Joseph W; Vedanthan, Rajesh
OBJECTIVES:Poor medication adherence in low-income and middle-income countries is a major cause of suboptimal hypertension and diabetes control. We aimed to identify key factors associated with medication adherence in western Kenya, with a focus on cost-related and economic wealth factors. SETTING:We conducted a cross-sectional analysis of baseline data of participants enrolled in the Bridging Income Generation with Group Integrated Care study in western Kenya. PARTICIPANTS:All participants were ≥35 years old with either diabetes or hypertension who had been prescribed medications in the past 3 months. PRIMARY AND SECONDARY OUTCOME MEASURES:Baseline data included sociodemographic characteristics, wealth and economic status and medication adherence information. Predictors of medication adherence were separated into the five WHO dimensions of medication adherence: condition-related factors (comorbidities), patient-related factors (psychological factors, alcohol use), therapy-related factors (number of prescription medications), economic-related factors (monthly income, cost of transportation, monthly cost of medications) and health system-related factors (health insurance, time to travel to the health facility). A multivariable analysis, controlling for age and sex, was conducted to determine drivers of suboptimal medication adherence in each overarching category. RESULTS:The analysis included 1496 participants (73.7% women) with a mean age of 60 years (range 35-97). The majority of participants had hypertension (69.2%), 8.8% had diabetes and 22.1% had both hypertension and diabetes. Suboptimal medication adherence was reported by 71.2% of participants. Economic factors were associated with medication adherence. In multivariable analysis that investigated specific subtypes of costs, transportation costs were found to be associated with worse medication adherence. In contrast, we found no evidence of association between monthly medication costs and medication adherence. CONCLUSION:Suboptimal medication adherence is highly prevalent in Kenya, and primary-associated factors include costs, particularly indirect costs of transportation. Addressing all economic factors associated with medication adherence will be important to improve outcomes for non-communicable diseases. TRIAL REGISTRATION NUMBER:NCT02501746.
PMCID:10481848
PMID: 37669842
ISSN: 2044-6055
CID: 5620092

India's COVID-19 crisis: a call for international action

Kuppalli, Krutika; Gala, Pooja; Cherabuddi, Kartikeya; Kalantri, S P; Mohanan, Manoj; Mukherjee, Bhramar; Pinto, Lancelot; Prakash, Manu; Pramesh, C S; Rathi, Sahaj; Pai, Nitika Pant; Yamey, Gavin; Pai, Madhukar
PMCID:8120195
PMID: 34000256
ISSN: 1474-547x
CID: 4876712

Maintaining care delivery for non-communicable diseases in the face of the COVID-19 pandemic in western Kenya

Kamano, Jemima; Naanyu, Violet; Ayah, Richard; Limo, Obed; Gathecha, Gladwell; Saenyi, Eugene; Jefwa, Pendo; Too, Kenneth; Manji, Imran; Gala, Pooja; Vedanthan, Rajesh
The coronavirus disease 2019 (COVID-19) pandemic has disrupted health systems worldwide, gravely threatening continuity of care for non-communicable diseases (NCDs), particularly in low-resource settings. We describe our efforts to maintain the continuity of care for patients with NCDs in rural western Kenya during the COVID-19 pandemic, using a five-component approach: 1) Protect: protect staff and patients; 2) Preserve: ensure medication availability and clinical services; 3) Promote: conduct health education and screenings for NCDs and COVID-19; 4) Process: collect process indicators and implement iterative quality improvement; and 5) Plan: plan for the future and ensure financial risk protection in the face of a potentially overwhelming health and economic catastrophe. As the pandemic continues to evolve, we must continue to pursue new avenues for improvement and expansion. We anticipate continuing to learn from the evolving local context and our global partners as we proceed with our efforts.
PMCID:8418157
PMID: 34527159
ISSN: 1937-8688
CID: 5043602

Perceptions of the Doctor-Patient Relationship Among Patients in a Private, Secondary-Level Hospital in Southern India

Gala, Pooja; Sriram, Veena; Kotian, Chitra; Ballala, Kirthinath; Vedanthan, Rajesh; Perish, Emily; Umakanth, Shashikiran; Meltzer, David
Introduction/UNASSIGNED:An epidemic of non-communicable diseases (NCDs) in India is fueling a growing demand for primary care and hospitalization services. Difficulties in coordinating inpatient and outpatient care create significant barriers to providing high-quality medical care. In this paper, we describe patient experiences, perceptions, and expectations of doctor-patient relationships in a secondary-level private hospital in Karnataka, India. Methods/UNASSIGNED:We conducted a cross-sectional, mixed-method needs assessment with surveys and in-depth interviews at Dr. TMA Pai Hospital (TMAPH), a secondary-level, private sector hospital in Karnataka, India. Inclusion criteria included all adults over 18 years old hospitalized at TMAPH in the past year. Patients were consecutively recruited from August 2019-October 2019 and asked to rate aspects of their relationship with their primary care provider (PCP). Descriptive statistics and multivariable logistic regression were used to analyze predictors of the doctor-patient relationship. Patients were interviewed regarding their perceptions of care coordination and doctor-patient relationships. General Thematic Analysis was utilized to analyze qualitative data and develop themes. Quantitative and qualitative findings were then merged to interpret the various dimensions of doctor-patient relationships. Results/UNASSIGNED:= 0.04). The following themes were developed from patient interviews: (1) patients trusted and respected their PCP believing they were receiving high quality care; and (2) despite perceived fragmentation in care, patients spoke favorably of their relationships with their doctors. Conclusions/UNASSIGNED:Among a sample of recently hospitalized patients, those with a PCP reported more positive doctor-patient relationships, though rates of dissatisfaction with doctors were still high. Further research and strategies are required to optimize continuity of care and doctor-patient relationships across the entire continuum of outpatient and inpatient care.
PMCID:9019150
PMID: 35463195
ISSN: 2296-2565
CID: 5216962

Medication Errors and Blood Pressure Control Among Patients Managed for Hypertension in Public Ambulatory Care Clinics in Botswana

Gala, Pooja; Moshokgo, Veronica; Seth, Bhavna; Ramasuana, Kegomoditswe; Kazadi, Emmanuel; M'buse, Rudy; Pharithi, Solomon; Gobotsamang, Kabelo; Szymanowski, Paige; Kerobale, Ruth Olyn; Balekile, Kelennetse; Tshimbalanga, Jacques; Tieng'o, Jane; Tapela, Neo; Barak, Tomer
Background The prevalence of hypertension in low- and middle-income countries is rapidly increasing, with most cases undiagnosed and many poorly controlled among those diagnosed. Medication reconciliation studies from high-income countries have demonstrated a high occurrence of antihypertensive medication errors and a strong association between medication errors and inadequate blood pressure control, but data from low- and middle-income countries are lacking. Methods and Results We conducted a cross-sectional study from April to October 2018 of adult patients on pharmacologic management for known hypertension at 7 public health facilities in Kweneng East District, Botswana. Our aims included to evaluate the frequency of uncontrolled hypertension, the frequency and type of medication errors causing discrepancies between patient-reported and prescribed antihypertensive medications, and the association between medication errors and uncontrolled hypertension. Descriptive analyses and multivariable logistic regression were used. The prevalence of uncontrolled hypertension was 55% among 280 enrolled adult patients, and 95 (34%) had ≥1 medication error. The most common errors included patients taking medications incorrectly (11.1%; 31/280), patients omitting medications (7.9%; 22/280), and unfilled prescriptions caused by pharmacy stock outs (7.5%%; 21/280). Uncontrolled hypertension was significantly associated with having ≥1 medication error compared with no errors (adjusted odds ratio, 3.26; 95% CI, 1.75-6.06; P<0.001). Conclusions Medication errors are strongly associated with poor blood pressure control in this setting. Further research is warranted to assess whether medication reconciliation and other low-cost interventions addressing root causes of medication errors can improve the control of hypertension and other chronic conditions in low- and middle-income countries.
PMCID:7033820
PMID: 31955639
ISSN: 2047-9980
CID: 4554922

Confidence and performance of health workers in cardiovascular risk factor management in rural Botswana: a cross-sectional study

Gala, Pooja; Seth, Bhavna; Moshokgo, Veronica; M'buse, Rudy; Kazadi, Emmanuel; Pharithi, Solomon; Gobotsamang, Kabelo; Dintwe, Keolebogile; Olyn, Ruth Kesolofetse; Lewis, Brett; Kalenga, Kitenge; Tapela, Neo; Barak, Tomer
ORIGINAL:0017408
ISSN: 2214-109x
CID: 5741402