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Browsing by Author "Wools-Kaloustian, Kara"

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    127 Reciprocal Innovation Workshops: Identify Shared Health Challenges for Mutual Benefit in Global Health
    (Cambridge University Press, 2022) Sors, Thomas; Wools-Kaloustian, Kara; O’Brien, Rishika Chauhan; Bermel, Luanne; Kiplagat, Jepchirchir; Lieberman, Marya; Morales-Soto, Nydia; Nyandiko, Winstone; Litzelman, Debra; Medicine, School of Medicine
    OBJECTIVES/GOALS: Our concept of reciprocal innovation (RI) supports global health (GH) research partnerships that address shared health challenges for mutual benefit in both high and low- and middle-income (LMIC) settings. To advance this GH approach, the Indiana CTSI launched a RI program building on longstanding global health partnerships in East Africa. METHODS/STUDY POPULATION: A core component of the program is annual RI workshops to promote reciprocal approaches in GH, identify priority areas for reciprocal research, and link investigators and stakeholders across settings. The first meeting in 2019 was in-person and focused on identifying health priority areas from the perspective of Indiana stakeholders. The second meeting was held virtually and focused on priority areas in East Africa. The third meeting focused on shared priority areas and discussing potential RI research projects. Agenda sessions include (1) presenting successful examples of funded RI projects; (2) breakout groups to share proposal ideas in preparation for the RI grants program; (3) building partnerships with colleagues in similar fields. RESULTS/ANTICIPATED RESULTS: As of 2021, three RI workshops have been held with an average of 60 attendees at each workshop. Participants identified several overlapping priority areas for research and RI in Indiana and East Africa, including research in chronic disease, substance abuse, infant and maternal health, and access to healthcare. A Global Health Innovation Exchange of RI projects was created to support connections between locally- and globally-focused investigators. The repository is used to share updates on project progress, outcomes, and published materials. Workshops have also been used to explore a reciprocal innovation virtual platform to facilitate and foster more regular collaborations between globally and locally-focused investigators and pursue research projects on shared health challenges for mutual benefit. DISCUSSION/SIGNIFICANCE: The collaboration at the stakeholder meetings set the foundation for continued partnership building, strong proposals for RI grants, and dissemination and translation of successful RI projects. To leverage momentum from the meetings, we are building a virtual RI platform to connect PIs across multiple CTSAs and increase the footprint of RI efforts
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    547. A Retrospective Cohort Study of Treatment Patterns and Clinical Outcomes in Patients with COVID-19
    (Oxford, 2020-10) Pritchard, Haley; Hiles, Jon; Teresa, Batteiger; Desai, Armisha; Wrin, Justin E; Hlavaty, Ariel; Agard, Amanda; Hinton, Bradley; Lucky, Christine W; Fleming, Elizabeth; Khan, Humaira; Bomkamp, John P; Derringer, Jon; Schneider, Jack; Ryder, Jonathan; Russ, Jason D; Khan, Haseeba; Kleyman, Svetlana; Enane, Leslie A; Stack, Matthew; Kussin, Michelle L; Myers, Courtney; Nagy, Allysa; Richardson, Noah; Elsheikh, Omar; Rahman, Omar; Kruer, Rachel; Trigonis, Russell; Butt, Saira; Bhumbra, Samina; Kapil, Sasha; Abi-Mansour, Tanya; Howe, Zachary; Abdallah, Wassim; Gupta, Samir; Wools-Kaloustian, Kara; Medicine, School of Medicine
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    A clinician-nurse model to reduce early mortality and increase clinic retention among high-risk HIV-infected patients initiating combination antiretroviral treatment
    (Wiley, 2012-02-17) Braitstein, Paula; Siika, Abraham; Hogan, Joseph; Kosgei, Rose; Sang, Edwin; Sidle, John; Wools-Kaloustian, Kara; Keter, Alfred; Mamlin, Joseph; Kimaiyo, Sylvester; Medicine, School of Medicine
    Background: In resource-poor settings, mortality is at its highest during the first 3 months after combination antiretroviral treatment (cART) initiation. A clear predictor of mortality during this period is having a low CD4 count at the time of treatment initiation. The objective of this study was to evaluate the effect on survival and clinic retention of a nurse-based rapid assessment clinic for high-risk individuals initiating cART in a resource-constrained setting. Methods: The USAID-AMPATH Partnership has enrolled more than 140,000 patients at 25 clinics throughout western Kenya. High Risk Express Care (HREC) provides weekly or bi-weekly rapid contacts with nurses for individuals initiating cART with CD4 counts of ≤100 cells/mm3. All HIV-infected individuals aged 14 years or older initiating cART with CD4 counts of ≤100 cells/mm3 were eligible for enrolment into HREC and for analysis. Adjusted hazard ratios (AHRs) control for potential confounding using propensity score methods. Results: Between March 2007 and March 2009, 4,958 patients initiated cART with CD4 counts of ≤100 cells/mm3. After adjusting for age, sex, CD4 count, use of cotrimoxazole, treatment for tuberculosis, travel time to clinic and type of clinic, individuals in HREC had reduced mortality (AHR: 0.59; 95% confidence interval: 0.45-0.77), and reduced loss to follow up (AHR: 0.62; 95% CI: 0.55-0.70) compared with individuals in routine care. Overall, patients in HREC were much more likely to be alive and in care after a median of nearly 11 months of follow up (AHR: 0.62; 95% CI: 0.57-0.67). Conclusions: Frequent monitoring by dedicated nurses in the early months of cART can significantly reduce mortality and loss to follow up among high-risk patients initiating treatment in resource-constrained settings.
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    A Global Health Reciprocal Innovation grant programme: 5-year review with lessons learnt
    (BMJ Publishing, 2023) Ruhl, Laura J.; Kiplagat, Jepchirchir; O'Brien, Rishika; Wools-Kaloustian, Kara; Scanlon, Michael; Plater, David; Thomas, Melissa R.; Pastakia, Sonak; Gopal-Srivastava, Rashmi; Morales-Soto, Nydia; Nyandiko, Winstone; Vreeman, Rachel C.; Litzelman, Debra K.; Laktabai, Jeremiah; Medicine, School of Medicine
    Unilateral approaches to global health innovations can be transformed into cocreative, uniquely collaborative relationships between low-income and middle-income countries (LMICs) and high-income countries (HIC), constituted as 'reciprocal innovation' (RI). Since 2018, the Indiana Clinical and Translational Sciences Institute (CTSI) and Indiana University (IU) Center for Global Health Equity have led a grants programme sculpted from the core elements of RI, a concept informed by a 30-year partnership started between IU (Indiana) and Moi University (Kenya), which leverages knowledge sharing, transformational learning and translational innovations to address shared health challenges. In this paper, we describe the evolution and implementation of an RI grants programme, as well as the challenges faced. We aim to share the successes of our RI engagement and encourage further funding opportunities to promote innovations grounded in the RI core elements. From the complex series of challenges encountered, three major lessons have been learnt: dedicating extensive time and resources to bring different settings together; establishing local linkages across investigators; and addressing longstanding inequities in global health research. We describe our efforts to address these challenges through educational materials and an online library of resources for RI projects. Using perspectives from RI investigators funded by this programme, we offer future directions resulting from our 5-year experience in applying this RI-focused approach. As the understanding and implementation of RI grow, global health investigators can share resources, knowledge and innovations that have the potential to significantly change the face of collaborative international research and address long-standing health inequities across diverse settings.
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    A qualitative study of the barriers and enhancers to retention in care for pregnant and postpartum women living with HIV
    (Public Library of Science, 2021-10-13) Humphrey, John; Alera, Marsha; Kipchumba, Bett; Pfeiffer, Elizabeth J.; Songok, Julia; Mwangi, Winfred; Musick, Beverly; Yiannoutsos, Constantin; Wachira, Juddy; Wools-Kaloustian, Kara; Medicine, School of Medicine
    Retention in care is a major challenge for pregnant and postpartum women living with HIV (PPHIV) in the prevention of mother-to-child HIV transmission (PMTCT) continuum. However, the factors influencing retention from the perspectives of women who have become lost to follow-up (LTFU) are not well described. We explored these factors within an enhanced sub-cohort of the East Africa International Epidemiology Databases to Evaluate AIDS Consortium. From 2018-2019, a purposeful sample of PPHIV ≥18 years of age were recruited from five maternal and child health clinics providing integrated PMTCT services in Kenya. Women retained in care were recruited at the facility; women who had become LTFU (last visit >90 days) were recruited through community tracking. Interview transcripts were analyzed thematically using a social-ecological framework. Forty-one PPHIV were interviewed. The median age was 27 years, 71% were pregnant, and 39% had become LTFU. In the individual domain, prior PMTCT experience and desires to safeguard infants' health enhanced retention but were offset by perceived lack of value in PMTCT services following infants' immunizations. In the peer/family domain, male-partner financial and motivational support enhanced retention. In the community/society domain, some women perceived social pressure to attend clinic while others perceived pressure to utilize traditional birth attendants. In the healthcare environment, long queues and negative provider attitudes were prominent barriers. HIV-related stigma and fear of disclosure crossed multiple domains, particularly for LTFU women, and were driven by perceptions of HIV as a fatal disease and fear of partner abandonment and abuse. Both retained and LTFU women perceived that integrated HIV services increased the risk of disclosure. Retention was influenced by multiple factors for PPHIV. Stigma and fear of disclosure were prominent barriers for LTFU women. Multicomponent interventions and refining the structure and efficiency of PMTCT services may enhance retention for PPHIV.
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    A type III effectiveness-implementation hybrid evaluation of a multicomponent patient navigation strategy for advanced-stage Kaposi’s sarcoma: protocol
    (Springer, 2022-05-13) Collier, Sigrid; Semeere, Aggrey; Byakwaga, Helen; Laker-Oketta, Miriam; Chemtai, Linda; Wagner, Anjuli D.; Bassett, Ingrid V.; Wools-Kaloustian, Kara; Maurer, Toby; Martin, Jeffrey; Kiprono, Samson; Freeman, Esther E.; Medicine, School of Medicine
    Background: For people with advanced-stage Kaposi’s sarcoma (KS), a common HIV-associated malignancy in sub-Saharan Africa, mortality is estimated to be 45% within 2 years after KS diagnosis, despite increasingly wide-spread availability of antiretroviral therapy and chemotherapy. For advanced-stage KS, chemotherapy in addition to antiretroviral therapy improves outcomes and saves lives, but currently, only ~50% of people with KS in western Kenya who have an indication for chemotherapy actually receive it. This protocol describes the evaluation of a multicomponent patient navigation strategy that addresses common barriers to service penetration of and fidelity to evidence-based chemotherapy among people with advanced-stage KS in Kenya. Methods: This is a hybrid type III effectiveness-implementation study using a non-randomized, pre- post-design nested within a longitudinal cohort. We will compare the delivery of evidence-based chemotherapy for advanced stage KS during the period before (2016–2020) to the period after (2021–2024), the rollout of a multicomponent patient navigation strategy. The multicomponent patient navigation strategy was developed in a systematic process to address key determinants of service penetration of and fidelity to chemotherapy in western Kenya and includes (1) physical navigation and care coordination, (2) video-based education, (3) travel stipend, (4) health insurance enrollment assistance, (5) health insurance stipend, and (6) peer mentorship. We will compare the pre-navigation period to the post-navigation period to assess the impact of this multicomponent patient navigation strategy on (1) implementation outcomes: service penetration (chemotherapy initiation) and fidelity (chemotherapy completion) and (2) service and client outcomes: timeliness of cancer care, mortality, quality of life, stigma, and social support. We will also describe the implementation process and the determinants of implementation success for the multicomponent patient navigation strategy. Discussion: This study addresses an urgent need for effective implementation strategies to improve the initiation and completion of evidence-based chemotherapy in advanced-stage KS. By using a clearly specified, theory-based implementation strategy and validated frameworks, this study will contribute to a more comprehensive understanding of how to improve cancer treatment in advanced-stage KS.
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    Accuracy of Alternative PHQ-9 Scoring Algorithms to Screen for Depression in People Living With HIV in Sub-Saharan Africa
    (Wolters Kluwer, 2025) Bernard, Charlotte; Font, Hélène; Zotova, Natalia; Wools-Kaloustian, Kara; Goodrich, Suzanne; Kamaru Kwobah, Edith; Rogers Awoh, Ajeh; Nko'o Mbongo'o, Guy Calvin; Nsonde, Dominique Mahambu; Gandou, Paul; Minga, Albert; Tine, Judicaël Malick; Ndiaye, Ibrahima; Dabis, François; Seydi, Moussa; de Rekeneire, Nathalie; Yotebieng, Marcel; Jaquet, Antoine; IeDEA Cohort Collaboration; Medicine, School of Medicine
    Background: Screening for depression remains a priority for people living with HIV (PLWH) accessing care. The 9-item Patient Health Questionnaire (PHQ-9) is a widely used depression screening tool, but has limited accuracy when applied across various cultural contexts. We aimed to evaluate the performance of alternative PHQ-9 scoring algorithms in sub-Saharan African PLWH. Setting: Five HIV programs in Cameroon, Côte d'Ivoire, Kenya, Senegal, and the Republic of Congo. Methods: Adult PLWH were screened for depression during the 2018-2022 period. Diagnosis confirmation was done by psychiatrist blinded clinical evaluation (gold standard). Diagnostic performances, including sensitivity and area under the curve (AUC) of the traditional PHQ-9 scoring (positive screening - score ≥ 10), were compared to alternative scoring algorithms including (1) the presence of ≥1 mood symptom (PHQ-9 items 1 and 2) combined with ≥2 other symptoms listed in the PHQ-9, and (2) a simplified recoding of each 4-response item into 2 categories (absence/presence). Results: A total of 735 participants were included [54% women, median age 42 years (interquartile range 34-50)]. Depression was diagnosed by a psychiatrist in 95 (13%) participants. Alternative scoring sensitivities (0.59-0.74) were higher than that of the traditional score's (0.39). Compared to traditional scoring, AUC was significantly higher for PHQ-9 alternative scoring. Across settings, alternative scoring algorithms increased sensitivity and reduced variability. Conclusions: As a primary screening test, new scoring algorithms seemed to improve the PHQ-9 sensitivity in identifying depression and reducing heterogeneity across settings. This alternative might be considered to identify PLWH in need of referral for further diagnostic evaluations.
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    Accuracy of nine-item Patient Health Questionnaire against psychiatric diagnosis for depression among people with HIV
    (Wolters Kluwer, 2024) Yotebieng, Marcel; Zotova, Natalia; Bernard, Charlotte; Goodrich, Suzanne; Rogers Awoh, Ajeh; Watnick, Dana; Nsonde, Dominique Mahambu; Tchiengang Moungang, Elodie Flore; Nguemo Noumedem, Julie Laure; Nko'o Mbongo'o, Guy Calvin; Minga, Albert; Seydi, Moussa; Gandou, Paul; Kwobah, Edith Kamaru; Atwoli, Lukoye; Jaquet, Antoine; Wools-Kaloustian, Kara; Anastos, Kathryn; IeDEA Consortium; Medicine, School of Medicine
    Objective: The aim of this study was to assess the performance of the nine-item Patient Health Questionnaire (PHQ-9) against psychiatrist diagnosis in people with HIV (PWH). Design: Cross-sectional analysis of data collected between January 2018 and July 2022 across five sites in Cameroon, Cote d'Ivoire, Kenya, Senegal, and the Republic of Congo. Participants were ≥18 years and receiving HIV care at the participating site. PHQ-9 was administered by study staff followed by a psychiatrist's evaluation within 3 days. Results: Overall, 778 participants with complete data were included: 297 (38.2%) in Cameroon, 132 (17.0%) in Congo, 148 (19.0%) in Cote d'Ivoire, 98 (12.6%) in Kenya, and 103 (13.2%) in Senegal. The area under the curve for PHQ-9 score was generally high ranging from 0.935 [95% confidence interval (CI): 0.893, 0.977] in Cote d'Ivoire to 0.768 (95% CI: 0.589, 0.947) in Congo. However, for the common cut-off score ≥10, sensitivity was low: 50% or lower in Cameroon, Congo and Senegal, 66.7% in Kenya and 70.6% in Cote d'Ivoire. But negative predictive values (NPV) were high: 98.9% (95% CI: 96.9%, 99.8%) in Cameroon, 96.1 (95% CI: 91.1, 98.7) in Cote d'Ivoire, 96.3% (95% CI: 89.7%, 99.2%) in Kenya, 95.7% (95% CI: 90.2%, 98.6%) in Congo, and 89.0% (95% CI: 81.2%, 94.4%) in Senegal. Interpretation: Across all countries, PHQ-9 score ≥10 performed very poorly (low sensitivity) as a tool to identify psychiatrist diagnosed depression. However, the observed high NPV suggests it can be used to rule out depression.
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    Accuracy of PHQ-9 Against Psychiatric Diagnosis for Depression Among People Living with HIV: A Mixed-Method Study in Cameroon, Kenya, and the Republic of Congo
    (Elsevier, 2022-05-13) Yotebieng, Marcel; Zotova, Natalia; Watnick, Dana; Goodrich, Suzanne; Rogers Awoh, Ajeh; Mahambu Nsonde, Dominique; Tchiengang Moungang, Elodie Flore; Nguemo Noumedem, Julie Laure; Mbongo'o Nko'o, Guy Calvin; Gandou, Paul; Kamaru Kwobah, Edith; Atwoli, Lukoye; Wools-Kaloustian, Kara; Anastos, Kathryn; Medicine, School of Medicine
    Background: Depression is highly prevalent among people living with HIV (PLWH) and is known to negatively impact HIV care and HIV clinical outcomes. Integration of depression management into HIV care is challenging because of the difficulties identifying depression. The aim of this study was to assess the performance of the 9-item Patient Health questionnaire (PHQ-9) as a diagnostic instrument against psychiatrist diagnosis in PLWH. Methods: Data were collected between January 2018 and June 2021 across three sites in Cameroon, Kenya, and the Republic of Congo. Participants were ≥18 years, diagnosed with HIV between 3-24 months prior to enrollment. PHQ-9 was administered by study staff followed by a psychiatrist’s evaluation within 3 days. In Cameroon, in-depth qualitative and cognitive interviews were conducted with a sub-sample of participants. Results: Overall, 530 participants with complete data were included: 300 (56.6%) in Cameroon, 132 (24·9%) in Congo, and 98 (18·5%) in Kenya. PHQ-9 was highly accurate in excluding current depression, with areas under the curve for the continuous PHQ-9 score from 0·888 (95% CI: 0·784, 0·992) in Cameroon, 0·802 (95% CI: 0·603, 1·00) in Kenya, to 0·768 (95% CI: 0·589, 0·947) in Congo and negative predictive values (NPV) of 98·9% (95% CI: 96·9%, 99·8%) in Cameroon, 95·7% (95% CI: 90·2%, 98·6%) in Congo, and 96·3% (95% CI: 89·7%, 99·2%) in Kenya for a score >9. However, its sensitivity and positive predictive value (PPV) were generally low, ranging respectively, from 50·0% (95% CI: 11·8%, 88·2%) and 17·7% (3·8%, 43·3%) in Cameroon, 50·0% (95% CI: 18·7%, 81·3%) and 29·4% (95% CI: 10·3%, 56·0%) in Congo, to 66·7% (95% CI: 29·9%, 92·5%) and 37·5% (95% CI: 15·2%, 64·6%) in Kenya for scores >9. Cognitive interviews identified challenges in understanding some questions as well as processing response categories. Interpretation: PHQ-9 performed very poorly (low sensitivity and PPV) as a tool to identify psychiatrist diagnosed depression and caution must be exercised before using it as the only guide to initiating PLWH on pharmacological treatment. However, the observed high NPV suggests it can be used to rule out depression or to identify those to be referred for further evaluation.
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    Achieving UNAIDS 90-90-90 targets for pregnant and postpartum women in sub-Saharan Africa: progress, gaps and research needs
    (Mediscript, 2018-11-15) Abuogi, Lisa L.; Humphrey, John M.; Mpody, Christian; Yotebieng, Marcel; Murnane, Pamela M.; Clouse, Kate; Otieno, Lindah; Cohen, Craig R.; Wools-Kaloustian, Kara; Medicine, School of Medicine
    The implementation of the 2013 World Health Organization Option B+ recommendations for HIV treatment during pregnancy has helped drive significant progress in achieving universal treatment for pregnant and postpartum women in sub-Saharan Africa (SSA). Yet, critical research and implementation gaps exist in achieving the UNAIDS 90-90-90 targets. To help guide researchers, programmers and policymakers in prioritising these areas, we undertook a comprehensive review of the progress, gaps and research needs to achieve the 90-90-90 targets for this population in the Option B+ era, including early infant HIV diagnosis (EID) for HIV-exposed infants. Salient areas where progress has been achieved or where gaps remain include: (1) knowledge of HIV status is higher among people with HIV in southern and eastern Africa compared to western and central Africa (81% versus 48%, UNAIDS); (2) access to antiretroviral therapy (ART) for pregnant women has doubled in 22 of 42 SSA countries, but only six have achieved the second 90, and nearly a quarter of pregnant women initiating ART become lost to follow-up; (3) viral suppression data for this population are sparse (estimates range from 30% to 98% peripartum), with only half of women maintaining suppression through 12 months postpartum; and (4) EID rates range from 15% to 62%, with only three of 21 high-burden SSA countries testing >50% HIV-exposed infants within the first 2 months of life. We have identified and outlined promising innovations and research designed to address these gaps and improve the health of pregnant and postpartum women living with HIV and their infants.
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