Browsing by Author "Laker-Oketta, Miriam"
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Item 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 MedicineBackground: 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.Item Beyond T Staging in the “Treat All” Era: Severity and Heterogeneity of Kaposi’s Sarcoma in East Africa(Wolters Kluwer, 2021) Freeman, Esther E.; Semeere, Aggrey; McMahon, Devon E.; Byakwaga, Helen; Laker-Oketta, Miriam; Regan, Susan; Wenger, Megan; Kasozi, Charles; Semakadde, Matthew; Bwana, Mwebesa; Kanyesigye, Michael; Kadama-Makanga, Philippa; Rotich, Elyne; Kisuya, Job; Wools-Kaloustian, Kara; Bassett, Ingrid V.; Busakhala, Naftali; Martin, Jeffrey; Medicine, School of MedicineBackground: Although many patients with Kaposi sarcoma (KS) in sub-Saharan Africa are diagnosed with AIDS Clinical Trials Group (ACTG) T1 disease, T1 staging insufficiently captures clinical heterogeneity of advanced KS. Using a representative community-based sample, we detailed disease severity at diagnosis to inform KS staging and treatment in sub-Saharan Africa. Methods: We performed rapid case ascertainment on people living with HIV, aged 18 years or older, newly diagnosed with KS from 2016 to 2019 at 3 clinic sites in Kenya and Uganda to ascertain disease stage as close as possible to diagnosis. We reported KS severity using ACTG and WHO staging criteria and detailed measurements that are not captured in the current staging systems. Results: We performed rapid case ascertainment within 1 month for 241 adults newly diagnosed with KS out of 389 adult patients with suspected KS. The study was 68% men with median age 35 years and median CD4 count 239. Most of the patients had advanced disease, with 82% qualifying as ACTG T1 and 64% as WHO severe/symptomatic KS. The most common ACTG T1 qualifiers were edema (79%), tumor-associated ulceration (24%), extensive oral KS (9%), pulmonary KS (7%), and gastrointestinal KS (4%). There was marked heterogeneity within T1 KS, with 25% of patients having 2 T1 qualifying symptoms and 3% having 3 or more. Conclusion: Most of the patients newly diagnosed with KS had advanced stage disease, even in the current antiretroviral therapy "treat-all" era. We observed great clinical heterogeneity among advanced stage patients, leading to questions about whether all patients with advanced KS require the same treatment strategy.Item Evaluation of four chemotherapy regimens for treatment of advanced AIDS-associated Kaposi sarcoma in Kenya: a cost-effectiveness analysis(Elsevier, 2022) Freeman, Esther E.; McCann, Nicole C.; Semeere, Aggrey; Reddy, Krishna P.; Laker-Oketta, Miriam; Byakwaga, Helen; Pei, Pamela P.; Hajny Fernandez, Maya E.; Kiprono, Samson; Busakhala, Naftali; Martin, Jeffery N.; Maurer, Toby; Bassett, Ingrid V.; Freedberg, Kenneth A.; Hyle, Emily P.; Dermatology, School of MedicineBackground: The most effective treatment for advanced AIDS-associated Kaposi sarcoma is paclitaxel or pegylated liposomal doxorubicin (PLD); neither is routinely used in sub-Saharan Africa due to limited availability and high cost. We examined the clinical impact, costs, and cost-effectiveness of paclitaxel or PLD in Kenya, compared with etoposide or bleomycin-vincristine. Methods: In this study, we use the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-International Model to project clinical outcomes and costs among people living with HIV and advanced Kaposi sarcoma on antiretroviral therapy. We compared four different treatment strategies: etoposide, bleomycin-vincristine, paclitaxel, or PLD. We derived cohort characteristics and costs from the Kenyan Academic Model for Providing Access to Healthcare network, and adverse events, efficacy, and mortality from clinical trials. We projected model outcomes over a lifetime and included life expectancy, per-person lifetime costs, and incremental cost-effectiveness ratios (ICERs). We conducted budget impact analysis for 5-year total costs and did deterministic and probabilistic sensitivity analyses to evaluate the effect of uncertainty in input parameters. Findings: We found that paclitaxel would be more effective than bleomycin-vincristine and would increase life expectancy by 4·2 years per person. PLD would further increase life expectancy by 0·6 years per person. Paclitaxel would be the most cost-effective strategy (ICER US$380 per year-of-life-saved compared with bleomycin-vincristine) and would remain cost-effective across a range of scenarios. PLD would be cost-effective compared with paclitaxel if its price were reduced to $100 per cycle (base case $180 per cycle). Implementing paclitaxel instead of bleomycin-vincristine would save approximately 6400 life-years and would increase the overall 5-year Kenyan health-care costs by $3·7 million; increased costs would be primarily related to ongoing HIV care given improved survival. Interpretation: Paclitaxel would substantially increase life expectancy and be cost-effective compared with bleomycin-vincristine for advanced AIDS-associated Kaposi sarcoma in Kenya and should be the standard of care. PLD would further improve survival and be cost-effective with a 44% price reduction.Item Feasibility of Rapid Case Ascertainment for Cancer in East Africa: An Investigation of Community-Representative Kaposi Sarcoma in the Era of Antiretroviral Therapy(Elsevier, 2021) Semeere, Aggrey; Byakwaga, Helen; Laker-Oketta, Miriam; Freeman, Esther; Busakhala, Naftali; Wenger, Megan; Kasozi, Charles; Ssemakadde, Matthew; Bwana, Mwebesa; Kanyesigye, Michael; Kadama-Makanga, Philippa; Rotich, Elyne; Kisuya, Job; Sang, Edwin; Maurer, Toby; Wools-Kaloustian, Kara; Kambugu, Andrew; Martin, Jeffrey; Medicine, School of MedicineBackground: Rapid case ascertainment (RCA) refers to the expeditious and detailed examination of patients with a potentially rapidly fatal disease shortly after diagnosis. RCA is frequently performed in resource-rich settings to facilitate cancer research. Despite its utility, RCA is rarely implemented in resource-limited settings and has not been performed for malignancies. One cancer and context that would benefit from RCA in a resource-limited setting is HIV-related Kaposi sarcoma (KS) in sub-Saharan Africa. Methods: To determine the feasibility of RCA for KS, we searched for all potential newly diagnosed KS among HIV-infected adults attending three community-based facilities in Uganda and Kenya. Searching involved querying of electronic medical records, pathology record review, and notification by clinicians. Upon identification, a team verified eligibility and attempted to locate patients to perform RCA, which included epidemiologic, clinical and laboratory measurements. Results: We identified 593 patients with suspected new KS. Of the 593, 171 were ineligible, mainly because biopsy failed to confirm KS (65%) or KS was not new (30%). Among the 422 remaining, RCA was performed within 1 month for 56% of patients and within 3 months for 65% (95% confidence interval: 59 to 70%). Reasons for not performing RCA included intervening death (47%), inability to contact (44%), refusal/unsuitable to consent (8.3%), and patient re-location (0.7%). Conclusions: We found that RCA - an important tool for cancer research in resource-rich settings - is feasible for the investigation of community-representative KS in East Africa. Feasibility of RCA for KS suggests feasibility for other cancers in Africa.Item LAMP-enabled diagnosis of Kaposi's sarcoma for sub-Saharan Africa(American Association for the Advancement of Science, 2023) McCloskey, Duncan; Semeere, Aggrey; Ayanga, Racheal; Laker-Oketta, Miriam; Lukande, Robert; Semakadde, Matthew; Kanyesigye, Micheal; Wenger, Megan; LeBoit, Philip; McCalmont, Timothy; Maurer, Toby; Gardner, Andrea; Boza, Juan; Cesarman, Ethel; Martin, Jeffrey; Erickson, David; Dermatology, School of MedicineKaposi's sarcoma (KS) is an endothelial cancer caused by the Kaposi's sarcoma-associated herpesvirus (KSHV) and is one of the most common cancers in sub-Saharan Africa. In limited-resource settings, traditional pathology infrastructure is often insufficient for timely diagnosis, leading to frequent diagnoses at advanced-stage disease where survival is poor. In this study, we investigate molecular diagnosis of KS performed in a point-of-care device to circumvent the limited infrastructure for traditional diagnosis. Using 506 mucocutaneous biopsies collected from patients at three HIV clinics in Uganda, we achieved 97% sensitivity, 92% specificity, and 96% accuracy compared to gold standard U.S.-based pathology. The results presented in this manuscript show that LAMP-based quantification of KSHV DNA extracted from KS-suspected biopsies has the potential to serve as a successful diagnostic for the disease and that diagnosis may be accurately achieved using a point-of-care device, reducing the barriers to obtaining KS diagnosis while increasing diagnostic accuracy.Item Survival Following Diagnosis of HIV-Associated Kaposi Sarcoma Among Adults in East Africa in the "Treat-All" Era(medRxiv, 2024-08-28) Byakwaga, Helen; Semeere, Aggrey; Laker-Oketta, Miriam; Busakhala, Naftali; Freeman, Esther; Rotich, Elyne; Wenger, Megan; Kadama-Makanga, Philippa; Kisuya, Job; Semakadde, Matthew; Mwine, Bronia; Kasozi, Charles; Mwebesa, Bwana; Maurer, Toby; Glidden, David V.; Wools-Kaloustian, Kara; Kambugu, Andrew; Martin, Jeffrey; Dermatology, School of MedicineBackground: Despite widespread access to antiretroviral therapy (ART) in the "Treat All" era, HIV-associated Kaposi sarcoma (KS) remains among the most common malignancies in sub-Saharan Africa. Survival after KS diagnosis has historically been poor in Africa, but knowledge whether survival has changed at the population level in the contemporary era has been limited by lack of community-representative surveillance and monitoring systems. Methods: We identified all adult persons living with HIV (PLWH) with a new diagnosis of KS made between 2016 and 2019 during outpatient or inpatient care at prototypical primary care-providing medical facilities in Kenya and Uganda using rapid case ascertainment. Participants were subsequently followed for vital status, including community tracking for those who became lost to follow-up. Findings: Among 411 participants with newly diagnosed KS, 71% were men, median age was 34 (IQR: 30 to 41) years, and 91% had ACTG T1 tumor extent. Over a median follow-up of 7.8 (IQR: 2.4 to 17.9) months, cumulative incidence of death (95% CI) at months 6, 12 and 18 were 34% (30% to 39%), 41% (36% to 46%) and 45% (40% to 51%), respectively. Having the highest number of anatomic sites (11 to 16) harboring KS lesions (hazard ratio 2.2 (95% CI: 1.3-3.8) compared to 1 to 3 sites) and presence of oral KS lesions (hazard ratio 2.2 (95% CI: 1.4-3.3)) were independently associated with higher mortality. Lower hemoglobin and CD4 count as well as higher plasma HIV RNA were also associated with higher mortality. Interpretation: Among PLWH with newly diagnosed KS in East Africa in the "Treat All" era, survival was poor and related to mucocutaneous extent of KS. The findings emphasize the need for better control of KS in Africa, including novel approaches for earlier detection, better linkage to oncologic care, and more potent therapy.Item Telling the story of intersectional stigma in HIV-associated Kaposi's sarcoma in western Kenya: a convergent mixed-methods approach(Wiley, 2022) Collier, Sigrid; Singh, Rhea; Semeere, Aggrey; Byakwaga, Helen; Laker-Oketta, Miriam; McMahon, Devon E.; Chemtai, Linda; Grant, Merridy; Butler, Lisa; Bogart, Laura; Bassett, Ingrid V.; Kiprono, Samson; Maurer, Toby; Martin, Jeffrey; Busakhala, Naftali; Freeman, Esther E.; Dermatology, School of MedicineIntroduction: The experience of stigma can be multifaceted for people with HIV and cancer. Kaposi's sarcoma (KS), one of the most common HIV-associated cancers in sub-Saharan Africa, often presents with visible skin lesions that may put people at risk for stigmatization. In this way, HIV-associated KS is unique, as people with KS can experience stigma associated with HIV, cancer, and skin disease simultaneously. The aim of this study is to characterize the intersectionality of HIV-related, cancer-related and skin disease-related stigma in people living with HIV and KS. Methods: We used a convergent mixed-methods approach nested within a longitudinal study of people with HIV-associated KS in western Kenya. Between February 2019 and December 2020, we collected quantitative surveys among all participants and conducted semi-structured interviews among a purposive sample of participants. Quantitative surveys were adapted from the abridged Berger HIV Stigma Scale to assess overall stigma, HIV-related stigma, cancer-related stigma, and skin disease-related stigma. Qualitative data were coded using stigma constructs from the Health Stigma and Discrimination Framework. Results: In 88 semi-structured interviews, stigma was a major barrier to KS diagnosis and treatment among people with HIV-associated KS. Participant's stories of stigma were dominated by HIV-related stigma, more than cancer-related or skin disease-related stigma. However, quantitative stigma scores among the 117 participants were similar for HIV-related (Median: 28.00; IQR: 28.0, 34.0), cancer-related (Median: 28.0; IQR: 28.0, 34.8), and skin disease-related stigma (Median: 28.0; IQR: 27.0, 34.0). In semi-structured interviews, cancer-related and skin disease-related stigma were more subtle contributors; cancer-related stigma was linked to fatalism and skin-related stigma was linked to visible disease. Participants reported resolution of skin lesions contributed to lessening stigma over time; there was a significant decline in quantitative scores of overall stigma in time since KS diagnosis (adjusted β = -0.15, p <0.001). Conclusions: This study highlights the role mixed-method approaches can play in better understanding stigma in people living with both HIV and cancer. While HIV-related stigma may dominate perceptions of stigma among people with KS in Kenya, intersectional experiences of stigma may be subtle, and quantitative evaluation alone may be insufficient to understand intersectional stigma in certain contexts.Item Understanding Diagnostic Delays for Kaposi Sarcoma in Kenya: A Qualitative Study(Wolters Kluwer, 2022-08-15) McMahon, Devon E.; Chemtai, Linda; Grant, Merridy; Singh, Rhea; Semeere, Aggrey; Byakwaga, Helen; Laker-Oketta, Miriam; Maurer, Toby; Busakhala, Naftali; Martin, Jeffrey; Bassett, Ingrid V.; Butler, Lisa; Freeman, Esther E.; Dermatology, School of MedicineBackground: Although HIV-associated Kaposi sarcoma (KS) is frequently diagnosed at an advanced stage in sub-Saharan Africa, reasons for diagnostic delays have not been well described. Methods: We enrolled patients >18 years with newly diagnosed KS between 2016–2019 into the parent study, based in Western Kenya. We then purposively selected 30 participants with diversity of disease severity and geographic locations to participate in semi-structured interviews. We employed two behavioral models in developing the codebook for this analysis: situated Information, Motivation and Behavior (sIMB) framework and Andersen model of total patient delay. We then analyzed the interviews using framework analysis. Results: The most common patient factors that delayed diagnosis were lack of KS awareness, seeking traditional treatments, lack of personal efficacy, lack of social support, and fear of cancer, skin biopsy, amputation, and HIV diagnosis. Health system factors that delayed diagnosis included prior negative healthcare interactions, incorrect diagnoses, lack of physical exam, delayed referral, and lack of tissue biopsy availability. Financial constraints were prominent barriers for patients to access and receive care. Facilitators for diagnosis included being part of an HIV care network, living near health facilities, trust in the healthcare system, desire to treat painful or disfiguring lesions, and social support. Conclusion: Lack of KS awareness among patients and providers, stigma surrounding diagnoses, and health system referral delays were barriers in reaching KS diagnosis. Improved public health campaigns, increased availability of biopsy and pathology facilities, and health provider training about KS are needed to improve early diagnosis of KS.