Search

Background: Long-acting injectable cabotegravir and rilpivirine is licensed for individualised treatment of HIV-1 infection in resource-rich settings. Additional evidence is required to support use in African treatment programmes where demographic factors, viral subtypes, previous treatment, and delivery and monitoring approaches differ. The aim of this study was to determine whether switching to long-acting therapy with injections every 8 weeks is non-inferior to daily oral therapy in Africa., Methods: CARES is a randomised, open-label, non-inferiority trial being conducted at eight sites in Uganda, Kenya, and South Africa. Participants with HIV viral load below 50 copies per mL on oral antiretroviral therapy and no history of virological failure were randomly assigned (1:1; web-based, permuted blocks) to receive cabotegravir (600 mg) and rilpivirine (900 mg) by intramuscular injection every 8 weeks, or to continue oral therapy. Viral load was monitored every 24 weeks. The primary outcome was week 48 viral load below 50 copies per mL, assessed with the Food and Drug Administration snapshot algorithm (non-inferiority margin 10 percentage points) in the intention-to-treat exposed population. This trial is registered with the Pan African Clinical Trials Registry (202104874490818) and is ongoing up to 96 weeks., Findings: Between Sept 1, 2021, and Aug 31, 2022, we enrolled 512 participants (295 [58%] female; 380 [74%] previous non-nucleoside reverse transcriptase inhibitor exposure). Week 48 viral load was below 50 copies per mL in 246 (96%) of 255 participants in the long-acting therapy group and 250 (97%) of 257 in the oral therapy group (difference -0·8 percentage points; 95% CI -3·7 to 2·3), demonstrating non-inferiority (confirmed in per-protocol analysis). Two participants had virological failure in the long-acting therapy group, both with drug resistance; none had virological failure in the oral therapy group. Adverse events of grade 3 or greater severity occurred in 24 (9%) participants on long-acting therapy and ten (4%) on oral therapy; one participant discontinued long-acting therapy (for injection-site reaction)., Interpretation: Long-acting therapy had non-inferior efficacy compared with oral therapy, with a good safety profile, and can be considered for African treatment programmes., Funding: Janssen., Competing Interests: Declaration of interests CK reports funding paid to institution and donation of drugs to institution from Janssen for the work reported in this manuscript. SS reports funding paid to institution and personal fees for speaking at symposia from Janssen and donation of drugs to institution from ViiV, all outside the work reported in this manuscript. FC reports funding paid to institution and donation of drugs to institution from Janssen and funding paid to institution from ViiV, Gilead, Wellcome Trust, and the National Institute of Health Research UK outside the work reported in this manuscript; and unpaid role as Chair of Steering Committee for an investigator-initiated long-acting implementation trial. KM reports personal fees for speaking at symposia from Janssen outside of the work reported in this manuscript. VVE is an employee of Johnson & Johnson and holds stock options in Johnson & Johnson; and a patent related to rilpivirine. PM was an employee of Janssen at the time of trial design, and then an employee of ViiV during the time of trial conduct, manuscript submission, and publication; and holds stock from GSK as an employee of ViiV. FAB is an employee of Johnson & Johnson and holds stock options of Johnson & Johnson. NIP reports grants paid to institution, donation of drugs to institution, and personal fees for speaking at symposia from Janssen outside the work reported in this manuscript; and is the Chief Investigator on a trial with funding paid to institution by the EU for testing anti-tuberculosis drug combinations based on the drug ganfeborole, owned by GSK. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Background: Heart failure (HF), is a leading cause of cardiovascular morbidity and mortality in Sub-Saharan Africa. Cardiac rehabilitation (CR) is known to improve functional capacity and reduce morbidity associated with HF. Although CR is a low-cost intervention, global access and adherence rates to CR remain poor. In regions such as Western Kenya, CR programs do not exist. We sought to establish the feasibility CR for HF in this region by testing adherence to institution and home-based models of CR., Methods: One hundred participants with New York Heart Association (NYHA) class II and III HF symptoms were prospectively enrolled from a tertiary health facility in Western Kenya. Participants were non-randomly assigned to participate in one of two CR models based on their preference. Institution based cardiac rehabilitation (IBCR) comprised 36 facility-based exercise sessions over a period of 12 weeks. Home based cardiac rehabilitation (HBCR) comprised weekly pedometer guided exercise targets over a period of 12 weeks. An observational arm (OA) receiving usual care was also enrolled. The primary endpoint of CR feasibility was assessed based on study participants to adherence to at least 25% of exercise sessions. Secondary outcomes of change in NYHA symptom class, and six-minute walk time distance (6MWTD) were also evaluated. Data were summarized and analyzed as means (SD) and frequencies. Paired t-tests, Chi Square, Fisher's, and ANOVA tests were used for comparisons., Findings: Mean protocol adherence was greater than 25% in both CR models; 46% ± 18 and 29% ± 11 (P < 0.05) among IBCR and HBCR participants respectively. Improvements by at least one NYHA class were observed among 71%, 41%, and 54%, of IBCR, HBCR and OA participants respectively. 6MWTD increased significantly by a mean of 31 ± 65 m, 40 ± 55 m and 38 ± 71 m in the IBCR, HBCR and OA respectively (P < 0.05)., Conclusions: IBCR and HBCR, are feasible rehabilitation models for HF in Western Kenya. Whereas improvement in functional capacity was observed, effectiveness of CR in this population remains unknown. Future randomized studies evaluating effect size, long term efficacy, and safety of cardiac rehabilitation in low resource settings such as Kenya are recommended., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2022 The Author(s).)

Background: Elevated blood pressure is the leading cause of death worldwide; however, treatment and control rates remain very low. An expanding literature supports the strategy of task redistribution of hypertension care to nurses., Objective: We aimed to evaluate the effect of a nurse-based hypertension management program in Kenya., Methods: We conducted a retrospective data analysis of patients with hypertension who initiated nurse-based hypertension management care between January 1, 2011, and October 31, 2013. The primary outcome measure was change in systolic blood pressure (SBP) over one year, analyzed using piecewise linear mixed-effect models with a cut point at 3 months. The primary comparison of interest was care provided by nurses versus clinical officers. Secondary outcomes were change in diastolic blood pressure (DBP) over one year, and blood pressure control analyzed using a zero-inflated Poisson model., Results: The cohort consisted of 1051 adult patients (mean age 61 years; 65% women). SBP decreased significantly from baseline to three months (nurse-managed patients: slope -4.95 mmHg/month; clinical officer-managed patients: slope -5.28), with no significant difference between groups. DBP also significantly decreased from baseline to three months with no difference between provider groups. Retention in care at 12 months was 42%., Conclusions: Nurse-managed hypertension care can significantly improve blood pressure. However, retention in care remains a challenge. If these results are reproduced in prospective trial settings with improvements in retention in care, this could be an effective strategy for hypertension care worldwide., Competing Interests: The authors declare that they do not have any competing interests., (Copyright: © 2020 The Author(s).)

Background: Globalization has increased the demand for international experiences in medical education. International experiences improve medical knowledge, clinical skills, and self-development; influence career objectives; and provide insights on ethical and societal issues. However, global health rotations can end up being no more than tourism if not structured to foster personal transformation and global citizenship., Objective: We conducted a qualitative assessment of trainee-reported critical incidents to more deeply understand the impact of our global health experience on trainees., Methods: A cross-sectional survey was administered to trainees who had participated in a 2-month elective in Kenya from January 1989 to May 2013. We report the results of a qualitative assessment of the critical incident reflections participants (n = 137) entered in response to the prompt, "Write about one of your most memorable experiences and explain why you chose to describe this particular one." Qualitative analyses were conducted using thematic analysis and crystallization immersion analytic methods based on the principles of grounded theory, employing a constructivists' research paradigm., Findings: Four major themes emerged. These themes were Opening Oneself to a Broader World View; Impact of Suffering and Death; Life-Changing Experiences; and Commitment to Care for the Medically Underserved., Conclusions: Circumstances that learners encounter in the resource-scarce environment in Kenya are eye-opening and life-changing. When exposed to these frame-shifting circumstances, students elaborate on or transform existing points of view. These emotionally disruptive experiences in an international health setting allowed students to enter a transformational learning process with a global mind. Students can see the world as an interdependent society and develop the capacity to advance both their enlightened self-interest and the interest of people elsewhere in the world as they mature as global citizens. Medical schools are encouraged to foster these experiences by finding ways to integrate them into curriculum., (Copyright © 2017 Icahn School of Medicine at Mount Sinai. Published by Elsevier Inc. All rights reserved.)