Decentralised hepatitis C testing and treatment in rural Cambodia: evaluation of a simplified service model integrated in an existing public health system.
Zhang, M; O'Keefe, D; Craig, J; Samley, K; Bunreth, V; Jolivet, P; Balkan, S; Marquardt, T; Dousset, JP; Le Paih, M
Background: Direct-acting antiviral treatment for hepatitis C virus (HCV) has provided the opportunity for simplified models of care delivered in decentralised settings by non-specialist clinical personnel. However, in low-income and middle-income countries, increasing overall access to HCV care remains an ongoing issue, particularly for populations outside of urban centres. We therefore aimed to implement a simplified model of HCV care via decentralised health services within a rural health operational district in Battambang province, Cambodia.
Methods: The study cohort included adult residents (≥18 years) of the health operational district of Moung Russei who were voluntarily screened at 13 local health centres. Serology testing was done by a rapid diagnostic test using SD Bioline HCV (SD Bioline HCV, Standard Diagnostics, South Korea) with capillary blood. HCV viral load testing was done by GeneXpert (Cepheid, Sunnyvale, CA, USA). Viraemic patients (HCV viral load ≥10 IU/mL) received pretreatment assessment by a general physician and minimal treatment evaluation tests at the health operational district referral hospital. Viraemic patients who did not have additional complications received all HCV care follow-up at the local health centres, provided by nursing staff, and patients who had decompensated cirrhosis, previously treated with a direct-acting antiviral, HBV co-infection, or other comorbidities requiring observation continued receiving care at the referral hospital with a general physician. Patients deemed eligible for treatment were prescribed oral sofosbuvir (400 mg) and daclatasvir (60 mg) once a day for 12 weeks, or 24 weeks for patients with decompensated cirrhosis or those previously treated with a direct-acting antiviral. HCV cure was defined as sustained virological response at 12 weeks after treatment (HCV viral load <10 IU/mL). Patients were assessed for serious and non-serious adverse events at any time between treatment initiation and 12 weeks post-treatment testing.
Findings: Between March 12, 2018, and Jan 18, 2019, 10 425 residents (ie, 7·6% of the estimated 136 571 adults in the health operational district of Moung Russei) were screened. Of those patients screened, the median age was 44 years (IQR 31-55) and 778 (7·5%) were HCV-antibody positive. 761 (97·8%) of 778 antibody-positive patients received HCV viral load testing, and 540 (71·0%) of those tested were HCV viraemic. Among these 540 patients, linkage to treatment and follow-up care was high, with 533 (98·7%) attending a baseline consultation at the HCV clinic, of whom 530 (99·4%) initiated treatment. 485 (91·5%) of 530 patients who initiated treatment received follow-up at a health centre and 45 (8·5%) were followed up at the referral hospital. Of the 530 patients who initiated direct-acting antiviral therapy, 515 (97·2%) completed treatment. Subsequently, 466 (90·5%) of 515 patients completed follow-up, and 459 (98·5%) of 466 achieved a sustained virological response at 12 weeks after treatment. Two (0·4%) adverse events (fatigue [n=1] and stomach upset [n=1]) and five (0·9%) serious adverse events (infection [n=2], cardiovascular disease [n=1], and panic attack [n=1], with data missing for one of the causes of serious adverse events) were reported among patients who initiated treatment. All serious adverse events were deemed to be unrelated to therapy.
Interpretation: This pilot project showed that a highly simplified, decentralised model of HCV care can be integrated within a rural public health system in a low-income or middle-income country, while maintaining high patient retention, treatment efficacy, and safety. The project delivered care via accessible, decentralised primary health centres, using non-specialist clinical staff, thereby enhancing the efficient use of limited resources and maximising the potential to test and treat individuals living with HCV infection.
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Roles and responsibilities of cultural mediators
Venables, E; Whitehouse, K; Spissu, C; Pizzi, L; Al Rousan, A; di Carlo, S
Hepatitis C viraemic and seroprevalence and risk factors for positivity in Northwest Cambodia: a household cross-sectional serosurvey.
Lynch, E; Falq, G; Sun, C; Bunchhoeung, PDT; Huerga, H; Loarec, A; Dousset, JP; Marquardt, T; Le Paih, M; Maman, D
Background: Despite a dramatic reduction in HCV drug costs and simplified models of care, many countries lack important information on prevalence and risk factors to structure effective HCV services.
Methods: A cross-sectional, multi-stage cluster survey of HCV seroprevalence in adults 18 years and above was conducted, with an oversampling of those 45 years and above. One hundred forty-seven clusters of 25 households were randomly selected in two sets (set 1=24 clusters ≥18; set 2=123 clusters, ≥45). A multi-variable analysis assessed risk factors for sero-positivity among participants ≥45. The study occurred in rural Moung Ruessei Health Operational District, Battambang Province, Western Cambodia.
Results: A total of 5098 individuals and 3616 households participated in the survey. The overall seroprevalence was 2.6% (CI95% 2.3-3.0) for those ≥18 years, 5.1% (CI95% 4.6-5.7) for adults ≥ 45 years, and 0.6% (CI95% 0.3-0.9) for adults 18-44. Viraemic prevalence was 1.9% (CI95% 1.6-2.1), 3.6% (CI95% 3.2-4.0), and 0.5% (CI95% 0.2-0.8), respectively. Men had higher prevalence than women: ≥18 years male seroprevalence was 3.0 (CI95% 2.5-3.5) versus 2.3 (CI95% 1.9-2.7) for women. Knowledge of HCV was poor: 64.7% of all respondents and 57.0% of seropositive participants reported never having heard of HCV. Risk factor characteristics for the population ≥45 years included: advancing age (p< 0.001), low education (higher than secondary school OR 0.7 [95% CI 0.6-0.8]), any dental or gum treatment (OR 1.6 [95% CI 1.3-1.8]), historical routine medical care (medical injection after 1990 OR 0.7 [95% CI 0.6-0.9]; surgery after 1990 OR 0.7 [95% CI0.5-0.9]), and historical blood donation or transfusion (blood donation after 1980 OR 0.4 [95% CI 0.2-0.8]); blood transfusion after 1990 OR 0.7 [95% CI 0.4-1.1]).
Conclusions: This study provides the first large-scale general adult population prevalence data on HCV infection in Cambodia. The results confirm the link between high prevalence and age ≥45 years, lower socio-economic status and past routine medical interventions (particularly those received before 1990 and 1980). This survey suggests high HCV prevalence in certain populations in Cambodia and can be used to guide national and local HCV policy discussion.
Concomitant treatment of chronic hepatitis C with direct acting antivirals and multidrug-resistant tuberculosis is effective and safe
Melikyan, N; Huerga, H; Atshemyan, H; Kirakosyan, O; Sargsyants, N; Aydinyan, T; Saribekyan, N; Khachatryan, N; Oganezova, I; Falcao, J; Balkan, S; Hewison, C
We assessed effectiveness and safety of concomitant chronic hepatitis C (HCV) treatment with direct acting antivirals (DAAs) and multidrug-resistant tuberculosis (MDR-TB). Of 322 MDR-TB patients (19.4% HCV), 30 were treated concomitantly (23.3% HIV-positive). Overall, 76.7% achieved HCV treatment success (95.8% among tested). One patient (3.3%) experienced a serious adverse event.
"It's a secret between us": a qualitative study on children and care-giver experiences of HIV disclosure in Kinshasa, Democratic Republic of Congo.
Sumbi, EM; Venables, E; Harrison, R; Garcia, M; Iakovidi, K; van Cutsem, G; Chalachala, JL
Background: It is estimated that 64,000 children under 15 years of age are living with HIV in the Democratic Republic of Congo (DRC). Non-disclosure - in which the child is not informed about their HIV status - is likely to be associated with poor outcomes during adolescence including increased risk of poor adherence and retention, and treatment failure. Disclosing a child's HIV status to them can be a difficult process for care-givers and children, and in this qualitative study we explored child and care-giver experiences of the process of disclosing, including reasons for delay.
Methods: A total of 22 in-depth interviews with care-givers and 11 in-depth interviews with HIV positive children whom they were caring for were conducted in one health-care facility in the capital city of Kinshasa. Care-givers were purposively sampled to include those who had disclosed to their children and those who had not. Care-givers included biological parents, grandmothers, siblings and community members and 86% of them were female. Interviews were conducted in French and Lingala. All interviews were translated and/or transcribed into French before being manually coded. Thematic analysis was conducted. Verbal informed consent/assent was taken from all interviewees.
Results: At the time of interview, the mean age of children and care-givers was 17 (15-19) and 47 (21-70) years old, respectively. Many care-givers had lost family members due to HIV and several were HIV positive themselves. Reasons for non-disclosure included fear of stigmatisation; wanting to protect the child and not having enough knowledge about HIV or the status of the child to disclose. Several children had multiple care-givers, which also delayed disclosure, as responsibility for the child was shared. In addition, some care-givers were struggling to accept their own HIV status and did not want their child to blame them for their own positive status by disclosing to them.
Conclusions: Child disclosure is a complex process for care-givers, health-care workers and the children themselves. Care-givers may require additional psycho-social support to manage disclosure. Involving multiple care-givers in the care of HIV positive children could offer additional support for disclosure.
Long Duration and Resurgence of SARS-CoV-2 in Cameroonian Population
Buri, D; Njuwa, FKG; Matchim, L; Akendji, B; Eteki, L; Fouda, NM; Bebbel, L; Ndifon, M; Hamadou, A; Tchiasso, D; Nicolay, B; Abbah, A; Tchoula, C; Kameni, BT; Rene, E; Nsaibirni, R; Ntone, R; Fanne, M; Eyangoh, S; Ouamba, JP; Koku, MT; Mandeng, N; Esso, L; Claire, OM; Epee, E; Mballa, GAE; Njouom, R; Boum, Y
Infection with SARS-CoV-2 can lead to a detectable serological immune response even though extent of its protection is still not yet well known. We report long duration and resurgence of SARS-CoV-2 in patients with COVID-19.
We included a cohort of 99 participants from our non-blinded non-randomized evaluation of COVID-19 tests in Cameroon. Demographic and clinical information was collected from participants including self-reported age, race, ethnicity, and gender. Qualitative data was described as proportions while quantitative data was described with means and accompanying ranges.
Duration of PCR for SARS-CoV-2 positivity was found to range from 4 – 81 days, with mean duration of 32.8 days in patients with PCR-positive. We also identified 4 participants who also had SARS-CoV-2 resurgence within a three-month period.
These observations raise questions on clinical decision to release COVID-19 cases from isolation after 14 days.
This is a pre-print article.
Populations précaires et Covid-19 : innover et collaborer pour faire face aux besoins sociaux et de santé
Jackson, Y; Sibourd-Baudry, S; Regard, S; Petrucci, R
La crise liée au Covid-19 a fragilisé les populations en situation préalable de précarité. L’émergence de l’insécurité alimentaire et de logement a poussé les acteurs de la santé, du travail social et les autorités à mettre en place des mesures innovantes et intersectorielles permettant de répondre rapidement et efficacement aux besoins essentiels de ces populations. Cet article présente trois de ces mesures, à savoir une équipe mobile interprofessionnelle de dépistage, un dispositif d’hébergement et d’encadrement sanitaire pour les personnes sans-abri et un programme de distribution alimentaire à large échelle. Ces trois exemples illustrent la nécessité d’une approche transversale et collaborative et le besoin d’agir sur les déterminants sociaux et politiques sous-tendant ces vulnérabilités.
The COVID-19 crisis has rapidly increased the vulnerability of groups of population already facing precarious living conditions. The emergence of food and housing insecurity have forced health and social actors along with the local authorities to implement innovative responses in order to respond to these unmet needs. This article presents some of these responses, such as an interdisciplinary mobile COVID-19 screening team, an emergency housing program and a large-scale food assistance program. These examples highlight the need for an intersectoral, coordinated and collaborative response simultaneously targeting different domains of insecurity in parallel to actions on the underpinning social and political determinants of these vulnerabilities.
Ethics of emerging infectious disease outbreak responses: Using Ebola virus disease as a case study of limited resource allocation.
Nichol, AA; Antierens, A
Emerging infectious diseases such as Ebola Virus Disease (EVD), Nipah Virus Encephalitis and Lassa fever pose significant epidemic threats. Responses to emerging infectious disease outbreaks frequently occur in resource-constrained regions and under high pressure to quickly contain the outbreak prior to potential spread. As seen in the 2020 EVD outbreaks in the Democratic Republic of Congo and the current COVID-19 pandemic, there is a continued need to evaluate and address the ethical challenges that arise in the high stakes environment of an emerging infectious disease outbreak response. The research presented here provides analysis of the ethical challenges with regard to allocation of limited resources, particularly experimental therapeutics, using the 2013-2016 EVD outbreak in West Africa as a case study. In-depth semi-structured interviews were conducted with senior healthcare personnel (n = 16) from international humanitarian aid organizations intimately engaged in the 2013-2016 EVD outbreak response in West Africa. Interviews were recorded in private setting, transcribed, and iteratively coded using grounded theory methodology. A majority of respondents indicated a clear propensity to adopt an ethical framework of guiding principles for international responses to emerging infectious disease outbreaks. Respondents agreed that prioritization of frontline workers' access to experimental therapeutics was warranted based on a principle of reciprocity. There was widespread acceptance of adaptive trial designs and greater trial transparency in providing access to experimental therapeutics. Many respondents also emphasized the importance of community engagement in limited resource allocation scheme design and culturally appropriate informed consent procedures. The study results inform a potential ethical framework of guiding principles based on the interview participants' insights to be adopted by international response organizations and their healthcare workers in the face of allocating limited resources such as experimental therapeutics in future emerging infectious disease outbreaks to ease the moral burden of individual healthcare providers.
Effectiveness of miltefosine in cutaneous leishmaniasis caused by Leishmania tropica in Pakistan after antimonial treatment failure or contraindications to first line therapy-A retrospective analysis.
Kamink, S; Masih, B; Ali, N; Ullah, A; Khan, SJ; Ashraf, S; Pylypenko, T; Grobusch, MP; Fernhout, J; den Boer, M; Ritmeijer, K
Background: Cutaneous leishmaniasis (CL) is a neglected tropical skin disease, caused by Leishmania protozoa. In Pakistan, where CL caused by L. tropica is highly endemic, therapy with pentavalent antimonials is the standard of care, but has significant toxicity when used in systemic therapy, while are no evidence-based safer alternative treatment options for L. tropica. The efficacy of oral miltefosine has not been studied in CL caused by L. tropica. We evaluated effectiveness and tolerability of miltefosine in patients with previous treatment failure or with contraindications to systemic antimonial treatment.
Methods: A retrospective review was conducted of a cohort of CL patients who were treated with a 28-day course of miltefosine between December 2017 and August 2019, in urban Quetta, Pakistan, an area endemic for L. tropica. Descriptive analyses were performed, and effectiveness was assessed by initial response after treatment, and final cure at routine follow up visits, six weeks to three months post-treatment. Tolerability was assessed by routinely reported adverse events.
Results: Of the 76 CL patients in the cohort, 42 (55%) had contraindications to systemic antimonial treatment, and 34 (45%) had failure or relapse after antimonial treatment. Twelve patients defaulted during treatment and 12 patients were lost to follow up. In the remaining 52 patients, final cure rate was 77% (40/52). In those with contraindications to systemic antimonial treatment the final cure rate was 83% (24/29) and in the failure and relapse group 70% (16/23). Twenty-eight patients (40.0%) reported 39 mild to moderate adverse events with the main complaints being nausea (41.0%), general malaise (25.6%), and stomach pain (12.8%).
Conclusion: Results indicate that miltefosine is an effective second line treatment in CL in areas endemic for L. tropica. Prospective studies with systematic follow up are needed to obtain definitive evidence of effectiveness and tolerability, including identification of risk factors for miltefosine treatment failure.
Description of a community paediatric strategy offering a package of services to prevent malnutrition among children in one health district in Mali
Roederer, T; Llosa, AE; Shepherd, S; Defourny, I; Lacharite, MO; Okonta, C; Magassa, M; Traore, M; Schaefer, M; Grais, RF
Background We present results from an intervention case study, the Soins Preventifs de l’Enfant (SPE) project, in Konséguéla health area, Mali. The intervention involved a network of community health workers providing a comprehensive preventive/therapeutic package, ultimately aiming at reducing under 24-month mortality. Associated costs were documented to assess the feasibility of replication and scale-up.
Methods SPE program monitoring data were obtained from booklets specific to the program between 2010 and 2014. Data included sex, age, vaccination status, anthropometric measurements, Ready-To-Use-Supplementary Food distribution, morbidities reported by the mother between visits, hospitalizations over 18 months of follow-up. Cross-sectional surveys in the district of Koutiala, of which Konséguéla is one health area, were conducted yearly between 2010 and 2014 for comparison, using difference-in-difference approach. Ethical approval was granted from the Malian Ethical Committee.
Results Global and Severe Acute Malnutrition prevalences decreased over time in Konséguéla as well as in the rest of the district, but the difference between areas was not significant. Children reaching 24 months were 20% less stunted in Konséguéla than children the same age outside (p<0.001). Mortality rates significantly decreased more in Konséguéla, while vaccination coverage for all antigens significantly increased in the meantime. The package cost approximately USD 95 per child per year; 56% of which was for the RUSF.
Conclusion The results of this case study suggest a sustained impact of a community based, comprehensive health package on major child health indicators. Most notably, while improvements in acute malnutrition were found in the district as a whole, those in the intervention area were more pronounced. Trends for other indicators suggest additional benefits.
Prediction of disease severity in young children presenting with acute febrile illness in resource-limited settings: a protocol for a prospective observational study.
Chandna, A; Aderie, EM; Ahmad, R; Arguni, E; Ashley, EA; Cope, T; Dat, VQ; Day, NPJ; Dondorp, AM; Illanes, V; De Jesus, J; Jimenez, C; Kain, K; Suy, K; Koshiaris, C; Lasry, E; Mayxay, M; Mondal, D; Perera, R; Pongvongsa, T; Rattanavong, S; Rekart, M; Richard-Greenblatt, M; Shomik, M; Souvannasing, P; Tallo, V; Turner, C; Turner, P; Wathira, N; Watson, JA; Yosia, M; Burza, S; Lubell, Y
Introduction: In rural and difficult-to-access settings, early and accurate recognition of febrile children at risk of progressing to serious illness could contribute to improved patient outcomes and better resource allocation. This study aims to develop a prognostic clinical prediction tool to assist community healthcare providers identify febrile children who might benefit from referral or admission for facility-based medical care.
Methods and analysis: This prospective observational study will recruit at least 4900 paediatric inpatients and outpatients under the age of 5 years presenting with an acute febrile illness to seven hospitals in six countries across Asia. A venous blood sample and nasopharyngeal swab is collected from each participant and detailed clinical data recorded at presentation, and each day for the first 48 hours of admission for inpatients. Multianalyte assays are performed at reference laboratories to measure a panel of host biomarkers, as well as targeted aetiological investigations for common bacterial and viral pathogens. Clinical outcome is ascertained on day 2 and day 28.Presenting syndromes, clinical outcomes and aetiology of acute febrile illness will be described and compared across sites. Following the latest guidance in prediction model building, a prognostic clinical prediction model, combining simple clinical features and measurements of host biomarkers, will be derived and geographically externally validated. The performance of the model will be evaluated in specific presenting clinical syndromes and fever aetiologies.
Ethics and dissemination: The study has received approval from all relevant international, national and institutional ethics committees. Written informed consent is provided by the caretaker of all participants. Results will be shared with local and national stakeholders, and disseminated via peer-reviewed open-access journals and scientific meetings.
The political and security dimensions of the humanitarian health response to violent conflict.
Wise, PH; Shiel, A; Southard, N; Bendavid, E; Welsh, J; Stedman, S; Fazal, T; Felbab-Brown, V; Polatty, D; Waldman, RJ; Spiegel, PB; Blanchet, K; Dayoub, R; Zakayo, A; Barry, M; Garcia, DM; Pagano, H; Black, R; Gaffey, MF; Bhutta, ZA; BRANCH Consortium
The nature of armed conflict throughout the world is intensely dynamic. Consequently, the protection of non-combatants and the provision of humanitarian services must continually adapt to this changing conflict environment. Complex political affiliations, the systematic use of explosive weapons and sexual violence, and the use of new communication technology, including social media, have created new challenges for humanitarian actors in negotiating access to affected populations and security for their own personnel. The nature of combatants has also evolved as armed, non-state actors might have varying motivations, use different forms of violence, and engage in a variety of criminal activities to generate requisite funds. New health threats, such as the COVID-19 pandemic, and new capabilities, such as modern trauma care, have also created new challenges and opportunities for humanitarian health provision. In response, humanitarian policies and practices must develop negotiation and safety capabilities, informed by political and security realities on the ground, and guidance from affected communities. More fundamentally, humanitarian policies will need to confront a changing geopolitical environment, in which traditional humanitarian norms and protections might encounter wavering support in the years to come.
This article is available for free at https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00130-6/fulltext.
Virologic response of adolescents living with perinatally acquired HIV receiving antiretroviral therapy in the period of early adolescence (10-14 years) in South Africa.
Nyakato, P; Schomaker, M; Sipambo, N; Technau, KG; Fatti, G; Rabie, H; Tanser, F; Eley, B; Euvrard, J; Wood, R; Tsondai, PR; Yiannoutsos, CT; Cornell, M; Davies, MA
Background and objectives:
Adolescents living with perinatally acquired HIV (ALPHIV) on antiretroviral therapy (ART) have been noted to have poorer adherence, retention and virologic control compared to adolescents with nonperinatally acquired HIV, children or adults. We aimed to describe and examine factors associated with longitudinal virologic response during early adolescence.
A retrospective cohort study
We included ALPHIV who initiated ART before age 9.5 years in South African cohorts of the International epidemiology Database to Evaluate AIDS-Southern Africa (IeDEA-SA) collaboration (2004–2016); with viral load (VL) values <400 copies/ml at age 10 years and at least one VL measurement after age 10 years. We used a log-linear quantile mixed model to assess factors associated with elevated (75th quantile) VLs.
We included 4396 ALPHIV, 50.7% were male, with median (interquartile range) age at ART start of 6.5 (4.5, 8.1) years. Of these, 74.9% were on a nonnucleoside reverse transcriptase inhibitor (NNRTI) at age 10 years. After adjusting for other patient characteristics, the 75th quantile VLs increased with increasing age being 3.13-fold (95% CI 2.66, 3.68) higher at age 14 versus age 10, were 3.25-fold (95% CI 2.81, 3.75) higher for patients on second-line protease-inhibitor and 1.81-fold for second-line NNRTI-based regimens (versus first-line NNRTI-based regimens). There was no difference by sex.
As adolescents age between 10 and 14 years, they are increasingly likely to experience higher VL values, particularly if receiving second-line protease inhibitor or NNRTI-based regimens, which warrant adherence support interventions.
We regret that this article is behind a paywall.
Delivery strategies for optimizing uptake of contraceptives among adolescents aged 15-19 years in Nsanje District, Malawi.
Makinja, AK; Maida, ZM; Nyondo-Mipando, AL
Despite documented benefits of contraceptives, uptake among young people aged 20–24 years is high compared to adolescents aged 15–19 years in Malawi. As the world’s population of 15–19-year-olds continues to grow the need to meet the increasing demand for contraceptive services and information that address adolescent-specific needs cannot be underestimated. To inform Sexual and Reproductive health services for the youth, we explored strategies for optimizing uptake of contraceptives among this age group.
An exploratory qualitative cross-sectional study was conducted at Nsanje District Hospital and Nyamadzere Community Day Secondary School guided by Social-Ecological Framework to understand strategies that may optimize the uptake of contraceptives among adolescents aged 15–19. Nsanje district was purposively selected based on the reason that it is the second district in Malawi with the highest rate of adolescent childbearing of girls aged 15–19 years. We conducted a Focus Group Discussion (FGD) with 9 traditional leaders, 11 Key Informant Interviews (KIIs) with health workers, 20 In-depth Interviews (IDIs) with 12 adolescents, 4 teachers, and 4 parents. All data were digitally recorded, transcribed verbatim into English. The data was analyzed and managed using deductive thematic analysis guided by Social-Ecological Framework.
Adolescents suggested accessing contraceptives from local drug stores, pharmacies and hospitals at a health system level and through Youth Centres, clubs, and corners at a Community level. There is a need to ensure a continuous supply of various kinds of contraceptives and the presence of youth-friendly health care workers in the specified areas.
There is no one way of delivering contraceptives to adolescents. Multiple avenues existent at the health facility and community could be leveraged to optimize delivery and uptake of contraceptives in a manner that is not intimidating to an adolescent while involving key stakeholders.
Clinical outcomes in a primary-level non-communicable disease programme for Syrian refugees and the host population in Jordan: A cohort analysis using routine data
Ansbro, E; Homan, T; Prieto Merino, D; Jobanputra, K; Qasem, J; Muhammad, S; Fardous, T; Perel, P
Little is known about the content or quality of non-communicable disease (NCD) care in humanitarian settings. Since 2014, Médecins Sans Frontières (MSF) has provided primary-level NCD services in Irbid, Jordan, targeting Syrian refugees and vulnerable Jordanians who struggle to access NCD care through the overburdened national health system. This retrospective cohort study explored programme and patient-level patterns in achievement of blood pressure and glycaemic control, patterns in treatment interruption, and the factors associated with these patterns.
Methods and findings
The MSF multidisciplinary, primary-level NCD programme provided facility-based care for cardiovascular disease, diabetes, and chronic respiratory disease using context-adapted guidelines and generic medications. Generalist physicians managed patients with the support of family medicine specialists, nurses, health educators, pharmacists, and psychosocial and home care teams. Among the 5,045 patients enrolled between December 2014 and December 2017, 4,044 eligible adult patients were included in our analysis, of whom 72% (2,913) had hypertension and 63% (2,546) had type II diabetes. Using visits as the unit of analysis, we plotted the following on a monthly basis: mean blood pressure among hypertensive patients, mean fasting blood glucose and HbA1c among type II diabetic patients, the proportion of each group achieving control, mean days of delayed appointment attendance, and the proportion of patients experiencing a treatment interruption. Results are presented from programmatic and patient perspectives (using months since programme initiation and months since cohort entry/diagnosis, respectively). General linear mixed models explored factors associated with clinical control and with treatment interruption. Mean age was 58.5 years, and 60.1% (2,432) were women. Within the programme’s first 6 months, mean systolic blood pressure decreased by 12.4 mm Hg from 143.9 mm Hg (95% CI 140.9 to 146.9) to 131.5 mm Hg (95% CI 130.2 to 132.9) among hypertensive patients, while fasting glucose improved by 1.12 mmol/l, from 10.75 mmol/l (95% CI 10.04 to 11.47) to 9.63 mmol/l (95% CI 9.22 to 10.04), among type II diabetic patients. The probability of achieving treatment target in a visit was 63%–75% by end of 2017, improving with programme maturation but with notable seasonable variation. The probability of experiencing a treatment interruption declined as the programme matured and with patients’ length of time in the programme. Routine operational data proved useful in evaluating a humanitarian programme in a real-world setting, but were somewhat limited in terms of data quality and completeness. We used intermediate clinical outcomes proven to be strongly associated with hard clinical outcomes (such as death), since we had neither the data nor statistical power to measure hard outcomes.
Good treatment outcomes and reasonable rates of treatment interruption were achieved in a multidisciplinary, primary-level NCD programme in Jordan. Our approach to using continuous programmatic data may be a feasible way for humanitarian organisations to account for the complex and dynamic nature of interventions in unstable humanitarian settings when undertaking routine monitoring and evaluation. We suggest that frequency of patient contact could be reduced without negatively impacting patient outcomes and that season should be taken into account in analysing programme performance.
Outcomes of AIDS-associated Kaposi sarcoma in Mozambique after treatment with pegylated liposomal doxorubicin
Coldiron, ME; Gutierrez Zamudio, AG; Manuel, R; Luciano, G; Rusch, B; Ciglenecki, I; Telnov, A; Grais, RF; Trellu, LT; Molfino, L
Kaposi’s sarcoma (KS) is a common HIV-associated malignancy frequently associated with poor outcomes. It is the most frequently diagnosed cancer in major cities of Mozambique. Antiretroviral therapy is the cornerstone of KS treatment, but many patients require cytotoxic chemotherapy. The traditional regimen in Mozambique includes conventional doxorubicin, bleomycin and vincristine, which is poorly tolerated. In 2016, pegylated liposomal doxorubicin was introduced at a specialized outpatient center in Maputo, Mozambique.
We performed a prospective, single-arm, open-label observational study to demonstrate the feasibility, safety, and outcomes of treatment with pegylated liposomal doxorubicin (PLD) in patients with AIDS-associated Kaposi sarcoma (KS) in a low-resource setting. Chemotherapy-naïve adults with AIDS-associated KS (T1 or T0 not responding to 6 months of antiretroviral therapy) were eligible if they were willing to follow up for 2 years. Patients with Karnofsky scores < 50 or contraindications to PLD were excluded. One hundred eighty-three patients were screened and 116 participants were enrolled. Patients received PLD on three-week cycles until meeting clinical stopping criteria. Follow-up visits monitored HIV status, KS disease, side effects of chemotherapy, mental health (PHQ-9) and quality of life (SF-12). Primary outcome measures included vital status and disease status at 6, 12, and 24 months after enrollment.
At 24 months, 23 participants (20%) had died and 15 (13%) were lost to follow-up. Baseline CD4 < 100 was associated with death (HR 2.7, 95%CI [1.2–6.2], p = 0.016), as was T1S1 disease compared to T1S0 disease (HR 2.7, 95%CI [1.1–6.4], p = 0.023). Ninety-two participants achieved complete or partial remission at any point (overall response rate 80%), including 15 (13%) who achieved complete remission. PLD was well-tolerated, and the most common AEs were neutropenia and anemia. Quality of life improved rapidly after beginning PLD.
PLD was safe, well-tolerated and effective as first-line treatment of KS in Mozambique. High mortality was likely due to advanced immunosuppression at presentation, underscoring the importance of earlier screening and referral for KS.
Accuracy of molecular drug susceptibility testing amongst tuberculosis patients in Karakalpakstan, Uzbekistan.
Gil, Horacio; Margaryan, Hasmik; Azamat, Ismailov; Ziba, Bekturdieva; Bayram, Halmuratov; Nazirov, Pirimqul; Gomez, Diana; Singh, Jatinder; Zayniddin, Sayfutdinov; Parpieva, Nargiza; Achar, Jay
In this retrospective study, we evaluated the diagnostic accuracy of molecular tests (MT) for the detection of DR‐TB, compared to the gold standard liquid‐based Drug Susceptibility Testing (DST) in Karakalpakstan.
A total of 6,670 specimens received in the Republican TB No 1 Hospital Laboratory of Karakalpakstan between January and July 2017 from new and retreatment patients were analyzed. Samples were tested using Xpert MTB/RIF and line probe assays (LPA) for the detection of mutations associated with resistance. The sensitivity and specificity of MTs were calculated relative to results based on DST.
The accuracy of MT for detection of rifampicin resistance was high, with sensitivity and specificity over 98%. However, we observed reduced sensitivity of LPA for detection of resistance; 86% for isoniazid (95%CI 82‐90%), 86% for fluoroquinolones (95%CI 68‐96%), 70% for capreomycin (95%CI 46‐88%) and 23% for kanamycin (95%CI 13‐35%).
We show that MTs are a useful tool for rapid and safe diagnosis of DR‐TB, however, clinicians should be aware of their limitations. Although detection of rifampicin resistance was highly accurate, our data suggests that resistance mutations circulating in the Republic of Karakalpakstan for other drugs were not detected by the methods used here. This merits further investigation.
Safety and effectiveness of an all-oral, bedaquiline-based, shorter treatment regimen for rifampicin-resistant tuberculosis in high HIV burden rural South Africa: a retrospective cohort analysis
Tack, I; Dumicho, A; Ohler, L; Shigayeva, A; Bulti, AB; White, K; Mbatha, M; Furin, J; Isaakidis, P
At the end of 2018, South Africa updated its all-oral regimen, to include bedaquiline (BDQ) and two months of linezolid (LZD) for all patients initiating the shorter 9 to 12 months regimen for rifampicin-resistant tuberculosis (RR-TB). We assessed a group of patients in rural KwaZulu-Natal for safety and effectiveness of this treatment regimen under programmatic conditions.
We conducted a retrospective cohort analysis on RR-TB patients treated with a standardized all-oral short regimen between July 1, 2018 and April 30, 2019 in three facilities in King Cetshwayo District. An electronic register (EDR Web) and facility-based clinical charts were used to collect variables which were entered into an Epi-Info database.
Our cohort included 117 patients; 68.4%(95%CI:59.3-76.3) were HIV positive. The median time to culture conversion was 56 days(95%CI:50-57). Treatment success was achieved in 75.2%(95%CI:66.5-82.3) of patients. Mortality within the cohort was 12.8%(95%CI:7.8-20.3). Anaemia was the most frequent severe adverse event. The median time to develop severe anaemia was 7.1 weeks(IQR 4.0-12.9) after treatment initiation. LZD was interrupted in 25.2%(95%CI:17.8-34.5) of participants.
An all-oral shorter regimen, including BDQ and LZD as core drugs for the treatment of RR-TB, shows good outcomes, in a high HIV burden rural setting. Adverse events (AEs) are common, especially for LZD, but could be managed in the program setting. Support is needed when introducing new regimens to upskill staff in the monitoring, management and reporting of AEs.
Impact of food supplements on early child development in children with moderate acute malnutrition: A randomised 2 x 2 x 3 factorial trial in Burkina Faso
Olsen, MF; Iuel-Brockdorff, AS; Yameogo, CW; Cichon, B; Fabiansen, C; Filteau, S; Phelan, K; Ouedraogo, A; Michaelsen, KF; Gladstone, M; Ashorn, P; Briend, A; Ritz, C; Friis, H; Christensen, VB
Lipid-based nutrient supplements (LNS) and corn–soy blends (CSBs) with varying soy and milk content are used in treatment of moderate acute malnutrition (MAM). We assessed the impact of these supplements on child development.
Methods and findings
We conducted a randomised 2 × 2 × 3 factorial trial to assess the effectiveness of 12 weeks’ supplementation with LNS or CSB, with either soy isolate or dehulled soy, and either 0%, 20%, or 50% of protein from milk, on child development among 6–23-month-old children with MAM. Recruitment took place at 5 health centres in Province du Passoré, Burkina Faso between September 2013 and August 2014. The study was fully blinded with respect to soy quality and milk content, while study participants were not blinded with respect to matrix. This analysis presents secondary trial outcomes: Gross motor, fine motor, and language development were assessed using the Malawi Development Assessment Tool (MDAT). Of 1,609 children enrolled, 54.7% were girls, and median age was 11.3 months (interquartile range [IQR] 8.2–16.0). Twelve weeks follow-up was completed by 1,548 (96.2%), and 24 weeks follow-up was completed by 1,503 (93.4%); follow-up was similar between randomised groups. During the study, 4 children died, and 102 children developed severe acute malnutrition (SAM). There was no difference in adverse events between randomised groups. At 12 weeks, the mean MDAT z-scores in the whole cohort had increased by 0.33 (95% CI: 0.28, 0.37), p < 0.001 for gross motor; 0.26 (0.20, 0.31), p < 0.001 for fine motor; and 0.14 (0.09, 0.20), p < 0.001 for language development. Children had larger improvement in language z-scores if receiving supplements with milk (20%: 0.09 [−0.01, 0.19], p = 0.08 and 50%: 0.11 [0.01, 0.21], p = 0.02), although the difference only reached statistical significance for 50% milk. Post hoc analyses suggested that this effect was specific to boys (interaction p = 0.02). The fine motor z-scores were also improved in children receiving milk, but only when 20% milk was added to CSB (0.18 [0.03, 0.33], p = 0.02). Soy isolate over dehulled soy increased language z-scores by 0.07 (−0.01, 0.15), p = 0.10, although not statistically significant. Post hoc analyses suggested that LNS benefited gross motor development among boys more than did CSB (interaction p = 0.04). Differences between supplement groups did not persist at 24 weeks, but MDAT z-scores continued to increase post-supplementation. The lack of an unsupplemented control group limits us from determining the overall effects of nutritional supplementation for children with MAM.
In this study, we found that child development improved during and after supplementation for treatment of MAM. Milk protein was beneficial for language and fine motor development, while suggested benefits related to soy quality and supplement matrix merit further investigation. Supplement-specific effects were not found post-intervention, but z-scores continued to improve, suggesting a sustained overall effect of supplementation.
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