Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 20
Filter
1.
PLOS Glob Public Health ; 3(6): e0001325, 2023.
Article in English | MEDLINE | ID: mdl-37315036

ABSTRACT

Gambiense Human African Trypanosomiasis (g-HAT) is a neglected tropical disease caused by trypanosomes transmitted by tsetse flies. In 2017, a pilot community-based project was launched in three villages in DRC with the overall goal of empowering community members to control tsetse using Tiny Targets which attract and kill tsetse. In this paper, we assess the community participation process in these three pilot villages over >4 years and evaluate to what extent this resulted in the empowerment of communities. We conducted a qualitative study using a participatory research approach. Together with community members of the three pilot villages from the endemic Kwilu province, we evaluated changes in project participation, community empowerment and perception of future participation at three different time points (September 2017, September 2018 and November 2021) over a 4-year period using participatory workshops and focus group discussions (FGD). We used a thematic content approach to analyse both workshop notes and FGD transcripts. The community identified five indicators to evaluate participation: (1) Leadership & Ownership, (2) Organisation & Planning, (3) Willingness, (4) Autonomy and (5) Community Involvement. The participation experience described by community members was characterised by a rapid growth of empowerment in the first year and sustained high levels thereafter. Community participants were willing to engage in potential future projects and continue to be supported by their Tiny Target project partner. However, they identified an imbalance in the power relationship within the committee and with the Tiny Target partners that limit the extent of empowerment attained. The intervention had broader benefits of community empowerment but this was limited by perceptions of being part of wider "top down" programme and by stakeholders attitude toward community participation. If empowerment is to be an important objective of projects and programmes then the needs identified by communities must be recognised and attitude of sharing power encouraged.

2.
Glob Public Health ; 17(12): 4146-4158, 2022 12.
Article in English | MEDLINE | ID: mdl-35748778

ABSTRACT

Human African trypanosomiasis (HAT) is considered a highly promising candidate for elimination within the next decade. This paper argues that the experiential knowledge of frontline health workers will be critical to achieve this goal. Interviews are used to explore the ways in which HAT workers understand, maintain, and adjust their skills amidst global and national challenges. We contrast two cases: South Sudan where HAT expertise is scattered and has been repeatedly rebuilt, and the Democratic Republic of Congo (DRC) where specialised mobile detection teams have pro-actively tested people at risk for almost a century. We describe HAT careers where skills are built through participation in HAT technology trials and screening programmes; in the DRC expertise is also supported through formal rotations in screening teams and HAT referral centres for new health workers. As cases fade, de-skilling is a real threat as awareness of populations and authorities diminishes and previously vertical programmes evolve, re-configuring professional development and career paths and associated opportunities for HAT practice. To avoid repeating the mistakes of the 1960s, when elimination also seemed close at hand, we need to recognise that the 'last mile' of elimination hinges on protecting the fragile expertise of frontline health workers.


Subject(s)
Trypanosomiasis, African , Animals , Humans , Trypanosomiasis, African/epidemiology , Trypanosomiasis, African/prevention & control , Trypanosomiasis, African/diagnosis , Democratic Republic of the Congo/epidemiology , South Sudan/epidemiology , Disease Eradication , Health Personnel
3.
Soc Sci Med ; 299: 114882, 2022 04.
Article in English | MEDLINE | ID: mdl-35299059

ABSTRACT

Human African Trypanosomiasis (HAT), commonly known as sleeping sickness, is closer than ever to being eliminated as a public health problem. The main narratives for the impressive drop in cases allude to drugs discovery and global financing and coordination. They raise questions about the relationship between well-funded international clinical research and much less well-endowed national disease control programmes. They need to be complemented with a solid understanding of how (and why) national programmes that do most of the frontline work are structured and operate. We analyse archives and in-depth interviews with key stakeholders and explore the role the national HAT programme played in the Democratic Republic of the Congo (DRC), a country that consistently accounts for over 60% of HAT cases worldwide. The programme grew strongly between 1996, when it was barely surviving, and 2016. Our political economy lens highlights how the leadership of the programme managed to carve itself substantial autonomy within the health system, forged new international alliances, and used clinical trials and international research to not only improve treatment and diagnosis but also to enhance its under-resourced disease control system. The DRC, a country often described as 'fragile', stands out as having an efficient national HAT programme that made full use of a window of opportunity that arose in the early 2000s when international researchers and donors responded to the ambition to simplify disease control and make HAT treatment more humane. We discuss the sustainability of both the vertical approach embodied in the DRC's national HAT programme and its funding model at a time when the number of HAT cases is at an all-time low and better integration within the health system is urgent. Our study provides insights for collaborations between unevenly-resourced international research efforts and national health programmes.


Subject(s)
Trypanosomiasis, African , Clinical Trials as Topic , Democratic Republic of the Congo/epidemiology , Humans , Public Health , Trypanosomiasis, African/epidemiology , Trypanosomiasis, African/prevention & control
4.
BMJ Glob Health ; 7(1)2022 01.
Article in English | MEDLINE | ID: mdl-34992076

ABSTRACT

The National Programme for the control of human African trypanosomiasis in Democratic Republic of Congo includes a large-scale vector control operation using Tiny Targets. These are small panels of insecticide-impregnated cloth that are deployed in riverine habitat where tsetse flies concentrate. The effectiveness of Tiny Targets depends partly on acceptance by local communities. In 2018, we conducted research to explore the perception and acceptability of Tiny Targets in two different village clusters where Tiny Targets had been deployed by the local community or external teams. We conducted fourteen focus group discussions and seven semistructured interviews in three villages from each cluster in the Yasa Bonga health zone. Our findings showed that acceptability was better in the cluster where communities were involved in the deployment of Tiny Targets. Also in this cluster, awareness about Tiny Targets was satisfactory and the project was implemented within local customs, which promoted a positive perception of Tiny Targets and their benefits. In the cluster where external teams deployed Tiny Targets, a lack of information and communication, stereotypes applied by communities towards the deployment teams and the impression of inadequate respect for local customs led to anxiety and a misleading interpretation of the purpose of Tiny Targets and negatively influenced acceptability. This study highlights the importance of involving communities for programme acceptance. Our research underlined how awareness campaigns and communication are essential, but also how working within the scope of community social norms and customs are equally important. Prospects for the successful use of Tiny Targets are greater when communities are involved because the use can be adapted to social norms.


Subject(s)
Diptera , Trypanosomiasis, African , Tsetse Flies , Animals , Democratic Republic of the Congo , Humans , Insect Control/methods , Trypanosomiasis, African/prevention & control
5.
Emerg Infect Dis ; 27(8): 2144-2153, 2021 08.
Article in English | MEDLINE | ID: mdl-34287133

ABSTRACT

We integrated sleeping sickness case detection into the primary healthcare system in 2 health districts in the Democratic Republic of the Congo. We replaced a less field-friendly serologic test with a rapid diagnostic test, which was followed up by human African trypanosomiasis microscopic testing, and used a mixed costing methodology to estimate costs from a healthcare provider perspective. We screened a total of 18,225 persons and identified 27 new cases. Average financial cost (i.e., actual expenditures) was US $6.70/person screened and $4,464/case diagnosed and treated. Average economic cost (i.e., value of resources foregone that could have been used for other purposes) was $9.40/person screened and $6,138/case diagnosed and treated. Our study shows that integrating sleeping sickness surveillance into the primary healthcare system is feasible and highlights challenges in completing the diagnostic referral process and developing a context-adapted diagnostic algorithm for the large-scale implementation of this strategy in a sustainable and low-cost manner.


Subject(s)
Diagnostic Tests, Routine , Trypanosomiasis, African , Animals , Delivery of Health Care , Democratic Republic of the Congo/epidemiology , Health Personnel , Humans , Trypanosomiasis, African/diagnosis , Trypanosomiasis, African/epidemiology
6.
PLoS Negl Trop Dis ; 14(12): e0008832, 2020 12.
Article in English | MEDLINE | ID: mdl-33315896

ABSTRACT

BACKGROUND: Human African trypanosomiases caused by the Trypanosoma brucei gambiense parasite is a lethal disease targeted for eradication. One of the main disease control strategies is active case-finding through outreach campaigns. In 2014, a new method for active screening was developed with mini, motorcycle-based, teams. This study compares the cost of two active case-finding approaches, namely the traditional mobile teams and mini mobile teams, in the two health districts of the Democratic Republic of the Congo. METHODS: The financial and economic costs of both approaches were estimated from a health care provider perspective. Cost and operational data were collected for 12 months for 1 traditional team and 3 mini teams. The cost per person screened and diagnosed was calculated and univariate sensitivity analysis was conducted to identify the main cost drivers. RESULTS: During the study period in total 264,630 people were screened, and 23 HAT cases detected. The cost per person screened was lower for a mini team than for a traditional team in the study setting (US$1.86 versus US$2.08). A comparable result was found in a scenario analysis, assuming both teams would operate in a similar setting, with the cost per person screened by a mini team 15% lower than the cost per person screened by a traditional team (1.86 $ vs 2.14$). The main explanations for this lower cost are that mini teams work with fewer human resources, cheaper means of transportation and do not perform the Capillary Tube Centrifugation test or card agglutination test dilutions. DISCUSSION: Active HAT screening with mini mobile teams has a lower cost and could be a cost-effective alternative for active case-finding. Further research is needed to determine if mini mobile teams have similar or better yields than traditional mobile teams in terms of detections and cases successfully treated.


Subject(s)
Delivery of Health Care/methods , Mass Screening/economics , Mass Screening/methods , Trypanosomiasis, African/diagnosis , Trypanosomiasis, African/epidemiology , Agglutination Tests , Delivery of Health Care/economics , Democratic Republic of the Congo/epidemiology , Health Care Costs , Humans , Sensitivity and Specificity , Trypanosoma brucei gambiense
7.
PLoS Negl Trop Dis ; 14(10): e0008745, 2020 10.
Article in English | MEDLINE | ID: mdl-33112859

ABSTRACT

To adequately plan mass drug administration campaigns, the Democratic Republic of the Congo (DRC) needs further support for the mapping and monitoring of schistosomiasis (SCH) and soil-transmitted helminths (STH). We conducted a community-based survey in the health districts of Mosango and Yasa Bonga of the Kwilu province, DRC. A stratified two-stage cluster random sampling method was used to include participants into three different strata: Preschool-aged children (PSAC), school-aged children (SAC), and adults who were further subdivided into women of reproductive age (WRA) and other adults. In total, surveyors visited 30 villages, and 1 206 individuals participated in the study. Stool samples were collected to perform duplicate Kato-Katz smears for the detection of SCH and STH infection. Hookworm was the most prevalent infection in both districts, 34.1% (95%CI: 32.0-38.4), followed by A. lumbricoides (2.7%; 95%CI: 1.3-2.9) and T. trichiura (1.9%; 95%CI: 1.1-2.7). We did not find any SCH infection. The prevalence of each STH infection was similar across all risk groups, and the majority of the infected individuals was carrying light intensity infection. Compared to SAC, other adults were equally infected with hookworm. The prevalence of STH infection in SAC guides the MDA implementation because schoolchildren are most at risk and easily accessible program targets if school attendance is high. The current treatment strategy targets PSAC, SAC and WRA. However, this study shows that adults in general could also benefit from deworming. Therefore, community-wide preventive chemotherapy would be the most appropriate choice to control the hookworm burden rapidly.


Subject(s)
Ascariasis/epidemiology , Hookworm Infections/epidemiology , Trichuriasis/epidemiology , Adolescent , Adult , Ancylostomatoidea/isolation & purification , Animals , Ascariasis/prevention & control , Ascaris lumbricoides/isolation & purification , Child , Democratic Republic of the Congo/epidemiology , Feces/parasitology , Female , Helminthiasis/epidemiology , Helminthiasis/prevention & control , Hookworm Infections/prevention & control , Humans , Male , Mass Drug Administration , Middle Aged , Prevalence , Residence Characteristics , Schools , Soil/parasitology , Surveys and Questionnaires , Trichuriasis/prevention & control , Trichuris/isolation & purification , Young Adult
8.
PLoS Negl Trop Dis ; 14(9): e0008696, 2020 09.
Article in English | MEDLINE | ID: mdl-32970689

ABSTRACT

Gambiense Human African Trypanosomiasis (g-HAT) is a neglected tropical disease caused by trypanosomes transmitted by tsetse flies. 70% of cases in 2019 (604/863) occurred in the Democratic Republic of Congo (DRC). The national programme for g-HAT elimination in DRC includes a large-scale deployment of Tiny Targets which attract and kill tsetse. This intervention is directed by vector-control specialists with small teams, moving in canoes, deploying Tiny Targets along riverbanks where tsetse concentrate. While the targets are deployed in communal areas, and the method is cheap and easy-to-use, local people have little involvement. This study aimed to evaluate if a community-led vector control programme was feasible in the context of DRC's g-HAT elimination programme. In 2017, a community-led intervention was implemented in three villages in the Kwilu province of DRC. This intervention was evaluated through an Action Research with qualitative data collected through 21 focus group discussions and 289 hours of observation. Also the geographical location and quality of each Tiny Targets were collected (total number deployed = 2429). This research revealed that community-based approach largely worked: people were motivated and proactive, showed a good application of the acquired knowledge resulting in an effective deployment of Tiny Targets. In addition, our study provided evidence that acceptability of the targets by the community can improve deployment quality by reducing target loss and damage. The approach was feasible in places where canoe-based teams could not reach. Against these advantages, a community-based approach was time-consuming and had to adapt to the seasonal and daily rhythms of the community. A community-based approach for tsetse control is technically feasible and recommended but limits to the speed and scale of the approach restraints its application as a standalone strategy in a large-scale national programme aiming to eliminate g-HAT in a short timeframe.


Subject(s)
Insect Control/methods , Insect Vectors , Neglected Diseases/prevention & control , Animals , Democratic Republic of the Congo/epidemiology , Disease Eradication , Feasibility Studies , Female , Humans , Insect Vectors/parasitology , Insect Vectors/physiology , Male , Neglected Diseases/parasitology , Pilot Projects , Trypanosoma , Trypanosomiasis, African/epidemiology , Trypanosomiasis, African/transmission , Tsetse Flies/parasitology , Tsetse Flies/physiology
9.
Trop Med Infect Dis ; 5(1)2020 Jan 01.
Article in English | MEDLINE | ID: mdl-31906341

ABSTRACT

While academic literature has paid careful attention to the technological efforts-drugs, tests, and tools for vector control-deployed to eliminate Gambiense Human African Trypanosomiasis (HAT), the human resources and health systems dimensions of elimination are less documented. This paper analyses the perspectives and experiences of frontline nurses, technicians, and coordinators who work for the HAT programme in the former province of Bandundu in the Democratic Republic of the Congo, at the epidemic's very heart. The research is based on 21 semi-structured interviews conducted with frontline workers in February 2018. The results highlight distinctive HAT careers as well as social elevation through specialised work. Frontline workers are concerned about changes in active screening strategies and the continued existence of the vector, which lead them to question the possibility of imminent elimination. Managers seem to anticipate a post-HAT situation and prepare for the employment of their staff; most workers see their future relatively confidently, as re-allocated to non-vertical units. The findings suggest concrete pathways for improving the effectiveness of elimination efforts: improving active screening through renewed engagements with local leaders, conceptualising horizontal integration in terms of human resources mobility, and investing more in detection and treatment activities (besides innovation).

10.
Infect Dis Ther ; 8(3): 353-367, 2019 Sep.
Article in English | MEDLINE | ID: mdl-31309434

ABSTRACT

INTRODUCTION: The integration of human African trypanosomiasis (HAT) activities into primary health services is gaining importance as a result of the decreasing incidence of HAT and the ongoing developments of new screening and diagnostic tools. In the Democratic Republic of Congo, this integration process faces multiple challenges. We initiated an operational research project to document drivers and bottlenecks of the process. METHODS: Three health districts piloted the integration of HAT screening and diagnosis into primary health services. We analysed the outcome indicators of this intervention and conducted in-depth interviews with health care providers, seropositives, community health workers and HD management team members. Our thematic interview guide focused on factors facilitating and impeding the integration of HAT screening. RESULTS: The study showed a HAT-RDT-positive rate of 2.2% in Yasa Bonga, 2.9% in Kongolo and 3% in Bibanga, while the proportion of reported seropositives that received confirmatory examinations was 76%, 45.6% and 68%, respectively. Qualitative analyses indicated that some seropositives were unable to access the confirmation facility. The main reasons that were given included distance, RDT rupture, lack of basic screening equipment and financial barriers (additional hospital fees not included in free treatment course), fear of lumbar puncture and the perception of HAT as a disease of supernatural origin. CONCLUSION: Passive screening using HAT RDTs in primary health services inevitably has some limitations. However, regarding the epidemiological context and some obstacles to integrated implementation, this cannot on its own be a relevant alternative to the elimination of HAT by 2020. FUNDING: We acknowledge the agency that provided financial support for this study, the Belgian Development Cooperation. The funder had no role in the study design, data collection and analysis, decision to publish or preparation of the manuscript. Philippe Mulenga received financial support thanks to a doctoral grant from the Belgian Development Cooperation under the FA4 agreement. Funding for the study and Rapid Service Fees was provided by the Epidemiology and Tropical Diseases Unit of the Institute of Tropical Medicine, Antwerp.

11.
Am J Trop Med Hyg ; 100(4): 899-906, 2019 04.
Article in English | MEDLINE | ID: mdl-30719963

ABSTRACT

Human African trypanosomiasis is close to elimination in several countries in sub-Saharan Africa. The diagnosis and treatment is currently rapidly being integrated into first-line health services. We aimed to document the perspective of stakeholders on this integration process. We conducted 12 focus groups with communities in three health zones of the Democratic Republic of the Congo and held 32 interviews with health-care providers, managers, policy makers, and public health experts. The topic guide focused on enabling and blocking factors related to the integrated diagnosis and treatment approach. The data were analyzed with NVivo (QSR International, Melbourne, Australia) using a thematic analysis process. The results showed that the community mostly welcomed integrated care for diagnosis and treatment of sleeping sickness, as they value the proximity of first-line health services, but feared possible financial barriers. Health-care professionals thought integration contributed to the elimination goal but identified several implementation challenges, such as the lack of skills, equipment, motivation and financial resources in these basic health services. Patients often use multiple therapeutic itineraries that do not necessarily lead them to health centers where screening is available. Financial barriers are important, as health care is not free in first-line health centers, in contrast to the population screening campaigns. Communities and providers signal several challenges regarding the integration process. To succeed, the required training of health professionals, as well as staff deployment and remuneration policy and the financial barriers in the primary care system need to be addressed, to ensure coverage for those most in need.


Subject(s)
Health Personnel/education , Primary Health Care/economics , Stakeholder Participation , Trypanosomiasis, African/prevention & control , Democratic Republic of the Congo/epidemiology , Focus Groups , Health Services/economics , Health Services/standards , Humans , Primary Health Care/methods , Primary Health Care/standards , Qualitative Research , Trypanosomiasis, African/diagnosis , Trypanosomiasis, African/drug therapy , Trypanosomiasis, African/economics
13.
Am J Trop Med Hyg ; 97(5): 1454-1460, 2017 Nov.
Article in English | MEDLINE | ID: mdl-28820708

ABSTRACT

There is little published information on the epidemiology of neurological disorders in rural Central Africa, although the burden is considered to be substantial. This study aimed to investigate the pattern, etiology, and outcome of neurological disorders in children > 5 years and adults admitted to the rural hospital of Mosango, province of Kwilu, Democratic Republic of Congo, with a focus on severe and treatable infections of the central nervous system (CNS). From September 2012 to January 2015, 351 consecutive patients hospitalized for recent and/or ongoing neurological disorder were prospectively evaluated by a neurologist, subjected to a set of reference diagnostic tests in blood or cerebrospinal fluid, and followed-up for 3-6 months after discharge. No neuroimaging was available. Severe headache (199, 56.7%), gait/walking disorders (97, 27.6%), epileptic seizure (87, 24.8%), and focal neurological deficit (86, 24.5%) were the predominant presentations, often in combination. Infections of the CNS were documented in 63 (17.9%) patients and mainly included bacterial meningitis and unspecified meningoencephalitis (33, 9.4%), second-stage human African trypanosomiasis (10, 2.8%), and human immunodeficiency virus (HIV)-related neurological disorders (10, 2.8%). Other focal/systemic infections with neurological manifestations were diagnosed in an additional 60 (17.1%) cases. The leading noncommunicable conditions were epilepsy (61, 17.3%), psychiatric disorders (56, 16.0%), and cerebrovascular accident (23, 6.6%). Overall fatality rate was 8.2% (29/351), but up to 23.8% for CNS infections. Sequelae were observed in 76 (21.6%) patients. Clinical presentations and etiologies of neurological disorders were very diverse in this rural Central African setting and caused considerable mortality and morbidity.


Subject(s)
Hospitals, Rural , Nervous System Diseases/epidemiology , Adolescent , Adult , Democratic Republic of the Congo/epidemiology , Disease Management , Epilepsy/complications , Epilepsy/epidemiology , Female , Follow-Up Studies , HIV Infections/complications , HIV Infections/epidemiology , Humans , Male , Meningitis, Bacterial/complications , Meningitis, Bacterial/epidemiology , Meningoencephalitis/complications , Meningoencephalitis/epidemiology , Middle Aged , Nervous System Diseases/etiology , Prevalence , Prospective Studies , Trypanosomiasis, African/complications , Trypanosomiasis, African/epidemiology , Young Adult
14.
Malar J ; 16(1): 19, 2017 01 07.
Article in English | MEDLINE | ID: mdl-28061851

ABSTRACT

BACKGROUND: Intermittent preventive treatment (IPT) is likely to be the most promising therapeutic strategy to prevent malaria and its related adverse outcomes in schoolchildren. However, its successful implementation will depend on acceptability to key stakeholders such as parents and teachers. METHODS: A qualitative research was conducted, following a clinical trial assessing the effectiveness of IPT in schoolchildren (IPTsc), to understand the perceptions and experiences of parents and teachers with IPTsc, in two schools of Mokali, in Kinshasa, Democratic Republic of the Congo. Eighty parents participated in 8 focus group discussions and 6 school staff were involved in 6 semi-structured interviews. RESULTS: Parents experiences with IPTsc divided them into two groups (owning positive experiences and owning negative experiences with IPTsc). Three major themes emerged as key factors associated with reluctance of parents to IPT use in schoolchildren. These included wrong malaria-related knowledge, bad experience with IPTsc administered during the trial and misunderstanding of IPTsc. The school staff were generally willing to be trained to give medicine to schoolchildren within the scope of IPT. However, most parents were more comfortable with the use of health workers than teachers for drug administration. More importantly, all parents accepting IPT suggested to diagnose malaria infection before any administration of IPT, which is not in line with IPT principal. CONCLUSION: These results suggest that more efforts are needed to improve overall malaria-related knowledge in the community, specifically chemo-prevention strategies and the safety of the drugs used, to ensure the success of health interventions.


Subject(s)
Antimalarials/administration & dosage , Chemoprevention/methods , Disease Transmission, Infectious/prevention & control , Health Knowledge, Attitudes, Practice , Malaria/prevention & control , Patient Acceptance of Health Care , Child , Democratic Republic of the Congo , Female , Humans , Interviews as Topic , Male , Parents , Rural Population , School Teachers
15.
PLoS Negl Trop Dis ; 10(2): e0004362, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26881924

ABSTRACT

BACKGROUND: Sleeping sickness (human African trypanosomiasis [HAT]) is caused by protozoan parasites and characterized by a chronic progressive course, which may last up to several years before death. We conducted two Phase 2 studies to determine the efficacy and safety of oral pafuramidine in African patients with first stage HAT. METHODS: The Phase 2a study was an open-label, non-controlled, proof-of-concept study where 32 patients were treated with 100 mg of pafuramidine orally twice a day (BID) for 5 days at two trypanosomiasis reference centers (Angola and the Democratic Republic of the Congo [DRC]) between August 2001 and November 2004. The Phase 2b study compared pafuramidine in 41 patients versus standard pentamidine therapy in 40 patients. The Phase 2b study was open-label, parallel-group, controlled, randomized, and conducted at two sites in the DRC between April 2003 and February 2007. The Phase 2b study was then amended to add an open-label sequence (Phase 2b-2), where 30 patients received pafuramidine for 10 days. The primary efficacy endpoint was parasitologic cure at 24 hours (Phase 2a) or 3 months (Phase 2b) after treatment completion. The primary safety outcome was the rate of occurrence of World Health Organization Toxicity Scale Grade 3 or higher adverse events. All subjects provided written informed consent. FINDINGS/CONCLUSION: Pafuramidine for the treatment of first stage HAT was comparable in efficacy to pentamidine after 10 days of dosing. The cure rates 3 months post-treatment were 79% in the 5-day pafuramidine, 100% in the 7-day pentamidine, and 93% in the 10-day pafuramidine groups. In Phase 2b, the percentage of patients with at least 1 treatment-emergent adverse event was notably higher after pentamidine treatment (93%) than pafuramidine treatment for 5 days (25%) and 10 days (57%). These results support continuation of the development program for pafuramidine into Phase 3.


Subject(s)
Antiprotozoal Agents/administration & dosage , Antiprotozoal Agents/adverse effects , Benzamidines/administration & dosage , Benzamidines/adverse effects , Trypanosomiasis, African/drug therapy , Administration, Oral , Adolescent , Adult , Angola , Democratic Republic of the Congo/epidemiology , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/pathology , Female , Humans , Male , Middle Aged , Pentamidine/administration & dosage , Pentamidine/adverse effects , Treatment Outcome , Young Adult
16.
PLoS Negl Trop Dis ; 10(2): e0004363, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26882015

ABSTRACT

BACKGROUND: Sleeping sickness (human African trypanosomiasis [HAT]) is a neglected tropical disease with limited treatment options that currently require parenteral administration. In previous studies, orally administered pafuramidine was well tolerated in healthy patients (for up to 21 days) and stage 1 HAT patients (for up to 10 days), and demonstrated efficacy comparable to pentamidine. METHODS: This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospitals in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included. The primary efficacy endpoint was the combined rate of clinical and parasitological cure at 12 months. The primary safety outcome was the frequency and severity of adverse events. The study was registered on the International Clinical Trials Registry Platform at www.clinicaltrials.gov with the number ISRCTN85534673. FINDINGS/CONCLUSIONS: The overall cure rate at 12 months was 89% in the pafuramidine group and 95% in the pentamidine group; pafuramidine was non-inferior to pentamidine as the upper bound of the 95% confidence interval did not exceed 15%. The safety profile of pafuramidine was superior to pentamidine; however, 3 patients in the pafuramidine group had glomerulonephritis or nephropathy approximately 8 weeks post-treatment. Two of these events were judged as possibly related to pafuramidine. Despite good tolerability observed in preceding studies, the development program for pafuramidine was discontinued due to delayed post-treatment toxicity.


Subject(s)
Benzamidines/administration & dosage , Benzamidines/adverse effects , Pentamidine/administration & dosage , Pentamidine/adverse effects , Trypanosomiasis, African/drug therapy , Administration, Oral , Adolescent , Adult , Aged , Angola , Child , Democratic Republic of the Congo , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/pathology , Female , Humans , Injections, Intramuscular , Kidney Diseases/chemically induced , Kidney Diseases/pathology , Male , Middle Aged , Pregnancy , Sudan , Treatment Outcome , Trypanosoma brucei gambiense , Young Adult
17.
PLoS Negl Trop Dis ; 9(4): e0003686, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25856578

ABSTRACT

BACKGROUND: Socio-cultural and economic factors constitute real barriers for uptake of screening and treatment of Human African Trypanosomiasis (HAT) in the Democratic Republic of Congo (DRC). Better understanding and addressing these barriers may enhance the effectiveness of HAT control. METHODS: We performed a qualitative study consisting of semi-structured interviews and focus group discussions in the Bandundu and Kasaï Oriental provinces, two provinces lagging behind in the HAT elimination effort. Our study population included current and former HAT patients, as well as healthcare providers and program managers of the national HAT control program. All interviews and discussions were voice recorded on a digital device and data were analysed with the ATLAS.ti software. FINDINGS: Health workers and community members quoted a number of prohibitions that have to be respected for six months after HAT treatment: no work, no sexual intercourse, no hot food, not walking in the sun. Violating these restrictions is believed to cause serious, and sometimes deadly, complications. These strong prohibitions are well-known by the community and lead some people to avoid HAT screening campaigns, for fear of having to observe such taboos in case of diagnosis. DISCUSSION: The restrictions originally aimed to mitigate the severe adverse effects of the melarsoprol regimen, but are not evidence-based and became obsolete with the new safer drugs. Correct health information regarding HAT treatment is essential. Health providers should address the perspective of the community in a constant dialogue to keep abreast of unintended transformations of meaning.


Subject(s)
Taboo , Trypanosomiasis, African/drug therapy , Trypanosomiasis, African/epidemiology , Animals , Democratic Republic of the Congo/epidemiology , Focus Groups , Humans , Male , Melarsoprol/therapeutic use , Middle Aged , Qualitative Research , Trypanocidal Agents/therapeutic use
18.
PLoS One ; 9(10): e110167, 2014.
Article in English | MEDLINE | ID: mdl-25340726

ABSTRACT

BACKGROUND: Neurological disorders of infectious origin are common in rural sub-Saharan Africa and usually have serious consequences. Unfortunately, these syndromes are often poorly documented for lack of diagnostic tools. Clinical management of these diseases is a major challenge in under-equipped rural health centers and hospitals. We documented health care provider knowledge, attitudes and practices related to this syndrome in two rural health zones in Bandundu Province, Democratic Republic of Congo. METHODS: We used a qualitative research approach combining observation, in-depth interviews and focus group discussions. We observed 20 patient-provider contacts related to a neurological syndrome, conducted 12 individual interviews and 4 focus group discussions with care providers. All interviews were audiotaped and the transcripts were analyzed with the software ATLAS.ti. RESULTS: Care providers in this region usually limit their diagnostic work-up to clinical examination primarily because of the financial hurdles in this entirely out-of-pocket payment system. The patients prefer to purchase drugs rather than diagnostic tests. Moreover the general lack of diagnostic tools and the representation of the clinician as a "diviner" do not enhance any use of laboratory or other diagnostic methods. CONCLUSION: Innovation in diagnostic technology for neurological disorders is badly needed in Central-Africa, but its uptake in clinical practice will only be a success if tools are simple, affordable and embedded in a patient-centered approach.


Subject(s)
Attitude of Health Personnel , Health Knowledge, Attitudes, Practice , Health Personnel , Nervous System Diseases/diagnosis , Rural Population , Congo , Focus Groups , Geography , Humans , Nervous System Diseases/therapy , Referral and Consultation , Syndrome
19.
PLoS Negl Trop Dis ; 6(1): e1467, 2012 Jan.
Article in English | MEDLINE | ID: mdl-22272367

ABSTRACT

BACKGROUND: Control of human African trypanosomiasis (sleeping sickness) in the Democratic Republic of Congo is based on mass population active screening by mobile teams. Although generally considered a successful strategy, the community participation rates in these screening activities and ensuing treatment remain low in the Kasai-Oriental province. A better understanding of the reasons behind this observation is necessary to improve regional control activities. METHODS: Thirteen focus group discussions were held in five health zones of the Kasai-Oriental province to gain insights in the regional perceptions regarding sleeping sickness and the national control programme's activities. PRINCIPAL FINDINGS: Sleeping sickness is well known among the population and is considered a serious and life-threatening disease. The disease is acknowledged to have severe implications for the individual (e.g., persistence of manic periods and trembling hands, even after treatment), at the family level (e.g., income loss, conflicts, separations) and for communities (e.g., disruption of community life and activities). Several important barriers to screening and treatment were identified. Fear of drug toxicity, lack of confidentiality during screening procedures, financial barriers and a lack of communication between the mobile teams and local communities were described. Additionally, a number of regionally accepted prohibitions related to sleeping sickness treatment were described that were found to be a strong impediment to disease screening and treatment. These prohibitions, which do not seem to have a rational basis, have far-reaching socio-economic repercussions and severely restrict the participation in day-to-day life. CONCLUSIONS/SIGNIFICANCE: A mobile screening calendar more adapted to the local conditions with more respect for privacy, the use of less toxic drugs, and a better understanding of the origin as well as better communication about the prohibitions related to treatment would facilitate higher participation rates among the Kasai-Oriental population in sleeping sickness screening and treatment activities organized by the national HAT control programme.


Subject(s)
Trypanosomiasis, African/diagnosis , Trypanosomiasis, African/epidemiology , Democratic Republic of the Congo/epidemiology , Female , Focus Groups , Health Knowledge, Attitudes, Practice , Humans , Male , Trypanocidal Agents/therapeutic use , Trypanosomiasis, African/drug therapy
20.
PLoS Negl Trop Dis ; 3(2): e383, 2009.
Article in English | MEDLINE | ID: mdl-19221604

ABSTRACT

BACKGROUND: In Human African Trypanosomiasis, neurological symptoms dominate and cardiac involvement has been suggested. Because of increasing resistance to the available drugs for HAT, new compounds are desperately needed. Evaluation of cardiotoxicity is one parameter of drug safety, but without knowledge of the baseline heart involvement in HAT, cardiologic findings and drug-induced alterations will be difficult to interpret. The aims of the study were to assess the frequency and characteristics of electrocardiographic findings in the first stage of HAT, to compare these findings to those of second stage patients and healthy controls and to assess any potential effects of different therapeutic antiparasitic compounds with respect to ECG changes after treatment. METHODS: Four hundred and six patients with first stage HAT were recruited in the Democratic Republic of Congo, Angola and Sudan between 2002 and 2007 in a series of clinical trials comparing the efficacy and safety of the experimental treatment DB289 to the standard first stage treatment, pentamidine. These ECGs were compared to the ECGs of healthy volunteers (n = 61) and to those of second stage HAT patients (n = 56). RESULTS: In first and second stage HAT, a prolonged QTc interval, repolarization changes and low voltage were significantly more frequent than in healthy controls. Treatment in first stage was associated with repolarization changes in both the DB289 and the pentamidine group to a similar extent. The QTc interval did not change during treatment. CONCLUSIONS: Cardiac involvement in HAT, as demonstrated by ECG alterations, appears early in the evolution of the disease. The prolongation of the QTC interval comprises a risk of fatal arrhythmias if new drugs with an additional potential of QTC prolongation will be used. During treatment ECG abnormalities such as repolarization changes consistent with peri-myocarditis occur frequently and appear to be associated with the disease stage, but not with a specific drug.


Subject(s)
Heart Diseases/chemically induced , Heart Diseases/etiology , Heart/drug effects , Trypanocidal Agents/pharmacology , Trypanocidal Agents/therapeutic use , Trypanosomiasis, African/drug therapy , Trypanosomiasis, African/physiopathology , Adult , Arrhythmias, Cardiac/chemically induced , Arrhythmias, Cardiac/etiology , Electrocardiography , Female , Humans , Male , Trypanocidal Agents/adverse effects , Trypanosomiasis, African/pathology
SELECTION OF CITATIONS
SEARCH DETAIL
...