Setting up a pragmatic clinical trial in a low-resource setting: A qualitative assessment of GoLBeT, a trial of podoconiosis management in Northern Ethiopia.

BACKGROUND: Clinical trials are often perceived as being expensive, difficult and beyond the capacity of healthcare workers in low-resource settings. However, in order to improve healthcare coverage, the World Health Organization (WHO) World Health Report 2013 stated that all countries need to become generators as well as recipients of data. This study is a methodological examination of the steps and processes involved in setting up the Gojjam Lymphoedema Best Practice Trial (GoLBeT; ISRCTN67805210), a highly pragmatic clinical trial conducted in northern Ethiopia. Challenges to the trial and strategies used to deal with them were explored, together with the reasons for delays. METHODOLOGY AND PRINCIPAL FINDINGS: Qualitative research methods were used to analyse emails and reports from the period between trial inception and recruitment. This analysis was complemented by interviews with key informants from the trial operational team. The Global Health Research Process Map was used as a framework against which to compare the steps involved in setting up the trial. A mini-group discussion was conducted with the trial operational team after study completion for reflection and further recommendations. This study showed that the key areas of difficulty in setting up and planning this trial were: the study design, that is, deciding on the study endpoint, where and how best to measure it, and assuring statistical power; recruitment and appropriate training of staff; planning for data quality; and gaining regulatory approvals. Collaboration, for example with statisticians, the trial steering committee, the study monitors, and members of the local community was essential to successfully setting up the trial. CONCLUSIONS AND SIGNIFICANCE: Lessons learnt from this trial might guide others planning pragmatic trials in settings where research is not common, allowing them to anticipate possible challenges and address them through trial design, planning and operational delivery. We also hope that this example might encourage similar pragmatic studies to be undertaken. Such studies are rarely undertaken or locally led, but are an accessible and efficient way to drive improved outcomes in public health.

Valuing Health State: An EQ-5D-5L Value Set for Ethiopians.

OBJECTIVES: There is a growing interest in health technology assessment and economic evaluations in developing countries such as Ethiopia. The objective of this study was to derive an EQ-5D-5L value set from the Ethiopian general population to facilitate cost utility analysis. METHODS: A nationally representative sample (N = 1050) was recruited using a stratified multistage quota sampling technique. Face-to-face, computer-assisted interviews using the EuroQol Portable Valuation Technology (EQ-PVT) protocol of composite time trade-off (c-TTO) and discrete choice experiments (DCEs) were undertaken to elicit preference scores. The feasibility of the EQ-PVT protocol was pilot tested in a sample of the population (n = 110). A hybrid regression model combining c-TTO and DCE data was used to estimate the final value set. RESULTS: In the pilot study, the acceptability of the tasks was good, and there were no special concerns with undertaking the c-TTO and DCE tasks. The coefficients generated from a hybrid model were logically consistent. The predicted values for the EQ-5D-5L ranged from -0.718 to 1. Level 5 anxiety/depression had the largest impact on utility decrement (-0.458), whereas level 5 self-care had the least impact (-0.222). The maximum predicted value beyond full health was 0.974 for the 11112 health state. CONCLUSIONS: This is the first EQ-5D-5L valuation study in Africa using international valuation methods (c-TTO and DCE) and also the first using the EQ-PVT protocol to derive a value set. We expect that the availability of this value set will facilitate health technology assessment and health-related quality-of-life research and inform policy decision making in Ethiopia.

Cost-effectiveness and social outcomes of a community-based treatment for podoconiosis lymphoedema in the East Gojjam zone, Ethiopia.

BACKGROUND: Podoconiosis is a disease of the lymphatic vessels of the lower extremities that is caused by chronic exposure to irritant soils. It results in leg swelling, commonly complicated by acute dermatolymphangioadenitis (ADLA), characterised by severe pain, fever and disability. METHODS: We conducted cost-effectiveness and social outcome analyses of a pragmatic, randomised controlled trial of a hygiene and foot-care intervention for people with podoconiosis in the East Gojjam zone of northern Ethiopia. Participants were allocated to the immediate intervention group or the delayed intervention group (control). The 12-month intervention included training in foot hygiene, skin care, bandaging, exercises, and use of socks and shoes, and was supported by lay community assistants. The cost-effectiveness analysis was conducted using the cost of productivity loss due to acute dermatolymphangioadenitis. Household costs were not included. Health outcomes in the cost-effectiveness analysis were: the incidence of ADLA episodes, health-related quality of life captured using the Dermatology Life Quality Index (DLQI), and disability scores measured using the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0). RESULTS: The cost of the foot hygiene and lymphoedema management supplies was 529 ETB (69 I$, international dollars) per person per year. The cost of delivery of the intervention as part of the trial, including transportation, storage, training of lay community assistants and administering the intervention was 1,890 ETB (246 I$) per person. The intervention was effective in reducing the incidence of acute dermatolymphangioadenitis episodes and improving DLQI scores, while there were no significant improvements in the disability scores measured using WHODAS 2.0. In 75% of estimations, the intervention was less costly than the control. This was due to improved work productivity. Subgroup analyses based on income group showed that the intervention was cost-effective (both less costly and more effective) in reducing the number of acute dermatolymphangioadenitis episodes and improving health-related quality of life in families with monthly income <1,000 ETB (130 I$). For the subgroup with family income ≥1,000 ETB, the intervention was more effective but more costly than the control. CONCLUSIONS: Whilst there is evident benefit of the intervention for all, the economic impact would be greatest for the poorest.

Lymphoedema management to prevent acute dermatolymphangioadenitis in podoconiosis in northern Ethiopia (GoLBeT): a pragmatic randomised controlled trial.

BACKGROUND: Podoconiosis (also known as endemic, non-filarial elephantiasis) affects about 4 million subsistence farmers in tropical Africa. Poor awareness of the condition and inadequate evidence for the efficacy of treatment mean that no government in an endemic country yet offers lymphoedema management for patients with podoconiosis. Among patients with filarial lymphoedema, trials suggest that limb care is effective in reducing the most disabling sequelae: episodes of acute dermatolymphangioadenitis. We aimed to test the hypothesis that a simple, inexpensive lymphoedema management package would reduce the incidence of acute dermatolymphangioadenitis in adult patients with podoconiosis in northern Ethiopia. METHODS: We did a pragmatic randomised controlled trial at health posts and health centres in 18 sub-districts of Aneded woreda (district) in Amhara, northern Ethiopia. Participants were adults aged 18 years and older, had a diagnosis of at least stage 2 podoconiosis (persistent lymphoedema) and a negative antigen test for filariasis, and intended to remain within Aneded woreda for the duration of the trial. Patients were randomly assigned (1:1) to either receive a package containing instructions for foot hygiene, skin care, bandaging, exercises, and use of socks and shoes, with support by lay Community Podoconiosis Agents at monthly meetings (intervention group) or to receive no intervention (control group). Participants were aware of their group assignment, but researchers doing all analyses were masked to treatment group. The primary outcome was incidence of acute dermatolymphangioadenitis episodes in the total period of observation of each participant, measured by use of validated patient self-reported pictorial diaries. This trial was registered with the International Standard Randomised Controlled Trials Number Register, number ISRCTN67805210. FINDINGS: Between Dec 1, 2014, and June 30, 2015, 1339 patients were screened, and 696 patients were enrolled and randomly allocated to treatment groups. We allocated 350 patients to the intervention group and 346 patients to the control group. 321 (92%) patients from the intervention group and 329 (95%) patients from the control group provided follow-up results at 12 months. During the 12 months of follow-up, 16 550 new episodes of acute dermatolymphangioadenitis occurred during 765·2 person-years. The incidence of acute dermatolymphangioadenitis was 19·4 episodes per person-year (95% CI 18·9-19·9) in the intervention group and 23·9 episodes per person-year (23·4-24·4) in the control group. The ratio of incidence rate in the intervention group to that of the control group was 0·81 (0·74 to 0·89; p<0·0001), with a rate difference of -4·5 (-5·1 to -3·8) episodes per person-year. No serious adverse events related to the intervention were reported. INTERPRETATION: A simple, inexpensive package of lymphoedema self-care is effective in reducing the frequency and duration of acute dermatolymphangioadenitis. We recommend its implementation by the governments of endemic countries. FUNDING: Joint Global Health Trials scheme (from the Wellcome Trust, the UK Medical Research Council, and UK Aid).

Assessment of awareness of HIV/AIDS among selected target groups in and around Addis Ababa, Ethiopia.

A total of 2278 individuals were interviewed using a pre-tested questionnaire with key indicators such as mode of transmission, attitude towards HIV/AIDS patients, information sources, sex, educational and marital status. Findings indicate that most of the respondents (93.2%) were aware of the reality of HIV/AIDS and considered it as a killer disease (89.2%). A significant number of them had negative attitude towards HIV/AIDS patients. Some 30.4% believed HIV/AIDS patients can be identified through symptoms rather than clinical diagnosis. There is significant association between knowledge of HIV/AIDS and target group (p < 0.001), age (p < 0.05), sex (p < 0.05), marital status (p < 0.05) and educational level (p < 0.001). There is also a remarkable knowledge difference among respondents on means of prolonging life of individuals with HIV/AIDS. Some have never heard about how to prolong the life of such patients (10.2%). Farmers (42.5%) indicated that there is no means of prolonging the life of such patients. Respondents' knowledge on combating HIV/AIDS related diseases as a means of prolonging the life of succumbed individuals was rather low (5.5%). Low level awareness, therefore, may deter HIV/AIDS patients from seeking necessary medical attention.

Assessment of behavioural risk factors for HIV/AIDS in selected target groups in and around Addis Ababa and Nazareth cities, Ethiopia.

A stratified cross-sectional survey was conducted on 2 278 people residing in and around Addis Ababa and Nazareth cities to assess the behavioural risk factors in HIV/AIDS in selected target groups from August 2000 to December 2000. The target groups, consisting of students, urban residents, farmers, and commercial sex workers, were interviewed using pre-tested questionnaires including indicators such as age, sex, educational and occupational status, sexual practice, preventive measures, condom use, etc. The findings revealed that 116 (32.6%) of the sex workers, 37 (21.5%) of the farmers, 33 (12%) of the students and 45 (11.3%) of the urban residents had started sexual intercourse between the ages of 13-15 years. The mean age at the time of sexual commencement for all respondents was 18.2 ± 3.1 SD years. Among those who had already started sexual intercourse, 766 (63.7%) respondents had non-regular partners. Of the total respondents only 813 (36.2%) were using condoms while the remaining were opting for either abstinence (674 (30%)) or one-to-one sexual relationship (885 (39.4%)) for prevention of HIV/AIDS. Ten (32.3%) of the farmers, 32 (19.8%) of the urban residents, 34 (17.5%) of the students and 33 (9.3%) of the sex workers were using condoms occasionally. The findings suggest that a well-coordinated campaign against the disease should be undertaken by targeting those who are at high risk. Condom use should also be promoted especially among the youth who seem to be engaged in sexual intercourse with multiple partners.