Prevalence of trachoma in Somali region, Ethiopia: results from trachoma impact surveys in 50 woredas.

BACKGROUND: Following interventions to eliminate trachoma in Somali region, Ethiopia, we aimed to re-estimate the prevalence of trachomatous trichiasis (TT) and trachomatous inflammation-follicular (TF) at woreda level and identify the factors associated with the disease. METHODS: We implemented cross-sectional community-based surveys in 50 trachoma-endemic woredas, using a standardized survey. Households were the secondary sampling unit. Surveys were undertaken through a combination of interviews of household heads and direct inspection of water, sanitation and hygiene (WASH) access, plus clinical evaluation of eligible household members for TT and TF. RESULTS: Overall, 41 (82%) of the 50 woredas had met the WHO-recommended active trachoma elimination threshold (prevalence of TF <5% in 1-9-y-olds) and 42 (84%) had met the TT threshold (prevalence of TT unknown to the health system <0.2% in ≥15-y-olds). Only 18% of households had access to an improved drinking water source within a 30-min trip and only 25% had an improved latrine. CONCLUSIONS: Additional rounds of antibiotic mass drug administration, plus interventions to enhance facial cleanliness and improve the environment, are required in nine woredas. TT surgical campaigns are needed in eight woredas. Greater access to WASH is required across all the woredas that were surveyed.

Gender differences in the surgical management of trachomatous trichiasis: an exploratory analysis of global trachoma survey data, 2015-2019.

BACKGROUND: Trachomatous trichiasis (TT) is a painful, potentially blinding eye condition that can be managed through epilation or surgery. Women are affected by TT approximately twice as often as men and are believed to face gendered barriers to receiving surgical care to prevent vision loss. METHODS: We used data from 817 cross-sectional surveys conducted during 2015-2019 in 20 African countries to estimate the prevalence difference (PD) between female and male eyes for four outcomes potentially indicating gender-related differences in TT management: (1) received surgery and developed postoperative TT (PTT), (2) never offered surgery, (3) offered surgery but declined it, and (4) offered epilation but never offered surgery. RESULTS: The prevalence was modestly elevated among female eyes compared with male eyes for having PTT (PD:1.8 [95% confidence limits (CL): 0.6, 3.0]) and having declined surgery for the eye (PD: 6.2 [95% CL: 1.8, 10.7]). The proportion offered epilation was similar by gender (PD:0.5 [95% CL: -0.4, 1.3]), while never having been offered surgery was somewhat more prevalent among male eyes (PD: -2.1 [95% CL: -3.5, -0.7]). CONCLUSIONS: Our results suggest potential gender differences in TT management. More research is needed to determine the causes and implications of the observed differences.

Prevalence of Trachoma After Three Rounds of Antibiotic Mass Drug Administration in 13 Woredas of Gambella Region, Ethiopia.

BACKGROUND: Following baseline surveys in 2013 and 2014, trachoma elimination interventions, including three rounds of azithromycin mass drug administration (MDA), were implemented in 13 woredas (administrative districts) of Gambella Regional State, Ethiopia. We conducted impact surveys to determine if elimination thresholds have been met or if additional interventions are required. METHODS: Cross-sectional population-based surveys were conducted in 13 woredas of Gambella Regional State, combined into five evaluation units (EUs), 6─12 months after their last MDA round. A two-stage systematic (first stage) and random (second stage) sampling technique was used. WHO-recommended protocols were implemented with the support of Tropical Data. Household water, sanitation and hygiene (WASH) access was assessed. RESULTS: The age-adjusted prevalence of trachomatous inflammation - follicular (TF) in 1-9-year-olds in the five EUs ranged from 0.3-19.2%, representing a general decline in TF prevalence compared to baseline estimates. The age- and gender-adjusted prevalence of trachomatous trichiasis (TT) unknown to the health system in those aged ≥ 15 years ranged from 0.47-3.08%. Of households surveyed, 44% had access to an improved drinking water source within a 30-minute return journey of the house, but only 3% had access to an improved latrine. CONCLUSION: In two EUs, no further MDA should be delivered, and a surveillance survey should be conducted after two years without MDA. In one EU, one further round of MDA should be conducted followed by another impact survey. In two EUs, three further MDA rounds are required. Surgery, facial cleanliness and environmental improvement interventions are needed throughout the region.

Potential mitigating role of ivermectin on the spread of Chlamydia trachomatis by Musca sorbens.

Trachoma is the world's most frequent cause of blindness from an infectious agent. The disease caused by infection is associated with lack of access to sanitation and low hygiene standards. Trachoma is controlled through the Surgery, Antibiotics, Facial cleanliness, and Environmental improvement (SAFE) strategy, which delivers azithromycin (AZM) mass drug administration (MDA) in endemic areas. The putative vector Musca sorbens principally reproduce in human faecal matter left in the environment due to open defecation. Ivermectin (IVM) is on the WHO's essential medicines list and is administered as preventative chemotherapy against two neglected tropical diseases (NTDs)-onchocerciasis, as an annual or bi-annual treatment, and lymphatic filariasis, as an annual treatment in combination with albendazole. Ivermectin has a known inhibitive effect on insects that reproduce in dung. To assess if IVM could be a viable vector control tool against M. sorbens, this study evaluates existing data from trachoma, onchocerciasis and lymphatic filariasis mass drug administration (MDA) operations in Ethiopia. Persistent and recrudescent trachoma in evaluation units (EUs) were examined for whether AZM MDA in EUs was accompanied by IVM MDA, and whether co-administration was associated with greater likelihood of trachoma control. Results show an association suggesting that EUs that received both IVM and AZM MDA benefit from improved control of trachoma in persistent or recrudescent areas, when compared to EUs that received AZM MDA. This initial investigation supports the potential for ivermectin's use to support SAFE. Findings warrant further work to validate ivermectin's impact on M. sorbens reproduction through controlled lab and field-based studies.

Perceptions and acceptability of co-administered albendazole, ivermectin and azithromycin mass drug administration, among the health workforce and recipient communities in Ethiopia.

Several neglected tropical diseases (NTDs) employ mass drug administration (MDA) as part of their control or elimination strategies. This has historically required multiple distinct campaigns, each targeting one or more NTDs, representing a strain on both the recipient communities and the local health workforce implementing the distribution. We explored perceptions and attitudes surrounding combined MDA among these two groups of stakeholders. Our qualitative study was nested within a cluster randomized non-inferiority safety trial of combined ivermectin, albendazole and azithromycin MDA. Using semi-structured question guides, we conducted 16 key informant interviews with selected individuals involved in implementing MDA within the participating district. To better understand the perceptions of recipient communities, we also conducted four focus group discussions with key community groups. Individuals were selected from both the trial arm (integrated MDA) and the control arm (standard MDA) to provide a means of comparison and discussion. All interviews and focus group discussions were led by fluent Afaan oromo speakers. Interviewers transcribed and later translated all discussions into English. The study team synthesized and analyzed the results via a coding framework and software. Most respondents appreciated the time and effort saved via the co-administered MDA strategy but there were some misgivings amongst community beneficiaries surrounding pill burden. Both the implementing health work force members and beneficiaries reported refusals stemming from lack of understanding around the need for the new drug regimen as well as some mistrust of government officials among the youth. The house-to-house distribution method, adopted as a COVID-19 prevention strategy, was by far preferred by all beneficiaries over central-point MDA, and may have led to greater acceptability of co-administration. Our data demonstrate that a co-administration strategy for NTDs is acceptable to both communities and health staff.

Corrigendum to "Safety of integrated mass drug administration of azithromycin, albendazole and ivermectin versus standard treatment regimens: a cluster-randomised trial in Ethiopia".

[This corrects the article DOI: 10.1016/j.eclinm.2023.101984.].

Safety of integrated mass drug administration of azithromycin, albendazole and ivermectin versus standard treatment regimens: a cluster-randomised trial in Ethiopia.

Background: Neglected Tropical Disease (NTD) programs require separate and distinct drug regimens for treatment. This has required countries to undertake multiple independent mass drug administration (MDA) programmes, each targeting one or more diseases. The possibility of safely combining different drug regimens together in one MDA may offer several advantages to national programs. We conducted a study to assess the safety of combining ivermectin, albendazole and azithromycin in one integrated MDA. Methods: We conducted an open-label, non-inferiority cluster-randomised trial comparing the frequency of adverse events in communities receiving co-administered ivermectin, albendazole and azithromycin to that in communities given albendazole and ivermectin MDA followed by azithromycin MDA after a two-week interval. The study took place in 58 gares (small administrative units) across two kebeles (sub-districts) in Kofele woreda (district) in the Oromia region of Ethiopia. We randomly assigned 29 gares to the combined treatment arm and 29 gares to the control arm. The study team revisited all individuals within 48 h and actively collected data on the occurrence of adverse events using a dedicated questionnaire and a pre-specified list of adverse events. The study team followed the same process in the control arm for the azithromycin distribution and again after the ivermectin plus albendazole distribution. Following this initial active surveillance, passive surveillance was undertaken for one week after the first visit. The primary outcome was the frequency of adverse events occurring following MDA. The study team determined that the safety of the combined MDA would be non-inferior to that of separate MDAs if the upper limit of the two-sided CI for the difference in rates was equal to or lower than 5%. The trial was registered with ClinicalTrials.gov, NCT03570814. Findings: The study took place from December 2021 to January 2022. The combined MDA arm consisted of 7292 individuals who were eligible to participate, of whom 7068 received all three medications. The separate MDA arm consisted of 6219 eligible individuals of whom 6211 received ivermectin and albendazole and 4611 received azithromycin two weeks later. Overall, adverse events were reported by 197 (1.2%) of individuals. The most commonly reported adverse events included headache, gastrointestinal disturbance and dizziness. There were no serious adverse events in either arm. The cluster-level mean frequency of reported adverse events varied markedly between clusters, ranging from 0.1 to 10.4%. The cluster-level mean frequency of adverse events was 1.4% in the combined MDA arm and 1.2% following ivermectin and albendazole MDA (absolute difference 0.2%, 95% confidence interval [CI] -0.6% to +1.1%). This met the pre-defined 1.5% non-inferiority margin. For the combined MDA comparison to the stand-alone azithromycin MDA the absolute difference was -0.4% (1.4 versus 1.8%, 95% CI -0.8 to +1.5) which also met the pre-specified non-inferiority margin. Interpretation: This study is the largest of its kind to date and demonstrates that the safety of combined MDA of azithromycin, ivermectin and albendazole is non-inferior to the safety of ivermectin-plus-albendazole MDA then azithromycin MDA conducted separately although we may not have been powered to detect very small differences between arms. Co-administration of these three medicines is safe and feasible in this setting and allows national programs to develop new strategies for integrated MDA programs. Funding: Ivermectin (Mectizan) was donated by the Mectizan Donation Program, albendazole was donated by GlaxoSmithKline, and azithromycin (Zithromax®) was donated by Pfizer via the International Trachoma Initiative (ITI). The trial was funded by ITI using operational research funds from the Bill and Melinda Gates Foundation.

Prevalence of Trachoma from 66 Impact Surveys in 52 Woredas of Southern Nations, Nationalities and Peoples' and Sidama Regions of Ethiopia, 2017-2019.

PURPOSE: Trachoma is endemic in Southern Nations, Nationalities and Peoples' (SNNP) and Sidama regions of Ethiopia. We aimed to measure the prevalence of trachomatous inflammation-follicular (TF) among children aged 1 - 9 years and the prevalence of trachomatous trichiasis (TT) unknown to the health system among people aged ≥15 years following interventions for trachoma in 52 woredas of SNNP and Sidama regions. METHODS: From 2017 - 2019, 66 two-stage cluster sampling cross-sectional population-based surveys were carried out in 52 woredas (third-level administrative divisions) using a standardized World Health Organization-recommended survey methodology. This included one impact survey in 40 woredas, two consecutive impact surveys in 10 woredas and three consecutive impact surveys in two woredas. Water, sanitation and Hygiene (WASH) access was assessed using a modified version of the United Nations Children's Fund/WHO Joint Monitoring Programme questionnaire. RESULTS: By the end of this survey series, 15 (23%) of the woredas had met the active trachoma elimination threshold (TF prevalence <5%) and 12 (18%) had met the TT threshold (TT ≤ 0.2%). Regarding WASH coverage, 20% of households had access to an improved drinking water source within a 30-min journey and 3% had an improved latrine. There was strong evidence that TF was less common in 4 - 6-year-olds and 7 - 9-year-olds than 1 - 3-year-olds. CONCLUSION: Based on the findings, further antibiotic mass drug administration is required in 37 woredas and active TT case finding is needed in 40 woredas. In these surveys, access to WASH facilities was very low; WASH improvements are required.

Prevalence of Trachoma in Benishangul Gumuz Region, Ethiopia, after Implementation of the SAFE Strategy: Results of Four Population-Based Surveys.

PURPOSE: We aimed to estimate the prevalence of trachomatous inflammation-follicular (TF) in 1-9-year-olds and trachomatous trichiasis (TT) unknown to the health system in ≥15-year-olds in Benishangul Gumuz (BGZ) region, Ethiopia. This will help to assess progress towards the elimination of trachoma as a public health problem and determine the need for future interventions against trachoma in the region. METHODS: Cross-sectional population-based trachoma prevalence surveys were conducted in four evaluation units (EUs) of BGZ using World Health Organization-recommended survey methodologies. Individuals were examined for clinical signs of trachoma. Household access to water, sanitation and hygiene facilities (WaSH) was assessed. RESULTS: A total of 11,778 people aged ≥1 year were examined. The prevalence of TF in 1-9-year-olds was <5% in three EUs and ≥5% in one EU. The prevalence of TT unknown to the health system in people aged ≥15-years was ≥0.2% in all four EUs. The proportion of households with an improved drinking water source within a 30-minute round-trip ranged from 27-60%. The proportion of households with an improved latrine ranged from <1-6%. CONCLUSIONS: Surgical interventions for TT are required in all EUs in BGZ. One annual round of mass drug administration (MDA) of azithromycin is required in one EU before resurvey to reassess progress in lowering TF prevalence below the WHO elimination threshold of 5% in 1-9-year-olds. MDA should be stopped in the other three EUs and trachoma surveillance surveys should be conducted at least 24 months after the surveys described here. Ongoing strengthening of WaSH infrastructure may help sustain the low prevalence of trachoma.

An observational assessment of the safety of mass drug administration for trachoma in Ethiopian children.

BACKGROUND: The International Trachoma Initiative (ITI) provides azithromycin for mass drug administration (MDA) to eliminate trachoma as a public health problem. Azithromycin is given as tablets for adults and powder for oral suspension (POS) is recommended for children aged <7 y, children <120 cm in height (regardless of age) or anyone who reports difficulty in swallowing tablets. An observational assessment of MDA for trachoma was conducted to determine the frequency with which children aged 6 mo through 14 y received the recommended dose and form of azithromycin according to current dosing guidelines and to assess risk factors for choking and adverse swallowing events (ASEs). METHODS: MDA was observed in three regions of Ethiopia and data were collected on azithromycin administration and ASEs. RESULTS: A total of 6477 azithromycin administrations were observed; 97.9% of children received the exact recommended dose. Of children aged 6 mo to <7 y or <120 cm in height, 99.6% received POS. One child experienced choking and 132 (2%) experienced ≥1 ASEs. Factors significantly associated with ASEs included age 6-11 mo or 1-6 y, non-calm demeanor and requiring coaxing prior to drug administration. CONCLUSIONS: There is a high level of adherence to the revised azithromycin dosing guidelines and low incidence of choking and ASEs.

The implementation and impact of a pilot hydrocele surgery camp for LF-endemic communities in Ethiopia.

BACKGROUND: Ethiopia aims to eliminate lymphatic filariasis by 2020, through a dual approach of mass drug administration to interrupt transmission and morbidity control which includes making hydrocele surgery available in all endemic areas. Locating patients requiring surgery, providing high quality surgeries, and following up patients are all formidable challenges for many resource-challenged or difficult-to-reach communities. To date, hydrocele surgery in Ethiopia has only occurred when a patient has the knowledge, time and resources to travel to regional hospitals. Ethiopia tested the novel approach of using a surgical camp, defined as mobilizing, transporting, providing surgery at a static site, and following up of a large cohort of hydrocele patients within a hospital's catchment area, to address delays in seeking and receiving care. METHODOLOGY AND RESULTS: Health extension workers mobilized 252 patients with scrotal swelling from a list of 385 suspected hydrocele cases from seven endemic districts in the region of Beneshangul-Gumuz. Clinical health workers and surgeons confirmed 119 as eligible for surgery. Of 70 additional patients who self-referred, 56 were eligible for surgery. Over a two-week period at a regional hospital, 175 hydrocele excision surgeries were conducted. After discharge three days after surgery, trained clinical health workers followed up with the patients on Day 5, Day 8, Day 14 and 1st-month benchmarks with a randomized follow-up of a selection of patients conducted at 9-12 months. There were no post-operative complications upon discharge at Day 3 and 22, while minor complications occurred (12.6%) between Day 3 and one month. The 9-12 month follow-up found patients self-reported an improvement in quality of life, health and economic status. CONCLUSION: A hydrocele surgery camp was effective at providing a large number of quality surgeries in a short time. Using peripheral health workers to mobilize and follow up patients helped address delays in seeking and receiving quality care. Mainstreaming patient mobilization and follow-up into a community health system could be effective in other countries. The camp's results also influenced two regions in Ethiopia to change their policies in order to offer free hydrocele surgery (including patient transport, consultation, surgery, diagnostic tests and necessary medications).

Integrated morbidity management for lymphatic filariasis and podoconiosis, Ethiopia.

PROBLEM: Lymphatic filariasis and podoconiosis are the major causes of tropical lymphoedema in Ethiopia. The diseases require a similar provision of care, but until recently the Ethiopian health system did not integrate the morbidity management. APPROACH: To establish health-care services for integrated lymphoedema morbidity management, the health ministry and partners used existing governmental structures. Integrated disease mapping was done in 659 out of the 817 districts, to identify endemic districts. To inform resource allocation, trained health extension workers carried out integrated disease burden assessments in 56 districts with a high clinical burden. To ensure standard provision of care, the health ministry developed an integrated lymphatic filariasis and podoconiosis morbidity management guideline, containing a treatment algorithm and a defined package of care. Experienced professionals on lymphoedema management trained government-employed health workers on integrated morbidity management. To monitor the integration, an indicator on the number of lymphoedema-treated patients was included in the national health management information system. LOCAL SETTING: In 2014, only 24% (87) of the 363 health facilities surveyed provided lymphatic filariasis services, while 12% (44) provided podoconiosis services. RELEVANT CHANGES: To date, 542 health workers from 53 health centres in 24 districts have been trained on integrated morbidity management. Between July 2013 and June 2016, the national health management information system has recorded 46 487 treated patients from 189 districts. LESSONS LEARNT: In Ethiopia, an integrated approach for lymphatic filariasis and podoconiosis morbidity management was feasible. The processes used could be applicable in other settings where these diseases are co-endemic.

The National Programme to Eliminate Lymphatic Filariasis from Ethiopia.

Lymphatic filariasis (LF) is one of the most debilitating and disfiguring diseases common in Ethiopia and is caused by Wuchereria bancrofti. Mapping for LF has shown that 70 woredas (districts) are endemic and 5.9 million people are estimated to be at risk. The national government's LF elimination programme commenced in 2009 in 5 districts integrated with the onchocerciasis programme. The programme developed gradually and has shown significant progress over the past 6 years, reaching 100% geographical coverage for mass drug administration (MDA) by 2016. To comply with the global LF elimination goals an integrated morbidity management and disability prevention (MMDP) guideline and a burden assessment programme has also been developed; MMDP protocols and a hydrocoele surgical handbook produced for country-wide use. In Ethiopia, almost all LF endemic districts are co-endemic with malaria and vector control aspects of the activities are conducted in the context of malaria programme as the vectors for both diseases are mosquitoes. In order to monitor the elimination, 11 sentinel and spot-check sites have been established and baseline information has been collected. Although significant achievements have been achieved in the scale up of the LF elimination programme, there is still a need to strengthen operational research to generate programme-relevant evidence, to increase access to morbidity management services, and to improve monitoring and evaluation of the LF programme. However, the current status of implementation of the LF national programme indicates that Ethiopia is poised to achieve the 2020 goal of elimination of LF. Nevertheless, to achieve this goal, high and sustained treatment coverage and strong monitoring and evaluation of the programme are essential.

Integrated morbidity management for lymphatic filariasis and podoconiosis, Ethiopia

Problem Lymphatic filariasis and podoconiosis are the major causes of tropical lymphoedema in Ethiopia. The diseases require a similar provision of care, but until recently the Ethiopian health system did not integrate the morbidity management. Approach To establish health-care services for integrated lymphoedema morbidity management, the health ministry and partners used existing governmental structures. Integrated disease mapping was done in 659 out of the 817 districts, to identify endemic districts. To inform resource allocation, trained health extension workers carried out integrated disease burden assessments in 56 districts with a high clinical burden. To ensure standard provision of care, the health ministry developed an integrated lymphatic filariasis and podoconiosis morbidity management guideline, containing a treatment algorithm and a defined package of care. Experienced professionals on lymphoedema management trained government-employed health workers on integrated morbidity management. To monitor the integration, an indicator on the number of lymphoedema-treated patients was included in the national health management information system.Local setting In 2014, only 24% (87) of the 363 health facilities surveyed provided lymphatic filariasis services, while 12% (44) provided podoconiosis services.Relevant changes To date, 542 health workers from 53 health centres in 24 districts have been trained on integrated morbidity management. Between July 2013 and June 2016, the national health management information system has recorded 46 487 treated patients from 189 districts.Lessons learnt In Ethiopia, an integrated approach for lymphatic filariasis and podoconiosis morbidity management was feasible. The processes used could be applicable in other settings where these diseases are co-endemic

Ethiopia and its steps to mobilize resources to achieve 2020 elimination and control goals for neglected tropical diseases webs joined can tie a lion.

In June 2013, at the launch of its National Neglected Tropical Disease (NTD) Master Plan, the Ethiopian government pledged to achieve WHO NTD elimination and control targets by 2020. With an estimated 80 million people living in areas where one or more NTDs are endemic, this goal presented an enormous challenge for the Federal Ministry of Health. However, as of September 2015, the Federal Ministry of Health has managed to mobilize support to implement mass drug administration in 84% of the trachoma endemic districts and 100% of the endemic districts for onchocerciasis, lymphatic filariasis, soil-transmitted helminthes and schistosomiasis. The national program still is facing large gaps in its podoconiosis and leishmaniasis programs, and it faces significant other challenges to stay on track for 2020 targets. However, this unprecedented scale-up in support was achieved through significant government investment in NTD interventions and creative coordination between donors and implementing partners, which may provide valuable lessons for other national NTD programs trying to achieve nationwide coverage.