One versus two doses of ivermectin-based mass drug administration for the control of scabies: A cluster randomised non-inferiority trial.

BACKGROUND: Mass drug administration (MDA) based on two doses of ivermectin, one week apart, substantially reduces prevalence of both scabies and impetigo. The Regimens of Ivermectin for Scabies Elimination (RISE) trial assessed whether one-dose ivermectin-based MDA would be as effective. METHODS: RISE was a cluster-randomised trial in Solomon Islands. We assigned 20 villages in a 1:1 ratio to one- or two-dose ivermectin-based MDA. We planned to test whether the impact of one dose on scabies prevalence at 12 and 24 months was non-inferior to two, at a 5% non-inferiority margin. RESULTS: We deferred endpoint assessment to 21 months due to COVID-19. We enrolled 5239 participants in 20 villages at baseline and 3369 at 21 months from an estimated population of 5500. At baseline scabies prevalence was similar in the two arms (one-dose 17·2%; two-dose 13·2%). At 21 months, there was no reduction in scabies prevalence (one-dose 18·7%; two-dose 13·4%), and the confidence interval around the difference included values substantially greater than 5%. There was however a reduction in prevalence among those who had been present at the baseline assessment (one-dose 15·9%; two-dose 10·8%). Additionally, we found a reduction in both scabies severity and impetigo prevalence in both arms, to a similar degree. CONCLUSIONS: There was no indication of an overall decline in scabies prevalence in either arm. The reduction in scabies prevalence in those present at baseline suggests that the unexpectedly high influx of people into the trial villages, likely related to the COVID-19 pandemic, may have compromised the effectiveness of the MDA. Despite the lack of effect there are important lessons to be learnt from this trial about conducting MDA for scabies in high prevalence settings. TRIAL REGISTRATION: Registered with Australian New Zealand Clinical Trials Registry ACTRN12618001086257.

Protocol for a cluster-randomised non-inferiority trial of one versus two doses of ivermectin for the control of scabies using a mass drug administration strategy (the RISE study).

INTRODUCTION: Scabies is a significant contributor to global morbidity, affecting approximately 200 million people at any time. Scabies is endemic in many resource-limited tropical settings. Bacterial skin infection (impetigo) frequently complicates scabies infestation in these settings. Community-wide ivermectin-based mass drug administration (MDA) is an effective control strategy for scabies in island settings, with a single round of MDA reducing population prevalence by around 90%. However, current two-dose regimens present a number of barriers to programmatic MDA implementation. We designed the Regimens of Ivermectin for Scabies Elimination (RISE) trial to investigate whether one-dose MDA may be as effective as two-dose MDA in controlling scabies in high-prevalence settings. METHODS AND ANALYSIS: RISE is a cluster-randomised non-inferiority trial. The study will be conducted in 20 isolated villages in Western Province of Solomon Islands where population prevalence of scabies is approximately 20%. Villages will be randomly allocated to receive either one dose or two doses of ivermectin-based MDA in a 1:1 ratio. The primary objective of the study is to determine if ivermectin-based MDA with one dose is as effective as MDA with two doses in reducing the prevalence of scabies after 12 months. Secondary objectives include the effect of ivermectin-based MDA on impetigo prevalence after 12 and 24 months, the prevalence of scabies at 24 months after the intervention, the impact on presentation to health facilities with scabies and impetigo, and the safety of one-dose and two-dose MDA. ETHICS AND DISSEMINATION: This trial has been approved by the ethics review committees of the Solomon Islands and the Royal Children's Hospital, Australia. Results will be disseminated in peer-reviewed publications and in meetings with the Solomon Islands Ministry of Health and Medical Services and participating communities. TRIAL REGISTRATION DETAILS: Australian New Zealand Clinical Trials Registry: ACTRN12618001086257. Date registered: 28 June 2018.

Prevalence of scabies and impetigo in the Solomon Islands: a school survey.

BACKGROUND: Scabies, a parasitic disease of the skin, is a major public health problem, largely affecting children. Scabies is often complicated by impetigo which can result in serious complications including invasive infections and immune mediated diseases. Scabies and impetigo are reported to have high prevalence in tropical settings including the Solomon Islands. METHODS: We conducted a cross-sectional prevalence survey at Gizo Primary School in the Western Province of the Solomon Islands in August 2018. The diagnosis of scabies was based on criteria developed by the International Alliance for the Control of Scabies in 2018. Population attributable risk was calculated to determine the effect of scabies on the prevalence of impetigo, and both adjusted and unadjusted risk ratios were calculated to identify differences between sexes and age groups. RESULTS: A total of 324 students were assessed (47.5% of those enrolled at the school). The prevalence of scabies was 54.3% (95% confidence interval [CI] 48.7-59.8) and most disease was mild (68.8%). The prevalence was higher in males (63.5%; adjusted risk ratio [ARR] 1.4, 95% CI 1.1-1.7), and in those aged 10-12 years (61.4%; ARR 1.8, 95% CI 1.1-2.9 when compared to those aged 4-6 years). The prevalence of impetigo was 32.1%, with males more likely to be affected (41.7%, ARR 1.7, 95% CI 1.2-2.4) but with no significant differences between age groups. 63.5% of those with impetigo had scabies, corresponding to a population attributable risk of 11.8%. CONCLUSIONS: There is a very high burden of scabies and impetigo among primary school students in Gizo. There is a critical need for the development and implementation of control programs in areas where scabies is endemic.

Prevalence of Trachoma in Kano State, Nigeria: Results of 44 Local Government Area-Level Surveys.

PURPOSE: We sought to determine the prevalence of trachoma in 44 Local Government Areas (LGAs) of Kano State, Nigeria. METHODS: A population-based prevalence survey was conducted in each Kano LGA. We used a two-stage systematic and quasi-random sampling strategy to select 25 households from each of 25 clusters in each LGA. All consenting household residents aged 1 year and above were examined for trachomatous inflammation-follicular (TF), trachomatous inflammation-intense (TI) and trichiasis. RESULTS: State-wide crude prevalence of TF in persons aged 1-9 years was 3.4% (95% CI 3.3-3.5%), and of trichiasis in those aged ≥15 years was 2.3% (95% CI 2.1-2.4%). LGA-level age- and sex-adjusted trichiasis prevalence in those aged ≥15 years ranged from 0.1% to 2.9%. All but 4 (9%) of 44 LGAs had trichiasis prevalences in adults above the elimination threshold of 0.2%. State-wide prevalence of trichiasis in adult women was significantly higher than in adult men (2.6% vs 1.8%; OR = 1.5, 95% CI 1.3-1.7; p = 0.001). Four of 44 LGAs had TF prevalences in 1-9-year-olds between 10 and 15%, while another six LGAs had TF prevalences between 5 and 9.9%. In 37 LGAs, >80% of households had access to water within 30 minutes round-trip, but household latrine access was >80% in only 19 LGAs. CONCLUSION: Trichiasis is a public health problem in most LGAs in Kano. Surgeons need to be trained and deployed to provide community-based trichiasis surgery, with emphasis on delivery of such services to women. Antibiotics, facial cleanliness and environmental improvement are needed in 10 LGAs.