This clinical trial compares two treatments - ivermectin and moxidectin - to learn which is better at reducing the proportion of people with onchocerciasis (river blindness) when given through mass drug administration (MDA) in Angola. Both drugs are approved by the United States Food and Drug Administration (FDA) to treat this disease. The study also explores how these treatments affect other infections common in the region, including intestinal worms (soil-transmitted helminths) and scabies. The trial aims to answer the following key questions: * How do moxidectin and ivermectin compare in reducing the prevalence (how common the disease is) and intensity (amount of parasites per person) of onchocerciasis in the community? * Do the treatments differ in their effect on the prevalence and intensity of soil-transmitted helminths and the prevalence of scabies? * Does moxidectin reduce transmission of onchocerciasis more effectively than ivermectin, based on genetic testing of parasites in people and lab testing of the blackflies that carry the infection? * How many more years of treatment would be needed to reach elimination with each drug, based on mathematical disease modelling? * How do communities feel about receiving moxidectin versus ivermectin, and what factors help or make it harder to carry out MDA programs with moxidectin versus ivermectin? The study takes place in Bié Province, Angola, and involves 20 groups of villages randomly assigned to receive either moxidectin or ivermectin once a year for four years. Prior to every round of MDA, researchers will collect skin, stool and blood samples from a sample of the people living in the study area. We believe the results will help guide global policy on the use of moxidectin in efforts to eliminate onchocerciasis and control related diseases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
52,000
2 mg tablets
3 mg tablets
Villages in Andulo and Nharea Municipalities
Andulo, Bíe Province, Angola
RECRUITINGPrevalence of Onchocerca volvulus microfilariae
Prevalence of O. volvulus microfilariae at 36 months in skin snips, the marker most likely to show change in the shorter term as demonstrated by the therapeutic trials
Time frame: 36 months after the first intervention
Prevalence of O. volvulus microfilaria/mg skin
Time frame: 12, 24 and 36 months after the first intervention
Microfilariae density (mean, median)
Time frame: 12, 24 and 36 months after the first intervention
Prevalence of nodules
Time frame: 12, 24 and 36 months after the first intervention
Prevalence of onchocerciasis skin disease
Time frame: 12, 24 and 36 months after the first intervention
Proportion of black flies with infective O. volvulus larvae
Infection assessed based on all 3 are markers recommended by WHO to define population-level elimination
Time frame: 12, 24 and 36 months after the first intervention
Prevalence of anti-Ov-16
Time frame: 12, 24 and 36 months after the first intervention
Prevalence of Ascaris lumbricoides
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Intensity of Ascaris lumbricoides infection
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Prevalence of Trichuris trichiura
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Intensity of Trichuris trichiura infection
Measured through qPCR
Time frame: Baseline and 12, 24 and 36 months after the first intervention
Prevalence of hookworm
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Intensity of hookworm infection
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Prevalence of Strongyloides stercoralis
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Intensity of Strongyloides stercoralis infection
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Prevalence of scabies/impetigo
Time frame: 12, 24 and 36 months after the first intervention
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