Better Options for Lymphatic Filariasis Treatment

• MoxDA - Moxidectin + Diethylcarbamzine (DEC) + Albendazole (Drug): Mass drug administration with moxidectin co-administered with DEC and albendazole (MoxDA). Participants who are ineligible to receive moxidectin will be offered modified treatment options: 1. Children aged ≥ 2 years but < 4 years - DEC, albendazole, and permethrin 5% cream 2. Participants who have a severe illness, a known or suspected allergy to ivermectin, moxidectin, DEC or albendazole, are pregnant or breastfeeding a baby up to 7 days of age, or are under 2 years of age - permethrin 5% cream (unless allergic)
• IDA - Ivermectin + DEC + albendazole (Drug): Mass drug administration with ivermectin co-administered with DEC and albendazole (IDA). Participants who are ineligible to receive moxidectin will be offered modified treatment options: 1. Children aged < 2 years or weight < 15 kg - DEC, albendazole, and permethrin 5% cream 2. Participants who have a severe illness, a known or suspected allergy to ivermectin, moxidectin, DEC or albendazole, are pregnant or breastfeeding a baby up to 7 days of age, or are under 2 years of age - permethrin 5% cream (unless allergic)

Primary outcomes

• Proportion of microfilariae (Mf)-positive participants at Baseline who are Mf-negative at Month 12 following treatment with MoxDA or IDA [12 months post-treatment]: Lymphatic filariasis (LF) Mf measured by ultrafiltration
• Incidence and severity of adverse events [7 days, 12 months and 24 months post-treatment]: Frequency, type, and severity of adverse events reported by treatment group

Secondary outcomes

• Proportion of Mf-positive participants at Baseline who are Mf-negative at Month 24 following treatment with MoxDA or IDA [24 months post-treatment]: LF Mf measured using ultrafiltration
• Mean Mf density and mean change from Baseline at Months 12 and 24 following treatment with MoxDA or IDA in participants who are Mf-positive at Baseline [12 and 24 months post-treatment]: LF Mf measured using ultrafiltration
• Proportion of participants who are circulating filarial antigen (CFA)-positive at baseline who become CFA-negative at Months 12 and/or 24 following treatment with MoxDA or IDA [12 and 24 months post-treatment]: CFA measured using rapid lateral flow assay
• Change in community prevalence of LF, as measured by Mf, at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessments between Months 12 and 24 [12 and 24 months post-treatment]: LF Mf measured using ultrafiltration
• Change in community prevalence of LF, as measured by CFA, at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthl [12 and 24 months post-treatment]: CFA measured using rapid lateral flow assay
• Proportion of participants with presence of Mf between Month 12 and Month 24 among those who were Mf positive at Month 12 following treatment with MoxDA or IDA [12 to 24 months post-treatment]: LF Mf measured using ultrafiltration
• Time to first detection of Mf in participants with presence of Mf between Month 12 and Month 24 among those who were Mf positive at Month 12 following treatment with MoxDA or IDA [12 to 24 months post-treatment]: Lf Mf measured using ultrafiltration
• Community acceptability of MDA with MoxDA or IDA assessed by surveys, focus group discussions, and/or key informant interviews before Baseline and approximately 2 months following MDA at Baseline and Month 12 [Pre- and post-treatment at Baseline and post-treatment at Month 12]
• Change in community prevalence of scabies and impetigo at Months 12 and 24 following annual community MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessment between Months 12 and 24 [12 and 24 months post-treatment]: Scabies and impetigo measured using modified International Alliance for the Control of Scabies (IACS) criteria based on examination of normally exposed skin
• Change in community seroprevalence of S. stercoralis at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessments between Months 12 and 24 [12 and 24 months post-treatment]
• Change in community prevalence of LF, as measured by Mf and CFA, at Months 12 and 24 following annual MDA with MoxDA or IDA, in addition to directed treatment of individuals who are Mf positive at 3-monthly assessments between Months 12 and 24 [12 and 24 months post-treatment]: LF Mf measured using ultrafiltration and CFA measured using rapid lateral flow assay

Sex: All, accepts healthy volunteers

Inclusion Criteria:

1. Provision of signed and dated informed consent.
2. Resident in one of the study locations.

Exclusion Criteria:

There are no exclusion criteria to participation in the study.

Treatment Exclusion Criteria:

Participants are ineligible to receive the treatment regimen allocated to their village if they meet any of the following criteria:

1. Severe illness (any illness that is severe enough to interfere with activities of daily living);
2. Known or suspected allergy to ivermectin, moxidectin, diethylcarbamazine or albendazole;
3. Pregnant;
4. Breastfeeding a baby within 7 days of birth;
5. Age < 4 years for villages randomised to moxidectin, diethylcarbamazine, and albendazole (MoxDA); or
6. Age < 2 years or weight < 15 kg for villages randomized to ivermectin, diethylcarbamazine and albendazole (IDA).