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Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis

Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01905423
Acronym
DOLF-Indo
Enrollment
17108
Registered
2013-07-23
Start date
2011-05-31
Completion date
2015-12-31
Last updated
2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphatic Filariasis, Soil Transmitted Helminth Infections

Keywords

Filariasis, Albendazole, Diethylcarbamazine, STH Soil Transmitted Helminths, MDA Mass Drug Administration

Brief summary

Approximately 3,500 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis endemic areas. The study will be performed in Indonesia in B. timori and W. bancrofti endemic areas over a period of 4 years. Participants will be studied only once in cross-sectional surveys. Some subjects may be included in more than one annual population survey, but this is not a longitudinal study. Purpose of the study is to evaluate different mass drug administration (MDA) regimens for lymphatic filariasis and also to study the impact of MDA on soil transmitted helminth infections (STH). MDA will administered by others (e.g., Ministry of Health). Results of this study may enhance efforts to control and eliminate these important neglected tropical diseases. The investigators will test the hypothesis that accelerated mass drug administration will be superior to annual MDA for elimination of lymphatic filariasis and for control of soil transmitted helminth infections (STH): 1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF). 2. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations.

Detailed description

Lymphatic filariasis (LF) is a deforming and disabling infectious disease that causes elephantiasis and genital deformity (especially hydroceles). The infection affects some 120 million people in 81 countries in tropical and subtropical regions with well over 1 billion people at risk of acquiring the disease. LF is caused by Wuchereria bancrofti and Brugia spp. (B. malayi and B.timori), nematode parasites that are transmitted by mosquitoes. This study is based on the assumption that currently used mass drug administration (MDA) regimens and schedules are not optimal for achieving elimination of LF. These regimens (either annual Albendazole (Alb) 400 mg plus diethylcarbamazine (DEC) 6 mg/kg or Alb 400 mg plus ivermectin (Iver) 200 µg/kg for LF) were developed more than 10 years ago. Drugs used for LF MDA are also active against soil transmitted helminth infections (STH, e.g., Ascaris, Hookworm, and Trichuris). De-worming campaigns using anthelminthics usually target special groups of the population, such as schoolchildren, and have limited impact on the transmission. Treatment of the total population and semiannual treatments may reduce re-infection considerably and will most likely lead to reduced infection densities and infection prevalences. Suppression of STH is an important ancillary benefit of MDA programs for filarial infections. Purpose: The study aims to compare the effectiveness once yearly (1X) versus twice yearly (2X) mass drug administration (MDA) for the elimination of lymphatic filariasis and for control of soil-transmitted helminths (intestinal parasites) in large populations. Mass drug administration will be provided by the Indonesia Ministry of Health. This project will assess the impact of the public health program. Procedures: Study procedures include collection of finger prick blood that will be tested for microfilaremia and for serology testing (antigenemia and antibody testing). Stool samples will be collected to detect STH infections. All assays will be performed in Indonesia (filarial serology tests, blood smears for detection of microfilariae (MF), and stool examinations for detection of worm eggs). Washington University researchers developed the protocol, will provide training and guidance to Indonesian researchers, and work with them to analyze the data. Indonesian researchers will consent the participants, obtain stool and blood specimens, perform laboratory tests on the specimens, and enter data on participants and lab results.

Interventions

DRUGAlbendazole (annual)

Albendazole 400 mg pnce annually

DRUGDiethylcarbamazine (annual)

Diethylcarbamazine 6 mg/kg once annually

DRUGAlbendazole (semiannual)

Albendazole 400 mg twice annually

DRUGDiethylcarbamazine (semiannual)

Diethylcarbamazine 6 mg/kg twice annually

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Areas should be endemic for filariasis and have limited or no prior experience with MDA. Males and Females greater than or equal to 5 years of age.

Exclusion criteria

* Children less than 5 years of age.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant Blood3 yearsMicrofilariae (filarial parasites) will be detected in blood smears by microscopy. Samples will be collected in annual and semiannual community surveys. Prevalence rates (a measure of the disease rates in the population sampled) are expressed as % positive for microfilaremia (having microfilaria in the blood).

Secondary

MeasureTime frameDescription
Prevalence of Positive Brugia Rapid Antifilarial Antibody Tests3 yearsThis outcome is reported as the frequency of participants with positive Brugia Rapid antifilarial antibody tests. Data was only collected at baseline and at year 3 for this outcome measure and no antibody data was collected for the Pekalongan study sites.
Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card Test3 yearsPrevalence of filarial antigenemia (detected with the Binax Filariasis Now card test ICT card test) among the population surveyed. Prevalence data are expressed as %.
Prevalence of Ascaris Infection2 YearsPrevalence of Ascaris infection is defined by the number of participants with any Ascaris worm eggs present in their stool sample as analyzed with microscopy.
Prevalence of Hookworm Infection2 yearsPrevalence of hookworm infection is defined by the number of participants with any hookworm eggs present in their stool sample as analyzed with microscopy.
Prevalence of Trichuris Infection2 yearsPrevalence of trichuris infection is defined by the number of participants with any trichuris worm eggs present in their stool sample as analyzed with microscopy.

Countries

Indonesia

Participant flow

Recruitment details

This was a cross-sectional study. The final end points of the study are measures of community prevalence. Participant involvement in the study ended after each survey period. Participants were not followed across survey periods, but could be and were likely recruited into more than one survey period.

Participants by arm

ArmCount
Annual MDA Treated Group (Paga)
This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly
1,443
Annual MDA Treated Group (Lewomada)
This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly
722
Semiannual MDA Treated Group
This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly
1,033
Annual MDA Treated Group (Pekalongan)
The Pekalongan study site was dropped from further analysis after the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites. This group will receive annual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will be administered by the Indonesian Ministry of Health as part of their national filariasis elimination program. Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly
1,482
Semiannual MDA Treated Group (Pekalongan)
The Pekalongan study site was dropped from further analysis after the first year follow-up due to lower than expected prevalence of lymphatic filariasis infections. Baseline and year 1 follow-up results are presented separately from the other study sites. This group will receive semiannual MDA (Albendazole 400 mg plus diethylcarbamazine 6 mg/kg) which will also be administered by the Indonesian Ministry of Health. Albendazole and diethylcarbamazine: Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly vs twice yearly
1,326
Total6,006

Baseline characteristics

CharacteristicAnnual MDA Treated Group (Paga)Annual MDA Treated Group (Lewomada)Semiannual MDA Treated GroupAnnual MDA Treated Group (Pekalongan)Semiannual MDA Treated Group (Pekalongan)Total
Age, Customized
Age at Baseline (pre-MDA)
15 years and younger
597 Participants285 Participants374 Participants353 Participants372 Participants1981 Participants
Age, Customized
Age at Baseline (pre-MDA)
Age unknown
52 Participants0 Participants6 Participants0 Participants0 Participants58 Participants
Age, Customized
Age at Baseline (pre-MDA)
Older than 15
794 Participants437 Participants653 Participants1129 Participants954 Participants3967 Participants
Sex/Gender, Customized
Gender at Baseline (pre-MDA)
Females
897 Participants411 Participants545 Participants816 Participants721 Participants3390 Participants
Sex/Gender, Customized
Gender at Baseline (pre-MDA)
Gender unknown
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Sex/Gender, Customized
Gender at Baseline (pre-MDA)
Males
546 Participants311 Participants488 Participants666 Participants605 Participants2616 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 4,4560 / 3,2970 / 4,1110 / 2,7570 / 2,487
other
Total, other adverse events
0 / 4,4560 / 3,2970 / 4,1110 / 2,7570 / 2,487
serious
Total, serious adverse events
0 / 4,4560 / 3,2970 / 4,1110 / 2,7570 / 2,487

Outcome results

Primary

Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant Blood

Microfilariae (filarial parasites) will be detected in blood smears by microscopy. Samples will be collected in annual and semiannual community surveys. Prevalence rates (a measure of the disease rates in the population sampled) are expressed as % positive for microfilaremia (having microfilaria in the blood).

Time frame: 3 years

Population: The Pekalongan study sites were dropped after the first year due to lower than expected prevalence of lymphatic filariasis infections. The overall number of participants analyzed for each group may be slightly less than the total sample size for that group due to the fact that not all data was collected for all participants.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Paga (1x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodBaseline (pre-MDA)54 Participants
Paga (1x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodYear 111 Participants
Paga (1x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodYear 26 Participants
Paga (1x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodYear 30 Participants
Lewomada (1x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodBaseline (pre-MDA)36 Participants
Lewomada (1x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodYear 33 Participants
Lewomada (1x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodYear 19 Participants
Lewomada (1x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodYear 26 Participants
Pruda (2x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodYear 312 Participants
Pruda (2x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodYear 137 Participants
Pruda (2x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodYear 215 Participants
Pruda (2x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodBaseline (pre-MDA)146 Participants
Pekalongan (1x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodBaseline (pre-MDA)46 Participants
Pekalongan (1x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodYear 128 Participants
Pekalongan (1x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodYear 30 Participants
Pekalongan (1x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodYear 20 Participants
Pekalongan (2x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodYear 30 Participants
Pekalongan (2x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodYear 20 Participants
Pekalongan (2x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodYear 130 Participants
Pekalongan (2x Annual MDA)Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant BloodBaseline (pre-MDA)45 Participants
Secondary

Prevalence of Ascaris Infection

Prevalence of Ascaris infection is defined by the number of participants with any Ascaris worm eggs present in their stool sample as analyzed with microscopy.

Time frame: 2 Years

Population: The Pekalongan study sites were dropped after the first year. No soil transmitted helminth infection data was collected after year 2. The overall number of participants analyzed for each group may be slightly less than the total sample size for that group due to the fact that not all data was collected for all participants.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Paga (1x Annual MDA)Prevalence of Ascaris InfectionBaseline88 Participants
Paga (1x Annual MDA)Prevalence of Ascaris InfectionYear 2107 Participants
Paga (1x Annual MDA)Prevalence of Ascaris InfectionYear 1135 Participants
Lewomada (1x Annual MDA)Prevalence of Ascaris InfectionYear 117 Participants
Lewomada (1x Annual MDA)Prevalence of Ascaris InfectionBaseline56 Participants
Lewomada (1x Annual MDA)Prevalence of Ascaris InfectionYear 218 Participants
Pruda (2x Annual MDA)Prevalence of Ascaris InfectionYear 17 Participants
Pruda (2x Annual MDA)Prevalence of Ascaris InfectionBaseline34 Participants
Pruda (2x Annual MDA)Prevalence of Ascaris InfectionYear 23 Participants
Pekalongan (1x Annual MDA)Prevalence of Ascaris InfectionBaseline19 Participants
Pekalongan (1x Annual MDA)Prevalence of Ascaris InfectionYear 20 Participants
Pekalongan (1x Annual MDA)Prevalence of Ascaris InfectionYear 111 Participants
Pekalongan (2x Annual MDA)Prevalence of Ascaris InfectionYear 16 Participants
Pekalongan (2x Annual MDA)Prevalence of Ascaris InfectionBaseline58 Participants
Pekalongan (2x Annual MDA)Prevalence of Ascaris InfectionYear 20 Participants
Secondary

Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card Test

Prevalence of filarial antigenemia (detected with the Binax Filariasis Now card test ICT card test) among the population surveyed. Prevalence data are expressed as %.

Time frame: 3 years

Population: This outcome data was not collected for Paga at year 3 or for Pekalongan sites after year 1 (Pekalongan study site was dropped completely after year 1). The overall number of participants analyzed for each group may be less than the total sample size for that group due to the fact that not all data was collected for all participants.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Paga (1x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestBaseline14 Participants
Paga (1x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestYear 10 Participants
Paga (1x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestYear 22 Participants
Paga (1x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestYear 30 Participants
Lewomada (1x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestBaseline47 Participants
Lewomada (1x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestYear 336 Participants
Lewomada (1x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestYear 112 Participants
Lewomada (1x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestYear 213 Participants
Pruda (2x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestYear 372 Participants
Pruda (2x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestYear 191 Participants
Pruda (2x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestYear 2106 Participants
Pruda (2x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestBaseline235 Participants
Pekalongan (1x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestBaseline118 Participants
Pekalongan (1x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestYear 151 Participants
Pekalongan (1x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestYear 30 Participants
Pekalongan (1x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestYear 20 Participants
Pekalongan (2x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestYear 30 Participants
Pekalongan (2x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestYear 20 Participants
Pekalongan (2x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestYear 163 Participants
Pekalongan (2x Annual MDA)Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card TestBaseline102 Participants
Secondary

Prevalence of Hookworm Infection

Prevalence of hookworm infection is defined by the number of participants with any hookworm eggs present in their stool sample as analyzed with microscopy.

Time frame: 2 years

Population: Hookworm prevalence was not analyzed for Pekalongan sites. Hookworm data was not collected after year 2 for any sites. The overall number of participants analyzed for each group may be slightly less than the total sample size for that group due to the fact that not all data was collected for all participants.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Paga (1x Annual MDA)Prevalence of Hookworm InfectionYear 265 Participants
Paga (1x Annual MDA)Prevalence of Hookworm InfectionYear 1118 Participants
Paga (1x Annual MDA)Prevalence of Hookworm InfectionBaseline25 Participants
Lewomada (1x Annual MDA)Prevalence of Hookworm InfectionYear 1118 Participants
Lewomada (1x Annual MDA)Prevalence of Hookworm InfectionYear 297 Participants
Lewomada (1x Annual MDA)Prevalence of Hookworm InfectionBaseline226 Participants
Pruda (2x Annual MDA)Prevalence of Hookworm InfectionBaseline35 Participants
Pruda (2x Annual MDA)Prevalence of Hookworm InfectionYear 190 Participants
Pruda (2x Annual MDA)Prevalence of Hookworm InfectionYear 287 Participants
Pekalongan (1x Annual MDA)Prevalence of Hookworm InfectionBaseline0 Participants
Pekalongan (1x Annual MDA)Prevalence of Hookworm InfectionYear 20 Participants
Pekalongan (1x Annual MDA)Prevalence of Hookworm InfectionYear 10 Participants
Pekalongan (2x Annual MDA)Prevalence of Hookworm InfectionYear 10 Participants
Pekalongan (2x Annual MDA)Prevalence of Hookworm InfectionBaseline0 Participants
Pekalongan (2x Annual MDA)Prevalence of Hookworm InfectionYear 20 Participants
Secondary

Prevalence of Positive Brugia Rapid Antifilarial Antibody Tests

This outcome is reported as the frequency of participants with positive Brugia Rapid antifilarial antibody tests. Data was only collected at baseline and at year 3 for this outcome measure and no antibody data was collected for the Pekalongan study sites.

Time frame: 3 years

Population: This outcome data was only collected at baseline and at year 3 for Paga \& Pruda and no antibody data was collected at all for the Pekalongan study sites. The overall number of participants analyzed for each group may be less than the total sample size for that group due to the fact that not all data was collected for all participants.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Paga (1x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsBaseline175 Participants
Paga (1x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsYear 10 Participants
Paga (1x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsYear 20 Participants
Paga (1x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsYear 316 Participants
Lewomada (1x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsBaseline229 Participants
Lewomada (1x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsYear 336 Participants
Lewomada (1x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsYear 1168 Participants
Lewomada (1x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsYear 2134 Participants
Pruda (2x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsYear 337 Participants
Pruda (2x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsYear 10 Participants
Pruda (2x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsYear 20 Participants
Pruda (2x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsBaseline297 Participants
Pekalongan (1x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsBaseline0 Participants
Pekalongan (1x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsYear 10 Participants
Pekalongan (1x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsYear 30 Participants
Pekalongan (1x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsYear 20 Participants
Pekalongan (2x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsYear 30 Participants
Pekalongan (2x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsYear 20 Participants
Pekalongan (2x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsYear 10 Participants
Pekalongan (2x Annual MDA)Prevalence of Positive Brugia Rapid Antifilarial Antibody TestsBaseline0 Participants
Secondary

Prevalence of Trichuris Infection

Prevalence of trichuris infection is defined by the number of participants with any trichuris worm eggs present in their stool sample as analyzed with microscopy.

Time frame: 2 years

Population: The Pekalongan study sites were dropped after the first year. No soil transmitted helminth infection data was collected after year 2. The overall number of participants analyzed for each group may be slightly less than the total sample size for that group due to the fact that not all data was collected for all participants.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Paga (1x Annual MDA)Prevalence of Trichuris InfectionBaseline68 Participants
Paga (1x Annual MDA)Prevalence of Trichuris InfectionYear 284 Participants
Paga (1x Annual MDA)Prevalence of Trichuris InfectionYear 193 Participants
Lewomada (1x Annual MDA)Prevalence of Trichuris InfectionYear 125 Participants
Lewomada (1x Annual MDA)Prevalence of Trichuris InfectionBaseline45 Participants
Lewomada (1x Annual MDA)Prevalence of Trichuris InfectionYear 223 Participants
Pruda (2x Annual MDA)Prevalence of Trichuris InfectionYear 18 Participants
Pruda (2x Annual MDA)Prevalence of Trichuris InfectionBaseline8 Participants
Pruda (2x Annual MDA)Prevalence of Trichuris InfectionYear 213 Participants
Pekalongan (1x Annual MDA)Prevalence of Trichuris InfectionBaseline120 Participants
Pekalongan (1x Annual MDA)Prevalence of Trichuris InfectionYear 20 Participants
Pekalongan (1x Annual MDA)Prevalence of Trichuris InfectionYear 135 Participants
Pekalongan (2x Annual MDA)Prevalence of Trichuris InfectionYear 165 Participants
Pekalongan (2x Annual MDA)Prevalence of Trichuris InfectionBaseline352 Participants
Pekalongan (2x Annual MDA)Prevalence of Trichuris InfectionYear 20 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026