Trial Outcomes & Findings for Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis (NCT NCT01905423)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

17108 participants

Primary outcome timeframe

3 years

Results posted on

2020-11-17

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Paga (1x Annual MDA) The village of Paga received once annual MDA for a total of 3 rounds over 24 months.	Lewomada (1x Annual MDA) Village of Lewomada received once annual MDA for a total of 3 rounds over 24 months.	Pruda (2x Annual MDA) The village of Pruda received twice annual MDA for a total of 5 rounds over 24 months.	Pekalongan (1x Annual MDA) 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 received one round of MDA and was surveyed one year later.	Pekalongan (2x Annual MDA) 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 received two rounds of MDA and was surveyed one year later.
Overall Study STARTED	4456	3297	4111	2757	2487
Overall Study Baseline	1443	722	1033	1482	1326
Overall Study Year 1 Follow-up	994	846	1007	1275	1161
Overall Study Year 2 Follow-up	1114	858	1043	0	0
Overall Study Year 3 Follow-up	905	871	1028	0	0
Overall Study COMPLETED	4456	3297	4111	2757	2487
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Annual MDA Treated Group (Paga) n=1443 Participants 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	Annual MDA Treated Group (Lewomada) n=722 Participants 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	Semiannual MDA Treated Group n=1033 Participants 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	Annual MDA Treated Group (Pekalongan) n=1482 Participants 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	Semiannual MDA Treated Group (Pekalongan) n=1326 Participants 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	Total n=6006 Participants Total of all reporting groups
Age, Customized Age at Baseline (pre-MDA) · 15 years and younger	597 Participants n=5 Participants	285 Participants n=7 Participants	374 Participants n=5 Participants	353 Participants n=4 Participants	372 Participants n=21 Participants	1981 Participants n=8 Participants
Age, Customized Age at Baseline (pre-MDA) · Older than 15	794 Participants n=5 Participants	437 Participants n=7 Participants	653 Participants n=5 Participants	1129 Participants n=4 Participants	954 Participants n=21 Participants	3967 Participants n=8 Participants
Age, Customized Age at Baseline (pre-MDA) · Age unknown	52 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	58 Participants n=8 Participants
Sex/Gender, Customized Gender at Baseline (pre-MDA) · Females	897 Participants n=5 Participants	411 Participants n=7 Participants	545 Participants n=5 Participants	816 Participants n=4 Participants	721 Participants n=21 Participants	3390 Participants n=8 Participants
Sex/Gender, Customized Gender at Baseline (pre-MDA) · Males	546 Participants n=5 Participants	311 Participants n=7 Participants	488 Participants n=5 Participants	666 Participants n=4 Participants	605 Participants n=21 Participants	2616 Participants n=8 Participants
Sex/Gender, Customized Gender at Baseline (pre-MDA) · Gender unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Paga (1x Annual MDA) n=4401 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly	Lewomada (1x Annual MDA) n=3297 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly	Pruda (2x Annual MDA) n=4079 Participants Participants from this village 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 Semiannual: Albendazole and diethylcarbamazine Semiannual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg twice yearly	Pekalongan (1x Annual MDA) n=2730 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly	Pekalongan (2x Annual MDA) n=2427 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly
Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant Blood Year 1	11 Participants	9 Participants	37 Participants	28 Participants	30 Participants
Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant Blood Year 2	6 Participants	6 Participants	15 Participants	0 Participants	0 Participants
Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant Blood Year 3	0 Participants	3 Participants	12 Participants	0 Participants	0 Participants
Prevalence of Microfilaria in Blood as Determined by Microscopy of Participant Blood Baseline (pre-MDA)	54 Participants	36 Participants	146 Participants	46 Participants	45 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Paga (1x Annual MDA) n=2308 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly	Lewomada (1x Annual MDA) n=3297 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly	Pruda (2x Annual MDA) n=2054 Participants Participants from this village 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 Semiannual: Albendazole and diethylcarbamazine Semiannual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg twice yearly	Pekalongan (1x Annual MDA) Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly	Pekalongan (2x Annual MDA) Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly
Prevalence of Positive Brugia Rapid Antifilarial Antibody Tests Baseline	175 Participants	229 Participants	297 Participants	0 Participants	0 Participants
Prevalence of Positive Brugia Rapid Antifilarial Antibody Tests Year 1	0 Participants	168 Participants	0 Participants	0 Participants	0 Participants
Prevalence of Positive Brugia Rapid Antifilarial Antibody Tests Year 2	0 Participants	134 Participants	0 Participants	0 Participants	0 Participants
Prevalence of Positive Brugia Rapid Antifilarial Antibody Tests Year 3	16 Participants	36 Participants	37 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Paga (1x Annual MDA) n=3511 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly	Lewomada (1x Annual MDA) n=3297 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly	Pruda (2x Annual MDA) n=4095 Participants Participants from this village 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 Semiannual: Albendazole and diethylcarbamazine Semiannual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg twice yearly	Pekalongan (1x Annual MDA) n=2696 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly	Pekalongan (2x Annual MDA) n=2407 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly
Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card Test Baseline	14 Participants	47 Participants	235 Participants	118 Participants	102 Participants
Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card Test Year 1	0 Participants	12 Participants	91 Participants	51 Participants	63 Participants
Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card Test Year 2	2 Participants	13 Participants	106 Participants	0 Participants	0 Participants
Prevalence of Circulating Filarial Antigen in Blood as Determined by ICT Card Test Year 3	0 Participants	36 Participants	72 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Paga (1x Annual MDA) n=708 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly	Lewomada (1x Annual MDA) n=1230 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly	Pruda (2x Annual MDA) n=523 Participants Participants from this village 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 Semiannual: Albendazole and diethylcarbamazine Semiannual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg twice yearly	Pekalongan (1x Annual MDA) n=699 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly	Pekalongan (2x Annual MDA) n=792 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly
Prevalence of Ascaris Infection Baseline	88 Participants	56 Participants	34 Participants	19 Participants	58 Participants
Prevalence of Ascaris Infection Year 1	135 Participants	17 Participants	7 Participants	11 Participants	6 Participants
Prevalence of Ascaris Infection Year 2	107 Participants	18 Participants	3 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Paga (1x Annual MDA) n=708 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly	Lewomada (1x Annual MDA) n=1230 Participants Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly	Pruda (2x Annual MDA) n=523 Participants Participants from this village 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 Semiannual: Albendazole and diethylcarbamazine Semiannual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg twice yearly	Pekalongan (1x Annual MDA) Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly	Pekalongan (2x Annual MDA) Participants from this village 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 Annual: Albendazole and diethylcarbamazine Annual Albendazole 400 mg plus diethylcarbamazine 6 mg/kg once yearly
Prevalence of Hookworm Infection Baseline	25 Participants	226 Participants	35 Participants	0 Participants	0 Participants
Prevalence of Hookworm Infection Year 1	118 Participants	118 Participants	90 Participants	0 Participants	0 Participants
Prevalence of Hookworm Infection Year 2	65 Participants	97 Participants	87 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.