Trial Outcomes & Findings for Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) (NCT NCT03014167)
NCT ID: NCT03014167
Last Updated: 2026-01-22
Results Overview
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
357716 participants
Primary outcome timeframe
5 years (Three years of drug administration and two years of surveillance)
Results posted on
2026-01-22
Participant Flow
All participants were approached during a baseline census and offered the opportunity to participant in the study. Consent was taken from an adult household member for the entire household.
Prior to restricted randomization, clusters were demarcated (40 per site) with 1650+ individuals following local administrative boundaries. Study clusters were then randomized to treatment arm by restricted randomization and followed for the study period. While the arms were at the cluster level, outcomes were assessed both at the cluster level and at the individual level by taking random samples among those living in the study clusters.
Unit of analysis: Clusters
Participant milestones
| Measure |
Community-wide Deworming (Intervention)
Twice-yearly community-wide treatment delivered by drug distributors door to door for three years. All individuals above the age of 12 months (India/Benin) or 24 months of age (MalawI) who were not pregnant in the first trimester will receive a single dose of albendazole.
The intervention followed delivery of the standard of care school-age-targeted deworming delivered annually (Benin/Malawi) or biannually (India) described below.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
School-age-targeted Deworming (Control)
Pre-school (pre-SAC) and school-age children (SAC) 1-14 years of age (Benin), 1-19 years of age (India) or 2-19 years of age (Malawi) were offered treatment in schools or community gatherings annually (Benin/Malawi) or twice-yearly (India) per standard of care national treatment guidelines for three years.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
|---|---|---|
|
Overall Study
STARTED
|
177705 60
|
179207 60
|
|
Overall Study
COMPLETED
|
119342 60
|
116665 60
|
|
Overall Study
NOT COMPLETED
|
58363 0
|
62542 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
Baseline characteristics by cohort
| Measure |
Community-wide Deworming (Intervention)
n=177705 Participants
Twice-yearly community-wide treatment delivered by drug distributors door to door for three years. All individuals above the age of 12 months (India/Benin) or 24 months of age (MalawI) who were not pregnant in the first trimester will receive a single dose of albendazole.
The intervention followed delivery of the standard of care school-age-targeted deworming delivered annually (Benin/Malawi) or biannually (India) described below.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
School-age-targeted Deworming (Control)
n=180011 Participants
Pre-school (pre-SAC) and school-age children (SAC) 1-14 years of age (Benin), 1-19 years of age (India) or 2-19 years of age (Malawi) were offered treatment in schools or community gatherings annually (Benin/Malawi) or twice-yearly (India) per standard of care national treatment guidelines for three years.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
Total
n=357716 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age category · Infants (<1 year)
|
4337 Participants
n=177705 Participants
|
4396 Participants
n=180011 Participants
|
8733 Participants
n=357716 Participants
|
|
Age, Customized
Age category · Pre-school-age children (1-4 years)
|
18491 Participants
n=177705 Participants
|
18634 Participants
n=180011 Participants
|
37125 Participants
n=357716 Participants
|
|
Age, Customized
Age category · School-age children (5-14 years)
|
42471 Participants
n=177705 Participants
|
43062 Participants
n=180011 Participants
|
85533 Participants
n=357716 Participants
|
|
Age, Customized
Age category · Adults (15+ years)
|
112284 Participants
n=177705 Participants
|
113618 Participants
n=180011 Participants
|
225902 Participants
n=357716 Participants
|
|
Age, Customized
Age category · Unknown
|
122 Participants
n=177705 Participants
|
301 Participants
n=180011 Participants
|
423 Participants
n=357716 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
86233 Participants
n=177705 Participants
|
87430 Participants
n=180011 Participants
|
173663 Participants
n=357716 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
91466 Participants
n=177705 Participants
|
92564 Participants
n=180011 Participants
|
184030 Participants
n=357716 Participants
|
|
Sex/Gender, Customized
Sex · Other
|
6 Participants
n=177705 Participants
|
17 Participants
n=180011 Participants
|
23 Participants
n=357716 Participants
|
|
Race/Ethnicity, Customized
Language · Majority language
|
168000 Participants
n=177705 Participants
|
169596 Participants
n=180011 Participants
|
337596 Participants
n=357716 Participants
|
|
Race/Ethnicity, Customized
Language · Minority Language
|
7334 Participants
n=177705 Participants
|
8149 Participants
n=180011 Participants
|
15483 Participants
n=357716 Participants
|
|
Race/Ethnicity, Customized
Language · Unknown
|
2371 Participants
n=177705 Participants
|
2266 Participants
n=180011 Participants
|
4637 Participants
n=357716 Participants
|
|
Region of Enrollment
Benin
|
48241 participants
n=177705 Participants
|
46728 participants
n=180011 Participants
|
94969 participants
n=357716 Participants
|
|
Region of Enrollment
Malawi
|
61007 participants
n=177705 Participants
|
60811 participants
n=180011 Participants
|
121818 participants
n=357716 Participants
|
|
Region of Enrollment
India
|
68457 participants
n=177705 Participants
|
72472 participants
n=180011 Participants
|
141929 participants
n=357716 Participants
|
|
Baseline STH prevalence: qPCR
N. americanus
|
2288 Participants
n=15119 Participants • Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
|
2214 Participants
n=14861 Participants • Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
|
4502 Participants
n=29980 Participants • Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
|
|
Baseline STH prevalence: qPCR
A. lumbricoides
|
141 Participants
n=15119 Participants • Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
|
148 Participants
n=14861 Participants • Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
|
289 Participants
n=29980 Participants • Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
|
|
Baseline STH prevalence: qPCR
A. duodenale
|
23 Participants
n=15119 Participants • Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
|
17 Participants
n=14861 Participants • Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
|
40 Participants
n=29980 Participants • Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
|
|
Baseline STH prevalence: qPCR
T. trichiura
|
23 Participants
n=15119 Participants • Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
|
19 Participants
n=14861 Participants • Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
|
42 Participants
n=29980 Participants • Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
|
|
Baseline STH prevalence: qPCR
Any STH species
|
2444 Participants
n=15119 Participants • Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
|
2368 Participants
n=14861 Participants • Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
|
4812 Participants
n=29980 Participants • Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals
|
PRIMARY outcome
Timeframe: 5 years (Three years of drug administration and two years of surveillance)Population: The number of participants analyzed is the number surveyed and sampled at endline
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
Outcome measures
| Measure |
Community-wide Deworming (Intervention)
n=18490 Participants
Twice-yearly community-wide treatment delivered by drug distributors door to door for three years. All individuals above the age of 12 months (India/Benin) or 24 months of age (MalawI) who were not pregnant in the first trimester will receive a single dose of albendazole.
The intervention followed delivery of the standard of care school-age-targeted deworming delivered annually (Benin/Malawi) or biannually (India) described below.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
School-age-targeted Deworming (Control)
n=18673 Participants
Pre-school (pre-SAC) and school-age children (SAC) 1-14 years of age (Benin), 1-19 years of age (India) or 2-19 years of age (Malawi) were offered treatment in schools or community gatherings annually (Benin/Malawi) or twice-yearly (India) per standard of care national treatment guidelines for three years.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
|---|---|---|
|
Comparison of Arms - Benin
Any STH species · N americanus
|
467 Participants
|
819 Participants
|
|
Comparison of Arms - Benin
N. americanus · N americanus
|
322 Participants
|
748 Participants
|
|
Comparison of Arms - Benin
A duodenale · N americanus
|
11 Participants
|
11 Participants
|
|
Comparison of Arms - Benin
T trichiura · N americanus
|
13 Participants
|
6 Participants
|
|
Comparison of Arms - Benin
A lumbricoides · N americanus
|
123 Participants
|
59 Participants
|
PRIMARY outcome
Timeframe: 5 years (Three years of drug administration and two years of surveillance)Population: The number of participants analyzed is the number surveyed and sampled at endline
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
Outcome measures
| Measure |
Community-wide Deworming (Intervention)
n=19894 Participants
Twice-yearly community-wide treatment delivered by drug distributors door to door for three years. All individuals above the age of 12 months (India/Benin) or 24 months of age (MalawI) who were not pregnant in the first trimester will receive a single dose of albendazole.
The intervention followed delivery of the standard of care school-age-targeted deworming delivered annually (Benin/Malawi) or biannually (India) described below.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
School-age-targeted Deworming (Control)
n=19896 Participants
Pre-school (pre-SAC) and school-age children (SAC) 1-14 years of age (Benin), 1-19 years of age (India) or 2-19 years of age (Malawi) were offered treatment in schools or community gatherings annually (Benin/Malawi) or twice-yearly (India) per standard of care national treatment guidelines for three years.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
|---|---|---|
|
Comparison of Arms - India
N. americanus (primary)
|
1906 Participants
Interval 0.32 to 0.52
|
4310 Participants
|
|
Comparison of Arms - India
A. duodenale
|
3 Participants
Interval 0.17 to 4.94
|
3 Participants
|
|
Comparison of Arms - India
A. lumbricoides
|
17 Participants
Interval 0.81 to 5.29
|
7 Participants
|
|
Comparison of Arms - India
T. trichiura
|
7 Participants
Interval 0.34 to 2.67
|
5 Participants
|
|
Comparison of Arms - India
Any STH species
|
1930 Participants
Interval 0.33 to 0.52
|
4318 Participants
|
PRIMARY outcome
Timeframe: 5 years (Three years of drug administration and two years of surveillance)Population: The number of participants analyzed is the number surveyed and sampled at endline
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
Outcome measures
| Measure |
Community-wide Deworming (Intervention)
n=20170 Participants
Twice-yearly community-wide treatment delivered by drug distributors door to door for three years. All individuals above the age of 12 months (India/Benin) or 24 months of age (MalawI) who were not pregnant in the first trimester will receive a single dose of albendazole.
The intervention followed delivery of the standard of care school-age-targeted deworming delivered annually (Benin/Malawi) or biannually (India) described below.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
School-age-targeted Deworming (Control)
n=20258 Participants
Pre-school (pre-SAC) and school-age children (SAC) 1-14 years of age (Benin), 1-19 years of age (India) or 2-19 years of age (Malawi) were offered treatment in schools or community gatherings annually (Benin/Malawi) or twice-yearly (India) per standard of care national treatment guidelines for three years.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
|---|---|---|
|
Comparison of Arms - Malawi
N. americanus (primary)
|
827 Participants
Interval 0.34 to 0.46
|
1989 Participants
|
|
Comparison of Arms - Malawi
A. duodenale
|
6 Participants
Interval 0.07 to 1.4
|
15 Participants
|
|
Comparison of Arms - Malawi
A. lumbricoides
|
12 Participants
Interval 0.37 to 1.38
|
15 Participants
|
|
Comparison of Arms - Malawi
T. trichiura
|
2 Participants
Interval 0.03 to 2.63
|
4 Participants
|
|
Comparison of Arms - Malawi
Any STH species
|
846 Participants
Interval 0.35 to 0.47
|
2016 Participants
|
PRIMARY outcome
Timeframe: 5 years (Three years of drug administration and two years of surveillance)Population: The age- and sex-weighted prevalence of N. americanus was calculated at the cluster level and defined as transmission interruption if the bound of the one-side 95% confidence interval was \<2%.
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
Outcome measures
| Measure |
Community-wide Deworming (Intervention)
n=20 Study clusters
Twice-yearly community-wide treatment delivered by drug distributors door to door for three years. All individuals above the age of 12 months (India/Benin) or 24 months of age (MalawI) who were not pregnant in the first trimester will receive a single dose of albendazole.
The intervention followed delivery of the standard of care school-age-targeted deworming delivered annually (Benin/Malawi) or biannually (India) described below.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
School-age-targeted Deworming (Control)
n=20 Study clusters
Pre-school (pre-SAC) and school-age children (SAC) 1-14 years of age (Benin), 1-19 years of age (India) or 2-19 years of age (Malawi) were offered treatment in schools or community gatherings annually (Benin/Malawi) or twice-yearly (India) per standard of care national treatment guidelines for three years.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
|---|---|---|
|
N. Americanus Transmission Interruption - Benin
Transmission interruption
|
11 Study clusters
|
6 Study clusters
|
|
N. Americanus Transmission Interruption - Benin
Did not achieve transmission interruption
|
9 Study clusters
|
14 Study clusters
|
PRIMARY outcome
Timeframe: 5 years (Three years of drug administration and two years of surveillance)Population: The age- and sex-weighted prevalence of N. americanus was calculated at the cluster level and defined as transmission interruption if the bound of the one-side 95% confidence interval was \<2%. The study cluster is a demarcated section of the study area (40 per country) with 1650+ individuals following local administrative boundaries.
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
Outcome measures
| Measure |
Community-wide Deworming (Intervention)
n=20 Study clusters
Twice-yearly community-wide treatment delivered by drug distributors door to door for three years. All individuals above the age of 12 months (India/Benin) or 24 months of age (MalawI) who were not pregnant in the first trimester will receive a single dose of albendazole.
The intervention followed delivery of the standard of care school-age-targeted deworming delivered annually (Benin/Malawi) or biannually (India) described below.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
School-age-targeted Deworming (Control)
n=20 Study clusters
Pre-school (pre-SAC) and school-age children (SAC) 1-14 years of age (Benin), 1-19 years of age (India) or 2-19 years of age (Malawi) were offered treatment in schools or community gatherings annually (Benin/Malawi) or twice-yearly (India) per standard of care national treatment guidelines for three years.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
|---|---|---|
|
N. Americanus Transmission Interruption - India
Transmission interruption
|
1 Study clusters
|
0 Study clusters
|
|
N. Americanus Transmission Interruption - India
Did not achieve transmission interruption
|
19 Study clusters
|
20 Study clusters
|
PRIMARY outcome
Timeframe: 5 years (Three years of drug administration and two years of surveillance)Population: The age- and sex-weighted prevalence of N. americanus was calculated at the cluster level and defined as transmission interruption if the bound of the one-side 95% confidence interval was \<2%. The study cluster is a demarcated section of the study area (40 per country) with 1650+ individuals following local administrative boundaries.
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
Outcome measures
| Measure |
Community-wide Deworming (Intervention)
n=20 Study clusters
Twice-yearly community-wide treatment delivered by drug distributors door to door for three years. All individuals above the age of 12 months (India/Benin) or 24 months of age (MalawI) who were not pregnant in the first trimester will receive a single dose of albendazole.
The intervention followed delivery of the standard of care school-age-targeted deworming delivered annually (Benin/Malawi) or biannually (India) described below.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
School-age-targeted Deworming (Control)
n=20 Study clusters
Pre-school (pre-SAC) and school-age children (SAC) 1-14 years of age (Benin), 1-19 years of age (India) or 2-19 years of age (Malawi) were offered treatment in schools or community gatherings annually (Benin/Malawi) or twice-yearly (India) per standard of care national treatment guidelines for three years.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
|---|---|---|
|
N. Americanus Transmission Interruption - Malawi
Transmission interruption
|
0 Study clusters
|
0 Study clusters
|
|
N. Americanus Transmission Interruption - Malawi
Did not achieve transmission interruption
|
20 Study clusters
|
20 Study clusters
|
SECONDARY outcome
Timeframe: 5 years (Three years of drug administration and two years of surveillance)Population: The age- and sex-weighted prevalence of N. americanus was calculated at the cluster level and defined as transmission interruption if the bound of the one-side 95% confidence interval was \<2%. The study cluster is a demarcated section of the study area (40 per country) with 1650+ individuals following local administrative boundaries.
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
Outcome measures
| Measure |
Community-wide Deworming (Intervention)
n=60 Study clusters
Twice-yearly community-wide treatment delivered by drug distributors door to door for three years. All individuals above the age of 12 months (India/Benin) or 24 months of age (MalawI) who were not pregnant in the first trimester will receive a single dose of albendazole.
The intervention followed delivery of the standard of care school-age-targeted deworming delivered annually (Benin/Malawi) or biannually (India) described below.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
School-age-targeted Deworming (Control)
n=60 Study clusters
Pre-school (pre-SAC) and school-age children (SAC) 1-14 years of age (Benin), 1-19 years of age (India) or 2-19 years of age (Malawi) were offered treatment in schools or community gatherings annually (Benin/Malawi) or twice-yearly (India) per standard of care national treatment guidelines for three years.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
|---|---|---|
|
N. Americanus Transmission Interruption - Pooled
Transmission interruption
|
12 Study clusters
|
6 Study clusters
|
|
N. Americanus Transmission Interruption - Pooled
Did not achieve transmission interruption
|
48 Study clusters
|
54 Study clusters
|
SECONDARY outcome
Timeframe: 5 years (Three years of drug administration and two years of surveillance)Population: The number of participants analyzed is the number surveyed and sampled at endline
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
Outcome measures
| Measure |
Community-wide Deworming (Intervention)
n=58827 Participants
Twice-yearly community-wide treatment delivered by drug distributors door to door for three years. All individuals above the age of 12 months (India/Benin) or 24 months of age (MalawI) who were not pregnant in the first trimester will receive a single dose of albendazole.
The intervention followed delivery of the standard of care school-age-targeted deworming delivered annually (Benin/Malawi) or biannually (India) described below.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
School-age-targeted Deworming (Control)
n=58554 Participants
Pre-school (pre-SAC) and school-age children (SAC) 1-14 years of age (Benin), 1-19 years of age (India) or 2-19 years of age (Malawi) were offered treatment in schools or community gatherings annually (Benin/Malawi) or twice-yearly (India) per standard of care national treatment guidelines for three years.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
|---|---|---|
|
Comparison of Arms - Pooled
Any STH species
|
3243 Participants
Interval 0.37 to 0.49
|
7153 Participants
|
|
Comparison of Arms - Pooled
N. americanus (primary)
|
3055 Participants
Interval 0.36 to 0.48
|
7047 Participants
|
|
Comparison of Arms - Pooled
A. duodenale
|
20 Participants
Interval 0.33 to 1.51
|
29 Participants
|
|
Comparison of Arms - Pooled
A. lumbricoides
|
152 Participants
Interval 0.89 to 2.18
|
81 Participants
|
|
Comparison of Arms - Pooled
T. trichiura
|
22 Participants
Interval 0.76 to 3.12
|
15 Participants
|
SECONDARY outcome
Timeframe: 5 years (Three years of drug administration and two years of surveillance)Population: The age- and sex-weighted prevalence of any STH species was calculated at the cluster level and defined as transmission interruption if the bound of the one-side 95% confidence interval was \<2%.
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Outcome measures
| Measure |
Community-wide Deworming (Intervention)
n=60 Study clusters
Twice-yearly community-wide treatment delivered by drug distributors door to door for three years. All individuals above the age of 12 months (India/Benin) or 24 months of age (MalawI) who were not pregnant in the first trimester will receive a single dose of albendazole.
The intervention followed delivery of the standard of care school-age-targeted deworming delivered annually (Benin/Malawi) or biannually (India) described below.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
School-age-targeted Deworming (Control)
n=60 Study clusters
Pre-school (pre-SAC) and school-age children (SAC) 1-14 years of age (Benin), 1-19 years of age (India) or 2-19 years of age (Malawi) were offered treatment in schools or community gatherings annually (Benin/Malawi) or twice-yearly (India) per standard of care national treatment guidelines for three years.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
|---|---|---|
|
STH Transmission Interruption - Pooled
Transmission interruption
|
9 Study clusters
|
5 Study clusters
|
|
STH Transmission Interruption - Pooled
Did not achieve transmission interruption
|
51 Study clusters
|
55 Study clusters
|
SECONDARY outcome
Timeframe: 5 years (Three years of drug administration and two years of surveillance)Population: The age- and sex-weighted prevalence of any STH species was calculated at the cluster level and defined as transmission interruption if the bound of the one-side 95% confidence interval was \<2%.
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Outcome measures
| Measure |
Community-wide Deworming (Intervention)
n=20 Study clusters
Twice-yearly community-wide treatment delivered by drug distributors door to door for three years. All individuals above the age of 12 months (India/Benin) or 24 months of age (MalawI) who were not pregnant in the first trimester will receive a single dose of albendazole.
The intervention followed delivery of the standard of care school-age-targeted deworming delivered annually (Benin/Malawi) or biannually (India) described below.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
School-age-targeted Deworming (Control)
n=20 Study clusters
Pre-school (pre-SAC) and school-age children (SAC) 1-14 years of age (Benin), 1-19 years of age (India) or 2-19 years of age (Malawi) were offered treatment in schools or community gatherings annually (Benin/Malawi) or twice-yearly (India) per standard of care national treatment guidelines for three years.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
|---|---|---|
|
STH Transmission Interruption - Benin
Transmission interruption
|
9 Study clusters
|
5 Study clusters
|
|
STH Transmission Interruption - Benin
Did not achieve transmission interruption
|
11 Study clusters
|
15 Study clusters
|
SECONDARY outcome
Timeframe: 5 years (Three years of drug administration and two years of surveillance)Population: The age- and sex-weighted prevalence of any STH was calculated at the cluster level and defined as transmission interruption if the bound of the one-side 95% confidence interval was \<2%.
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Outcome measures
| Measure |
Community-wide Deworming (Intervention)
n=20 Study clusters
Twice-yearly community-wide treatment delivered by drug distributors door to door for three years. All individuals above the age of 12 months (India/Benin) or 24 months of age (MalawI) who were not pregnant in the first trimester will receive a single dose of albendazole.
The intervention followed delivery of the standard of care school-age-targeted deworming delivered annually (Benin/Malawi) or biannually (India) described below.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
School-age-targeted Deworming (Control)
n=20 Study clusters
Pre-school (pre-SAC) and school-age children (SAC) 1-14 years of age (Benin), 1-19 years of age (India) or 2-19 years of age (Malawi) were offered treatment in schools or community gatherings annually (Benin/Malawi) or twice-yearly (India) per standard of care national treatment guidelines for three years.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
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|---|---|---|
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STH Transmission Interruption - India
Transmission interruption
|
0 Study clusters
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0 Study clusters
|
|
STH Transmission Interruption - India
Did not achieve transmission interruption
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20 Study clusters
|
20 Study clusters
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SECONDARY outcome
Timeframe: 5 years (Three years of drug administration and two years of surveillance)Population: The age- and sex-weighted prevalence of any STH species was calculated at the cluster level and defined as transmission interruption if the bound of the one-side 95% confidence interval was \<2%.
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Outcome measures
| Measure |
Community-wide Deworming (Intervention)
n=20 Study clusters
Twice-yearly community-wide treatment delivered by drug distributors door to door for three years. All individuals above the age of 12 months (India/Benin) or 24 months of age (MalawI) who were not pregnant in the first trimester will receive a single dose of albendazole.
The intervention followed delivery of the standard of care school-age-targeted deworming delivered annually (Benin/Malawi) or biannually (India) described below.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
School-age-targeted Deworming (Control)
n=20 Study clusters
Pre-school (pre-SAC) and school-age children (SAC) 1-14 years of age (Benin), 1-19 years of age (India) or 2-19 years of age (Malawi) were offered treatment in schools or community gatherings annually (Benin/Malawi) or twice-yearly (India) per standard of care national treatment guidelines for three years.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
|
|---|---|---|
|
STH Transmission Interruption - Malawi
Transmission interruption
|
0 Study clusters
|
0 Study clusters
|
|
STH Transmission Interruption - Malawi
Did not achieve transmission interruption
|
20 Study clusters
|
20 Study clusters
|
Adverse Events
Community-wide Deworming (Intervention)
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Community-wide Deworming (Intervention)
n=242344 participants at risk
Twice-yearly community-wide treatment delivered by drug distributors door to door for three years. All individuals above the age of 12 months (India/Benin) or 24 months of age (Malawi) who were not pregnant in the first trimester will receive a single dose of albendazole.
The intervention followed delivery of the standard of care school-age-targeted deworming delivered annually (Benin/Malawi) or biannually (India) described below.
Albendazole: All eligible individuals will receive a single dose of 400 mg albendazole.
NOTE: AEs were passively collected only in the intervention arm of the study as the government delivered the standard of care.
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|---|---|
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Gastrointestinal disorders
Viral fever
|
0.00%
1/242344 • Number of events 1 • 2 years, 9 months. Treatment with albendazole is known to be safe and billions of doses have been distributed over the previous decades. Therefore, a comparison between arms was not an objective of the study and adverse events were only collected to reduce the risk of harm to research subjects. Therefore, adverse events were passively ascertained during rounds of mass drug administration contacted the study staff and a study clinician reviewed and responded to adverse events.
|
|
Gastrointestinal disorders
Acute gastroenteritis
|
0.00%
3/242344 • Number of events 3 • 2 years, 9 months. Treatment with albendazole is known to be safe and billions of doses have been distributed over the previous decades. Therefore, a comparison between arms was not an objective of the study and adverse events were only collected to reduce the risk of harm to research subjects. Therefore, adverse events were passively ascertained during rounds of mass drug administration contacted the study staff and a study clinician reviewed and responded to adverse events.
|
|
General disorders
Fainting
|
0.00%
4/242344 • Number of events 4 • 2 years, 9 months. Treatment with albendazole is known to be safe and billions of doses have been distributed over the previous decades. Therefore, a comparison between arms was not an objective of the study and adverse events were only collected to reduce the risk of harm to research subjects. Therefore, adverse events were passively ascertained during rounds of mass drug administration contacted the study staff and a study clinician reviewed and responded to adverse events.
|
|
Infections and infestations
Fever / malaria
|
0.00%
4/242344 • Number of events 4 • 2 years, 9 months. Treatment with albendazole is known to be safe and billions of doses have been distributed over the previous decades. Therefore, a comparison between arms was not an objective of the study and adverse events were only collected to reduce the risk of harm to research subjects. Therefore, adverse events were passively ascertained during rounds of mass drug administration contacted the study staff and a study clinician reviewed and responded to adverse events.
|
|
Gastrointestinal disorders
Impacted bowel
|
0.00%
1/242344 • Number of events 1 • 2 years, 9 months. Treatment with albendazole is known to be safe and billions of doses have been distributed over the previous decades. Therefore, a comparison between arms was not an objective of the study and adverse events were only collected to reduce the risk of harm to research subjects. Therefore, adverse events were passively ascertained during rounds of mass drug administration contacted the study staff and a study clinician reviewed and responded to adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Judd Walson
Johns Hopkins University Bloomberg School of Public Health
Phone: 2066124571
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place