Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AI155739-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
| Imperial College London | OTHER |
| London School of Hygiene and Tropical Medicine | OTHER |
| Institut de Recherche Clinique du Benin |
Not provided
Not provided
Not provided
Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to targeted populations, including pre-school age children and school-age children. However mathematical models suggests that current MDA strategies are not sufficient for interrupting disease transmission in most areas. Meanwhile many lymphatic filariasis (LF) programs have successfully treated entire populations with albendazole (in combination with ivermectin or diethylcarbamazine) and are transitioning to a state of post-MDA surveillance. This project will conduct a series of community-based cluster randomized trials in India, Malawi, and Benin to determine if maintaining three years of MDA with albendazole to entire communities following the cessation of LF programs can interrupt STH transmission in focal geographic areas. Additionally, this study aims to compare the efficacy of community-wide MDA versus targeted MDA of children in interrupting the transmission of STH. Nested implementation science research will be used to optimize the intervention, identify contextual factors influencing trial efficacy, and evaluate the feasibility of sustaining and scaling community-wide MDA for STH. These data will provide evidence necessary to inform future guidelines, policies, and operational plans as country partners engage in intensified approaches to eliminate these disabling diseases.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community-wide deworming | Experimental | Twice-yearly community-wide treatment delivered by drug distributors door to door or via community gatherings, depending upon the format of the prior LF program, for three years. All individuals above the age of 12 months will receive a single dose of albendazole. |
|
| Targeted deworming | Active Comparator | Pre-school (pre-SAC) and school-age children (SAC) 12 months of age and older will receive albendazole delivered in accordance with national Ministry of Health guidelines for three years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albendazole | Drug | All eligible individuals will receive a single dose of 400 mg albendazole. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Arms - Benin | Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence | 5 years (Three years of drug administration and two years of surveillance) |
| Comparison of Arms - India | Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence | 5 years (Three years of drug administration and two years of surveillance) |
| Comparison of Arms - Malawi | Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence | 5 years (Three years of drug administration and two years of surveillance) |
| N. Americanus Transmission Interruption - Benin | Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole | 5 years (Three years of drug administration and two years of surveillance) |
| N. Americanus Transmission Interruption - India | Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole | 5 years (Three years of drug administration and two years of surveillance) |
| N. Americanus Transmission Interruption - Malawi | Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole | 5 years (Three years of drug administration and two years of surveillance) |
| Measure | Description | Time Frame |
|---|---|---|
| N. Americanus Transmission Interruption - Pooled | Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole | 5 years (Three years of drug administration and two years of surveillance) |
| Comparison of Arms - Pooled |
Not provided
Treatment Inclusion Criteria:
Treatment Exclusion Criteria:
Outcome Sampling Inclusion Criteria:
Outcome Sampling Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Judd L Walson, MD, MPH | University of Washington, Departments of Global Health, Medicine (Infectious Disease), Pediatrics and Epidemiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Recherche pour le Développement | Comé | Benin | ||||
| Christian Medical College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40752908 | Derived | Ajjampur SSR, Aruldas K, Asbjornsdottir KH, Avokpaho E, Bailey R, Cottrell G, Galagan SR, Halliday KE, Houngbegnon P, Ibikounle M, Israel GJ, Kaliappan SP, Kalua K, Legge H, Littlewood DTJ, Luty AJF, Manuel M, Massougbodji A, Means AR, Oswald WE, Pilotte N, Pullan R, Ramesh RM, Samikwa L, Simwanza J, Thomas KK, Williams SA, Witek-McManus S, Walson JL; DeWorm3 Trials Team. Feasibility of interrupting the transmission of soil-transmitted helminths: the DeWorm3 community cluster-randomised controlled trial in Benin, India, and Malawi. Lancet. 2025 Aug 2;406(10502):475-488. doi: 10.1016/S0140-6736(25)00766-4. | |
| 39380086 |
| Label | URL |
|---|---|
| University of Washington DeWorm3 Website | View source |
Not provided
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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Censused population prior to the intervention
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | N. Americanus Transmission Interruption - Pooled | Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole | 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. | Posted | Count of Units | Study clusters | 5 years (Three years of drug administration and two years of surveillance) | Study clusters | Study clusters |
|
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.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. NOTE: AEs were passively collected only in the intervention arm of the study as the government delivered the standard of care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral fever | Gastrointestinal disorders | Non-systematic Assessment | Tested positive for Typhoid O&H and hospitalized |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judd Walson | Johns Hopkins University Bloomberg School of Public Health | 2066124571 | jwalson1@jh.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 15, 2017 | Jul 30, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 2, 2024 | Jul 30, 2025 | SAP_003.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006373 | Helminthiasis |
| D005368 | Filariasis |
| ID | Term |
|---|---|
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
| OTHER |
| Institut de Recherche pour le Developpement | OTHER_GOV |
| Christian Medical College, Vellore, India | OTHER |
| Blantyre Institute for Community Ophthalmology (BICO) | UNKNOWN |
| Swiss Tropical & Public Health Institute | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
Mass drug administration intervention is not blinded to study participants but investigators and outcome assessors remain blind to link between allocation and outcome data
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence |
| 5 years (Three years of drug administration and two years of surveillance) |
| STH Transmission Interruption - Pooled | Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole | 5 years (Three years of drug administration and two years of surveillance) |
| STH Transmission Interruption - Benin | Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole | 5 years (Three years of drug administration and two years of surveillance) |
| STH Transmission Interruption - India | Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole | 5 years (Three years of drug administration and two years of surveillance) |
| STH Transmission Interruption - Malawi | Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole | 5 years (Three years of drug administration and two years of surveillance) |
| Vellore |
| India |
| London School of Hygiene and Tropical Medicine | Mangochi | Malawi |
| Derived |
| Means AR, Asbjornsdottir KH, Sharrock KC, Galagan SR, Aruldas K, Avokpaho E, Chabi F, Halliday KE, Houngbegnon P, Israel GJ, Kaliappan SP, Kennedy D, Legge H, Oswald WE, Palanisamy G, Rogers E, Timothy J, Pearman E, Ramesh RM, Simwanza J, Sheik-Abdullah JF, Sheikh M, Togbevi CI, Witek-McManus S, Pullan RL, Bailey R, Kalua K, Ibikounle M, Luty AJF, Ajjampur SSR, Walson JL. Coverage of community-wide mass drug administration platforms for soil-transmitted helminths in Benin, India, and Malawi: findings from the DeWorm3 project. Infect Dis Poverty. 2024 Oct 8;13(1):72. doi: 10.1186/s40249-024-01241-0. |
| 39242171 | Derived | Witek-McManus S, Simwanza J, Msiska R, Mangawah H, Oswald W, Timothy J, Galagan S, Pearman E, Shaikh M, Legge H, Walson J, Juziwelo L, Davey C, Pullan R, Bailey RL, Kalua K, Kuper H. Disability in childhood and the equity of health services: a cross-sectional comparison of mass drug administration strategies for soil-transmitted helminths in southern Malawi. BMJ Open. 2024 Sep 5;14(9):e083321. doi: 10.1136/bmjopen-2023-083321. |
| 38319937 | Derived | Saxena M, Roll A, Walson JL, Pearman E, Legge H, Nindi P, Chirambo CM, Titus A, Johnson J, Belou EA, Togbevi CI, Chabi F, Avokpaho E, Kalua K, Ajjampur SSR, Ibikounle M, Aruldas K, Means AR. "Our desire is to make this village intestinal worm free": Identifying determinants of high coverage of community-wide mass drug administration for soil transmitted helminths in Benin, India, and Malawi. PLoS Negl Trop Dis. 2024 Feb 6;18(2):e0011819. doi: 10.1371/journal.pntd.0011819. eCollection 2024 Feb. |
| 38175837 | Derived | Kazura E, Johnson J, Morozoff C, Aruldas K, Avokpaho E, Togbevi CI, Chabi F, Gwayi-Chore MC, Nindi P, Titus A, Houngbegnon P, Kaliappan SP, Jacob Y, Simwanza J, Kalua K, Walson JL, Ibikounle M, Ajjampur SSR, Means AR. Identifying opportunities to optimize mass drug administration for soil-transmitted helminths: A visualization and descriptive analysis using process mapping. PLoS Negl Trop Dis. 2024 Jan 4;18(1):e0011772. doi: 10.1371/journal.pntd.0011772. eCollection 2024 Jan. |
| 37899143 | Derived | Ramesh RM, Oswald WE, Israel GJ, Aruldas K, Galagan S, Legge H, Puthupalayam Kaliappan S, Walson J, Halliday KE, Ajjampur SSR. Representativeness of a mobile phone-based coverage evaluation survey following mass drug administration for soil-transmitted helminths: a comparison of participation between two cross-sectional surveys. BMJ Open. 2023 Oct 29;13(10):e070077. doi: 10.1136/bmjopen-2022-070077. |
| 37036890 | Derived | Sheahan W, Anderson R, Aruldas K, Avokpaho E, Galagan S, Goodman J, Houngbegnon P, Israel GJ, Janagaraj V, Kaliappan SP, Means AR, Morozoff C, Pearman E, Ramesh RM, Roll A, Schaefer A, Simwanza J, Witek-McManus S, Ajjampur SSR, Bailey R, Ibikounle M, Kalua K, Luty AJF, Pullan R, Walson JL, Asbjornsdottir KH. Overestimation of school-based deworming coverage resulting from school-based reporting. PLoS Negl Trop Dis. 2023 Apr 10;17(4):e0010401. doi: 10.1371/journal.pntd.0010401. eCollection 2023 Apr. |
| 36917597 | Derived | Aruldas K, Israel GJ, Johnson J, Titus A, Saxena M, Kaliappan SP, Ramesh RM, Walson JL, Means AR, Ajjampur SSR. Impact of adverse events during community-wide mass drug administration for soil-transmitted helminths on subsequent participation-a Theory of Planned Behaviour analysis. PLoS Negl Trop Dis. 2023 Mar 14;17(3):e0011148. doi: 10.1371/journal.pntd.0011148. eCollection 2023 Mar. |
| 36897877 | Derived | Aruldas K, Dawson K, Saxena M, Titus A, Johnson J, Gwayi-Chore MC, Muliyil J, Kang G, Walson JL, Khera A, Ajjampur SSR, Means AR. Evaluation of opportunities to implement community-wide mass drug administration for interrupting transmission of soil-transmitted helminths infections in India. PLoS Negl Trop Dis. 2023 Mar 10;17(3):e0011176. doi: 10.1371/journal.pntd.0011176. eCollection 2023 Mar. |
| 36461087 | Derived | Roll A, Saxena M, Orlan E, Titus A, Juvekar SK, Gwayi-Chore MC, Avokpaho E, Chabi F, Togbevi CI, Belou Elijan A, Nindi P, Walson JL, Ajjampur SSR, Ibikounle M, Kalua K, Aruldas K, Means AR. Policy stakeholder perspectives on barriers and facilitators to launching a community-wide mass drug administration program for soil-transmitted helminths. Glob Health Res Policy. 2022 Dec 2;7(1):47. doi: 10.1186/s41256-022-00281-z. |
| 35803632 | Derived | Morozoff C, Avokpaho E, Puthupalayam Kaliappan S, Simwanza J, Gideon SP, Lungu W, Houngbegnon P, Galactionova K, Sahu M, Kalua K, Luty AJF, Ibikounle M, Bailey R, Pullan R, Ajjampur SSR, Walson J, Means AR. Costs of community-wide mass drug administration and school-based deworming for soil-transmitted helminths: evidence from a randomised controlled trial in Benin, India and Malawi. BMJ Open. 2022 Jul 8;12(7):e059565. doi: 10.1136/bmjopen-2021-059565. |
| 35701056 | Derived | Avokpaho E, Lawrence S, Roll A, Titus A, Jacob Y, Puthupalayam Kaliappan S, Gwayi-Chore MC, Chabi F, Togbevi CI, Elijan AB, Nindi P, Walson JL, Ajjampur SSR, Ibikounle M, Kalua K, Aruldas K, Means AR. It depends on how you tell: a qualitative diagnostic analysis of the implementation climate for community-wide mass drug administration for soil-transmitted helminth. BMJ Open. 2022 Jun 14;12(6):e061682. doi: 10.1136/bmjopen-2022-061682. |
| 34403424 | Derived | Avokpaho EFGA, Houngbegnon P, Accrombessi M, Atindegla E, Yard E, Rubin Means A, Kennedy DS, Littlewood DTJ, Garcia A, Massougbodji A, Galagan SR, Walson JL, Cottrell G, Ibikounle M, Asbjornsdottir KH, Luty AJF. Factors associated with soil-transmitted helminths infection in Benin: Findings from the DeWorm3 study. PLoS Negl Trop Dis. 2021 Aug 17;15(8):e0009646. doi: 10.1371/journal.pntd.0009646. eCollection 2021 Aug. |
| 34281614 | Derived | Means AR, Orlan E, Gwayi-Chore MC, Titus A, Kaliappan SP, Togbevi CI, Chabi F, Halliday KE, Nindi P, Avokpaho E, Kalua K, Ibikounle M, Ajjampur SSR, Weiner BJ, Walson JL, Aruldas K. Structural readiness to implement community-wide mass drug administration programs for soil-transmitted helminth elimination: results from a three-country hybrid study. Implement Sci Commun. 2021 Jul 19;2(1):80. doi: 10.1186/s43058-021-00164-3. |
| 34226233 | Derived | Galactionova K, Sahu M, Gideon SP, Puthupalayam Kaliappan S, Morozoff C, Ajjampur SSR, Walson J, Rubin Means A, Tediosi F. Costing interventions in the field: preliminary cost estimates and lessons learned from an evaluation of community-wide mass drug administration for elimination of soil-transmitted helminths in the DeWorm3 trial. BMJ Open. 2021 Jul 5;11(7):e049734. doi: 10.1136/bmjopen-2021-049734. |
| 33979325 | Derived | Witek-McManus S, Simwanza J, Chisambi AB, Kepha S, Kamwendo Z, Mbwinja A, Samikwa L, Oswald WE, Kennedy DS, Timothy JWS, Legge H, Galagan SR, Emmanuel-Fabula M, Schaer F, Asbjornsdottir K, Halliday KE, Walson JL, Juziwelo L, Bailey RL, Kalua K, Pullan RL. Epidemiology of soil-transmitted helminths following sustained implementation of routine preventive chemotherapy: Demographics and baseline results of a cluster randomised trial in southern Malawi. PLoS Negl Trop Dis. 2021 May 12;15(5):e0009292. doi: 10.1371/journal.pntd.0009292. eCollection 2021 May. |
| 33930024 | Derived | Ajjampur SSR, Kaliappan SP, Halliday KE, Palanisamy G, Farzana J, Manuel M, Abraham D, Laxmanan S, Aruldas K, Rose A, Kennedy DS, Oswald WE, Pullan RL, Galagan SR, Asbjornsdottir K, Anderson RM, Muliyil J, Sarkar R, Kang G, Walson JL. Epidemiology of soil transmitted helminths and risk analysis of hookworm infections in the community: Results from the DeWorm3 Trial in southern India. PLoS Negl Trop Dis. 2021 Apr 30;15(4):e0009338. doi: 10.1371/journal.pntd.0009338. eCollection 2021 Apr. |
| 33137100 | Derived | DeWorm3 Trials Team. Baseline patterns of infection in regions of Benin, Malawi and India seeking to interrupt transmission of soil transmitted helminths (STH) in the DeWorm3 trial. PLoS Negl Trop Dis. 2020 Nov 2;14(11):e0008771. doi: 10.1371/journal.pntd.0008771. eCollection 2020 Nov. |
| 29346377 | Derived | Asbjornsdottir KH, Ajjampur SSR, Anderson RM, Bailey R, Gardiner I, Halliday KE, Ibikounle M, Kalua K, Kang G, Littlewood DTJ, Luty AJF, Means AR, Oswald W, Pullan RL, Sarkar R, Schar F, Szpiro A, Truscott JE, Werkman M, Yard E, Walson JL; DeWorm3 Trials Team. Assessing the feasibility of interrupting the transmission of soil-transmitted helminths through mass drug administration: The DeWorm3 cluster randomized trial protocol. PLoS Negl Trop Dis. 2018 Jan 18;12(1):e0006166. doi: 10.1371/journal.pntd.0006166. eCollection 2018 Jan. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline STH prevalence: qPCR | Among participants who were censused and randomly selected into the baseline survey. each species is among total and therefore do not sum to totals | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Secondary | Comparison of Arms - Pooled | Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence | The number of participants analyzed is the number surveyed and sampled at endline | Posted | Count of Participants | Participants | 5 years (Three years of drug administration and two years of surveillance) |
|
|
|
| Primary | Comparison of Arms - Benin | Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence | The number of participants analyzed is the number surveyed and sampled at endline | Posted | Count of Participants | Participants | 5 years (Three years of drug administration and two years of surveillance) |
|
|
|
| Primary | Comparison of Arms - India | Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence | The number of participants analyzed is the number surveyed and sampled at endline | Posted | Count of Participants | Participants | 5 years (Three years of drug administration and two years of surveillance) |
|
|
|
| Primary | Comparison of Arms - Malawi | Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence | The number of participants analyzed is the number surveyed and sampled at endline | Posted | Count of Participants | Participants | 5 years (Three years of drug administration and two years of surveillance) |
|
|
|
| Primary | N. Americanus Transmission Interruption - Benin | Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole | 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%. | Posted | Count of Units | Study clusters | 5 years (Three years of drug administration and two years of surveillance) | Study clusters | Study clusters |
|
|
|
| Primary | N. Americanus Transmission Interruption - India | Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole | 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. | Posted | Count of Units | Study clusters | 5 years (Three years of drug administration and two years of surveillance) | Study clusters | Study clusters |
|
|
|
| Secondary | STH Transmission Interruption - Pooled | Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole | 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%. | Posted | Count of Units | Study clusters | 5 years (Three years of drug administration and two years of surveillance) | Study clusters | Study clusters |
|
|
|
| Secondary | STH Transmission Interruption - Benin | Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole | 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%. | Posted | Count of Units | Study clusters | 5 years (Three years of drug administration and two years of surveillance) | Study clusters | Study clusters |
|
|
|
| Secondary | STH Transmission Interruption - India | Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole | 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%. | Posted | Count of Units | Study clusters | 5 years (Three years of drug administration and two years of surveillance) | Study clusters | Study clusters |
|
|
|
| Secondary | STH Transmission Interruption - Malawi | Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole | 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%. | Posted | Count of Units | Study clusters | 5 years (Three years of drug administration and two years of surveillance) | Study clusters | Study clusters |
|
|
|
| Primary | N. Americanus Transmission Interruption - Malawi | Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole | 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. | Posted | Count of Units | Study clusters | 5 years (Three years of drug administration and two years of surveillance) | Study clusters | Study clusters |
|
|
|
| 0 |
| 242,344 |
| 13 |
| 242,344 |
| 0 |
| 242,344 |
|
| Acute gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment | Hospitalized |
|
| Fainting | General disorders | Non-systematic Assessment | 4 cases of fainting following treatment with albendazole and praziquantel - all leading to hospitalization. Two were known epileptics and one also tested malaria positive |
|
| Fever / malaria | Infections and infestations | Non-systematic Assessment | Hospitalization for severe malaria |
|
| Impacted bowel | Gastrointestinal disorders | Non-systematic Assessment | Hospitalized |
|
Not provided
Not provided
| D009349 |
| Nematode Infections |
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Other |
|
| Unknown |
|
| A. lumbricoides |
|
| T. trichiura |
|
| Any STH species |
|
| A lumbricoides |
|
| T trichiura |
|
| Any STH species |
|
| A. lumbricoides |
|
| T. trichiura |
|
| Any STH species |
|
| A. lumbricoides |
|
| T. trichiura |
|
| Any STH species |
|