HelminthiasisPhase 4TUMIKIANCT02397772
Impact of Alternative Treatment Strategies and Delivery Systems for Soil-transmitted Helminths in Kenya
A Phase 4 study testing albendazole in people with Helminthiasis and Nematode Infection, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
Trial summary
The mainstay of control of soil-transmitted helminths (STH) is school-based deworming but recent modelling has highlights that in all but low very transmission settings, the treatment of school-aged children is unlikely to interrupt transmission, and that new treatment strategies are required. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helminthiasis, Nematode Infection, Disease Transmission, Infectious
- What is being tested?
- albendazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,761 participants
- Where
- 1 siteKenya
- Study dates
- Mar 2015to Jul 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Usual resident of study community or student enrolled in study school;
- Willingness of adult aged 18 years and above or parent/guardian to provide written informed consent;
- Provision of written assent to participate from children aged 8 years and above.
Who cannot join
- Visitor to household at time of household visits;
- Refusal of informed consent;
- Refusal to assent by children aged 8 years and above.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Different Treatment Strategies on the Transmission Dynamics of Soil-transmitted Helminths: a Cluster Randomised Trial in Kenya
The mainstay of control of soil-transmitted helminths (STH) is school-based deworming but recent modelling has highlights that in all but low very transmission settings, the treatment of school-aged children is unlikely to interrupt transmission, and that new treatment strategies are required. This study seeks to answer the question: is it possible to interrupt the transmission of STH and if so, what is the most cost-effective treatment strategy and delivery system to achieve this goal? In this study, two paired community cluster randomised trials in different settings in Kenya will evaluate the impact and cost-effectiveness of annual school-based deworming, annual community-based deworming, and biannual community-based deworming. The interventions are (i) annual mass anthelmintic treatment delivered either to pre-school and school-aged children, as part of a national school-based deworming programme, or to the entire community delivered by community health workers. The primary outcome measure is the prevalence of hookworm infection (the most common STH species), assessed by periodic cross-sectional, age-stratified parasitological surveys. Secondary outcomes include intensity of hookworm, prevalence and intensity of Ascaris lumbricoides, treatment coverage, and among a randomly selected sub-sample of participants who will be followed longitudinally, worm burden and proportion of eggs unfertilised. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis will investigate the community acceptability, feasibility given the local and regional health system structures and processes, and scale-up of the interventions.
Read the detailed description
The study will be conducted in two settings of Kenya that have contrasting epidemiological and programmatic characteristics, Kwale County on the south Kenyan coast and Bungoma County in western Kenya. Allocation to study group will be by cluster, using predefined units used in public health provision - termed Community Units (CUs), which comprise approximately 1,000 households or 5,000 people. CUs will be randomized to one of three groups, receiving either (i) annual school-based deworming; (ii) annual community-based deworming; (iii) biannual community-based deworming. In nine CUs, a longitudinal study will be conducted in order to better understand the transmission dynamics of STH.
- Being tested
- albendazole
- Keywords
- Soil-transmitted helminths, Intestinal Nematodes, Hookworm, Ascaris, Mass Treatment, Kenya
- Medical subject headings
- Helminthiasis, Nematode Infections, Communicable Diseases, Ancylostomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albendazoleDrug
Also called Zentel
Single dose of albendazole (400 mg)
| Study group | Role | What they receive |
|---|---|---|
| Annual school-based deworming | Active comparator | Pre-school and school children (typically 2-14 years) will receive albendazole treatment from trained school teachers, as part of the ongoing national school-based deworming programme. Receives: Drug: albendazole |
| Annual community-based deworming | Experimental | Standard school-based deworming supplemented by annual community-based deworming (2-99 years). All household members who are not enrolled in school will receive albendazole treatment from trained community health workers. Receives: Drug: albendazole |
| Biannual | Experimental | Biannual school- and community-based deworming (2-99 years). All household members who are not enrolled in school will receive albendazole treatment from trained community health workers Receives: Drug: albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hookworm in community members
The prevalence of hookworm will be measured in a final age-stratified, community cross-sectional survey, which will be conducted approximately 24 months after the start of the intervention. Selected individuals will be asked to provide a stool sample which will be examined in duplicate and within one hour of preparation using the Kato-Katz method. Parasite prevalence will be defined as the proportion of slides that are positive for hookworm eggs. A baseline survey will be conducted prior to implementing the intervention and an interim survey conducted at 12 months. In a random subset of individuals, additional confirmatory diagnosis of infection will be based on real-time polymerase chain reaction (PCR).
Measured: Endline survey conducted, approximately 24 months after starting the intervention
Secondary outcomes (3)
Prevalence of Ascaris lumbricoides in community members
The prevalence of Ascaris will be measured in a final age-stratified, community cross-sectional survey, which will be conducted approximately 24 months after the start of the intervention. Selected individuals will be asked to provide a stool sample which will be examined in duplicate and within one hour of preparation using the Kato-Katz method. Parasite prevalence will be defined as the proportion of slides that are positive for hookworm eggs. A baseline survey will be conducted prior to implementing the intervention and an interim survey conducted at 12 months. In a random subset of individuals, additional confirmatory diagnosis of infection will be based on real-time PCR.
Measured: Endline survey conducted, approximately 24 months after starting the intervention
Intensity of infection for each STH species
The intensity of STH species will be measured in a final age-stratified, community cross-sectional survey, which will be conducted approximately 24 months after the start of the intervention. Selected individuals will be asked to provide a stool sample which will be examined in duplicate and within one hour of preparation using the Kato-Katz method. Intensity of infection will be quantified as eggs per gram of faeces. A baseline survey will be conducted prior to implementing the intervention and an interim survey conducted at 12 months.
Measured: Endline survey conducted, approximately 24 months after starting the intervention
Treatment coverage
- Treatment coverage will be measured using both routine data, and data collected during scheduled STH stool surveys. Teachers and community health workers (CHWs) will be provided with treatment registers and asked to provide a full record of all individuals who have received treatment. To augment these data, population-based coverage surveys using multistage clustering sampling will be carried out among a random subsample of communities.
Measured: Up to month following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HelminthiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21,761 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, Kenya Ministry of Health, Imperial College London, Emory University
- Responsible party
- Sponsor
- Investigators
- Rachel L Pullan, PhD, Principal investigator, London School of Hygeiene & Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397772
- Sponsor's protocol ID
- 1354
- Other IDs
- 2826
- Acronym
- TUMIKIA
- Status last verified
- Aug 2018
- First submitted
- 19 Mar 2015
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Halliday KE, Oswald WE, Mcharo C, Beaumont E, Gichuki PM, Kepha S, Witek-McManus SS, Matendechero SH, El-Busaidy H, Muendo R, Chiguzo AN, Cano J, Karanja MW, Musyoka LW, Safari TK, Mutisya LN, Muye IJ, Sidigu MA, Anderson RM, Allen E, Brooker SJ, Mwandawiro CS, Njenga SM, Pullan RL. Community-level epidemiology of soil-transmitted helminths in the context of school-based deworming: Baseline results of a cluster randomised trial on the coast of Kenya. PLoS Negl Trop Dis. 2019 Aug 9;13(8):e0007427. doi: 10.1371/journal.pntd.0007427. eCollection 2019 Aug.
PubMed 31398204Pullan RL, Halliday KE, Oswald WE, Mcharo C, Beaumont E, Kepha S, Witek-McManus S, Gichuki PM, Allen E, Drake T, Pitt C, Matendechero SH, Gwayi-Chore MC, Anderson RM, Njenga SM, Brooker SJ, Mwandawiro CS. Effects, equity, and cost of school-based and community-wide treatment strategies for soil-transmitted helminths in Kenya: a cluster-randomised controlled trial. Lancet. 2019 May 18;393(10185):2039-2050. doi: 10.1016/S0140-6736(18)32591-1. Epub 2019 Apr 18.
PubMed 31006575Brooker SJ, Mwandawiro CS, Halliday KE, Njenga SM, Mcharo C, Gichuki PM, Wasunna B, Kihara JH, Njomo D, Alusala D, Chiguzo A, Turner HC, Teti C, Gwayi-Chore C, Nikolay B, Truscott JE, Hollingsworth TD, Balabanova D, Griffiths UK, Freeman MC, Allen E, Pullan RL, Anderson RM. Interrupting transmission of soil-transmitted helminths: a study protocol for cluster randomised trials evaluating alternative treatment strategies and delivery systems in Kenya. BMJ Open. 2015 Oct 19;5(10):e008950. doi: 10.1136/bmjopen-2015-008950.
PubMed 26482774
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Treatment Strategies on the Transmission Dynamics of Soil-transmitted Helminths: a Cluster Randomised Trial in Kenya
- ClinicalTrials.gov ID
- NCT02397772
- Acronym / sponsor ID
- TUMIKIA / 1354
- Keywords
- Soil-transmitted helminths, Intestinal Nematodes, Hookworm, Ascaris, Mass Treatment, Kenya
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,761 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, Kenya Ministry of Health, Imperial College London, Emory University
- Study start
- Mar 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The mainstay of control of soil-transmitted helminths (STH) is school-based deworming but recent modelling has highlights that in all but low very transmission settings, the treatment of school-aged children is unlikely to interrupt transmission, and that new treatment strategies are required. This study seeks to answer the question: is it possible to interrupt the transmission of STH and if so, what is the most cost-effective treatment strategy and delivery system to achieve this goal? In this study, two paired community cluster randomised trials in different settings in Kenya will evaluate the impact and cost-effectiveness of annual school-based deworming, annual community-based deworming, and biannual community-based deworming. The interventions are (i) annual mass anthelmintic treatment delivered either to pre-school and school-aged children, as part of a national school-based deworming programme, or to the entire community delivered by community health workers. The primary outcome measure is the prevalence of hookworm infection (the most common STH species), assessed by periodic cross-sectional, age-stratified parasitological surveys. Secondary outcomes include intensity of hookworm, prevalence and intensity of Ascaris lumbricoides, treatment coverage, and among a randomly selected sub-sample of participants who will be followed longitudinally, worm burden and proportion of eggs unfertilised. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis will investigate the community acceptability, feasibility given the local and regional health system structures and processes, and scale-up of the interventions.
Detailed description
The study will be conducted in two settings of Kenya that have contrasting epidemiological and programmatic characteristics, Kwale County on the south Kenyan coast and Bungoma County in western Kenya. Allocation to study group will be by cluster, using predefined units used in public health provision - termed Community Units (CUs), which comprise approximately 1,000 households or 5,000 people. CUs will be randomized to one of three groups, receiving either (i) annual school-based deworming; (ii) annual community-based deworming; (iii) biannual community-based deworming. In nine CUs, a longitudinal study will be conducted in order to better understand the transmission dynamics of STH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Annual school-based deworming | Active comparator | Drug: albendazolePre-school and school children (typically 2-14 years) will receive albendazole treatment from trained school teachers, as part of the ongoing national school-based deworming programme. |
| Annual community-based deworming | Experimental | Drug: albendazoleStandard school-based deworming supplemented by annual community-based deworming (2-99 years). All household members who are not enrolled in school will receive albendazole treatment from trained community health workers. |
| Biannual | Experimental | Drug: albendazoleBiannual school- and community-based deworming (2-99 years). All household members who are not enrolled in school will receive albendazole treatment from trained community health workers |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Usual resident of study community or student enrolled in study school;
- Willingness of adult aged 18 years and above or parent/guardian to provide written informed consent;
- Provision of written assent to participate from children aged 8 years and above.
Key exclusion criteria (3 listed)
- Visitor to household at time of household visits;
- Refusal of informed consent;
- Refusal to assent by children aged 8 years and above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| albendazoleAlso: ZentelSingle dose of albendazole (400 mg) | Drug | Annual community-based deworming, Annual school-based deworming, Biannual |
Primary outcome
Prevalence of hookworm in community members
Time frame: Endline survey conducted, approximately 24 months after starting the intervention
The prevalence of hookworm will be measured in a final age-stratified, community cross-sectional survey, which will be conducted approximately 24 months after the start of the intervention. Selected individuals will be asked to provide a stool sample which will be examined in duplicate and within one hour of preparation using the Kato-Katz method. Parasite prevalence will be defined as the proportion of slides that are positive for hookworm eggs. A baseline survey will be conducted prior to implementing the intervention and an interim survey conducted at 12 months. In a random subset of individuals, additional confirmatory diagnosis of infection will be based on real-time polymerase chain reaction (PCR).
3 secondary outcomes
Prevalence of Ascaris lumbricoides in community members
Time frame: Endline survey conducted, approximately 24 months after starting the intervention
Intensity of infection for each STH species
Time frame: Endline survey conducted, approximately 24 months after starting the intervention
Treatment coverage
Time frame: Up to month following treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Derived from this study: PubMed 31398204Halliday KE, Oswald WE, Mcharo C, Beaumont E, Gichuki PM, Kepha S, Witek-McManus SS, Matendechero SH, El-Busaidy H, Muendo R, Chiguzo AN, Cano J, Karanja MW, Musyoka LW, Safari TK, Mutisya LN, Muye IJ, Sidigu MA, Anderson RM, Allen E, Brooker SJ, Mwandawiro CS, Njenga SM, Pullan RL. Community-level epidemiology of soil-transmitted helminths in the context of school-based deworming: Baseline results of a cluster randomised trial on the coast of Kenya. PLoS Negl Trop Dis. 2019 Aug 9;13(8):e0007427. doi: 10.1371/journal.pntd.0007427. eCollection 2019 Aug.
- Derived from this study: PubMed 31006575Pullan RL, Halliday KE, Oswald WE, Mcharo C, Beaumont E, Kepha S, Witek-McManus S, Gichuki PM, Allen E, Drake T, Pitt C, Matendechero SH, Gwayi-Chore MC, Anderson RM, Njenga SM, Brooker SJ, Mwandawiro CS. Effects, equity, and cost of school-based and community-wide treatment strategies for soil-transmitted helminths in Kenya: a cluster-randomised controlled trial. Lancet. 2019 May 18;393(10185):2039-2050. doi: 10.1016/S0140-6736(18)32591-1. Epub 2019 Apr 18.
- Derived from this study: PubMed 26482774Brooker SJ, Mwandawiro CS, Halliday KE, Njenga SM, Mcharo C, Gichuki PM, Wasunna B, Kihara JH, Njomo D, Alusala D, Chiguzo A, Turner HC, Teti C, Gwayi-Chore C, Nikolay B, Truscott JE, Hollingsworth TD, Balabanova D, Griffiths UK, Freeman MC, Allen E, Pullan RL, Anderson RM. Interrupting transmission of soil-transmitted helminths: a study protocol for cluster randomised trials evaluating alternative treatment strategies and delivery systems in Kenya. BMJ Open. 2015 Oct 19;5(10):e008950. doi: 10.1136/bmjopen-2015-008950.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel L Pullan, PhD principal investigator
London School of Hygeiene & Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing albendazole in people with Helminthiasis and Nematode Infection, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hookworm in community members (time frame: Endline survey conducted, approximately 24 months after starting the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02397772, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.