MalariaIMPACT2NCT01130155
IMPACT2: Monitoring Interventions to Improve Artemisinin-based Combination Therapy (ACT) Access and Targeting
An observational study of Malaria and Anaemia, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
Trial summary
It is generally agreed that artemisinin-based combination therapy (ACT) is the malaria therapy of choice but there is much less agreement about the best ACT-deployment strategies. Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- How many people
- 33,900 participants
- Where
- 1 siteTanzania
- Study dates
- May 2010to Dec 2012
- Phase
- Observational
- 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 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: For the household survey, all selected households in Mtwara, and Mwanza and Mbeya Regions in Tanzania. For the health facility survey patients presenting to selected health facilities with fever or history of fever in the prior 24 hours.
Who may be able to join
- Household survey - All consenting and assenting residents available in selected households
- Health facility survey - patients presenting to selected health facilities with fever or history of fever in the prior 24 hours; Age >= 3 months, or Weight ≥ 5 kg; First visit to this health facility for this illness episode
Who cannot join
- Household survey - Children less than 3 months of age will be excluded from providing a blood sample
- Health facility survey - Signs of severe illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IMPACT2: Monitoring Interventions to Improve ACT Access and Targeting
It is generally agreed that artemisinin-based combination therapy (ACT) is the malaria therapy of choice but there is much less agreement about the best ACT-deployment strategies. Countries are now beginning to adopt policies to enhance ACT deployment that aim to address 2 key goals: (i) making ACTs more readily and speedily accessible to patients: or (ii) targeting ACTs to patients shown to have malaria parasitaemia.
The Tanzanian Government has secured funding to address both ACT access and targeting on a national scale. Access is to be improved through the distribution of subsidised ACTs through private facilities and retail drug shops under the Affordable Medicines Facility-malaria (AMFm). Targeting is to be addressed through enhancing microscopy and introducing rapid diagnostic tests (RDTs) in health facilities at every level of the system.
This study will evaluate these two interventions in 3 rural regions of Tanzania which are all expected to receive both interventions during the study period. The investigators will assess the effectiveness of the interventions in terms of coverage, equity, quality, adherence, and public health impact using a pre-post plausibility design based on before and after household, health facility and outlet surveys. The null hypothesis is that the interventions will have no impact on the coverage of prompt effective treatment for fever and malarial. In addition, the investigators will estimate the cost and cost-effectiveness of implementation from a health system and household perspective. Finally the investigators will explore the socio-cultural context and other factors that influence the implementation and outcome of the interventions.
- Keywords
- Antimalarials, Diagnosis, Access to treatment, Quality of care
- Medical subject headings
- Malaria, Anemia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mwanza Region | Households, and patients presenting at public health facilities in Mwanza Region | |
| Mbeya Region | Households, and patients presenting at public health facilities in Mbeya Region | |
| Mtwara Region | Households, and patients presenting at public health facilities in Mtwara Region |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of population reporting fever in last two weeks that received ACT within 24hrs/48hrs
Percent of population reporting fever in last two weeks that got a finger/heel stick for a malaria diagnostic test within 24hrs/48hrs
Proportion of patients presenting to public health facilities with fever who receive a diagnostic test for malaria
Proportion of patients presenting to public health facilities with fever who receive rapid diagnostic test (RDT) for malaria and are appropriately treated according to RDT results
Secondary outcomes (4)
Percent of patients receiving an ACT that adhered to full dose with correct dose timing
Mean and median household cost per febrile episode
The accuracy of RDTs performed by health workers
Adequacy of health facility resources for diagnosis and treatment of malaria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 33,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ifakara Health Institute, Centers for Disease Control and Prevention, Bill and Melinda Gates Foundation
- Investigators
- Catherine Goodman, PhD, Principal investigator, London School of Hygiene and Tropical MedicinePatrick Kachur, MD, Principal investigator, Centers for Disease Control and PreventionSalim Abdulla, PhD, Principal investigator, Ifakara Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130155
- Sponsor's protocol ID
- PHGBVG04
- Acronym
- IMPACT2
- Status last verified
- Jun 2011
- First submitted
- 24 May 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT2: Monitoring Interventions to Improve ACT Access and Targeting
- ClinicalTrials.gov ID
- NCT01130155
- Acronym / sponsor ID
- IMPACT2 / PHGBVG04
- Keywords
- Antimalarials, Diagnosis, Access to treatment, Quality of care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 33,900 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Ifakara Health Institute, Centers for Disease Control and Prevention, Bill and Melinda Gates Foundation
- Study start
- May 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 25 May 2010 (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.
It is generally agreed that artemisinin-based combination therapy (ACT) is the malaria therapy of choice but there is much less agreement about the best ACT-deployment strategies. Countries are now beginning to adopt policies to enhance ACT deployment that aim to address 2 key goals: (i) making ACTs more readily and speedily accessible to patients: or (ii) targeting ACTs to patients shown to have malaria parasitaemia.
The Tanzanian Government has secured funding to address both ACT access and targeting on a national scale. Access is to be improved through the distribution of subsidised ACTs through private facilities and retail drug shops under the Affordable Medicines Facility-malaria (AMFm). Targeting is to be addressed through enhancing microscopy and introducing rapid diagnostic tests (RDTs) in health facilities at every level of the system.
This study will evaluate these two interventions in 3 rural regions of Tanzania which are all expected to receive both interventions during the study period. The investigators will assess the effectiveness of the interventions in terms of coverage, equity, quality, adherence, and public health impact using a pre-post plausibility design based on before and after household, health facility and outlet surveys. The null hypothesis is that the interventions will have no impact on the coverage of prompt effective treatment for fever and malarial. In addition, the investigators will estimate the cost and cost-effectiveness of implementation from a health system and household perspective. Finally the investigators will explore the socio-cultural context and other factors that influence the implementation and outcome of the interventions.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mwanza Region | – | –Households, and patients presenting at public health facilities in Mwanza Region |
| Mbeya Region | – | –Households, and patients presenting at public health facilities in Mbeya Region |
| Mtwara Region | – | –Households, and patients presenting at public health facilities in Mtwara Region |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For the household survey, all selected households in Mtwara, and Mwanza and Mbeya Regions in Tanzania. For the health facility survey patients presenting to selected health facilities with fever or history of fever in the prior 24 hours.
Key inclusion criteria (2 listed)
- Household survey - All consenting and assenting residents available in selected households
- Health facility survey - patients presenting to selected health facilities with fever or history of fever in the prior 24 hours; Age >= 3 months, or Weight ≥ 5 kg; First visit to this health facility for this illness episode
Key exclusion criteria (2 listed)
- Household survey - Children less than 3 months of age will be excluded from providing a blood sample
- Health facility survey - Signs of severe illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent of population reporting fever in last two weeks that received ACT within 24hrs/48hrs
Percent of population reporting fever in last two weeks that got a finger/heel stick for a malaria diagnostic test within 24hrs/48hrs
Proportion of patients presenting to public health facilities with fever who receive a diagnostic test for malaria
Proportion of patients presenting to public health facilities with fever who receive rapid diagnostic test (RDT) for malaria and are appropriately treated according to RDT results
4 secondary outcomes
Percent of patients receiving an ACT that adhered to full dose with correct dose timing
Mean and median household cost per febrile episode
The accuracy of RDTs performed by health workers
Adequacy of health facility resources for diagnosis and treatment of malaria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- ACT ConsortiumLink provided by the sponsor.
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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.
Catherine Goodman, PhD principal investigator
London School of Hygiene and Tropical Medicine
Patrick Kachur, MD principal investigator
Centers for Disease Control and Prevention
Salim Abdulla, PhD principal investigator
Ifakara Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Anaemia, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Jun 2011. 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 Tanzania. 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.
Are results available for this study?
Results are not available in the source record.
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?
Percent of population reporting fever in last two weeks that received ACT within 24hrs/48hrs. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2011.