MalariaMaDrAZNCT02721186
Effectiveness of Mass Drug Administration for Reducing Seasonal Malaria Transmission in Zanzibar
A study testing MDA with DHAp and SLD Primaquine in people with Malaria and Plasmodium Infections, run by Ulrika Morris at 1 site in Tanzania.
Trial summary
The overall aim of this study is to determine the effectiveness of two rounds of mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHAp) + single low dose (SLD) primaquine for reducing seasonal malaria transmission in Shehias considered hotspots on Unguja Island, Zanzibar. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria, Plasmodium Infections
- What is being tested?
- MDA with DHAp and SLD Primaquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22,500 participants
- Where
- 1 siteTanzania
- Study dates
- 30 Apr 2016to 30 Sep 2017
- Phase
- Interventional
- 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Permanent or temporary resident of study Shehias (i.e., persons who stayed in the selected household the night before the interview)
- Provision of informed consent (refusal must be recorded)
- Age >6 months
Who cannot join
- Women pregnant in first trimester (assessed by a specific set of questions designed to exclude pregnancy)
- Severe disease that requires immediate referral to health facility or hospital
- Concurrent antimalarial treatment at time of MDA or during the last 14 days
- Inability to take oral medication
- Additional exclusion criteria for treatment with SLD Primaquine:
- Pregnancy (all trimesters, assessed by a specific set of questions designed to exclude pregnancy)
- Women breast feeding infants aged < 6months
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Zanzibar Malaria Elimination Programme
Mwanakwerekwe, Urban District, Zanzibar
About this study
Official title: Effectiveness of Mass Drug Administration (MDA) for Reducing Seasonal Malaria Transmission Towards Its Elimination in Hotspot Areas in Zanzibar - a Cluster-randomised Controlled Trial
The overall aim of this study is to determine the effectiveness of two rounds of mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHAp) + single low dose (SLD) primaquine for reducing seasonal malaria transmission in Shehias considered hotspots on Unguja Island, Zanzibar.
Read the detailed description
Study design: This is a cluster-randomised controlled study with two arms: an intervention arm with two rounds of MDA with dihydroartemisinin-piperaquine (DHAp) + single low dose (SLD) primaquine, and a control arm with no MDA.
Study site and study population: The study will be conducted in 16 hotspot Shehias (8 Shehias randomly allocated to each arm), in three districts (West, Central and South districts) in Unguja Island, Zanzibar. Hotspot Shehias [Shehia being the smallest administrative structure in Zanzibar] are defined as Shehias with an annual malaria incidence of >0.8%, calculated as the number of confirmed malaria infections notified at health facilities and during active case detection in 2015 / Shehia projected population for 2015. The study population will include all consenting residents of the selected Shehias, reaching approximately 24000 people.
Study implementation: Two rounds of MDA with DHAp (D-ARTEPP, Guilin Pharmaceutical (Shanghai) Co., Ltd., China) and SLD (0.25mg/kg) primaquine (Primaquine, Remedica Ltd.,Cyprus ) will be conducted approximately four weeks apart in the intervention Shehias, at the anticipated lowest point of malaria transmission prior to the onset of malaria transmission associated with the main rains in April-June 2016. The first drug dose including DHAp and SLD primaquine will be given under supervision whenever possible; the other two doses of the standard once daily DHAp regimen will be taken unsupervised at home. Labelled packets containing all three doses will be left with the head of household with clear instructions for individuals not present at the time of the household visit.
Study objectives: The primary objective of the study is to determine the effectiveness of two rounds of MDA with DHAp + SLD primaquine for reducing seasonal malaria transmission in Shehias considered hotspots on Unguja Island, Zanzibar. The secondary objectives of the study include determining MDA coverage, compliance, and safety after one and two rounds of DHAp + SLD primaquine.
- Conditions
- Malaria, Plasmodium Infections
- Being tested
- MDA with DHAp and SLD Primaquine
- Keywords
- Malaria, Plasmodium, Mass drug administration, Malaria elimination, Zanzibar, Dihydroartemisinin-Piperaquine, Single low dose Primaquine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDA with DHAp and SLD PrimaquineDrug
Also called Mass drug administration with DHAp and SLD Primaquine, MDA with Dihydroartemisinin-Piperaquine and SLD Primaquine, MDA with D-ARTEPP and single low dose Primaquine
| Study group | Role | What they receive |
|---|---|---|
| MDA with DHAp and SLD Primaquine | Experimental | MDA will be conducted at two time points with an approximate four-week interval. All consenting and eligible community members will be administered age-appropriate treatment dose of dihydroartemisinin-piperaquine (D-ARTEPP, Guilin Pharmaceutical (Shanghai) Co., Ltd., China) and single low dose (0.25mg/kg) primaquine (Primaquine, Remedica Ltd., Cyprus) in house-to-house campaigns. Receives: Drug: MDA with DHAp and SLD Primaquine |
| Control | No intervention | The control arm (no MDA) will have the standard care offered by the Ministry of Health and Social welfare which applies to both arms. This includes passive case detection of individuals seeking treatment at local health facilities, and universal coverage of long lasting insecticide treated bed nets and indoor residual spraying in the study areas. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative notified malaria incidence in the MDA and control Shehias
Cumulative notified malaria incidence determined as the number of confirmed malaria cases notified at health facilities (monitored through the malaria case notification system during the period of six months) over the Shehia population size determined by population enumeration at the time of the intervention.
Measured: 6 months after second round of MDA
Secondary outcomes (1)
PCR determined community prevalence of Plasmodium infections in the MDA and control Shehias
PCR determined community prevalence of Plasmodium infections determined by cross-sectional screening in every other household in the study area at the time of the first round of MDA, and at six months after the second round of MDA.
Measured: Baseline and 3 months after second round of MDA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start30 Apr 2016
- Primary completion31 Dec 2016
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulrika Morris
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, RTI International, The President's Malaria Initiative, University of California, San Francisco, Uppsala University, Zanzibar Malaria Elimination Programme
- Responsible party
- Sponsor-investigator, Ulrika Morris, Karolinska Institutet
- Investigators
- Anders Björkman, MD, PhD, Principal investigator, Karolinska InstitutetAbdullah S Ali, Programme Manager, Principal investigator, Zanzibar Malaria Elimination Programme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721186
- Sponsor's protocol ID
- MaDrAZ-001
- Other IDs
- ZAMREC/0001/January/2016
- Acronym
- MaDrAZ
- Status last verified
- Oct 2017
- First submitted
- 17 Mar 2016
- Last updated
- 5 Oct 2017
- Results posted
- No
Publications
Shah MP, Hwang J, Choi L, Lindblade KA, Kachur SP, Desai M. Mass drug administration for malaria. Cochrane Database Syst Rev. 2021 Sep 29;9(9):CD008846. doi: 10.1002/14651858.CD008846.pub3.
PubMed 34585740Morris U, Msellem MI, Mkali H, Islam A, Aydin-Schmidt B, Jovel I, Shija SJ, Khamis M, Ali SM, Hodzic L, Magnusson E, Poirot E, Bennett A, Sachs MC, Tarning J, Martensson A, Ali AS, Bjorkman A. A cluster randomised controlled trial of two rounds of mass drug administration in Zanzibar, a malaria pre-elimination setting-high coverage and safety, but no significant impact on transmission. BMC Med. 2018 Dec 10;16(1):215. doi: 10.1186/s12916-018-1202-8.
PubMed 30526588
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mass Drug Administration (MDA) for Reducing Seasonal Malaria Transmission Towards Its Elimination in Hotspot Areas in Zanzibar - a Cluster-randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02721186
- Acronym / sponsor ID
- MaDrAZ / MaDrAZ-001
- Conditions
- Malaria, Plasmodium Infections
- Keywords
- Malaria, Plasmodium, Mass drug administration, Malaria elimination, Zanzibar, Dihydroartemisinin-Piperaquine, Single low dose Primaquine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22,500 participants (actual)
- Lead sponsor
- Ulrika MorrisUniversity, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, RTI International, The President's Malaria Initiative, University of California, San Francisco, Uppsala University, Zanzibar Malaria Elimination Programme
- Study start
- 30 Apr 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 29 Mar 2016 (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 overall aim of this study is to determine the effectiveness of two rounds of mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHAp) + single low dose (SLD) primaquine for reducing seasonal malaria transmission in Shehias considered hotspots on Unguja Island, Zanzibar.
Detailed description
Study design: This is a cluster-randomised controlled study with two arms: an intervention arm with two rounds of MDA with dihydroartemisinin-piperaquine (DHAp) + single low dose (SLD) primaquine, and a control arm with no MDA.
Study site and study population: The study will be conducted in 16 hotspot Shehias (8 Shehias randomly allocated to each arm), in three districts (West, Central and South districts) in Unguja Island, Zanzibar. Hotspot Shehias [Shehia being the smallest administrative structure in Zanzibar] are defined as Shehias with an annual malaria incidence of >0.8%, calculated as the number of confirmed malaria infections notified at health facilities and during active case detection in 2015 / Shehia projected population for 2015. The study population will include all consenting residents of the selected Shehias, reaching approximately 24000 people.
Study implementation: Two rounds of MDA with DHAp (D-ARTEPP, Guilin Pharmaceutical (Shanghai) Co., Ltd., China) and SLD (0.25mg/kg) primaquine (Primaquine, Remedica Ltd.,Cyprus ) will be conducted approximately four weeks apart in the intervention Shehias, at the anticipated lowest point of malaria transmission prior to the onset of malaria transmission associated with the main rains in April-June 2016. The first drug dose including DHAp and SLD primaquine will be given under supervision whenever possible; the other two doses of the standard once daily DHAp regimen will be taken unsupervised at home. Labelled packets containing all three doses will be left with the head of household with clear instructions for individuals not present at the time of the household visit.
Study objectives: The primary objective of the study is to determine the effectiveness of two rounds of MDA with DHAp + SLD primaquine for reducing seasonal malaria transmission in Shehias considered hotspots on Unguja Island, Zanzibar. The secondary objectives of the study include determining MDA coverage, compliance, and safety after one and two rounds of DHAp + SLD primaquine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDA with DHAp and SLD Primaquine | Experimental | Drug: MDA with DHAp and SLD PrimaquineMDA will be conducted at two time points with an approximate four-week interval. All consenting and eligible community members will be administered age-appropriate treatment dose of dihydroartemisinin-piperaquine (D-ARTEPP, Guilin Pharmaceutical (Shanghai) Co., Ltd., China) and single low dose (0.25mg/kg) primaquine (Primaquine, Remedica Ltd., Cyprus) in house-to-house campaigns. |
| Control | No intervention | –The control arm (no MDA) will have the standard care offered by the Ministry of Health and Social welfare which applies to both arms. This includes passive case detection of individuals seeking treatment at local health facilities, and universal coverage of long lasting insecticide treated bed nets and indoor residual spraying in the study areas. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Permanent or temporary resident of study Shehias (i.e., persons who stayed in the selected household the night before the interview)
- Provision of informed consent (refusal must be recorded)
- Age >6 months
Key exclusion criteria (7 listed)
- Women pregnant in first trimester (assessed by a specific set of questions designed to exclude pregnancy)
- Severe disease that requires immediate referral to health facility or hospital
- Concurrent antimalarial treatment at time of MDA or during the last 14 days
- Inability to take oral medication
- Pregnancy (all trimesters, assessed by a specific set of questions designed to exclude pregnancy)
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 |
|---|---|---|
| MDA with DHAp and SLD PrimaquineAlso: Mass drug administration with DHAp and SLD Primaquine, MDA with Dihydroartemisinin-Piperaquine and SLD Primaquine, MDA with D-ARTEPP and single low dose Primaquine | Drug | MDA with DHAp and SLD Primaquine |
Primary outcome
Cumulative notified malaria incidence in the MDA and control Shehias
Time frame: 6 months after second round of MDA
Cumulative notified malaria incidence determined as the number of confirmed malaria cases notified at health facilities (monitored through the malaria case notification system during the period of six months) over the Shehia population size determined by population enumeration at the time of the intervention.
1 secondary outcome
PCR determined community prevalence of Plasmodium infections in the MDA and control Shehias
Time frame: Baseline and 3 months after second round of MDA
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 5 Oct 2017.
- Derived from this study: PubMed 34585740Shah MP, Hwang J, Choi L, Lindblade KA, Kachur SP, Desai M. Mass drug administration for malaria. Cochrane Database Syst Rev. 2021 Sep 29;9(9):CD008846. doi: 10.1002/14651858.CD008846.pub3.
- Derived from this study: PubMed 30526588Morris U, Msellem MI, Mkali H, Islam A, Aydin-Schmidt B, Jovel I, Shija SJ, Khamis M, Ali SM, Hodzic L, Magnusson E, Poirot E, Bennett A, Sachs MC, Tarning J, Martensson A, Ali AS, Bjorkman A. A cluster randomised controlled trial of two rounds of mass drug administration in Zanzibar, a malaria pre-elimination setting-high coverage and safety, but no significant impact on transmission. BMC Med. 2018 Dec 10;16(1):215. doi: 10.1186/s12916-018-1202-8.
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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.
Anders Björkman, MD, PhD principal investigator
Karolinska Institutet
Abdullah S Ali, Programme Manager principal investigator
Zanzibar Malaria Elimination Programme
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MDA with DHAp and SLD Primaquine in people with Malaria and Plasmodium Infections, run by Ulrika Morris 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 3 inclusion and 7 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 5 Oct 2017. 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?
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?
Cumulative notified malaria incidence in the MDA and control Shehias (time frame: 6 months after second round of MDA). 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 NCT02721186, which also lists 2 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 5 Oct 2017.