Malaria Clinical Trial
Official title:
Targeted Parasite Elimination in the Human and Mosquito to Reduce Malaria Transmission: A Cluster Randomised Controlled Factorial Design Trial of Reactive Focal Drug Administration (rfMDA) Versus Reactive Case Detection (RACD), With and Without Reactive Vector Control (RAVC), From the Low Endemic Setting of Namibia
Verified date | July 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a cluster randomised controlled trial with factorial study design comparing the impact of reactive community-based malaria interventions: 1) presumptive treatment (or rfMDA, reactive focal mass drug administration) versus reactive case detection (RACD), and 2) reactive IRS (indoor residual spraying) versus control on the incidence of malaria in Namibia.
Status | Completed |
Enrollment | 9845 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months and older |
Eligibility |
Inclusion Criteria: 1. Index Case Investigation Inclusion Criteria: - Malaria infection (either locally transmitted or imported) detected at a health facility via passive surveillance, and - Resides in a study Enumeration Area (EA), and - Provides informed consent 2. RACD Intervention Inclusion Criteria: - Provides informed consent, and - Index case resides in study EA, and - All non-index cases that reside or spent at least one night in the Target Area in the past 4 weeks, and - Residents of the six houses closest to the index case, and - If 25 people are not enrolled in the study at the first six houses, plus the index case household, after the second visit then additional houses can be approached on the third visit. 3. rfMDA Intervention Inclusion Criteria: - Provides informed consent, and - Index case resides in study EA, and - All non-index cases that reside or spent at least one night in the Target Area in the past 4 weeks, and - Residents of the six houses closest to the index case, and - If 25 people are not enrolled in the study at the first six houses, plus the index case household, after the second visit then additional houses can be approached on the third visit. 4. Artemether/Lumefantrine (A-L) (combination medication) Inclusion Criteria: - Consent to take A-L medication - Does not meet A-L Exclusion Criteria under item #4 below 5. Pill count Inclusion Criteria: - Provides consent, and - People who receive any number of RACD or rfMDA drug dose(s) 6. Reactive Vector Control Inclusion Criteria: - Informed consent provided by head of household or person in otherwise in charge of household, and - Index case resides in study EA, and - Index household and 6 non-index households closest to index household 7. Endline Survey, Individual, Inclusion Criteria: - Provides informed consent, and - Resides or spent at least 1 night in the EA in the preceding 4 weeks 8. Acceptability Assessment: Individual Interviews with study participants, Inclusion Criteria: - Provides informed consent, and - Resident of index household or of neighbouring households 9. Acceptability Assessment: Individual Interviews with key stakeholders, Inclusion Criteria: - In leadership position within Zambezi region, and - Provides informed consent 10. Acceptability Assessment: Individual Interview with refusers, Inclusion Criteria: - Refused to participate in rfMDA, RACD, and/or RAVC, and - Provides informed consent to take part in the anonymous survey 11. Acceptability Assessment: Focus group discussions with study participants, Inclusion Criteria: - Provides informed consent, and - Was eligible to be enrolled in the study in participant's Target Area, and - Either took part in RACD or rfMDA intervention (+/- RAVC), OR refused these interventions Exclusion Criteria: 1. Index Case Investigation Exclusion Criteria: - Malaria infection identified through active case detection - Refusal to participate 2. RACD Intervention Exclusion Criteria: - Index case does not reside in study EA, or - Refusal to participate in RACD, or - Household received the intervention in the previous 5 weeks, or - Household > 500 m from the index case, or - Severe or complicated malaria as assessed by study nurse (this will lead to referral for further evaluation at health facility but not enrolment in study) 3. rfMDA Intervention Exclusion Criteria: - Index case does not reside in study EA, or - Refusal to participate in rfMDA, or - Household received the intervention in the previous 5 weeks, or - Household > 500 m from the index case, or - Severe or complicated malaria as assessed by study nurse (this will lead to referral for further evaluation at health facility but not enrolment in study) 4. Artemether/Lumefantrine (combination medication) Exclusion Criteria: - Pregnancy in first trimester, or - Previous regular menstruation, with no menstruation for most recent 4 weeks, or - Weight < 5 kg*, or - Severe malaria, or - Known allergy to A-L, or - Refusal of the offered A-L - Note regarding A-L weight exclusion: Because of the pre-set required field at the top of the Eligibility section of this Application, the investigators have indicated a 6 month minimum age limit, primarily to note to the reader that there will be a lower age limit to infants enrolled. Yet during the actual conduct of this trial the investigators will utilize 5 kg weight as the cutoff, rather than using age. A lower weight cutoff of 5 kg is in accordance with A-L's manufacturer (Novartis)'s guidance on supporting pediatric data. 5. Pill count Exclusion Criteria: - Refusal to participate in pill count, or - Individuals who did not receive any drug doses through RACD or rfMDA 6. Reactive Vector Control Exclusion Criteria: - Refusal by head of household to participate in RAVC, or - Already received RAVC during current transmission season, or - Household is > 500 m from index case household (note: refusal to participate in RACD or rfMDA is not an exclusion criterion for RAVC) 7. Endline Survey, Individual, Exclusion Criteria: • Refusal to participate in Endline Survey (note: lack of participation in rfMDA or RACD is not an exclusion criterion) 8. Acceptability Assessment: Individual Interviews with study participants, Exclusion Criteria: - Refusal to participate in Acceptability Assessment, or - Speaks language not understood or able to be translated, or - Key stakeholder [see below] - Age < 15 years 9. Acceptability Assessment: Individual Interviews with key stakeholders, Exclusion Criteria: - Refusal to participate in Acceptability Assessment, or - Speaks language not understood or able to be translated, or - Not in leadership position 10. Acceptability Assessment: Individual Interview with refusers, Exclusion Criteria: - Refusal to participate in Acceptability Assessment, or - Speaks language not understood or able to be translated, or - Age < 15 years 11. Acceptability Assessment: Focus group discussions with study participants, Exclusion Criteria: - Refusal to participate in Acceptability Assessment, or - Speaks language not understood or able to be translated, or - Key stakeholder or in another leadership position, or - Age < 15 years |
Country | Name | City | State |
---|---|---|---|
Namibia | University of Namibia Multidisciplinary Research Centre | Windhoek |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Clinton Health Access Initiative, Nigeria, London School of Hygiene and Tropical Medicine, The Novartis Foundation, University of Southampton, University of Texas |
Namibia,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence | Incidence of confirmed, passively identified malaria cases | Up to 12 months | |
Secondary | All-age infection prevalence | The investigators will determine all-age infection prevalence using loop-mediated isothermal amplification (LAMP) during the cross-sectional household survey. This survey will be administered to a sample of residents of all intervention Enumeration Areas in the Study Area at study conclusion. | Up to 12 months | |
Secondary | All-age seroprevalence | The investigators will determine all-age seroprevalence using ELISA during the cross-sectional household survey. This survey will be administered to a sample of residents of all intervention EAs in the Study Area at study conclusion. | Up to 12 months | |
Secondary | Feasibility of attaining coverage | The investigators will compare coverage of each intervention package and determine the feasibility of reaching 80% coverage for each intervention package. For RACD intervention, this equates to the proportion of the population living in the Target Area that receives a finger prick to test for malaria. For TPE intervention, coverage equates to the proportion that receive an initial dose of antimalarial drug (intention to treat analysis). For RAVC intervention, coverage is defined as the proportion of houses in the Target Area that receive reactive Indoor Residual Spraying (IRS). | Up to 12 months | |
Secondary | Safety: Serious adverse events (SAEs) | The investigators will compare the count of serious adverse events (SAEs) relative to the total number of participants receiving an Intervention, across interventions. | Up to 12 months | |
Secondary | Acceptability | Using focus group discussions (FGDs), the investigators will ask two questions: "Was this intervention acceptable to [participant]?" and "Would [participant] participate in this intervention again if given the opportunity?". The investigators will compare the % of "yes" responses to each of these questions, in the TPE versus the RACD arms. | Up to 12 months | |
Secondary | Refusal rates | Refusal rates for each intervention | Up to 12 months | |
Secondary | Cost of intervention | The investigators will collect detailed expenditure data on costs of delivery of the TPE and RACD interventions. Calculations will include costs for all consumables, as well as staff time, which will be prospectively collected every 10th TPE or RACD event. The investigators will compare TPE versus RACD in terms of cost per intervention event as well as cost per population intervened upon. | Up to 12 months | |
Secondary | Medication adherence | The investigators will measure medication adherence in both TPE and RACD by scheduled pill counts in a random subset of subjects receiving each of those interventions. | Up to 12 months |
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