Malaria Incidence, Malaria (Plasmodium Falciparum)
Conditions
Keywords
Lesu, Malaria, Permethrin, Etofenprox
Brief summary
The objective is to test the protective effect of permethrin-treated and etofenprox-treated lesus against malaria in young children
Detailed description
The proposed study is a double-blind, randomized control trial of permethrin-treated and etofenprox-treated lesus to prevent P. falciparum malaria in children 2-4 months of age conducted at three sites in rural Uganda. Participating mother-infant pairs will receive a new bed net and two permethrin-treated or untreated lesus at enrollment. The total sample size will be 1,296 mother-infant pairs with 144 pairs in each group. The investigators will follow participants longitudinally for three years. Participants will be instructed and incentivized to present to one of the study clinics when a fever develops, where they will be evaluated, tested, and treated, if positive, for malaria. Participants will also attend scheduled clinic visits every two months for routine surveillance of adverse effects and to test for asymptomatic infection. Re-treatment and sham re-treatment of lesus will occur after 1 year of participation. Participants will be asked to return the lesus after 2 years of participation.
Interventions
Patterned cotton-blend fabric will be obtained and treated with permethrin at Perimeter Insect Guard. After treatment, the material will be cut into 2 x 1 meter swathes
Patterned cotton-blend fabric will be obtained and treated with etofenprox at Perimeter Insect Guard. After treatment, the material will be cut into 2 x 1 meter swathes
Untreated fabric of identical appearance (i.e., color and pattern) will be similarly cut and packaged for use
Sponsors
Study design
Eligibility
Inclusion criteria
* Mother is at least 18 years old * Mother has access to a working phone with a known number * Mother is the parent or legal guardian of a singleton (i.e., not a twin) infant 2-4 months of age * Has the ability to travel to a designated study site for visits and evaluation * Mother/Infant pair presents to their 10-week immunization visit at one of the designated study sites
Exclusion criteria
* Participation in another study of malaria prevention * Known allergic reaction to permethrin or etofenprox * Infant has a known HIV diagnosis (or exposure) or sickle cell disease that would be an indication for malaria prophylaxis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of clinical malaria in children between the etofenprox and control arms | From enrollment through Month 24 | Incidence of participants experiencing acute febrile illness AND positive malaria rapid diagnostic test (RDT) at a scheduled or unscheduled study visit. |
| Incidence of clinical malaria in children between the permethrin and control arms | From enrollment through Month 24 | Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of deaths from malaria between the etofenprox and control arms during wrap use | From enrollment to Month 24 | Number of deaths documented during hospitalization. |
| Number of deaths from malaria between the permethrin and control arms after wrap use has been discontinued | From Month 24 to Month 36 | Number of deaths documented during hospitalization. |
| Number of deaths from malaria between the etofenprox and control arms after wrap use has been discontinued | From Month 24 to Month 36 | Number of deaths documented during hospitalization. |
| Difference between the permethrin and control arms in change from baseline of childrens' hemoglobin levels | At baseline, 12 Months, and 24 Months | Hemoglobin measured using a Hemocue device. |
| Difference between the etofenprox and control arms in change from baseline of childrens' hemoglobin levels | At baseline, 12 Months, and 24 Months | Hemoglobin measured using a Hemocue device. |
| Incidence of non-malarial febrile episodes in children between the permethrin and control arms | From enrollment through Month 24 | Incidence of participants experiencing acute febrile illness and negative malaria RDT at a scheduled or unscheduled study visit. |
| Incidence of non-malarial febrile episodes in children between the etofenprox and control arms | From enrollment through Month 24 | Incidence of participants experiencing acute febrile illness and negative malaria RDT at a scheduled or unscheduled study visit. |
| Wrap attrition | From enrollment through Month 24 | The number of wraps lost or damaged and requiring replacement. |
| Incidence of rebound clinical malaria in children between the permethrin and control arms | From Month 24 through Month 36 | Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit after wrap discontinuation. |
| Incidence of rebound clinical malaria in children between the etofenprox and control arms | From Month 24 through Month 36 | Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit after wrap discontinuation. |
| Number of adverse reactions to wraps between the permethrin and control arms | From enrollment through Month 24 | Counts of the top 5 most common adverse reactions reported by participants on questionnaires and assessed by clinic staff. |
| Number of adverse reactions to wraps between the etofenprox and control arms | From enrollment through Month 24 | Counts of the top 5 most common adverse reactions reported by participants on questionnaires and assessed by clinic staff. |
| Number of participants with care-seeking events attributable to the permethrin wrap versus the control | From enrollment through Month 24 | Number of participants with care-seeking events attributable to the permethrin wrap versus the control wrap. |
| Number of participants with care-seeking events attributable to the etofenprox wrap versus the control | From enrollment through Month 24 | Number of participants with care-seeking events attributable to the etofenprox wrap versus the control wrap. |
| Number of participants with hospitalizations attributable to the permethrin wrap versus the control | From enrollment through Month 24 | Number of participants with hospitalizations attributable to the permethrin wrap versus the control wrap. |
| Number of participants with hospitalizations attributable to the etofenprox wrap versus the control | From enrollment through Month 24 | Number of participants with hospitalizations attributable to the etofenprox wrap versus the control wrap. |
| Number of participants with death attributable to the permethrin wrap versus the control | From enrollment through Month 24 | Number of participants with death attributable to the permethrin wrap versus the control wrap. |
| Number of participants with death attributable to the etofenprox wrap versus the control | From enrollment through Month 24 | Number of participants with death attributable to the etofenprox wrap versus the control wrap. |
| Change in child's height-for-weight between the permethrin and control arms | From enrollment through Month 24 | Change in Z-score for height-for-weight. A height-for-weight Z-score indicates how a child's height compares with a reference population of children of the same weight. A score of 0 represents the reference average; positive values indicate above-average height-for-weight, and negative values indicate below-average height-for-weight. Z = 0: Average height-for-weight in the reference population Z = +1: One standard deviation above the reference average Z = -1: One standard deviation below the reference average Z = -2: Substantially below the reference average |
| Change in child's height-for-weight between the etofenprox and control arms | From enrollment through Month 24 | Change in Z-score for height-for-weight. A height-for-weight Z-score indicates how a child's height compares with a reference population of children of the same weight. A score of 0 represents the reference average; positive values indicate above-average height-for-weight, and negative values indicate below-average height-for-weight. Z = 0: Average weight-for-age in the reference population Z = +1: One standard deviation above the reference average Z = -1: One standard deviation below the reference average Z = -2: Substantially below the reference average |
| Change in child's height-for-age between the permethrin and control arms | From enrollment through Month 24 | Change in Z-score for height-for-age. A height-for-age Z-score indicates how a child's height compares with a reference population of children of the same age. A score of 0 represents the reference average; positive values indicate above-average height-for-age, and negative values indicate below-average height-for-age. Z = 0: Average height-for-age in the reference population Z = +1: One standard deviation above the reference average Z = -1: One standard deviation below the reference average Z = -2: Substantially below the reference average |
| Change in child's height-for-age between the etofenprox and control arms | From enrollment through Month 24 | Change in Z-score for height-for-age. Change in Z-score for height-for-age. A height-for-age Z-score indicates how a child's height compares with a reference population of children of the same age. A score of 0 represents the reference average; positive values indicate above-average height-for-age, and negative values indicate below-average height-for-age. Z = 0: Average height-for-age in the reference population Z = +1: One standard deviation above the reference average Z = -1: One standard deviation below the reference average Z = -2: Substantially below the reference average |
| Change in child's percentile on the Developmental Profile 4: Social-Emotional Scale between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Social-Emotional subscale of the Developmental Profile 4. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers. |
| Change in child's percentile on the Developmental Profile 4: Cognitive Scale between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Cognitive subscale of the Developmental Profile 4. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers. |
| Change in child's percentile on the Developmental Profile 4: Communication Scale between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Communication subscale of the Developmental Profile 4. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers. |
| Change in child's growth score on the Developmental Profile 4: Physical Scale between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Physical subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance |
| Change in child's growth score on the Developmental Profile 4: Physical Scale between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Physical subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance |
| Change in child's growth score on the Developmental Profile 4: Adaptive Behavior Scale between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Adaptive Behavior subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance |
| Change in child's growth score on the Developmental Profile 4: Adaptive Behavior Scale between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Adaptive Behavior subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance |
| Change in child's growth score on the Developmental Profile 4: Social-Emotional Scale between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Social-Emotional subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance |
| Change in child's growth score on the Developmental Profile 4: Social-Emotional Scale between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Social-Emotional subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance |
| Change in child's growth score on the Developmental Profile 4: Cognitive Scale between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Cognitive subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance |
| Change in child's growth score on the Developmental Profile 4: Cognitive Scale between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Cognitive subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance |
| Change in child's growth score on the Developmental Profile 4: Communication Scale between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Communication subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance |
| Change in child's growth score on the Developmental Profile 4: Communication Scale between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Communication subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance |
| Change in child's age equivalent on the Developmental Profile 4: Physical Scale between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Physical subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores. Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11. Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children. |
| Change in child's age equivalent on the Developmental Profile 4: Physical Scale between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Physical subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores. Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11. Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children. |
| Change in child's age equivalent on the Developmental Profile 4: Adaptive Behavior Scale between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Adaptive Behavior subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores. Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11. Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children. |
| Number of deaths from any cause between the permethrin and control arms during wrap use | From enrollment to Month 24 | Number of deaths documented, regardless of cause. |
| Number of deaths from any cause between the etofenprox and control arms during wrap use | From enrollment to Month 24 | Number of deaths documented, regardless of cause. |
| Number of deaths from any cause between the permethrin and control arms after wrap use has been discontinued | From Month 24 to Month 36 | Number of deaths documented, regardless of cause. |
| Incidence of clinical malaria in children between the permethrin and control arms per site | From enrollment through Month 24 | Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit. |
| Incidence of clinical malaria in children between the etofenprox and control arms per site | From enrollment through Month 24 | Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit. |
| Incidence of hospitalizations due to malaria between the permethrin and control arms | From enrollment to Month 36 | Incidence of admissions from clinic after a positive malaria RDT. |
| Incidence of hospitalizations due to malaria between the etofenprox and control arms | From enrollment to Month 36 | Incidence of admissions from clinic after a positive malaria RDT. |
| Change in child's weight-for-age between the permethrin and control arms | From enrollment through Month 24 | Change in Z-score for weight-for-age. Change in Z-score for weight-for-age. A weight-for-age Z-score indicates how a child's weight compares with a reference population of children of the same age. A score of 0 represents the reference average; positive values indicate above-average weight-for-age, and negative values indicate below-average weight-for-age. Z = 0: Average weight-for-age in the reference population Z = +1: One standard deviation above the reference average Z = -1: One standard deviation below the reference average Z = -2: Substantially below the reference average |
| Change in child's weight-for-age between the etofenprox and control arms | From enrollment through Month 24 | Change in Z-score for weight-for-age. Change in Z-score for weight-for-age. Change in Z-score for weight-for-age. A weight-for-age Z-score indicates how a child's weight compares with a reference population of children of the same age. A score of 0 represents the reference average; positive values indicate above-average weight-for-age, and negative values indicate below-average weight-for-age. Z = 0: Average weight-for-age in the reference population Z = +1: One standard deviation above the reference average Z = -1: One standard deviation below the reference average Z = -2: Substantially below the reference average |
| Change in child's acute malnutrition between the permethrin and control arms | From enrollment through Month 24 | Change in Mid-upper arm circumference (MUAC). |
| Change in child's acute malnutrition between the etofenprox and control arms | From enrollment through Month 24 | Change in Mid-upper arm circumference (MUAC). |
| Change in child's score on the Mullen Scales of Early Learning between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Change in median composite scores on the Mullen Scales of Early Learning. The Early Learning Composite from the Mullen Scales of Early Learning (MSEL) will be used to measure developmental functioning. The Early Learning Composite (ELC) is a standardized composite score derived from the 5 subtests measured on the MSEL. It has a mean of 100 and a standard deviation of 15. Higher scores indicate stronger performance. |
| Change in child's score on the Mullen Scales of Early Learning between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Change in mean composite scores on the Mullen Scales of Early Learning. The Early Learning Composite from the Mullen Scales of Early Learning (MSEL) will be used to measure developmental functioning. The Early Learning Composite (ELC) is a standardized composite score derived from the 5 subtests measured on the MSEL. It has a mean of 100 and a standard deviation of 15. Higher scores indicate stronger performance. |
| Change in child's percentile on the Developmental Profile 4: Physical Scale between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Physical subscale of the Developmental Profile 4, which includes items measuring gross- and fine-motor skills, coordination, strength, stamina, and flexibility. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers. |
| Change in child's percentile on the Developmental Profile 4: Adaptive Behavior Scale between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Adaptive Behavior subscale of the Developmental Profile 4, which includes items measuring age-appropriate independent functioning. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers. |
| Change in child's percentile on the Developmental Profile 4: Social-Emotional Scale between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Social-Emotional subscale of the Developmental Profile 4, which includes items measuring skills related to interpersonal behavior and demonstration of social and emotional competence. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers. |
| Change in child's percentile on the Developmental Profile 4: Cognitive Scale between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Cognitive subscale of the Developmental Profile 4, which includes items measuring perception, concept development, number relations, reasoning, memory, classification, time concepts, and related mental acuity tasks. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers. |
| Change in child's percentile on the Developmental Profile 4: Communication Scale between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Communication subscale of the Developmental Profile 4, which reflects the ability to understand spoken and written language as well as to use both verbal and nonverbal skills to communicate. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers. |
| Change in child's percentile on the Developmental Profile 4: Physical Scale between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Physical subscale of the Developmental Profile 4. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers. |
| Change in child's percentile on the Developmental Profile 4: Adaptive Behavior Scale between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Adaptive Behavior subscale of the Developmental Profile 4. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers. |
| Change in child's age equivalent on the Developmental Profile 4: Adaptive Behavior Scale between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Adaptive Behavior subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores. Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11. Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children. |
| Change in child's age equivalent on the Developmental Profile 4: Social-Emotional Scale between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Social-Emotional subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores. Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11. Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children. |
| Change in child's age equivalent on the Developmental Profile 4: Social-Emotional Scale between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Social-Emotional subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores. Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11. Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children. |
| Change in child's age equivalent on the Developmental Profile 4: Cognitive Scale between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Cognitive subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores. Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11. Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children. |
| Change in child's age equivalent on the Developmental Profile 4: Cognitive Scale between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Cognitive subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores. Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11. Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children. |
| Change in child's age equivalent on the Developmental Profile 4: Communication Scale between the permethrin and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Communication subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores. Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11. Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children. |
| Number of deaths from any cause between the etofenprox and control arms after wrap use has been discontinued | From Month 24 to Month 36 | Number of deaths documented, regardless of cause. |
| Change in child's age equivalent on the Developmental Profile 4: Communication Scale between the etofenprox and control arms | Enrollment, Year 1, Year 2, Year 3 | Performance on the Communication subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores. Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11. Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children. |
| Number of deaths from malaria between the permethrin and control arms during wrap use | From enrollment to Month 24 | Number of deaths documented during hospitalization. |
Countries
Uganda
Contacts
University of North Carolina, Chapel Hill