Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

Phase 4

Completed

Conditions: Malaria Vaccines
Malaria

Registration Number: NCT02251704

Lead Sponsor: GlaxoSmithKline

Brief Summary: This epidemiology study was conducted in parallel with the EPI-MAL-002 (NCT02374450) and EPI-MAL-003 (NCT03855995) studies, enrolling participants from the same health and demographic surveillance system (HDSS) (or equivalent system) populations. The co-primary objectives were to produce longitudinal estimates of parasite prevalence in humans and to record the usage of malaria control measures in areas where the EPI-MAL-002 and EPI-MAL-003 studies were conducted.

Detailed Description: This study involved 10 annual cross-sectional surveys conducted during malaria peak transmission seasons. The surveys provided point estimates of parasite prevalence and subsequently enabled a longitudinal assessment of the level of endemicity in each area covered by EPI-MAL-002 and EPI-MAL-003. The study was conducted in parallel with EPI-MAL-002 and EPI-MAL-003 to assess parasite prevalence and malaria control measures before (EPI-MAL-002) and after (EPI-MAL-003) vaccine introduction.

By taking into account variations in malaria transmission intensity (MTI) and malaria control intervention coverage, it enabled a more complete assessment of the benefits and risks of the vaccine introduction, and thereby provided greater insight into the potential vaccine impact in EPI-MAL-002/-003 by adjusting incidence data for overall changes in transmission and other malaria control intervention coverage, and assisted in the generalisation of results to other populations.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 54115

Inclusion Criteria

Participants whose parent(s)/Legally Acceptable Representative(s) [LAR(s)], in the opinion of the investigator, could and would comply with the requirements of the protocol.
A male or female aged 6 months to under 10 years at the time of the survey.
Signed informed consent or thumb-printed and witnessed informed consent was obtained from the parent(s)/LAR(s) of the child.

Exclusion Criteria

Child was in care.
Had current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Infected With Plasmodium Falciparum (P. Falciparum) by World Health Organisation (WHO) Age Group	At Day 1 (survey completion visit)	The number of participants was summarized by the WHO age group (0.5-1 year \[Y\] and 2-9Y) and by center number/ country \[Burkina Faso (BF), Senegal (SN), Tanzania (TZ), Kenya (KE), Ghana (GH), Malawi (MA)\]/ city. Unexposed (UNEXP) sites are the ones in which the RTS,S vaccine was not planned to be implemented during the course of the study however, vaccinated participants could still have been randomly selected in this population if vaccination happened in an exposed (EXP) site, due to cross-site migration. The infection was identified using a blood smear slide and determined using microscopy.
Number of Participants Infected With P. Falciparum by Joint Technical Expert Group (JTEG) Age Group	At Day 1 (survey completion visit)	The number of participants was summarized by the JTEG age group (0.5-4Y and 5-9Y) by center number/ country \[BF, SN, TZ, KE, GH, MA\]/ city. UNEXP sites are the ones in which the RTS,S vaccine was not planned to be implemented during the course of the study however, vaccinated participants could still have been randomly selected in this population if vaccination happened in an EXP site, due to cross-site migration. The infection was identified using a blood smear slide and determined using microscopy.
Number of Participants Using Malaria Control Interventions: Bednet Usage and Type of Bednet	At Day 1 (survey completion visit)	The number of participants using malaria control interventions was summarized by: participants sleeping under a mosquito net the night before their visit, participants who have a new bednet (less than 1 year), participants who have a impregnated bednet (dipped in liquid to repel mosquitos after purchase), participants who have a pierced/torn bednet, participants with bednets classified by hole size (defined as holes big enough to let one finger go through) and number of holes (less than \[\<\] 5 holes, more or equal \[\>=\] to 5 holes, not applicable \[NA\] which is a participant who did not sleep under a bed net, missing confirmed \[MC\] which is a participant who slept under a mosquito net but who didn't answer to the question on holes).
Number of Participants Using Malaria Control Interventions: Mosquito Coils, Insecticide Sprays, Commercial Repellants, Traditional Repellants and Indoor Residual Sprays	At Day 1 (survey completion visit)	The number of participants using malaria control interventions was summarized by: mosquito coils, insecticide sprays, commercial repellants, traditional repellants and indoor residual sprays (in the past 12 months, 1 to 12 months, NA \[the participant didn't use the residual spray\], missing \[participant used spray but didn't answer to how long ago\]).

Secondary Outcome Measures

Name	Time	Method
Number of Participants Infected With P. Falciparum by Center, Gender and Infection Status	At Day 1 (survey completion visit)	The number of participants was summarized by: center number/ country \[BF, SN, TZ, KE, GH, MA\]/ city, gender (female, male) and infection status (infected, not infected).
Number of Participants Infected With Plasmodium Species Other Than P. Falciparum	At Day 1 (survey completion visit)	The infections with other Plasmodium species were determined using a blood smear slide and microscopy. The number of participants infected with P. malaria, P. vivax and P. ovale was summarized.
Number of Participants Who Received Dose 3 of the Diphtheria, Tetanus, Pertussis/ Hepatitis B/ Haemophilus Influenzae Type b (DTP/HepB/Hib) Vaccine or Dose 1 of the Measles Vaccine	At Day 1 (survey completion visit)
Number of Participants Who Received Anti-malarial Therapy or Any Other Medication Within 14 Days Prior to the Study Visit	Up to 14 days prior to the study visit at Day 1	The number of participants who received anti-malarial therapy out of those who reported malaria in the last 14 days prior to the study visit was summarized.
Number of Participants With Measured Fever at the Time of Their Study Visit	At Day 1 (survey completion visit)	Fever was defined as an axillary temperature of 37.5°C or higher.
Number of Participants With Reported Fever in the 24 Hours Prior to Their Study Visit	Up to 24 hours prior to their study visit at Day 1	Fever was defined as an axillary temperature of 37.5°C or higher.
Number of Participants Demonstrating Care-seeking Behavior Following Reported Fever or Malaria up to 14 Days Prior to Their Study Visit	Up to 14 days prior to their study visit at Day 1	The number of participants demonstrating care-seeking behavior following reported fever or malaria was summarized by where the participant was taken for treatment (home, drug seller, pharmacy, private clinic, health center, hospital, other, not applicable \[no treatment received\]), by when the participant was taken for treatment (at onset, when the participant did not improve, when the participant got worse, other, not applicable \[no treatment received\], missing \[participant was taken for treatment but did not answer the question regarding when\]) and by what time the participant was taken for treatment (the same day, the next day, 2 days later, more than 2 days later, not applicable \[no treatment received\], missing \[participant was taken for treatment but did not answer the question regarding the time\]).
Number of Participants in Each Geo-referenced Segment	At Day 1 (survey completion visit)	The number of participants was summarized by: center number/ country \[BF, SN, TZ, KE, GH, MA\]/ city followed by the segment ID. Positioning of the participant's residence was attributed to a segment with a unique ID from the grid referencing study area map in which the participant resided; where necessary, grouping small geographically proximate villages so that each segment had at least 10 study participants to avoid personally identifiable information (PII), and proceeding as far as geographically appropriate.
Number of Participants Experiencing Malaria Risk Factors Categorized by the Number of Participants Living in the Same House (by Parasite Density)	At Day 1 (survey completion visit)	Participants were categorized by the number of people living in the same house relative to enrolled participants as follows: less than of equal to (\<=) 3 per 1 enrolled (LE 3/1), 4-5 per 1 (4-5/1), more than (\>) 5 per 1 (GT 5/1); \<=3 per 2 enrolled (LE 3/2), 4-5 per 2 (4-5/2), \>5 per 2 (GT 5/2); \<=3 per 3 enrolled (LE 3/3), 4-5 per 3 (4-5/3), \>5 per 3 (GT 5/3); 4-5 per more than 3 enrolled (4-5/GT 3), \>5 per more than 3 enrolled (GT 5/GT 3). Participants were also categorized by parasite density: low (\<2500 parasites/μL), medium (2500-9999/μL), high (10000-19999/μL), very high (\>=20000/μL), negative, and missing.
Number of Participants Experiencing Malaria Risk Categorized by Location (by Parasite Density)	At Day 1 (survey completion visit)	Participants were categorized by location as follows: situation area (rural, urban, semi-rural) and type of location (large city, small city, town, countryside). Participants were also categorized by parasite density: low (\<2500 parasites/μL), medium (2500-9999/μL), high (10000-19999/μL), very high (\>=20000/μL), negative, and missing.
Number of Participants Experiencing Malaria Risk Factors Categorized by House Information (by Parasite Density)	At Day 1 (survey completion visit)	Participants were categorized by house characteristics as follows: wall material (mud, brick, cement/plaster, clay, other), floor material (natural, rudimentary, vinyl/asphalt strips, parquet/polished wood, ceramic tiles, cement, carpet, clay, other), roof type (iron sheet, tiles, clay, other), window type (closed, open, no window, partially open, other), presence of nets (not present, present on all windows, present on some windows, other, missing), main drinking water source (closed, open), whether the open source was in the compound (yes, no, not available \[NA\]), and presence or absence of electricity. Participants were also categorized by parasite density: low (\<2500 parasites/μL), medium (2500-9999/μL), high (10000-19999/μL), very high (\>=20000/μL), negative, and missing.