Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

Browse trials for

• Malaria 1,184
• Malaria, Falciparum 455

Keywords

• Malaria
• MTI
• Surveillance study
• Africa
• RTS,S/AS01
• Epidemiology
• Plasmodium falciparum
• Malaria control interventions

Malaria

1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.

This study's enrollment of 54,115 is above the median of 252 across 937 interventional studies indexed under Malaria.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Study arms

• Other
  Survey 1 Group

  Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 1.

  Diagnostic Test: Assessment of body temperature · Procedure: Blood sampling

• Other
  Survey 2 Group

  Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 2.

  Diagnostic Test: Assessment of body temperature · Procedure: Blood sampling

• Other
  Survey 3 Group

  Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 3.

  Diagnostic Test: Assessment of body temperature · Procedure: Blood sampling

• Other
  Survey 4 Group

  Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 4.

  Diagnostic Test: Assessment of body temperature · Procedure: Blood sampling

• Other
  Survey 5 Group

  Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 5.

  Diagnostic Test: Assessment of body temperature · Procedure: Blood sampling

• Other
  Survey 6 Group

  Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 6.

  Diagnostic Test: Assessment of body temperature · Procedure: Blood sampling

• Other
  Survey 7 Group

  Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 7.

  Diagnostic Test: Assessment of body temperature · Procedure: Blood sampling

• Other
  Survey 8 Group

  Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 8.

  Diagnostic Test: Assessment of body temperature · Procedure: Blood sampling

• Other
  Survey 9 Group

  Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 9.

  Diagnostic Test: Assessment of body temperature · Procedure: Blood sampling

• Other
  Survey 10 Group

  Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 10.

  Diagnostic Test: Assessment of body temperature · Procedure: Blood sampling

Interventions

• Diagnostic testAssessment of body temperature

  Axillary body temperature of all participants recorded by a digital thermometer at the time of survey.

• ProcedureBlood sampling

  Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.

Primary outcomes

1. Number of Participants Infected With Plasmodium Falciparum (P. Falciparum) by World Health Organisation (WHO) Age Group

   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.

   Time frame: At Day 1 (survey completion visit)

2. Number of Participants Infected With P. Falciparum by Joint Technical Expert Group (JTEG) Age Group

   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.

   Time frame: At Day 1 (survey completion visit)

3. Number of Participants Using Malaria Control Interventions: Bednet Usage and Type of Bednet

   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).

   Time frame: At Day 1 (survey completion visit)

4. Number of Participants Using Malaria Control Interventions: Mosquito Coils, Insecticide Sprays, Commercial Repellants, Traditional Repellants and Indoor Residual Sprays

   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 \[participant used spray but didn't answer to how long ago\]).

   Time frame: At Day 1 (survey completion visit)

Secondary outcomes

1. Number of Participants Infected With P. Falciparum by Center, Gender and Infection Status

   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).

   Time frame: At Day 1 (survey completion visit)

2. Number of Participants Infected With Plasmodium Species Other Than P. Falciparum

   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.

   Time frame: At Day 1 (survey completion visit)

3. 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

   Time frame: At Day 1 (survey completion visit)

4. Number of Participants Who Received Anti-malarial Therapy or Any Other Medication Within 14 Days Prior to the Study Visit

   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.

   Time frame: Up to 14 days prior to the study visit at Day 1

5. Number of Participants With Measured Fever at the Time of Their Study Visit

   Fever was defined as an axillary temperature of 37.5°C or higher.

   Time frame: At Day 1 (survey completion visit)

6. Number of Participants With Reported Fever in the 24 Hours Prior to Their Study Visit

   Fever was defined as an axillary temperature of 37.5°C or higher.

   Time frame: Up to 24 hours prior to their study visit at Day 1

7. Number of Participants Demonstrating Care-seeking Behavior Following Reported Fever or Malaria up to 14 Days Prior to Their Study Visit

   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 \[participant was taken for treatment but did not answer the question regarding the time\]).

   Time frame: Up to 14 days prior to their study visit at Day 1

8. Number of Participants in Each Geo-referenced Segment

   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.

   Time frame: At Day 1 (survey completion visit)

9. Number of Participants Experiencing Malaria Risk Factors Categorized by the Number of Participants Living in the Same House (by Parasite Density)

   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.

   Time frame: At Day 1 (survey completion visit)

10. Number of Participants Experiencing Malaria Risk Categorized by Location (by Parasite Density)

    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.

    Time frame: At Day 1 (survey completion visit)

11. Number of Participants Experiencing Malaria Risk Factors Categorized by House Information (by Parasite Density)

    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.

    Time frame: At Day 1 (survey completion visit)