Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04839900 |
| Other study ID # |
1704068 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2021 |
| Est. completion date |
December 30, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
PATH |
| Contact |
Busiku Hamainza, PhD |
| Phone |
+260977941761 |
| Email |
bossbusk[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To study if a proactive strategy of weekly household visits by community health workers
(CHWs) to identify people with malaria symptoms, offer diagnostic testing, and treatment for
those with positive tests in Chadiza District, Eastern Province, can decrease malaria
incidence and prevalence compared to conventional community case management.
Description:
This study will be a two arm, cluster-randomized controlled trial to determine whether year
round weekly household visits by CHWs to detect and test people of all ages with fever or
history of fever with RDTs (and offer diagnosis and referral or treatment of diarrhea and
pneumonia for children under 5 years), and offer treatment with an ACT for those who test
positive compared to standard passive iCCM by CHWs (which includes malaria case management
for all ages in Zambia), is associated with a greater reduction in confirmed malaria cases
and parasite prevalence over a 2-year follow-up period.
Randomization will occur at the level of the CHW catchment areas. Thirty-three clusters will
be enrolled in each arm for a total of 66 clusters. Primary study outcomes will be evaluated
based on household-level cross-sectional surveys conducted at baseline and end-line and
confirmed malaria case data collected through the health system throughout the study period.
Primary objectives:
1. Assess whether year-round weekly proactive iCCM compared to passive iCCM with malaria
case management for all ages reduces the prevalence of patent (by rapid diagnostic test
(RDT)) and subpatent (by PCR) parasitemia detected at the household level in cross
sectional household surveys.
2. Determine whether the confirmed malaria case incidence (detected by CHWs (either
proactively or passively) and at health facilities) decreases over time in communities
with weekly proactive iCCM compared to passive iCCM by comparing the difference in slope
of confirmed malaria incidence in proactive vs routine arms using an interrupted time
series analysis
Secondary objectives:
1. Assess whether access to care (proportion of the population with fever in the past two
weeks who received care from a qualified health provider, including community health
worker), promptness of care (within 24 and 48 hours of symptoms), access to diagnostic
malaria testing (proportion of the population with fever in the past two weeks who
received a diagnostic test for malaria), and treatment with artemisinin-based
combination therapy (ACT) if RDT is reported positive, is improved by proactive iCCM
compared to passive iCCM
2. Describe the incidence of febrile disease, by arm, as well as the incidence of
symptomatic malaria infection (febrile persons with a positive RDT), detected during
proactive iCCM visits
3. Compare the incidence of malaria, by arm, detected at health facilities
4. Compare the proportion of malaria cases detected at community vs health facility, by arm
5. Determine if proactive iCCM reduces severe disease (malaria in all ages, diarrhea and
pneumonia among < 5) compared to passive iCCM identified at health facility and
community level)
6. Compare level of parasite exposure in intervention and control arms using multiplex bead
based assay for long, medium and short duration antibodies
7. Determine programmatic cost per additional case detected and treated at the community
level with proactive iCCM
8. Describe the feasibility, challenges, and benefits of proactive iCCM from the
perspective of the facility health worker, CHW, and community members
9. Describe the benefits and challenges associated with incorporating diagnosis and
treatment of pneumonia and diarrhea for children under 5 years
