Universal versus conditional three-day follow up visit for children with uncomplicated fever at the community level: design of a cluster-randomized, community-based, non-inferiority trial in Tanganyika, Democratic Republic of Congo

Abstract

BackgroundThe current recommendation within integrated Community Case Management guidelines that all children presenting with uncomplicated fever and no danger signs be followed up after three days may not be necessary. Such fevers often resolve rapidly (usually within 48–96 h), and previous studies suggest that expectant home care for uncomplicated fever can be safely recommended. We aim to determine the non-inferiority of a conditional versus a universal follow-up visit for these children.MethodsWe are conducting a cluster-randomized, community-based, non-inferiority trial enrolling ~4300 children (ages 2–59 months) presenting to community health workers (CHWs) with uncomplicated fever in Tanganyika Province, Democratic Republic of the Congo. Clusters (n = 28) of CHWs are randomized to advise caretakers of such children to either 1) return for a follow-up visit on Day 3 following the initial consultation (Day 1), regardless of illness resolution (as per current guidelines) or 2) return for a follow-up visit on Day 3 only if the child’s signs have not resolved. Enrolled children are followed up at Day 7 for a repeat assessment and recording of the primary outcome of the study, “failure”, which is defined as having fever, diarrhea, pneumonia or decline of health status (e.g. hospitalization, presenting danger signs, or death).DiscussionThe results of this trial will be interpreted in conjunction with a similarly designed trial currently ongoing in Ethiopia. If a follow-up visit conditional on continued illness is shown to be non-inferior to current guidelines stipulating universal follow-up, appropriate updating of such guidelines could reduce time and human resource pressures on both providers and caregivers throughout communities of sub-Saharan Africa and South Asia.Trial registrationThis trial was registered at ClinicalTrials.gov (NCT02595827) on November 2nd, 2015

Universal versus conditional day 3 follow-up for children with non-severe unclassified fever at the community level in the Democratic Republic of the Congo: A cluster-randomized, community-based non-inferiority trial

“…Further details of our cluster-randomized non-inferiority trial have been published elsewhere [ 16 ]. Briefly, each of the 28 health areas (14 in each zone) consisted of a health center and a team of 1 to 18 associated CHWs: literate, locally resident volunteers who received 5 days of training on the iCCM algorithm and other core competencies (e.g., communication and recording) as per DRC Ministry of Public Health guidelines.…”

“…We used restricted randomization balanced on zone and health area estimates of (1) population size, (2) prior 6-month likelihood of mRDT-negative febrile children (number of children mRDT negative/under-5 population), and (3) geographic distance from CHW to zonal health center to allocate the 28 health areas (and all the CHWs and the children they enrolled within these areas) to either universal or conditional follow-up advice (also see sample size section below) [ 16 ].…”

“…Paper forms were checked for accuracy and completeness by a data officer, then entered twice into a secure online database (REDCap) [ 17 ] using customized data entry screens with built-in validation checks. Additional details have been previously published [ 16 ].…”

Testing a simplified tool and training package to improve integrated Community Case Management in Tanganyika Province, Democratic Republic of Congo: a quasi-experimental study

“…However, there is still not enough evidence globally that payment of community health workers (CHWs) will resolve the issue of motivation and retention and further research on these areas is needed. In interviews conducted as part of another research study [24] with RECOs in other health zones in the region, many RECOs noted that their work takes up a great deal of time, largely due to the number of tools required to complete, leaving them with limited time for their income-generating activities. Other studies have also found that RECOs are frustrated and confused by complex tools and protocols [8] and Guenther et al [25] have pointed out that complexity also reduces the quality of data and its utility for program improvement.…”

Universal Versus Conditional Third Day Follow-Up Visit for Children With Nonsevere Unclassified Fever at the Community Level in Ethiopia: Protocol for a Cluster Randomized Noninferiority Trial

“…To compensate for this, we will address this issue during interviews, as well as on pilot testing of the interview guides, to ensure that any gender-related issues will be prevented. This study, along with a sister study in Democratic Republic of Congo [ 27 ], is the only study designed to look at this critical policy issue. It therefore has high potential to contribute to the knowledge base by assessing and evaluating recommended practices for treating febrile children whose illness cannot be diagnosed at the community level using iCCM guidelines.…”