Clinical trial NCT03036059: Twice Yearly Treatment for the Control of LF
Official title: Cluster Randomized Community-based Trial of Annual Versus Biannual Single-dose Ivermectin Plus Albendazole Against Wuchereria Bancrofti Infection in Human and Mosquito Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lymphatic Filariasis
Helminth Infection
Keywords: Twice a year treatment
Biannual treatment
Wuchereria bancrofti
Lead sponsor: Noguchi Memorial Institute for Medical Research
Sponsor class: OTHER
Collaborators: name: Ghana Health Services
First posted: 2017-01-30
Enrollment: 1462
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Global Program for the Elimination of Lymphatic Filariasis (GPELF) has been in operation sing the year 2000, with the aim of eliminating the disease by the year 2020, following 5-6 rounds of effective annual Mass Drug Administration (MDA). The treatment regimen is Ivermectin (IVM) in combination with Diethylcarbamazine (DEC) or Albendazole (ALB). In Ghana, MDA has been undertaken since 2001. While the disease has been eliminated in many areas, transmission has persisted in some implementation units that had experienced 15 or more rounds of MDA. Alternative intervention strategies, including twice yearly MDA and sleeping under insecticidal nets have significantly accelerated transmission interruption in some settings of high transmission intensity. Thus, it is evident that new intervention strategies could eliminate residual infection in areas of persistent transmission and speed up the LF elimination process. This study therefore seeks to test the hypothesis that biannual treatment of LF endemic communities will accelerate interruption of LF transmission.

Two cluster randomized trials will be implemented in LF endemic communities in Ghana. The interventions will be yearly or twice-yearly MDA delivered to entire endemic communities. Allocation to study group will be by clusters identified using the prevalence of LF. Clusters will be randomised to one of two groups: receiving either (1) annual treatment with IVM+ALB; (2) annual MDA with IVM +ALB, followed by an additional MDA 6 months later. The primary outcome measure is the prevalence of LF infection, assessed by four cross-sectional surveys. Entomological assessments will also be undertaken to evaluate the transmission intensity of the disease in the study clusters. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, microfilaria prevalence will be assessed longitudinally. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system.


Eligibility criteria: Inclusion Criteria:

* Residency in the disease endemic community for at least 12 months
* Willingness to provide informed consent/assent
* Willingness to donate blood (per the protocol)

Exclusion Criteria:

* Recent residents (\<12 months)
* Inability to give informed consent
* Pregnant and lactating women
* Children below the age of 5.

Primary outcomes:
measure: Change from baseline prevalence of Lymphatic Filariasis at 24 months
timeFrame: 0 and 24 months
Secondary outcomes:
measure: Longitudinal assessment of transmission dynamics of Lymphatic Filariasis for modelling the impact of treatment
timeFrame: 0, 12, 24, 30 months
measure: Evaluation of community acceptability of twice-yearly treatment, through questionnaires and focus group discussions
timeFrame: 24 months
measure: Feasibility of scale-up of twice-yearly treatment, through questionnaires and focus group discussions
timeFrame: 24 months
Other outcomes:
Locations:
city: Legon-Accra
country: Ghana
facility: Noguchi Memorial Institute for Medical Research
Study officials:
affiliation: Noguchi Memorial Institute for Medical Research
name: Dziedzom K de Souza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Souza DK, Ahorlu CS, Adu-Amankwah S, Otchere J, Mensah SK, Larbi IA, Mensah GE, Biritwum NK, Boakye DA. Community-based trial of annual versus biannual single-dose ivermectin plus albendazole against Wuchereria bancrofti infection in human and mosquito populations: study protocol for a cluster randomised controlled trial. Trials. 2017 Oct 2;18(1):448. doi: 10.1186/s13063-017-2196-9.