Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201702002012425 Date of Approval: 02/02/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Twice Yearly Treatment for the Control of LF
Official scientific title Cluster Randomized Community-based Trial of Annual Versus Biannual Single-dose Ivermectin Plus Albendazole Against Wuchereria Bancrofti Infection in Human and Mosquito Populations  
Brief summary describing the background and objectives of the trial 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. Among a random subsample of participants, microfilaria prevalence will be assessed longitudinally. Cost and cost-effectiveness, and feasibility and scale-up of each delivery system will be evaluated.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Lymphatic Filariasis
Sub-Disease(s) or condition(s) being studied Lymphatic Filariasis
Purpose of the trial Treatment: Other
Anticipated trial start date 01/03/2017
Actual trial start date 01/03/2017
Anticipated date of last follow up 01/12/2019
Actual Last follow-up date 01/12/2019
Anticipated target sample size (number of participants) 1440
Actual target sample size (number of participants) 1440
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NCT03036059 ClinicalTrials.gov
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Computerized random number generation No allocation concealment Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Computerized random number generation No allocation concealment Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Expanded frequency group 400 ug/kg Ivermectin + 400 mg Albendazole, Tablets given every 6 months for 2 years 2 years annual MDA with IVM +ALB, followed by an additional MDA 6 months later 720
Control Group Control group 400 ug/kg Ivermectin + 400 mg Albendazole Tablets given once a year for two years 2 years The control group will recceive the normal mass drug administration given by the NTD program, once a year for two years 720 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Residency in the disease endemic community for at least 12 months 2. Willingness to provide informed consent/assent 3. Willingness to donate blood (per the protocol) 1. Recent residents (<12 months) 2. Inability to give informed consent 3. Pregnant and lactating women 4. Children below the age of 5. 5 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/01/2017 NMIMR IRB
Ethics Committee Address
Street address City Postal code Country
University of Ghana Legon - Accra Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/04/2017 Ghana Health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
PO Box MB 190 Accra Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change from baseline prevalence of Lymphatic Filariasis at 24 months Month 0: Baseline measurement Month 24: Final outcome assessment
Secondary Outcome Longitudinal assessment of transmission dynamics of Lymphatic Filariasis for modelling the impact of treatment Month 0 Month 12 Month 24 Month 30
Secondary Outcome Evaluation of community acceptability of twice-yearly treatment, through questionnaires and focus group discussions Month 24
Secondary Outcome Feasibility of scale-up of twice-yearly treatment, through questionnaires and focus group discussions Month 24
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Communities in the Western Region of Ghana (actual recruitment centres are yet to be identified) Not Applicable Not Applicable Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Francie van Zijl Drive, Parow Valley 7505 Cape Town South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor EDCTP Francie van Zijl Drive, Parow Valley 7505 Cape Town South Africa Funding Agency
Secondary Sponsor Noguchi Memorial Institute for Medical research University of Ghana Legon-Accra Ghana University
COLLABORATORS
Name Street address City Postal code Country
Ghana Neglected Tropical Diseases Programme Accra Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dziedzom de Souza ddesouza@noguchi.ug.edu.gh +233244434966 University of Ghana
City Postal code Country Position/Affiliation
Legon-Accra Ghana Research Fellow
Role Name Email Phone Street address
Public Enquiries Susan Adu-Amankwah sadu-amankwah@noguchi.ug.edu.gh +233244734811 University of Ghana
City Postal code Country Position/Affiliation
Legon-Accra Ghana Clinical Trials Coordinator
Role Name Email Phone Street address
Scientific Enquiries Dziedzom de Souza ddesouza@noguchi.ug.edu.gh +233244434966 University of Ghana
City Postal code Country Position/Affiliation
Legon-Accra Ghana Research Fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information