East New Britain Province Monitoring & Evaluation

NCT04124250 | Completed

• 1 other identifier: STUDY20191141
• Study Type: observational
• Target: 12,930
• Locations: 1 country
• Sites: 1

Brief Summary

While tremendous progress towards elimination of lymphatic filariasis (LF) has been made in the 20 years since the 1997 Fiftieth World Health Assembly, it is unlikely the goal of eliminating LF as a public health problem by 2020 will be achieved. As of 2016, it was estimated that 856 million people are still living in areas with ongoing transmission of LF and require mass drug administration (MDA) \[1\]. Of the 52 countries that remain endemic and require MDA, 22 (42%) have not started MDA in all endemic implementation units (IUs) \[1\]. In addition, several countries have found that, despite completing the required number of treatment rounds, the response to the present MDA regimen has been suboptimal in some IUs, requiring additional rounds of MDA.

Conditions

Lymphatic Filariasis Elimination by Mass Drug Administration; Monitoring and Evaluation of Mass Drug Administration for Lymphatic Filariasis; Acceptability of Mass Drug Administration for Lymphatic Filariasis

Outcome Measures

Primary Outcomes (2)

• To determine the presence of W. bancrofti microfilariae

  Perform blood smears of venous blood collected at night

  3 years

• To determine the presence of W. bancrofti circulating antigen

  Fingerstick blood will be collected to assess the presence and semi-quantitative levels of circulating filarial antigen using Alere filarial test strips

  3 years

Secondary Outcomes (2)

• To determine the presence and frequency anopheline mosquitos infected with lymphatic filariasis (Xenomonitoring)

  3 years

• To determine the knowledge and attitudes about lymphatic filariasis and acceptability of the mass drug program for lymphatic filariasis

  2 years

Interventions

Observational OTHER

Mass Drug Administration with a single co-administered dose of Ivermectin, DEC and Albendazole performed by Provincial and National Health Departments annually for two years

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two distinct age groups will be sampled as part of each assessment: children 5-9 years old and adolescents and adults \>10 years. The child and adult surveys will be conducted in the same selected clusters; however, the adult survey will be conducted in a subset of the households (HHs) selected for the child survey because there are likely to be more eligible adults per HH than children.

You may qualify if:

• All individuals ages 5 years to 80 years living in selected villages will be eligible to enroll.
• Must live in the villages for at least 12 months

You may not qualify if:

• Minors ages 4 and under will not be eligible to enroll.
• Lived in selected village for less than 12 months.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Case Western Reserve University: collaborator
• Washington University School of Medicine: collaborator
• Papua New Guinea Institute for Medical Research: collaborator
• Papua New Guinea ENB Provincial Health Authority: collaborator
• Papua New Guinea National Department of Health: collaborator

Study Sites (1)

East New Britain Provincial Health Authority

Kokopo, East New Britain Province, Papua New Guinea

Location

Related Publications (5)

• Fischer PU, King CL, Jacobson JA, Weil GJ. Potential Value of Triple Drug Therapy with Ivermectin, Diethylcarbamazine, and Albendazole (IDA) to Accelerate Elimination of Lymphatic Filariasis and Onchocerciasis in Africa. PLoS Negl Trop Dis. 2017 Jan 5;11(1):e0005163. doi: 10.1371/journal.pntd.0005163. eCollection 2017 Jan. No abstract available.

  PMID: 28056015 RESULT

• Irvine MA, Stolk WA, Smith ME, Subramanian S, Singh BK, Weil GJ, Michael E, Hollingsworth TD. Effectiveness of a triple-drug regimen for global elimination of lymphatic filariasis: a modelling study. Lancet Infect Dis. 2017 Apr;17(4):451-458. doi: 10.1016/S1473-3099(16)30467-4. Epub 2016 Dec 22.

  PMID: 28012943 RESULT

• Schmaedick MA, Koppel AL, Pilotte N, Torres M, Williams SA, Dobson SL, Lammie PJ, Won KY. Molecular xenomonitoring using mosquitoes to map lymphatic filariasis after mass drug administration in American Samoa. PLoS Negl Trop Dis. 2014 Aug 14;8(8):e3087. doi: 10.1371/journal.pntd.0003087. eCollection 2014 Aug.

  PMID: 25122037 RESULT

• Rao RU, Nagodavithana KC, Samarasekera SD, Wijegunawardana AD, Premakumara WD, Perera SN, Settinayake S, Miller JP, Weil GJ. A comprehensive assessment of lymphatic filariasis in Sri Lanka six years after cessation of mass drug administration. PLoS Negl Trop Dis. 2014 Nov 13;8(11):e3281. doi: 10.1371/journal.pntd.0003281. eCollection 2014.

  PMID: 25393404 RESULT

• Bun K, Mode B, Susapu M, Salo J, Bjerum C, Payne M, Tisch D, Sekihara M, Giorgi E, Weil GJ, Fischer PU, Robinson L, Laman M, King CL. Alternative approaches for monitoring and evaluation of lymphatic filariasis following mass drug treatment with ivermectin, diethylcarbamazine and albendazole in East New Britain Province, Papua New Guinea. PLoS Negl Trop Dis. 2025 Jan 27;19(1):e0012128. doi: 10.1371/journal.pntd.0012128. eCollection 2025 Jan.

  PMID: 39869653 DERIVED

Related Links

• World Health Organization. Alternative mass drug administration regimens to eliminate lymphatic filariasis. 2017;
• Merck Commemorates 30 Years of MECTIZAN® Donation Program Progress \| Merck Newsroom Home

Biospecimen

Retention: SAMPLES WITH DNA

Blood spots from participants

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 11, 2019
• Study Start: September 17, 2019
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

PA (1)