A multicenter, community-based, mixed methods assessment of the acceptability of a triple drug regimen for elimination of lymphatic filariasis

PLoS Negl Trop Dis. 2021 Mar 3;15(3):e0009002. doi: 10.1371/journal.pntd.0009002. eCollection 2021 Mar.

Abstract

Background: Many countries will not reach elimination targets for lymphatic filariasis in 2020 using the two-drug treatment regimen (diethylcarbamazine citrate [DEC] and albendazole [DA]). A cluster-randomized, community-based safety study performed in Fiji, Haiti, India, Indonesia and Papua New Guinea tested the safety and efficacy of a new regimen of ivermectin, DEC and albendazole (IDA).

Methodology/principal findings: To assess acceptability of IDA and DA, a mixed methods study was embedded within this community-based safety study. The study objective was to assess the acceptability of IDA versus DA. Community surveys were performed in each country with randomly selected participants (>14 years) from the safety study participant list in both DA and IDA arms. In depth interviews (IDI) and focus group discussions (FGD) assessed acceptability-related themes. In 1919 individuals, distribution of sex, microfilariae (Mf) presence and circulating filarial antigenemia (CFA), adverse events (AE) and age were similar across arms. A composite acceptability score summed the values from nine indicators (range 9-36). The median (22.5) score indicated threshold of acceptability. There was no difference in scores for IDA and DA regimens. Mean acceptability scores across both treatment arms were: Fiji 33.7 (95% CI: 33.1-34.3); Papua New Guinea 32.9 (95% CI: 31.9-33.8); Indonesia 30.6 (95% CI: 29.8-31.3); Haiti 28.6 (95% CI: 27.8-29.4); India 26.8 (95% CI: 25.6-28) (P<0.001). AE, Mf or CFA were not associated with acceptability. Qualitative research (27 FGD; 42 IDI) highlighted professionalism and appreciation for AE support. No major concerns were detected about number of tablets. Increased uptake of LF treatment by individuals who had never complied with MDA was observed.

Conclusions/significance: IDA and DA regimens for LF elimination were highly and equally acceptable in individuals participating in the community-based safety study in Fiji, Haiti, India, Indonesia, and Papua New Guinea. Country variation in acceptability was significant. Acceptability of the professionalism of the treatment delivery was highlighted.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Albendazole / administration & dosage
  • Albendazole / therapeutic use
  • Diethylcarbamazine / administration & dosage
  • Diethylcarbamazine / therapeutic use
  • Elephantiasis, Filarial / drug therapy*
  • Female
  • Filaricides / administration & dosage
  • Filaricides / therapeutic use*
  • Focus Groups
  • Humans
  • Ivermectin / administration & dosage
  • Ivermectin / therapeutic use
  • Male
  • Mass Drug Administration / methods*
  • Middle Aged
  • Patient Acceptance of Health Care*
  • Professionalism
  • Surveys and Questionnaires

Substances

  • Filaricides
  • Ivermectin
  • Albendazole
  • Diethylcarbamazine

Grants and funding

This work was supported by grant OPPGH5342 from the Bill & Melinda Gates Foundation to Washington University. The Fiji and India studies were supported in part by the Coalition for Operational Research on Neglected Tropical Diseases (COR-NTD), which is funded at the Task Force for Global Health primarily by the Bill & Melinda Gates Foundation, by the United Kingdom Department for International Development, and by the United States Agency for International Development through its Neglected Tropical Diseases Program. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.