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

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. Author summary: The acceptability of a new combination treatment regimen for lymphatic filariasis (ivermectin, plus DEC and albendazole, or IDA) was assessed as part of a larger community-based safety study in Fiji, Haiti, India, Indonesia and Papua New Guinea. To understand how trial participants and communities felt about the new treatment, a survey was carried out with people who had participated in the safety study receiving either the standard treatment [DEC plus albendazole (DA)] or the new treatment regimen (IDA). Focus group discussions and in-depth interviews were performed in the same communities. Results showed that there was no difference in acceptability between the DA and IDA. Adverse events and presence of filarial infection did not affect acceptability. The most important indicator associated with acceptability was country. All countries accepted the treatment regimens. Fiji had the highest acceptability scores, followed by Papua New Guinea, Indonesia, Haiti and India. Results from the qualitative research showed that study participants appreciated the professionalism of the drug delivery team and the support offered for the management of any adverse events. [ABSTRACT FROM AUTHOR]
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