Taenia Solium Elimination Versus Control: What is the Best Way Forward for Sub-Saharan Africa?

As T. solium is a zoonosis, it's control will be evaluated in a One Health perspective, tackling both the human and pig host. The study will be carried out in the Katete district, in the Eastern Province of Zambia, an area reported to be endemic for T. solium in both pigs and humans. The pig interventions will not be described here, as requested by ClinicalTrials.gov Suitability of communities in the Katete district was assessed during a pilot survey conducted by the proposers (April 2015).

Two communities were selected that fulfilled all of the eligibility criteria. The Nyembe neighbourhood community (1,210 people, 5 villages, 520 pigs), within the Nyembe Rural Health Centre (RHC) catchment was selected for the elimination study arm; and Chimvira neighbourhood community (1,470 people, 11 villages, 827 pigs), in the Mtandaza Rural Health Centre catchment, was selected for the control study arm.

The interventional study will entail a high-input elimination study arm (E), in which multiple control options targeting both the final (human, mass drug administration, health education) and intermediate (pig) hosts (treatment and vaccination), are combined; and a lower-input control study arm (CI), which will use a single control option targeting only the porcine host (treatment).

Teams of suitably qualified and trained human and veterinary medical staff will go from door-to-door to each household in the study communities.

Procedures will include collection of both qualitative and quantitative data from human participants and pigs; subject-related interventions in both human participants and pigs; and laboratory analysis of collected samples.

For the baseline surveys, one randomly-selected consenting adult member and one randomly-selected assenting (and parental consent) child member (above 5 years) from each household will be sampled (serum: diagnosis of human cysticercosis; and stool: diagnosis of taeniasis), whereas for all subsequent surveys in the elimination arm (see protocol for specific time points), all eligible consenting members of the elimination communities will be invited to participate (stool samples: diagnosis of taeniasis). All eligible consenting members from the control arm will be included at the final study sampling (stool: diagnosis of taeniasis and serum: diagnosis of cysticercosis). It is expected that all age, sex and socioeconomic groups will be equally represented.

For the socio-economic questionnaires, 50% of the households will be randomly selected and the head of the household addressed.

The school based questionnaire will be administered to grade 5-6 children attending school in each of the study communities.

For the perception questionnaires: here also 50% of the households will be targeted (random selection), until data saturation has been reached.

For the focus group discussions (FGD): 6 FGD (3 with each time 10 men, 3 with each time 10 women) will be conducted in the elimination study arm, 12 in the control study arm (6 iterations involving 10 men and 6 iterations involving 10 women), at defined time points (table 1), until data saturation has been reached.

Inclusion criteria

• Willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, and taking oral anthelmintic tablets (the latter specific for the elimination arm)
• Willing and able to provide informed consent (signature or thumb print with impartial witness; assent for minors with parental consent).
• Living in, attending school in, or regularly visiting the bore holes present in, the study communities
• Aged five years of age or older
• People without epilepsy

Exclusion criteria

• Unwilling or unable to participate in some or all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, or taking oral anthelmintic tablets (the latter specific for the elimination arm)

• Unwilling or unable to provide written (signature or thumb print with impartial witness) informed consent (or assent for minors)
• Living outside of, and not regularly visiting, or attending school in, the study communities
• Children aged four years or younger
• People with epilepsy (identified cases by the Rural Health Centre, questions included in the registration procedure)
• Seriously ill individuals (people unable to engage in the normal activities of daily living without assistance because of their illnesses)