Setting: Hawassa, Southern Region of Ethiopia.
Objectives: To determine compliance to isoniazid (INH) preventive therapy (IPT) and its effectiveness in preventing (TB) disease in children in contact with adults with pulmonary TB (PTB).
Design: This was a prospective cohort study of children <15 years old in contact with adults with smear-positive PTB. Asymptomatic children ≤5 years were provided IPT independently of their Tuberculin Skin Test (TST) status and children >5 years old were given advice but did not receive IPT, as recommended by the National TB control programme. Compliance to IPT and incidence of clinical TB were determined monthly for six months and then quarterly for up to 30 months.
Results: One hundred and eighty four children in contact with 83 smear-positive PTB cases were identified. Eighty two were ≤5 and 102>5 years old. Only 27 (33%) of 82 children given IPT took it for >4 months and 10 (12%) completed the 6-month course. The main reason for non-compliance was the perception that drugs were not necessary when the child was healthy. Eleven children (all except one >5 years old) developed symptoms of TB disease and initiated treatment, resulting in an incidence of 28.6 cases for all and 53.5 for children >5 years old per 1000 children-year.
Conclusion: Compliance to IPT in children is poor in Southern Region of Ethiopia and this was associated with the parents' perception of the low importance of chemoprophylaxis in asymptomatic children. Poor compliance might be an important barrier for the wider implementation of IPT.
Trial registration: Clinicaltrials.gov NCT00456469.